ANNEXURE I TERMS OF REFERENCE -...
Transcript of ANNEXURE I TERMS OF REFERENCE -...
M/s. PRANSHAV HEALTH CARE, JHAGADIA, BHARUCH
Jyoti Om Chemical Research Centre Pvt. Ltd.
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ANNEXURE I
TERMS OF REFERENCE
• Site description and plant lay out.
• List of raw materials and consumption quantity.
• List of finished products and production quantity.
• Manufacturing process details with mass balance.
• Details of flue gas emission, process emissions, waste water discharge & solid
wastegeneration and disposal.
• Complete water balance.
• Details of Effluent Treatment plant.
• Details of air pollution control systems.
• One season base line data of soil, water, air and noise for study area.
• Environment impact assessment due to excavation and constructionactivities,
manufacturing process and its operations etc.
• Details of Environmental Management Plan (EMP) and mitigationmeasures.
• Occupational health and safety program for the project.
• TOR prescribed by MoEF for this sector will be taken in to account.
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ANNEXURE II
LIST OF PARTNERS
Name of Partners Address
1. Mr. Jignesh Sureshbhai Patel 2, Sukhshanti Society-2, Near Gattuchowkdi,
GIDC, Ankleshwar-393002
Mob. No.- 9824206088
2. Mr. Ankit Sureshbhai Patel 2, Sukhshanti Society-2, Near Gattuchowkdi,
GIDC, Ankleshwar-393002
Mob. No.- 9824140088
3. Mrs. Manjulaben Sureshbhai
Patel
2, Sukhshanti Society-2, Near Gattuchowkdi,
GIDC, Ankleshwar-393002
Mob. No.- 9824140088
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ANNEXURE III A
SITE PLAN
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ANNEXURE III B
PLANT LAYOUT
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ANNEXURE IV
LIST OF EXISTING PRODUCTS (As per CTE No. 70101)
Sr. No. Product Name Quantity (MT/M)
1 Potassium Chloride 500
(either individual of total 7
product)
2 Potassium fluoride
3 Potassium Bromide
4 Potassium sulphate
5 Calcium sulphate
6 Magnesium sulphate
7 Sodium Bromide
8 Manganese Sulphate 27% solution 50
LIST OF PROPOSED PRODUCTS
Sr. No. Product Name Quantity
(MT/M)
Group A Individual Product
1 Atorvastatin calcium 20.00
2 CH base (Product) 50.00
3 Pentaprazol Sodium 30.00
4 Tertiary Butyl Hydroquinon 40.00
Group B Pharmaceutical Drug 20
PROTON PUMP INHIBITOR (REDUCTION OF
GASTRIC ACID/ ANTACID)
5 Esomeprazole Magnesium Dihydrate
6 Dexlansoprazole
OCULAR CARBONIC ANHYDRASE INHIBITOR(FOR
OPEN ANGLE GLAUCOMA
7 Brinzolamide
8 Dorzolamide HCl
ANTI-DIABETIC DRUGS
9 Canagliflogin
10 Dapagliflozin
11 Vildagliptin
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CHEMOTHERAPEUTIC DRUG
12 Capecitabine
ANTIBIOTIC (3RD
GENERATION CEPHALOSPORIN)
13 Cefsulodine Sodium
ANTICOAGULANTS
14 Dabigetran
15 Rivaroxaban
FOR TREATMENT OF PREMATURE EJACULATION
16 Dapoxetine Hydrochloride
FOR TREATMENT OF HIV INFECTION
17 Darunavir
ANTHRAQUINONE (FOR TREATMENT OF
OSTEOARTHRITIS)
18 Diacerein
ANTI-HYPERTENSIVE DRUGS
19 Irbesartan
20 Telmisartan
21 Cilnipine
22 NEBIVOLOL HCL
LEUKOTRIENE ANTAGONIST (FOR TREATMENT
OF BRONCHIAL ASTHMA)
23 Montelukast Sodium
ANTI-FUNGAL DRUGS
24 Posaconazole
ATYPICAL ANTI-PSYCHOTIC (FOR TREATMENT
OF SCHIZOPHRENIA)
25 Quetiapine Hemifumarate
PREVENT OSTEOPOROSIS
26 Risedronate Sodium
ANTIDEPRESSANT DRUGS
27 Vilazodone HCl
28 Agomealtine
ANTI-PSYCHOTIC DRUG
29 Levosulpiride
FOR TREATMENT OF BENIGN PROSTATIC
HYPERPLASIA
30 Tamsulosin HCl
ANTI-EPILEPTIC DRUGS
31 Carbamazepine
32 Levetiracetam
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ANTIMUSCARINIC DRUG (FOR TREATMENT OF
OVERACTIVE BLADDER SYNDROME)
33 Fesoterodine
HYPERTENSION
34 Bosentan Monohydrate
FOR TREATMENT OF GOUT
35 Febuxostat
Group C Paraben 50
36 Methyl Paraben
37 Ethyl Paraben
38 Propyl Paraben
39 Butyl Paraben
40 Iso Propyl Paraben
Group d Intermediate 40
41 4- Amino Pyridine
42 Dimethyl Ameno Propiophenone
43 Guaicol
45 Veratrole
46 Diethyl Ethyl Melonate
47 3,5 Dinitrobenzoic acid
48 P - Hydroxy Aceto Phenone
49 2-Mercaptobenzimidazole
50 Bronopol (BP)
51 2 Mercapto 5 Methoxy Benzimimidazone
52 3,5 Dibenzyloxy Acetophenone
53 1(2,3 Dichloro Phenyl) Piperazine
54 1h,1,2,4 Triazole
55 Acebrophylline
56 Lasamide
57 Methyl Nicotinate
58 Fingolimod HCL
59 Cetyl Pyridinium Chloride
60 Ambroxol Hydrochloride
61 1 (2,4 Dichloro Phynyl) 2 (1- Imidazoleylethanol
62 Furoic Acid
Group E Fine Chemicals 200
63 Methyl Acetate
64 Ethyl Acetate
Total 450
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TABLE: 1
LIST OF BY-PRODUCTS
Sr. No. Product Name Quantity (MT/M)
1 Acetic acid 2.56
2 Sodium L (+) Mandelate 9.429
3 Propanoic acid 14.76
4 Trityl chloride 13.014
5 Methane Sulfonic acid 3.156
6 Potassium Bromide 8.139
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ANNEXURE V
EXISTING PRODUCT’S RAW MATERIAL CONSUMPTION QUANTITY (As
per CTE No. 70101)
Sr.
No.
Product Quantity
(MT/MT)
Raw Material Quantity
(MT/MT)
1 Potassium Chloride 500
(either
individual
of total 7
product)
Potassium hydroxide 662.50
Hydrochloric Acid 759.50
Total 1422.00
2 Potassium fluoride Potassium hydroxide 867.50
Hydrofloric Acid 352.00
Total 1219.50
3 Potassium Bromide Potassium hydroxide 420.50
Hydrobromic Acid 709.50
Total 1130.00
4 Potassium sulphate Potassium hydroxide 575.00
Sulphuric Acid 402.00
Total 977.00
5 Calcium sulphate Calcium carbonate 367.50
Sulphuric Acid 519.50
Total 887.00
6 Magnesium
sulphate
Magnesium oxide 166.50
Sulphuric Acid 817.00
Total 983.50
7 Sodium Bromide Sodium hydroxide 396.00
Hydrobromic Acid 818.50
Total 1214.50
8 Manganese Sulphate
27% solution
50 Manganese oxide 4.30
Sulphuric Acid 46.35
Total 50.65
PROPOSED PRODUCT’S RAW MATERIAL CONSUMPTION QUANTITY
Sr.
No.
Product Quantity
(MT/MT)
Raw Material Quantity
(MT/MT)
1 Atorvastatin
calcium
20 1,1-Dimethyl Ethyl -6-(2-
Aminoethyl) 15.39
4-Fluoro -2-Methyl-1-
Oxopropyl 23.52
Cyclohexane 60.00
Iso Propyl Alcohol(IPA) 50.01
Hydrochloric Acid 1.40
Acetonitrile 70.00
Sodium Hydroxide 2.92
Calcium Acetate 3.58
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Hyflow 0.24
TOTAL 227.06
2 CH Base 50 Hexa Methyl Di Amine 337.00
Sodium Di Cynamide 517.00
N Butanol 1008.00
Water 965.00
Tri Ethyl Amine 25.00
Sodium Hydroxide Flakes 150.00
Pca Hcl 925.00
Methanol 15.00
TOTAL 3942.00
3 Pentaprazol Sodium
30 2-Chloro 2,3 Dimethoxy
Pyridine 34.69
5-Dithiomethoxymenzimidazole 33.28
NaOH 191.63
Methenol 192.66
DCM 1245.00
TEBA 0.52
Sodium Hypochlorite 147.19
Sodium Thiosulphate Soln. 61.88
MDC 147.19
Acetic Acid 28.59
IPE 486.09
Ethyl Acetate 301.41
Charcoal 0.94
TOTAL 2871.05
4 Tertiary Butyl
Hydroquinone
40 Phosphoric Acid 2.40
Toluene 2.00
Hydroquinone 27.20
Tertiary Butanol (TBA) 18.40
TOTAL 50.00
5 Brinzolamide
4(S)-4-hydroxy-6-sulfonamide
dioxide 52.20
Methane sulfonic anhydride 12.00
Ethyl amine 6.60
Aq.Ammonia 3.99
Con.HCl 2.01
Sodium hydroxide 2.19
Pyridine 3.99
Tetra Hydrofuran(THF) 201.00
Isopropyl alcohol(IPA) 219.00
Sodium bicarbonate 2.01
Carbon 2.01
Hyflow 2.01
TOTAL 509.00
6 Canagliflogin
2-(5-bromo-2-methyl benzul)-5-
(4-flurophenyl)thiophene 42.47
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Silyl D-gloconolactone 55.40
Methanol 333.33
Acetone 500.00
Potassium carbonate 6.67
TOTAL 937.86
7 Capecitabine
2,3-Di-O-Acetyl-5-Deoxy-5-
Fluorocytidine 24.94
n-Pentyl Chloroformate 11.40
Sodium Hydroxide 8.30
Sodium Bicarbonate 1.00
Hydrochloric acid 1.46
Methylene Chloride(MDC) 80.00
Methanol 50.00
Ethyl Acetate 110.00
Activated Carbon 1.00
TOTAL 288.10
8 Cefsulodine Sodium
RS-A-Sulfophenyl Acetic Acid 10.29
(S) –A- Methyl Benzyl Amine 5.77
Acetonitrile 123.00
1-Hydroxy Benzotriazole 6.17
Methane Sulphonyl Chloride 5.23
Sodium Bicarbonate 1.00
Methylene Dichloride(MDC) 102.50
Hexane 194.50
Sodium Hydroxide 2.26
7-Amino Cephalosporic Acid 11.96
Boron Trifluride Etherate 37.50
Tert-Butyl Acetate 5.10
Sodium Carbonate 1.00
Hyflow 1.50
Zinc Chloride 0.50
Triethyl Amine 0.50
Ethyl Acetate 20.50
Di Isopropyl Ether(Diipe) 10.00
Pyridine-4-Carboxamide 4.83
Sodium Iodide 4.00
Dimethyl Formamine 5.52
Ethanol 5.00
Sodium Acetate 3.10
Hydrochloride 0.50
Carbon 10.00
TOTAL 613.53
9 Dabigetran
3-[(1-Methyl-2-{[4-(5-oxo-4,5-
dihydro-[1,2,4]oxadiazol-3-yl)-
phenylamino]-methyl)-
1Hbenzoimidazole-5-carbonyl)-
pyridin-2-yl amino]- 19.40
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propionic acidethyl ester
P-toluene sulphonic acid 5.00
Acetic acid 4.00
Ethanol 500.00
Hexa chlorofomate 5.60
Acetone 240.00
Potassium Hydroxide 1.92
Hydrochloric acid 0.08
TOTAL 776.00
10 Dapoxetine
Hydrochloride
�-(Dimethylamino)
Benzenepropanol 21.25
1-Fluoronaphthalene 17.30
Sodium Hydroxide 7.15
Hydrochloric Acid 6.50
Dimethyl Sulfoxide(DMSO) 250.00
n-Propanol 200.00
Activated carbon 5.00
TOTAL 508.20
11 Darunavir
(3R,3as,4ar)-
Hexahydrofuro[2,3-B]Furan-3-
Ol 9.51
4-Amino-N-(2R,3S)(3-Amino-
2-Hydroxy-4-Phenyl-Butyl)-N-
Isobutyl Benzenesulfonamide 28.59
Disucinimidyl Carbonate 18.72
Sulphuric Acid 0.20
2-Methyl2-Butanol 1.20
Methylene Chloride(MDC) 60.00
Cyclohexane 48.00
Sodium Bicarbonate 0.40
Sodium Chloride 0.20
Sodium Sulphate 0.20
Sodium Hydroxide 0.17
Activated Carbon 0.40
Total 167.57
12 Dexlansoprazole
2-[3-Methyl-4-(2,2,2-Trifluoro-
Ethoxy)-Pyridin-2-
Ylmethanesulfinyl]-1H-
Benzoimidazole
29.41
L (+) Mandelic Acid 12.12
Sodium Bicarbonate 8.44
Diethyl Tartarate 20.00
Titanium Isopropoxide 6.00
Triethyl Amine 4.00
Acetone 120.00
Dichloromethane(MDC) 80.40
Hydrochloric Acid 1.98
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TOTAL 282.35
13 Diacerein
Aloe Emodine 39.32
Sodium Dichromate Dihydrate 43.36
Sulphuric Acid 18.28
Sodium Hydroxide 12.04
Tetrahydrofuran(THF) 800.00
Acetone 220.00
Propionic Anhydride 35.20
Conc.HCl 7.28
Toluene 44.00
Acetic Anhydride 20.36
N-Methyl Pyrrolidone 69.97
Methanol 44.00
Activated Carbon 4.00
Celite 4.00
Total 1361.82
14 Dorzolamide HCl
(±)-Trans-5,6-Dihydro-4H-4-
Ethyl Amino-6-
Methylthieno[2,3-B]Thiopyran-
2-Sulfonamide-7,7-Dioxide
59.80
Hydrochloric Acid 6.72
N-Butanol 464.00
Methanol 604.00
Ethyl Acetate 296.00
Acetone 16.00
(-)Di-Para-Toluoyl-Ltartaric
Acid Monohydrate
20.00
Activated Carbon 6.00
Sodium Bicarbonate 30.00
Sodium Chloride 30.00
Sodium Hydroxide 5.16
Total 1537.68
15 Dapagliflozin
Intermediate-I 17.40
Intermediate-II 24.93
N-Butyl Lithium In THF 4.73
Toluene 86.67
Acetonitrile 33.33
Methylene Dichloride(MDC) 86.67
Triethyl Tin Hydride 0.33
Trifluro Borate-Etharate 0.67
Total 254.73
16 Esomeprazole
Magnesium
5-Methoxy-2-[[(4-methoxy-3,5-
dimethylpyridin-2-
yl)methyl]thio]-1H-
benzimidazole 48.06
Hydrogen Peroxide 4.97
Vanadium acetyl acetonate 0.14
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Sodium hydroxide 2.94
Acetone 224.00
Methanol 90.00
Acetic acid 1.20
Ammonia liquor 0.60
Magnesium Chloride 4.70
Methylenechloride(MDC) 160.00
Toluene 100.00
(S)-(-)-1,1-Bi-2-Naphthol 0.40
TOTAL 637.01
17 Irbesartan
2-Butyl-1,3-
Diazaspiro[4,4]Non-1-Ene-4-
One Hydrochloride 23.17
5-[4'-(Bromomethyl) Biphenyl-
2-Yl]-1-Trityl-1Htetrazole 55.99
Methanolic HCl 6.89
Ethylacetate 100.00
Methanol 133.33
Toluene 100.00
Methylene Methylene 113.33
Isopropanol(IPA) 120.00
Acetone 100.00
30% Sodiumhydroxide Lye 26.07
Sulfuric Acid 5.00
Activated Carbon 0.67
Total 784.43
18 Montelukast
Sodium
2-[2-[3(S)-[3-[2-(7-Chloro-2-
Quinolinyl)-Ethenyl]Phenyl]-3-
Hydroxypropyl]Phenyl-2-
Propanol
26.53
2-[1-(Sulfonyl
Methyl)Cyclopropyl]Acetic
Acid
8.46
Methane Sulfonyl Chloride 6.63
Sodium Hydroxide 3.63
N,N-Diisopropylethylamine 0.13
Hydrochloric Acid 0.91
Sodium Chloride 0.13
Acetic Acid 0.26
Toluene 20.00
Acetonitrile 17.33
Methanol 26.67
N-Hexane 34.67
Activated Carbon 0.27
Total 145.63
19
Posaconazole
N-{4-[4-(4-Hydroxyphenyl)-
Piperazin-1-Yl]-Phenyl}- 12.06
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Carbamic Acid Phenyl Ester
Formic Acid N'-(2-Benzyloxy-1-
Ethyl-Propyl)-Hydrazide 7.32
(5R-Cis)-5-(2,4-
Difluorophenyl)-5-(1,2,4-
Triazol-1-
Ylmethyl)Tetrahydrofuran-3-
Methanol Tosylate 13.96
Methanol Tosylate 1.24
2,3,4,6,7,8,9,10-Octahydro
Pyrimido[1,2-A]Azepine 1.50
Tetrahydrofuran(THF) 35.00
Formic Acid 50.00
Dimethyl Sulfoxide 90.00
Palladium 1.00
Activated Carbon 1.50
Hydrochloric Acid 0.09
Total 2213.67
20 Quetiapine
Hemifumarate
Dibenzo-(1,4)-Thiazepine-
11(10H)-One 31.48
2-(2-(Piperazin-1-
Yl)Ethoxy)Ethanol 24.13
Fumaric Acid 8.04
Thionyl Chloride 1.00
Hydrochloric Acid 0.46
Sodium Hydroxide 0.50
Sodium Carbonate 6.00
Toluene 140.00
Ethanol 170.00
Activated Carbon 1.00
Total 382.61
21 Risedronate Sodium
3- Pyridyl Acetic Acid 22.27
3- Pyridyl Acetic Acid 26.64
Diethyl Carbonate 15.00
Caustic Soda Lye 1.00
Sodium Hydroxide Flakes 6.17
Phosphorous Trichloride 0.50
Methane Sulfonic Acid 10.00
Isopropyl Alcohol 116.00
Hydrochloric Acid 4.40
Hyflow 1.00
Activated Carbon 1.00
Total 203.98
22 Telmisartan
1H-Benzimidazole-2npropyl-4-
Methyl-6-(1-Methyl
Benzimidazole-2yl] 23.13
4-Methyl-(Bromomethyl) Bi 23.18
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Phenyl Carboxylate
Potassium Hydroxide 4.26
Methyl Iso Butyl Ketone
(MIBK) 83.20
Hydrochloric Acid 0.68
Sodium Hydroxide 0.44
Acetic Acid 29.87
Methanol 60.93
Charcoal Activated Carbon 0.27
Total 225.95
23 Vilazodone HCl
5-{4-[4-(5-Cyano-1H-Indol-3-
Yl)-Butyl]-Piperazin-1-Yl}-
Benzofuran-2-Carboxylicacid
Methyl Ester 48.20
Ammonia 1.04
Methanol 522.00
Hydrochloric Acid 2.20
Sodium Hydroxide 30% 2.44
Isopopyl Alcohol(IPA) 240.00
Activated Carbon 4.00
Total 819.87
24 Levosulpiride
Mono Ethylene Glycol 20.00
2-Methoxy-5-Sulphomyl Methyl
Benzoate 15.00
S-1-Ethyl-5-Aminomethyl
Pyrollidine 7.80
Total 42.80
25
Cilnidipine
Toluene 20.00
2-Methoxy-Ethyl-(3-Nitro
Benzylidine)Acetoacetate 14.00
3-Amino Crotonic Acid
Cinnamyl Ester 10.00
Total 44.00
26 NEBIVOLOL HCL
Benzo Pyran Acetaldehyde 166.67
Benzo Pyran Ethelamine 55.56
Sodium Cyano Borohydried 19.44
THF 3611.11
Methenol 1944.44
Sodium bicarbonate 561.11
Ethyl Acetate 1111.11
6N HCl 277.78
2N HCl 111.94
diethyl Ether 111.11
TOTAL 7970.27
27 Tamsulosin HCl Dimethylformamide 206.86
Ethoxy Phenoxy Ethyl Bromide 21.90
(R)-(-)[2-Aminopropyl]-2- 32.95
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Methoxy Benzene Sulfonamide
Methylene Chloride 1366.86
Ammonia Liquor 100.95
Isopropyl Alcohol 978.29
Isopropyl Alcohol (Wash) 495.81
IPA 43.81
HCl 43.81
Water+IPA (7+12.5) (wash) 111.42
IPA 26.67
IPA+HCl (14+13.6) 25.90
Activated carbon 1.14
TOTAL 3456.38
28 Carbamazepine Methanol 20.28
Iminostilbenecarbonyl Chloride 25.64
Ammonia Liquor 56.15
Toluene 0.80
NaOH 0.57
Acetone 101.30
Hyflo 0.25
Activated carbon 0.24
Acetone (wash) 28.78
Total 234.03
29 FESOTERODINE Benzyl Amine DPTT 109.08
Sodium Carbonate 114.52
Cerric Ammonium Nitrate 250.88
NaBH4 15.48
Fumic Acid 29.54
Hydrogen Gas 0.26
Isobutyryl Chloride 6.80
Triethylamine 6.02
TOTAL 532.58
30 Bosentan
Monohydrate
4,6‐Dichloro‐5‐(2‐Methoxyphen
oxy)‐2,2‐Bipysimidine 14.52
4‐Tert‐Butylbenzene
Sulfonamide 8.86
Hydrochloric Acid 3.58
Potassium Carbonate 24.12
Sodium Tert Butoxide 19.96
Ethylene Glycol 246.78
TOTAL 317.82
31 VILDAGLIPTIN
DMF 108.00
KSM-II 14.40
KSM-I 15.40
Pottasium Carbonate 62.20
Isopropyl Acetate 100.80
Dichromomethane 425.00
Potassium Hydrogen Sulfate 75.00
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NaCl 13.40
Charcoal 1.00
Acetone 264.60
Total 1079.80
32 RIVAROXABAN
(4‐4‐Aminophenyl)‐Morpholin‐3
‐One 28.22
Glycidyl Phthalimide 32.74
4‐Dimethylaminopyridine(DMA
P) 0.14
Cdi 80.68
5‐Chlorothiophene‐2‐Cacoxylic
Acid 24.60
Sodium Acetate 29.60
Oxalyl Chloride 29.90
Aq. Methyl Amine 32.54
Hydrochloric Acid 13.54
Total 271.96
33 FEBUXOSTAT
Ksm 30.94
Isobutyl Bromide 23.24
Potassium Carbonate 36.68
Ammonium Hydroxide. Hcl 6.46
Sodium Carbonate 6.28
Sodium Hydroxide 5.94
Hydrochloric Acid 5.78
Acetone 15.00
Total 130.32
34 AGOMEALTINE
2‐(7‐Methoxy‐1‐Napthyl)Aceton
itrile/ Agomelatine 22.47
Hydrogen Gas 0.45
Isopropyl Alcohal HCl 16.63
Sodium Acetate Anhydrous 9.44
Acetic Anhydrous 11.46
TOTAL 60.45
35 Levetiracetam
DCM 775.00
Sodium Sulphate 57.60
TBAB 1.20
S(+)-2 amino butyramide
hydrochloride 23.00
4-Chloro Butyryl Chloride 28.80
KOH 51.60
Activated Charcoal 5.20
Hyflo 60.00
Ethyl Acetate 323.20
Acetic Acid 14.00
TOTAL 1339.60
36 Methyl Paraben
50 PHBA 50.00
Methanol 14.53
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37 Propyl Paraben
38 Ethyl paraben
39 Butyl Paraben
40 Iso Propyl Paraben
41 4- Amino Pyridine
42 Dimethyl Ameno
Propiophenone
43 Guaicol
44 Veratrole
45 Diethyl Ethyl
Melonate
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Sodium Bi Carb Soln (5%)
TOTAL
PHBA
Propanol
Sodium Bi Carb Soln (5%)
TOTAL
PHBA
Ethanol
Sodium Bicarb Soln (5%)
TOTAL
PHBA
Butanol
Sodium Bicarb Soln (5%)
TOTAL
PHBA
Iso Propanol
Sodium Bicarb Soln (5%)
TOTAL
40 NaOH
Bromine
ISO Nicotinamide
Methanol
Total
Fresh IPA
Recovered IPA
Paraformaldehyde
DMA Hcl
Acetophenone
TOTAL
Sodium carbonate
Fresh Toluene
Recovered Toluene
Catechol
DMS
HCl
TOTAL
NaOH
Fresh Toluene
Recovered Toluene
Catechol
DMS
HCl
TOTAL
Fresh Alcohol
Recovered Alcohol
Sodium
DEM
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27.78
92.31
39.37
19.13
8.66
67.17
44.12
35.29
6.47
85.88
37.50
30.00
5.50
73.00
50.00
40.00
11.00
101.00
148.00
140.00
80.00
40.00
408.00
8.00
72.00
36.00
48.00
48.00
212.00
62.40
12.00
112.00
54.80
60.00
100.00
401.20
74.00
6.00
56.00
48.00
80.00
100.00
364.00
10.00
190.00
24.00
80.00
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Ethylchloride 96.00
Fresh Toluene 6.00
Recovered Toluene 74.00
TOTAL 480.00
46 3,5 Dinitrobenzoic
Acid
Sulphuric Acid 45.00
Benzoic Acid 24.00
Nitric Acid 135.00
Caustic lye solution 21.00
Total 225.00
47 P Hydroxy
Acetophenone
Anisol 100.00
Aluminium Chloride 0.56
Acetyl Chloride 80.00
Dichloro Methane + Methyl
Chloride 4.00
Recovered Dichloro Methane +
Methyl Chloride 50.00
TOTAL 234.56
48 Cetylpyridinium
Chloride
Cetyl Chloride 30.68
Fresh Pyridine 1.80
Recovered pyridine 16.76
Fresh Methyl ethyl ketone 12.00
Recovered methyl ethyl ketone 148.00
Fresh Acetone 8.00
Recovered Acetone 72.00
TOTAL 289.24
49 Lauryl Pyridinium
Chloride
Lauryl Chloride 28.88
Fresh Pyridine 2.40
Recovered Pyridine 20.00
Fresh Methyl Ethyl Ketone 16.00
Recovered Methyl Ethyl Ketone 144.00
Fresh Acetone 8.00
Recovered Acetone 72.00
TOTAL 291.28
50 Ambroxol
Hydrochloride
Ambraxol Base 36.48
Recovered IPA 380.00
Carbon 0.60
HCl 12.00
IPA washing 20.00
TOTAL 449.08
51 ACEBROPHYLLI
NE
Acefilline 16.00
Ambroxol Base 18.40
Carbon 0.60
DMF washing 20.00
Recovered DMF 380.00
TOTAL 435.00
52 3,5 Dibenzyloxy
Acetophenone
Anisol 28.80
3,5 Dribromo Acetophenone 36.00
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Fresh Toluene 2.00
Recovered Toluene 16.00
Sulphuric Acid 0.04
TOTAL 82.84
53 Methyl Nicotinate Nicotonic acid 56.00
Methanol 102.84
Sulphuric acid 42.00
Liquor Ammonia 28.00
Fresh Benzene 4.80
Recovered Benzene 45.20
Total 278.84
54 Furoic Acid Caustic soda 160.00
Chlorine gas 100.00
Furfuraldehyde 120.00
HCl 92.00
Total 472.00
55 1 (2,3 Di chloro
Phenyl) Piperazine
Bydroghloride
2,3 Dichloro Aniline 78.80
Recovered 2,3 Dichloro Aniline 24.00
Fresh orthoxylene 4.00
Bis Salt 75.20
Caustic soda lye 30.00
Caustic soda lye 30.00
Fresh toluene 4.00
Recovered toluene 36.00
Fresh Acetone 4.00
Recovered Acetone 56.00
HCl 68.80
TOTAL 410.80
56 1 H 1,2, 4 Triazole Formamide 75.00
Fresh Toluene 3.00
Recovered Toluene 27.00
Hydrazine Hydrate 37.50
Fresh IPA 6.00
Recovered IPA 54.00
Total 202.50
57 LASAMIDE Dichloro Benzoic acid 62.40
Chloro Sulphonic acid 320.00
Carbon 0.60
Liquor Ammonia 160.00
HCl 220.00
Total 763.00
58 1 (2,4 Di Chloro
Phenyl) -2 (1
Imidozolyl) Ethanol
Meta Di Chloro benzene 40.00
Aluminium Chloride 48.00
Fresh Hexane 17.20
Recovered Hexane 154.80
Chloro Acetyl Chloride 40.00
Caystic Lye 28.00
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Soda Ash 44.00
Imidazole 28.00
Fresh Toluene 10.00
Recovered Toluene 140.00
Sodium borohydrate 12.00
TOTAL 562.00
59 Fingolimod HCL Methylene chloride 611.12
Octylbenzene 22.35
Aluminium chloride 17.21
Bromoacetyl bromide 25.92
NaHCO3+water 262.62
Sodium sulphate 29.37
Methylene chloride (wash) 183.54
Acetone 246.96
Diethylacetamido malonate 43.86
Potassium carbonate 28.10
Acetone (wash) 100.06
Hexane 1794.38
Hexane (wash) 1158.14
Molecular sieve pellet 9.58
MDC 63.91
Triethylsilane 46.70
MDC 126.26
TiCCl4 47.82
Ethyl acetate 525.84
Ethyl acetate (wash) 1428.52
Silica gel 112.83
TOTAL 6885.10
60 2-
MERCAPTOBENZ
IMIDAZOLE
ODPA 30.40
Carbon Disulfide 28.00
Sodium sulphide 2.24
Sodium Hydroxide(47%) 77.60
TOTAL 138.24
61 Bronopol (BP)
Nitro Methane 66.67
Methanol 13.33
Caustic 66.67
Formaldehyde 9.33
Carbon 29.33
Bromine 0.67
TOTAL 35.33
62 2 Mercapto 5
Methoxy
Benzimimidazone
4-Methyl 2-Nitro Anisidine 40.00
Sodium hydro Sulfide 146.40
Carbon disulfide 30.40
Caustic 3.20
Carbon 1.60
Sulfuric acid 0.80
TOTAL 222.40
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63 Methyl Acetate
200
Methanol 86.00
Acitic acid 162.00
TOTAL 248.00
64 Ethyl Acetate
Methanol 104.60
Acitic acid 136.40
TOTAL 241.00
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ANNEXURE VI
BREIF MANUFACTURING PROCESS :
Existing Product:
SODIUM BROMIDE
BRIF PROCESS
First take diluted hydrobromic acid in reactor. Then slowly add sodium hydroxide
solution. When additions completed, and then transfer material in other vessels for
vaporization of water from product. When formation of crystal is started then transfer
mass in crystallizer. Most of material comes in crystal from then centrifuge, drying
and pack material in bags. ML come out from centrifuge will be reused in evaporation
in next batch. Evaporate water will be use in Boiler or Cooling or Solution preparation
or garden.
REACTION
NaOH + HBr NaBr + H2O
40 81 103 18
Flow Diagram:
POTASSIUM BROMIDE
BRIF PROCESS
First take diluted hydrobromic acid in reactor. Then slowly add Potassium hydroxide
solution. When additions completed, and then transfer material in other vessels for
vaporization of water from product. When formation of crystal is started then transfer
mass in crystallizer. Most of material comes in crystal from then centrifuge, drying
Reaction Vessel
Evaporation & Crystallizers
Drying & Packing
NaOH/CaO
Bromin
NaBr
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and pack material in bags ML come out from centrifuge will be reused in evaporator
in next batch. Evaporate water will be use in Boiler or Cooling or Solution preparation
or garden.
REACTION
KOH + HBr KBr + H2O
56 81 119 18
Flow Diagram:
POTASSIUM SULPHATE
BRIF PROCESS
First take diluted Sulphuric Acid in reactor. Then slowly add potassium hydroxide
solution. When addition completed transfer material in other vessels for vaporization
of water from product. When formation of crystal is started then transfer mass in
crystallizer. Most of material comes in crystal form then centrifuge, drying and pack
material in bags. ML come out from centrifuge will be reused in evaporator in next
batch. Evaporate water will be use in Boiler or Cooling or Solution preparation or
garden.
REACTION
2KOH + H2SO4 K2SO4 + 2H2O
112 98 174 36
Flow Diagram:
Reaction Vessel
Evaporation & Crystallizers
Drying & Packing
NaOH/CaO
Bromin
KBr
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MAGNESIUM SULPHATE
BRIF PROCESS
First take diluted Sulphuric Acid in reactor. Then slowly add Magnesium Oxide.
When addition completed transfer material in other vessels for vaporization of water
from product. When formation of crystal is started then transfer mass in crystallizer.
Most of material comes in crystal form then centrifuge, drying and pack material in
bags. ML come out from centrifuge will be reused in evaporator in next batch.
Evaporate water will be use in Boiler or Cooling or Solution preparation or garden.
REACTION
MgO + H2SO4 MgSO4 + H2O
40 98 120 18
Flow Diagram:
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POTASSIUM FLUORIDE
BRIF PROCESS
First take diluted Hydrofluoric Acid in reactor. Then slowly add potassium hydroxide
solution. When addition completed transfer material in other vessels for vaporization
of water from product. When formation of crystal is started then transfer mass in
crystallizer. Most of material comes in crystal form then centrifuge, drying and pack
material in bags. ML come out from centrifuge will be reused in evaporator in next
batch. Evaporate water will be use in Boiler or Cooling or Solution preparation or
garden.
REACTION
KOH + HF KF + H2O
56 20 58 18
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Flow Diagram:
MAGNESIUM SULPHATE
BRIF PROCESS
Diluted Sulphuric Acid is taken in MSRL Vessel. Then manganese oxide powder
(MnO) is added to the mixture with stirring. The reaction takes place and MnO
dissolves in the solution. Remove inorganic impurities by filtration. Solid will be sent
to TSDF site. Transfer material in other vessels for vaporization of water from
product. When formation of crystal is started then transfer mass in crystallizer. Most
of material comes in crystal form then centrifuge, drying and pack material in bags.
ML come out from centrifuge will be reused in evaporator in next batch. Evaporate
water will be use in Boiler or Cooling or Solution preparation or garden.
REACTION
MnO + H2SO4 MnSO4 + H2O
71 98 151 18
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Flow diagram
CALCIUM SULPHATE
BRIF PROCESS
Lime stone treated with sulphuric acid in an acid resistant MS tank. It takes about 8-
10 Hrs. for reaction to complete. Transfer material in other vessels for vaporization of
water from product. Then transfer reaction mass in centrifuge, drying and pack
material in bags. ML come out from centrifuge will be reused in evaporator in next
batch. Evaporate water will be use in Boiler or Cooling or Solution preparation or
garden.
REACTION
CaCo3 + H2SO4 CaSO4 + H2O + CO2
100 98 136 18 44
Flow diagram
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Proposed Product:
1.Atorvastatin Calcuim
Manufacturing Process :
Stage I:
2-(2-(4-fluorophenyl)-2-oxo-1-phenylethyl)-4-methyl-3-oxo-N-phenylpentanamide
reacts with tert-butyl 2-((4R,6R)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-
yl)acetate in presence of pivalic aicd. cyclohexane and Isopropylalcohol gives tert-
butyl2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-
1H-pyrrol-1-yl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate.
Stage II:
Tert-butyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4
(phenylcarbamoyl)-1H-pyrrol-1-yl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate reacts with
water in presence of Acetonitrile, Hydrochloric acid and Sodium carbonate gives
(3R,5R)-tert butyl 7-(2-(4- fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl)-
1H- pyrrol-1-yl)-3,5- dihydroxy heptanoate.
Stage III:
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(3R,5R)-tert butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-
1Hpyrrol-1-yl)-3,5-dihydroxyheptanoate reacts with water and calcium acetate in
presence of Acetonitrile, Ethyl acetate and sodium hydroxide gives mono calcium
mono (3R,5R)-7-(2-(4-Fluorophenyl)-5-isopropyl-3-phenyl-4--(phenylcarbamoyl)-
1H-pyrrol-1-yl)-3,5-dihydroxy heptanoate). The process flow diagram for
Atorvastatin Calcuim is presented and flow diagram is presented below.
Chemical Reaction:
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Flow diagram:
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Brinzolomide
Manufacturing Process :
Stage I:
4(S)-4-hydroxy-6-sulfonamide dioxide react with Methane sulfonic anhydride and
ethyl
amine in the presence of aq. ammonia and IPA media at 50 degrees and compound
isolating
with adjusting the mass PH with HCl in the presence o f IPA to give Brinzolamide.
Schematic diagram of Brinzolamide and flow diagram for Brinzolamide is given
below.
Chemical Reaction:
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Flow diagram
Canagliflozin
Manufacturing Process :
2-(5-bromo-2-methyl benzyl)-5-(4-flurophenyl) thiophene react with silyl-D-
gloconolactone in the presence of Methanol media and potassium carbonate catalyst
and compound isolate in Acetone media to give pure Canagliflozin. Schematic
diagram of Canagliflozin and flow diagram for Canagliflozin is presented below.
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Chemical Reaction:
Flow diagram
Capacitabine
Manufacturing Process :
2,3-di-o-acetyl-5-deoxy-5-fluorocytidine is condensed with n-Pentylchloroformate in
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Methylene chloride to give Capecitabine (Pharma). Schematic diagram of
Capecitabine and flow diagram for Capecitabine is presented below.
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Flow diagram
Cefsulodine Sodium
Manufacturing Process :
Stage I:
RS-a- Sulfophenyl acetic acid react with S- Methyl benzyl amine in the presence of
acetonitrile media at room temperature to give complex com stage-I.
Stage II:
1-Hydroxy benzotraizole react with methan sulphonyl chloride in the presence of
sodium
bicarbonate base and MDC media at 50 degrees then mass adjusting the PH with
sodium bi
carbonate and at room temperature and compound isolate in Hexane media to give
stage-II
solid.
Stage III:
7-Amino cephalosporonic acid react with tert-butyl acetate in the presence of boron
trifluoro etharate catalyst and Hexane media at 65 degrees to give stage-III solid.
Stage IV:
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Stage-I react with stage-II and stage-III in the presence of zinc chloride catalyst and
triethyl
amine base in MDC media and compound isolate in Ethyl acetate and hexane and di
isopropyl ether media to give stage-IV solid.
Stage V:
Stage –IV react with dimethyl amine formamine in the presence of pyridine-4-
carboxamide
and sodium iodide catalyst in Ethanol media then compound isolating with using
concentrated hydrochloric acid.
Stage VI:
Stage-V reacts with sodium acetate at 40 degrees and compound isolating ethanol
media to
give Cefsulodin pure compound. The process flow diagram for
and flow diagram is presented below.
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Chemical Reaction:
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Flow diagram:
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Dabigatran
Manufacturing Process :
Stage-I:
The propanoic acid methyl ester derivate of formulae-I is dissolved in ethanol and
acetic
acid, hydrogenated with damp Pd/C at RT at 2 bar hydrogen pressure. After
completion of
the reaction the catalyst is filtered off and dissolved in ethanol was added to filtrate.
To get
formulae-II precipitated out which was filtered off and dried.
Stage-II:
The Tosylate salt obtained in the stage I was dissolved in acetone and the mixture is
combined with hexyl chloroformate in presence of potassium hydroxide at
temperature
15oC. After completion of the reaction the precipitated product is filtered off and
washed
with acetone mixture. The resulting crude is crystallized with water. Schematic
diagram of
Dabigatran and flow diagram for Dabigatran is presented below.
Chemical Reaction:
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Flow diagram:
Dapoxetine Hydrochloride
Manufacturing Process :
�-(dimethylamino) benzenepropanol is reacted with 1-fluoronaphthalene in presence
of sodium hydroxide, followed by treated with hydrochloric acid in dimethyl
sulfoxide to yield Dapoxetine Hydrochloride (Pharma). Schematic diagram of
Dapoxetine and flow diagram for Dapoxetine Hydrochloride is presented below.
Chemical Reaction:
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Flow diagram:
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Darunavir
Manufacturing Process :
Stage-I:
(3aS,4S,6aR)-4-methoxy-terahydrofuro-[3,4-b]furan-2-(3H)one is reacted with
NaBH4 and Hydrochloric acid in presence of tetrahydrofuran to give (3R,3aS,6aR)-
hexahydrofuro[2,3-b]furan-3-ol.
Stage-II:
4-Amino-N-(2R,3S)(3-amino-2-hydroxy-4-phenyl-butyl)-N-isobutyl-
benzenesulfonamide is condensed with (3R,3aS,4aR)-hexahydrofuro[2,3-b]furan-3-ol
in the presence of disucinimidyl carbonate to yield Darunavir (Pharma). Schematic
diagram of Darunavir and flow diagram for Darunavir is presented below.
Chemical Reaction:
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Flow diagram:
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Dexlansoprazole
Manufacturing Process :
2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethanesulfinyl]-1H-
benzoimidazole is treated with (+)Diethyl tartarate, titanium isopropoxide, triethyl
amine and L(+) mandelic acid in presence of acetone to get Dexlansoprazole
mandelate salt, which is on neutralization with sodium bicarbonate in DCM yielded
Dexlansoprazole. Schematic diagram of Dexlansoprazole and flow diagram for is
presented below.
Chemical Reaction:
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Flow diagram
Diacerein
Manufacturing Process :
Aloe emodine is oxidized using chromic acid and tetrahydrofuran as a solvent to give
DCN-I (4,5-bis (Hydroxy)-9,10-dihydro-9, 10-dioxo-2-anthracenecarboxylic acid).
DCN-I is reacted with propionic anhydride in presence of sulfuric acid to get DCN-II
(9, 10- dioxo-4,5-dipropanoyloxyanthracene-2-carboxylic acid).
DCN-II is purified in THF and then hydrolyzed using sodium hydroxide in water to
give DCN-IV (4,5-dihydroxy-9,10-dioxoanthracene-2-carboxylic acid).
DCN-IV is reacted with acetic anhydride in presence of sulfuric acid to get Diacereine
crude and which is first purified with NMP & methanol mixture and then with NMP
& water mixture. Schematic diagram of Diacerein and flow diagram for Diacerein is
presented below.
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Flow diagram
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Dorzolamide HCl
Manufacturing Process :
Stage-I: (±)-Trans-5,6-dihydro-4H-4-Ethyl amino-6-methylthieno[2,3-b] thiopyran-2-
sulfonamide-7,7-dioxide is resoluted with (-)-Di-para-toluoyl-L-tartaric acid
monohydrate
and then reacted with hydrochloric acid in presence of water to yield Dorzolamide
Hydrochloride (Pharma). Schematic diagram of Dorzolamide Hydrochloride and flow
diagram for Dorzolamide Hydrochloride is presented below.
Flow diagram
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Dapagliflozin
Manufacturing Process :
Stage-I:
Intermediate-I react with Intermediate-II in the presence of n-butyl lithium, triethyl tin
hydride and trifluro borate catalyst and Toluene media at 60 degrees and compound
isolate
in acetonitrile and MDC media to give Dapagliflozin. Schematic diagram of
Dapagliflozin
and flow diagram for Dapagliflozin is presented below.
Chemical Reaction:
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Flow diagram
Esomeprazole Magnesium Dihydrate
Stage-I:
5-Methoxy-2-[[(4-methoxy-3,5-diemthylpyridin-2-yl)methyl]thio]-1H-benzimidazole
is
oxidized with hydrogen peroxide in presence of vanadium acetyl acetonate in acetone
and
methanol to yield (+)-Omeprazole (Stage-I compound).
Stage-II:
(±) Omeprazole is resoluted with (S)-(-)-1,1-Bi-2-Naphthol in methylene chloride and
toluene and then treated with magnesium chloride and water to yield Esomeprazole
Magnesium (Pharma). Schematic diagram of Esomeprazole Magnesium and flow
diagram for Esomeprazole Magnesium is presented below.
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Chemical Reaction:
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Flow diagram:
Irbesartan
Manufacturing Process :
Stage-I:
2-butyl-1,3-diazaspiro[4,4]non-1-ene-4-one hydrochloride is condensed with 5-[4'-
(bromomethyl)biphenyl-2-yl]-1-trityl-1H-tetrazole in the presence of methanolic
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hydrochloric acid to give Irbesartan. Schematic diagram of Irbesartan and flow
diagram for Irbesartan is presented below.
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Flow diagram:
Montelukast Sodium
Manufacturing Process :
Stage-I:
2-[2-3(S)-[3-[2-(7-chloro-2-quinolinyl)-ethyl]phenyl]-3-hydroxy propyl]phenyl-2-
propanol is
condensed with 2-[1-(sulfonyl methyl) cyclopropyl]acetic acid in presence of
Toluene,
Acetonitrile and reacted with Sodium hydroxide in presence of methanol to give
Montelukast Sodium (Pharma). Schematic diagram of Montelukast Sodium and flow
diagram for Montelukast Sodium is presented below.
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Chemical Reaction:
Flow diagrm:
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Posaconazole
Manufacturing Process :
N-{4-[4-(4-Hydroxy-phenyl)-piperazin-1-yl]-phenyl}-carbonic acid phenyl ester is
condensed with Formic acid N'-(2-benzyloxy-1-ethyl-propyl)-hydrazine and (5R-cis)-
5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)tetrahydrofuran-3-methanol
tosylate ester in the presence of Tetrahydrofuran and Formic acid to yield
Posaconazole (Pharma). Schematic diagram of Posaconazole and flow diagram for
Posaconazole is presented below.
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Chemical Reaction:
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Flow diagram
Quetiapine Hemifumarate
Manufacturing Process :
Stage-I:
Dibenzo-(1,4)-thiazepine-11(10H)-one is condensed with 2-(2-(piperazin-1-
yl)ethoxy)ethanol is treated with fumaric acid in presence of thionyl chloride and
ethanol to give Quetiapine Hemifumarate. Schematic diagram of Quetiapine
Hemifumarate and flow diagram for Quetiapine Hemifumarate is presented below.
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Chemical Reaction:
Flow diagram:
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Risedronate Sodium
Manufacturing Process :
Stage-I:
A mixture of 3- pyridylacetic acid, H3PO3, diethyl carbonate we stirred for 5-10
minutes at room temperature. PCl3 was added drop wise between 25-35°C To the
resulting reaction mixture; methanesulfonic acid was added drop wise between 40-
55°C. Reaction mixture was heated to 60-65°C for 1.0-1.5h. Further the reaction mass
was heated to 70-75°C for 4.0- 6.0h. After reaction completion, pre chilled water (70
ml) was added at 65-80°C in a drop wise manner and diethyl carbonate layer was
separated. To the resulting aqueous layer hydrochloric acid (10ml) was added and
heated to reflux for 10-15hrs and cooled to 0-15°C. Residronic acid was ejected; from
the resulting aqueous reaction mass at a pH of 1.4-1.8. The resulting suspension was
filtered and slurried in water then dried to obtain Risedronic acid.
Stage-II:
Output from stage 1 is taken in DI Water and reacted with aqueous Sodium
Hydroxide solution. The material is isolated in presence of Water, Iso propyl alcohol
mixture to get form A of hemipenta-hydrate at 14-18°C and filtered at 0-5°C. Wet
material is taken for reslurry water, Isopropyl alcohol at 14-18°C and filtered through
PNF. Wet material is dried in FBD at 40-45°C with air 55±5 % RH to reach to LOD
of 10-15 %. Schematic diagram of Risedronate Sodium and flow diagram for
Risedronate Sodium is presented below.
Reaction
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Flow diagram:
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Telmisartan
Manufacturing Process :
Stage-I:
1H-Benzimidazole-2n-propyl-4-methyl-6-(1-methyl benzimidazole-2yl] is Condensed
with
4-methyl-(bromomethyl) bi phenyl carboxylate in the presence of Methyl Isobutyl
Ketone
to form a 1-[4-(1,4-Dimethyl-2-propyl-1H-[2,5]bibenzoimidazolyl-1-yl methyl)-
biphenyl-2-
yl]ethanone [Telmesartan Ester]
Stage-II:
1-[4-(1,4-Dimethyl-2-propyl-1H-[2,5]bibenzoimidazolyl-1-ylmethyl)-biphenyl-2-
yl]ethanone
[Telmesartan Ester ] Hydrolysis with Potassium Hydroxide to form a 2-(4-{[4-methyl-
6-(1-
methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-
yl]methyl}phenyl)benzoic
acid [ Telmisartan ]
Stage-III:
2-(4-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-
1-yl]
methyl} phenyl) benzoic acid [ Telmisartan ] purification in methanol to form a 2-(4-
{[4-
methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-
yl]methyl}
phenyl) benzoic acid [ Telmisartan ]. Schematic diagram of Telmisartan and flow
diagram for Telmisartan is presented below.
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Chemical Reaction:
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Flow diagram
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Vilazodone hydrochloride
Manufacturing Process :
Stage-I:
5-{4-[4-(5-Cyano-1H-indol-3-yl)-butyl]-piperazin-1-yl}-benzofuran-2-carboxylicacid
methyl ester reacts with methanolic ammonia to yield 5-{4-[4-(5-Cyano-1H-indol-3-
yl)-butyl]- piperazin-1-yl}-benzofuran-2-carboxylic acid amide.
Stage-II:
5-{4-[4-(5-Cyano-1H-indol-3-yl)-butyl]-piperazin-1-yl}-benzofuran-2-
carboxylicacidamide reacts with IPA/HCl in methanol and water to yield Vilazidone
hydrochloride. Schematic diagram of Vilazidone hydrochloride and flow diagram for
Vilazidone hydrochloride is presented below.
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Flow diagram:
BOSENTAN
Manufacturing Process
Guiacol and diethyl chloromalonate were added drop wise in succession to a
previously prepared sodium ethoxide solution. The suspension was stirred at 45oC
with exclusion of moisture. Thereafter the ethanol was distilled off. The residue was
taken up in toluene, wash with water and 1% sodium hydroxide solution until organic
phase gets colorless. Finally wash with water and sat. brine solution. After drying on
sodium sulfate and evaporating the solvent, the residue was distilled to give diethyl
(O‐ethoxyphenoxy) malonate. Pyrimidine‐2‐carboxamidine hydrochloride and diethyl
(O‐ethoxyphenoxy)malonate were added while cooling with ice to a previously
prepared sodium methoxide solution from sodium and absolute methanol. Stir the
reaction mixture at room temperature with the exclusion of moisture. Solvent was
evaporated under reduced pressure. The residue was taken up in 1N NaOH solution.
Alkaline solution was acidified with 1N HCl. Precipitate was filtered off and
washed thoroughly with water and dried under vacuum. The
5‐(2‐methoxy‐phenoxy)‐2‐ (pyrimidin‐2‐yl) tetrahydro‐pyrimidine‐4,6‐dione used in
the next step without further purification. Pyrimidinone from step‐II was charged in to
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N, N diisopropyl‐N‐ethylamine. Phosphorous pentachloride (PCl5) was added portion
wise. Reflux the reaction mixture. The mixture was then evaporated under reduced
pressure. Residue was poured on to ice and extracted with ethyl acetate.
The combined extracts were washed with water, dried and evaporated in a vacuum.
The residue was chromatographed on silica gel using ethyl acetate yielded
4,6‐dichloro‐5‐(2‐methoxy‐phenoxy)‐2,2’‐bipyrimidine. To a solution of Step‐III in
DMSO, p‐tert‐butylbenzenesulphonamide was added. The mixture was heated at
100oC. The solution was concentrated under vacuum. The oily residue was poured on
to ice, and adjusted
pH 3. The suspension was extracted with ethyl acetate, combined organic layers and
washed with water. Dried over sodium sulphate and concentrated under reduced
pressure. The residue was chromatographed on silica gel with toluene‐ethyl acetate
9:1to give
4‐tert‐butyl‐N‐[6‐chloro‐5‐(2‐methoxy‐phenoxy)‐2‐(pyrimidin‐2‐yl)‐pyrimidin‐4‐yl]‐
benzenesulphonamide.
To a solution of sodium metal in ethylene glycol, charged Step 04. The mixture was
heated at 100oC. After completion of reaction, the reaction mass was poured on to ice
and adjusted to PH=3 with 1M tartaric acid. The suspension was extracted with ethyl
acetate. Combined organic layers were washed with water, dried over sodium sulphate
and concentrated under reduced pressure. The residue was chromatographed on silica
gel with dichloromethane‐‐ethyl acetate 9:1 to yield
4‐tert‐butyl‐N‐[6‐(2‐hydroxy‐ethoxy)‐5‐(2‐methoxy‐phenoxy)‐2‐(pyrimidin‐2‐yl)‐
pyrimidin‐4‐yl]‐benzenesulphonamide (Bosentan)
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Chemical Reaction
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Flow diagram
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FESOTERODINE NDMF
Manufacturing Process :
Stage‐‐‐‐I: Preparation of FES/KSM/I (Ester):
Reaction of Cinnamic acid with p‐Cresol in presence of Sulphuric acid gives
Coumarin
intermediate which on further reaction with Benzyl bromide in presence of Methanol
and base
gives Ester is isolated from Methanol.
Stage‐‐‐‐II: Preparation FES/KSM/II (Amide):
Ester is hydrolyzed using Potassium hydroxide and Methanol to give Acid
intermediate which on
further reaction with Thionyl chloride followed by reaction with Diisopropylamine
gives amide.
Amide is isolated from Isopropanol.
Stage‐‐‐‐III: Preparation of FES/KSM/III (KSM):
Amide on reduction with Sodium Borohydride and Borontrifluoride etherate gives
Amine (Oil)
having one chiral carbon and it is racemic. Racemic Amine (Oil) on resolution with
optically
active acid Di p‐toluoyl L‐tartaric acid followed by crystallizations gives KSM of
desired optical
and chemical purity.
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Chemical Reaction
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Flow diagram
63.FESOTERODINE FUMARATE
Manufacturing Process:
Step-II: Reduction and Debenzylation
Manufacture of R-(+)-2-(3-Diisopropylamino-1-phenylpropyl)-4-hydroxy methyl
phenol (Fesoterodine Fumarate Stage-II)
1 mole (R)-(-)-4-benzyloxy-3-(3-diisopropylamino-1-phenyl-propyl)-benzoic acid
methyl ester reacts with 1 mole Lithium Aluminium Hydride with 2 mole of water
media resulting 1 mole of intermediated (Fesoterodine Fumarate stage-I with the by-
product 1 mole Lithium Hydroxide and 1 mole Aluminium Hydroxide.
9.Further, 1 mole of above intermediate reacts (in-situ) with 1 mole Hydrogen (gas) in
the solvent media finally resulting 1 mole R-(+)-2-(3-Diisopropylamino-1-
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phenylpropyl)-4-hydroxy methylphenol (Fesoterodine Fumarate Stage-II) with the by-
product 1 mole Toluene.
Step-Final: Etherification and Salt formation
Manufacture of R-(+)-2-(3-Diisopropylamino-1-phenylpropyl)-4-
hydroxymethylphenyl isobutyrate hydrogen fumarate (Fesoterodine Fumarate
Stage-Final)
1 mole Fesoterodine fumarate stage-ii reacts with 1 mole Isobutyryl chloride in the
solvent media gives 1 mole of intermediated stage Fesoterodine free base with the by-
product 1 mole HCl which finally reacts (in-situ) with 1 mole Fumaric acid which
gives desired Fesoterodine Fumarate Stage-Final.
Chemical Reaction: Fesoterodine Fumarate, Stage-2
+
O
O
CH3
O
N
CH3 CH3
CH3
CH3
R-(-)-4-benzyloxy-3-(3-Diiso- propylamino-1-phenyl-propyl)- benzoic acid methyl ester
MF:C30H37NO3
FW:459.62
LiAlH4 +
Lithium Aluminium HydrideMF:LiAlH4
FW:37.95
2H2O
WaterMF:H2O
FW:2X18(36)
R-(+)-4-benzyloxy-3-(3-Diisopropyl- amino-1-phenyl-propyl)-phenyl methanol
MF:C29H37NO2
FW:431.60
OH
O
N
CH3 CH3
CH3
CH3
LiOH
Lithium HydroxideMF:LiOH
FW:23.95
Al(OH)3
Aluminium hydroxide
MF:Al(OH)3
FW:78
+ +
R-(+)-4-benzyloxy-3-(3-Diisopropyl- amino-1-phenyl-propyl)-phenyl methanol
MF:C29H37NO2
FW:431.60
OH
O
N
CH3 CH3
CH3
CH3
H2
FW:2.01
Hydrogen (gas)
MF:H2
CH3
FW:92.14
MF:C8H7
Toluene
+
Fesoterodine Fumarate, Stage-2
OH
OH
N
CH3 CH3
CH3
CH3
MF:C22H31NO2
FW:341.49
+
Fesoterodine Fumarate, Stage-Final
Fesoterodine Fumarate, Stage-2
OH
OH
N
CH3 CH3
CH3
CH3
MF:C22H31NO2
FW:341.49
+
CH3 CH3
O
Cl
Isobutyl chloride
MF:C4H7ClO
FW:106.55
OH
O
N
CH3 CH3
CH3
CH3
CH3
CH3 O
FW:411.58
MF:C26H37NO3
R-(+)-2-(3-Diisopropylamino-1-phenyl-propyl)-4-hydroxymethyl phenol isobutyrate ester
H Cl
Hydrochloric acid
MF:HCl
FW:36.5
+
OH
O
N
CH3 CH3
CH3
CH3
CH3
CH3 O
FW:411.58
MF:C26H37NO3
R-(+)-2-(3-Diisopropylamino-1-phenyl-propyl)-4-hydroxymethyl phenol isobutyrate ester
+
O
OH
O
OH
MF:C4H4O4
FW:116.07
Fumaric Acid
OH
O
N
CH3 CH3
CH3
CH3
CH3
CH3 O
O
OH
O
OH
MF:C30H41NO7
FW:527.65
Fesoterodine Fumarate, Stage-Final
Flow diagram:
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Vildagliptin
Manufacturing Process
Stage‐I
Reaction of (2S)‐1‐(chloroacetyl)‐2‐cyanopyrrolidine (KSM‐II) with
3‐Amino‐1‐hydroxy adamantine (KSM‐I) in presence of Potassium Carbonate and
Dimethyl Formamide (DMF) as a solvent gives Vildagliptin crude.
Stage‐II
Vildagliptin crude is purified by treatment of Aq. Potassium Hydrogen Sulphate and
Aq. Potassium Carbonate in presence of Dichloromethane, followed by Acetone
crystallization to give Vildagliptin API.
Chemical Reaction
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RIVASTIGMINE TARTRATE
Manufacturing Process
Stage‐‐‐‐I (Rivastigmine Tartrate Crude)
Carbamoylation of (S)‐3‐(1‐dimethyl amino ethyl) phenol carried out with
N‐ethyl‐N‐methyl Carbamoyl chloride in Toluene using Triethylamine as base and
4‐dimethyl amino pyridine as catalyst at 60‐65°C. After completion of reaction cool
reaction mass to 25‐35°C, filter the reaction mass, wash the solid salt with Toluene.
Charge water in to the filtrate, stir and separate layers. Wash the organic layer with
Sodium bicarbonate solution, Hydrochloric acid solution and then water and than
charcoalized with activated charcoal. Distill out toluene from filtrate to obtain
Rivastigmine Base. Charge Denature spirit and L (+) tartaric acid in Rivastigmine
Base, and heat to 55‐60°C to get clear solution and than charge Ethyl acetate,
Cool to 40°C and seed the reaction mass with Rivastigmine Tartrate, cool to 0‐5°C
and stir for 4‐ 5 hours, filter, Wash with Ethyl acetate and dry the crude Rivastigmine
Tartrate at 40‐50°C in
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vacuum oven.
Stage‐‐‐‐II (Rivastigmine Tartrate)
Dissolve Rivastigmine Tartrate in Ethyl Alcohol, heat to 55‐60°C to get clear
solution, charcoalized and distill out Ethyl Alcohol. Charge Ethyl Alcohol , heat to
55‐60°C and than charge Ethyl acetate, Cool to 40°C and seed the reaction mass with
Rivastigmine Tartrate, cool to 0‐5°C and stir for 4‐5 hours, filter, Wash with Ethyl
acetate and dry the Rivastigmine Tartrate at 40‐50°C in vacuum oven till constant
weight.
Chemical Reaction
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FLOWDIAGRAM
FEBUXOSTATE
Manufacturing Process
Ethyl‐2‐(3‐formyl‐4‐isobutoxyphenyl)‐4‐methylthiazole‐5‐carboxylate is reacted with
hydroxylamine hydrochloride to form oxime which is dehydrated with sodium
formate & formic acid to form
Ethyl2‐(3‐cyano‐4‐isobutoxyphenyl)‐4‐methyl‐5‐thiazolecarboxylate which on
hydrolysis gives Febuxostate.
Chemical Reaction
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FLOW DIAGRAM
AGOMELATINE
Manufacturing Process
Catalytic hydrogenation of (7‐Methoxy‐1‐naphthyl) acetonitrile using Methanol and
Ammonia gives 2‐(7‐Methoxy‐1‐naphthyl) ethanamine. Condensation of
2‐(7‐Methoxy‐1‐naphthyl) ethanamine with acetyl chloride in presence of base gives
crude Agolelatine. Which on purification gives final Agomelatine API.
Chemical Reaction:
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FLOWDIAGRAM
LEVETIRACETAM
Manufacturing Process
Stage‐‐‐‐I
S(+)‐2‐amino butyramide Hydrochloride reacts with 4‐chloro Butyryl chloride in
presence of Tetra butyl ammonium bromide, potassium hydroxide to give the
Levetiracetam crude (Stage‐I).
Stage‐‐‐‐II
Levetiracetam crude is purified by charcoal treatment with Dichloromethane solvent.
Then Dichloromethane is completely distilled out and finally crystallized in Ethyl
Acetate to give the Levetiracetam API.
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Chemical Reaction
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Flow diagram
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BOSENTAN
Manufacturing Process :
To sodium glycolate solution added bipyrimidine t-butyl sulfonamide. Stirred the
reaction mass at 95°C for 4 hours. Distilled out ethylene glycol to obtained residue,
which is dissolved in ethyl acetate and washed with 1N HCl. Organic layer is dried
and concentrated under vacuum. To the residue added diisopropyl ether and stirred for
1 hr, Solid precipitate out. Filtered the solid and dried the material under vacuum at
40°C.
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Chemical Reaction:
Flow diagram
ON
NN
N
OCH3
Cl
NHS
O
O
CH3
CH3CH3
ONa
ONa
ON
NN
N
OCH3
O
NHS
O
O
CH3
CH3CH3
ONaFormula Weight = 526.00716
106.03 + NaCl
Formula Weight = 573.59
58.44
di pyrimidine t-Butyl sulfonamide
ClH
36.5
ON
NN
N
OCH3
O
NHS
O
O
CH3
CH3CH3
OH
+NaCl58.44
BosentanFormula Weight = 551.61
Sodium glycolate
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Flow diagram
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METHYL PARABEN
Manufacturing Process :
PHBA and Methanol react with each other in a closed reactor at a reflux
temperature.After completion of reaction the resultant mass is cooled to room
temperature and centrifuge. The filtrates is used for the next batch. The solid mass
,MethylParaben is washed with Soda bicarbonate solution to remove acidity from the
material. It is washed with plain water .All washing are transferred to effluent
collection Tank, The solid material is dried and packed as Methyl Paraben.
Chemical Reaction:
C7H6O3 + CH3OH C8H8O3 + H2O
Flow Diagram
ETHYL PARABEN
Manufacturing Process :
PHBA and ethanol react with each other in a closed reactor at a reflux temperature.
After completion of reaction the resultant mass is cooled to room temperature and
centrifuge. The filtrate is used for the next batch. The solid mass, Ethyl Paraben is
washed with Soda bicarbonate solution to remove acidity from the material. It is
washed with plain water .All washing are transferred to effluent collection Tank, The
solid material is dried and packed as Ethyl Paraben
PHBA
Methanol
Reactor
Centrifuge
Washing
Dryer
Methyl Paraben
Wash With Water
Wash With NaHCo3solun
Effluent to CEPT
Evaporation loss 50kgs
Methanol
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Chemical Reaction:
C7H6O3 + C2H5OH C9H10O3 + H2O
Flow Diagram
PROPYL PARABEN
Manufacturing Process :
PHBA and Propanol react with each other in a closed reactor at a
refulxtemperature.After completion of reaction the resultant mass is cooled to room
temperature and centrifuge. The filtrate is used for the next batch. The solid mass,
Propyl Paraben is washed with Soda bicarbonate solution to remove acidity from the
material. It is washed with plain water.All washing are transferred to effluent
collection Tank, The solid material is dried and packed as Propyl Paraben.
Chemical Reaction:
C7H6O3 +C3H8O C10H12O3 + H2O
Flow Diagram
PHBA
Ethanol
Reactor
Centrifuge
Washing
Dryer
Ethyl Paraben
Wash With Water
Wash With NaHCo3soln
Effluent to CEPT
Evaporation loss
Ethanolmls
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PHBA
N-Propanol
Reactor
Centrifuge
Washing
Dryer
Propyl Paraben
Wash With Water
Wash With NaHCo3solun
Effluent to CEPT
Evaporation loss
N-Propanol Mls
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BUTYL PARABEN
Manufacturing Process:
PHBA andbutanol react with each other in a closed reactor at a reflux temperature.
After completion of reaction the resultant mass is cooled to room temperature and
centrifuge. The filtrates is used for the next batch. The solid mass ,ButylParaben is
washed with Soda bicarbonate solution to remove acidity from the material. It is
washed with plain water .All washing are transferred to effluent collection Tank, The
solid material is dried and packed as Butyl Paraben
Chemical Formula
C7H6O3+ CH3(CH2)3OH C11H14O3 + H2O
FlowDiagram
ISO PROYL PARABEN
Manufacturing Process :
PHBA and Isopropanol react with each other in a closed reactor at a reflux
temperature. After completion of reaction the resultant mass is cooled to room
temperature and centrifuge. The filtrate is used for the next batch. The solid mass,
Methyl Paraben is washed with Soda bicarbonate solution to remove acidity from the
PHBA
Butanol
Reaction
Centrifuge
Washing
Dryer
s
Butyl Paraben
Wash With Water
Wash With NaHCo3sol
Effluent to CEPT
Evaporation loss
105kgs
Mls of
butanol
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material. It is washed with plain water .All washing are transferred to effluent
collection Tank, The solid material is dried and packed as Methyl Paraben
Chemical Reaction:
C7H6O3 + CH3CH3 CHOH C10H12O3 + H2O
Flow Diagram
PHBA
Iso
propanol
Reaction
Centrifuge
Washing
Dryer
IsoPropyl Paraben
Wash With Water
Wash With NaHCO3Sol.
Effluent to CEPT
Evaporation loss
Iso propanelmls
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Chlorohexidine Base (CH-Base)
Manufacturing Process :
1. Charge N-Butanol, Hexa Methyl Diamine, Tri Ethyl Amine, Sodium Di Cynamide in
the Reactor.
2. Start addition of HCL.
3. Slowly start heating upto distillation of butanol at 1200C.
4. Reflux the reaction mass for 4 Hrs at 1180C to 124
0c.
5. Cool the reaction mass below 800C.
6. Add PCA HCL & Caustic solution.
7. Wash the reaction mass with water.
8. Separate the aqueous layer.
9. Cool the reaction mass upto 480C.
10. Centrifuge the material. Wash the cake with methanol.
11. Centrifuge, drying and pack the material.
12. Final Yield: 500 kg.
Chemical Reaction:
CH 3 NO2 + 2 H C HO HOCH2CH CH 2OHN O2 NaO H (M W. 40)Br2(M W.1 6 0)N O2 HOCH 2 C - C H 2 OH + Na Br + H2O(M W. 6 1) (M W. 60) (M W. 1 21)
Br(MW. 20 0 ) ( M W. 1 0 3 )
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Flow Diagram:
Stage 1
HEXA METHYL DI AMINE
SODIUM DI CYNAMIDE
N BUTANOL
TRI ETHYL AMINE
SODIUM HYDROXIDE
FLAKES
WATER
PCA HCL
GLR-1
REACTOR
GLR-1
REACTOR
SSR
REACTOR
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Stage 2
FILTERATE
NaOH
Salt
Butanol
Water
SDC
HMDA
TEA
WASHING
Salt
Butanol
Water
SDC
SSR
BASKET
CENTRIFU
SE CAKE
Crude CH Base
Butanol
Water
HMDA
Salt
SSR
REACTOR
CAKE Crude CH Base
Butanol
Water
IMP
Methenol
SSR
BASKET
CENTRIFU
SE
CAKE Crude CH Base
Butanol
Water
Methenol
FILTERATE Crude CH Base
Butanol
Water
IMP
Methenol
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LEVOSULPIRIDE
Manufacturing Process :
Charge Mono ethylene glycol in the reactor ,start stirring and charge slowly 2-
methoxy-5 sulphomyl methyl benzoate powder .Add slowly and gradually liquid ( S-)
1 –ethyl-2-aminomethylpyrolindine within 15 -20 min. Start heating and maintain at
60-70 °C for 8 hrs. Cool it up to 35 °C centrifuge it ,mother liquor is reused for next
batch. dry , pulverized and packed as Levosulpiride.
Chemical Reaction:
C9H11O5NS + C7H17N2 ↑C15H23N3O4S + CH3OH
SSR
FDP
CAKE Crude CH Base
Butanol
Water
Methenol
CAKE
Crude CH Base
Butanol
Water
Methenol
CAKE Crude CH Base
Water
Methenol
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Flow diagram
PANTAPRAZOLE SODIUM
Manufacturing Process :
STAGE-1
2-Chloromethyl-3,4-dimethoxy pyridine hydrochloride is reacted with 5-
difluoromethoxy- 2-mercapto benzimidazole in aqueous methanol in presence of
sodium hydroxide r to get the desired product.
STAGE-2
Pantoprazole sulfide is treated with Sodium hypoclorite solution in DCM-water
mixture at 0 to -5o C in presence of Aqueous sodium hydroxide and after completion
of reaction, the reaction mixture is quenched by the addition of aqueous sodium
thiosulfate solution. To the resulting reaction mixture is added DCM and water and
the reaction stirred for 30 minutes. The layers are separated. To the aqueous layer is
added fresh DCM and the pH of the resulting reaction mixture is adjusted to 9 to 9.5
by the addition of acetic acid and stirred for 30 minutes. Layers are separated and the
aqueous layer is again extracted with fresh DCM. The DCM extracts obtained after
the pH adjustment are combined and concentrated up to about 3 times volume of the
substrate. To the concentrated reaction mixture is added IPE to precipitate the
Mono ethylene Glycol
Methoxy Ester
Reactor
Dryer
Pulvrised
Amino
Pyrrolidine
Levosulpiride
Centrifuge MLS re
used in
next batch
Evoparation loss
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product, which is filtered, and the obtained solid washed with IPE and dried to get
Pantaprazole base.
STAGE-3
Pantaprazole sodium is prepatred by dissolving pantaprazole base in ethyl acetate and
adding sodium hydroxide solution, some ethyl acetate is distilled out to get solid
pantaprazole sodium. After filtration and washing with E a, pure pantaprazole Sodium
is obtained.
STAGE-4
Pantaprazole sodium is prepatred by dissolving pantaprazole base in ethyl acetate and
adding sodium hydroxide solution, some ethyl acetate is distilled out to get solid
pantaprazole sodium. After filtration and washing with E a, pure pantaprazole Sodium
is obtained.
STAGE-5
Pantaprazole sodium is prepatred by dissolving pantaprazole base in ethyl acetate and
adding sodium hydroxide solution, some ethyl acetate is distilled out to get solid
pantaprazole sodium. After filtration and washing with E a, pure pantaprazole Sodium
is obtained.
Chemical Reaction:
N
OCH3OCH3
Cl
.HCl
+
N
NH
SH
OCF2H
Methanol / Water
Aq. NaOHN
OCH3OCH3
N
NH
S
OCF2H
Pantoprazole sulfide
N
OCH3OCH3
N
NH
S
OCF2H
N
OCH3OCH3
S
O N
NH
OCF2H
N
OCH3OCH3
S
O N
NH
OCF2H
N
OCH3OCH3
S
O N
N
OCF2H
- 1. 5 H2O
Pantoprazole sulfide
Sodium hypochlorite (74.5)
DCM / Water / 2 NaOH(80)
Triethyl benz. ammon. chloride
IPE
Ethyl acetate
Aq. NaOH
Pantoprazole sodium
Pantoprazole base
Pantoprazole base
Pantoprazole sodium
2-(chloromethyl)-3,4-dimethoxypyridine
5-(difluoromethoxy)-1H-benzimidazole-2-thiol
m.wt= 224.08m.wt= 216.20
m.wt = 367.37
Pantoprazole sodium
Pantoprazole sulfide
m.wt = 367.37 m.wt = 383.36
Pantoprazole base
m.wt = 383.36 m.wt = 409.36
+ 2HCl
72.91
+2NaCl + NaOH + Na 2S4O6 + CH3COONa + 2H 2O58.5 40 270 82 36
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Flow Diagram
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CILNIDIPINE
Manufacturing Process :
Charge Toluene in the reactor ,start stirring and charge slowly 3-Nitro .Add slowly
and gradually 3-Amino within 1-2 hrs.Start heating and maintain at 80-90°C for 10
hrs. Cool it up to 35°C, centrifuge it ,mother liquor is reused for next batch, dry ,
pulverized and packed as Cilnidipine.
Chemical Reaction:
C14H16NO6 + C13H15NO2 C27H28N2O7 + H2O
Flow Diagram
Methyl Acetate
Manufacturing Process :
Methanol reacts with Acetic acid to get Methyl Acetate and release water.
Chemical Reaction
Toluene
3-Nitro
Reactor
Dryer
Pulvrised
3-Amino
Cilnidipine
Centrifuge MLS
reused in
next batch
Evoparation loss
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Flow Diagram
Ethyl Acetate
Manufacturing Process :
Ethanol reacts with Acetic acid to get Ethyl Acetate and release water.
Chemical Reaction
Flow Diagram
FINGOLIMOD HYDROCHLORIDE
Manufacturing Process :
Stage: 1
Charge MDC, Octylbenzene, anhydrous Aluminium chloride &Bromoacetyl Bromide
in to reactor, stir & heat the content. After completion of reaction, charge purified
water in to reactor, stir the content and separate the Aq. Layer & organic layer. Distil
out solvent completely and unload the material as FingolimodHCl stage-1.
Stage: 2
Ethyl Acetate
CH3CH2OH + CH3COOH CH3COOCH2CH3 + H2O
Ethanol Acetic Acid Ethyl Acetate Water
M.W. 46 M.W. 60 M.W.88 M.W.18
M e th y l A c e ta te
C H 3 O H + C H 3 C O O H C H 3 C O O C H 3 + H 2 O
M e th a n o l A c e t ic A c id M e th y l A c e t a te W a te r
M .W . 3 2 M .W .6 0 M .W . 7 4 M .W .1 8
REACTOR Methanol
Acetic acid
Methyl Acetate
Water to ETP
REACTOR Ethanol
Acetic acid
Ethyl Acetate
Water to ETP
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Charge Acetone, Diethylacetamidomalonate, Potassium carbonate anhydrous
&FingolimodHClstage-1 in to reactor, stir & heat the content. After completion of
reaction, filter the reaction mass through Neutsch. Transfer the product filtrate ML in
to another reactor. Distil out solvent and then co-distil with hexane. Transfer the
product filtrate ML in to another reactor then charge purified water, stir & separate the
Aqueous Layer, organic layer dried with sodium sulphate, filter the reaction mass
through Neutsch. Transfer the product filtrate ML in to another reactor. Distil out
solvent and then unload the materialas FingolimodHCl stage-2.
Stage: 3
Charge Methylene Chloride, Fingolimod Hydrochloride Stage-2, Molecular Sieves
4A Pellets (Size 3mm) in to reactor, Stir the content of the reactor. Cool the content of
reactor, charge solution of Triethylsilane in Methylene Chloride into reactor.
Meanwhile prepare solution by mixing Titanium Tetrachloride in Methylene Chloride
and then charge into reactor, stir & cool the content of the reactor. After completion of
reaction, charge purified water in to reactor, stir & separate the Aq. Layer & organic
layer wash with purified water. Distil out solvent and co-distil out solvent with
Hexane, then again charge with Hexane & Ethyl acetate in to reaction mass, stir the
content. Distil out solvent and transfer the degas mass in to another reactor & prepare
the silica bed in hexane & load the degas mass, eluate with Ethyl acetate & hexane,
collect the fraction. Distil out solvent and check the LOD then unload the material as
FingolimodHCl stage-3.
Chemical reaction: Fingolimod hydrochloride, stage-1
CH3
O
Cl
Br
Formula Weight:190.32
Molecular Formula: C14H22
octylbenzene
Formula Weight: 157.39
Molecular Formula: C2H
2BrClO
bromoacetyl chloride
CH3
O
Br
HCl
Formula Weight:311.26
Molecular Formula: C16
H23
BrO
2-bromo-1-(4-octylphenyl)ethanone Hydrochloric acid
Molecular Formula: HCl
Formula Weight:36.5
+
+
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CH3
O
Br
Formula Weight:311.26
Molecular Formula: C16H23BrO
2-bromo-1-(4-octylphenyl)ethanone
O
O
CH3
O
O
CH3
NH
O
CH3
Formula Weight: 217.22
Molecular Formula: C9H15NO5
diethyl (acetylamino)propanedioate
O
OCH3
OO
CH3
NH
O
CH3CH3
O
H Br
Formula Weight: 447.56Molecular Formula: C25H37NO6
Ketone melonic ester adduct (Fingolimod stage-2)
Formula Weight: 80.91Molecular Formula: HBr
hydrogen bromide
Fingolimod hydrochloride, stage-2
+
+
O
O
CH3O
O
CH3
NH
O
CH3
CH3
O
Formula Weight: 447.56
Molecular Formula: C25H37NO6
Ketone melonic ester adduct (Fingolimod stage-2)
Ti Cl
Cl
Cl
Cl
Formula Weight: 189.68
Molecular Formula: Cl4TiTitanium chloride
O
O
CH3O
O
CH3
NH
O
CH3
CH3
Formula Weight: 433.58
Molecular Formula: C25H39NO5
Fingolimod stage-3
OH2
TiO2
Chlorine(gas)Molecular Formula: 2Cl2Formula Weight: 141.82
Titanium dioxideMolecular Formula: TiO2
Formula Weight: 79.8
Water
Molecular Formula: H2O
Formula Weight: 18
+
Fingolimod hydrochloride, stage-3
+ +
+
2Cl2
+
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Flow diagram:
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TAMSULOSIN HYDROCHLORIDE
Manufacturing Process :
Stage: Final
Charge N,N-Dimethylformamide, Ethoxyphenoxy ethyl bromide, (R)-(-)-[2-
Aminopropyl]-2-methoxy benzene sulfonamide into reactor.Stir the content & heat it.
After reaction completion distil out N,N-Dimethylformamide completely under
vacuum. Charge Methylene chloride into reactor, adjust pH using Ammonia solution,
stir & cool the content. Settle the reaction mass and separate the lower product
enriched organic Layer in a clean HDPE drum.Keep the upper Aq. Layer in the
reactor. Charge Methylene chloride into reactor, stir the content.Stop stirring and
settle the reaction mass, separate the lower product enriched organic layer with
previously collected in HDPE drum.Unload the upper Aq. Layer in a clean HDPE
drum.Charges the combined product enriched organic layer followed by water into the
reactor and mix it. Stop stirring and settle the reaction mass. Separate the lower
product enriched organic Layer in a clean HDPE drum.Unload the upper Aq. Layer
with pre collected in HDPE drum. Charge the product enriched organic Layer in to
reactor. Distil out MDC completely then charge IPA in to reactor then distil out IPA.
Transfer the reaction mass in to another reactor, stir and cool the content of the reactor
&then centrifuge. Purification of wet cake using IPA and then acid base purification is
done. Charge IPA, wet cake in to reactor then add IPA & HCl. Stir and cool the
content &then centrifuge. Dry the product under vacuum tray dryer.
Chemical reaction:
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H2O
+
HCl
Hydrochloric acid
MF:HCl
FW:36.5
Tamsulosin HCl, Stage-Final
NH2
CH3
S OO
NH2
O
CH3
5-[(2R)-2-aminopropyl]-2-methoxy- benzenesulfonamide
MF:C10
H16
N2O
3S
FW:244.31
O
CH3
O
Br
MF:C10H13BrO2
FW:245.12
Ethoxy phenoxy ethyl bromide
+
NH
CH3
S OO
NH2
O
CH3 O
CH3
O
MF:C20
H29
ClN2O
5S
FW:444.98
HBr
Hydrobromic acid
MF:HBr
FW:80.9
Tamsulosine Hydrochloride, Stage-Final
+ +
Water
MW:H2O
FW:18
HCl
+ H2O+
Water
MW:H2O
FW:18
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Flow diagram:
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CARBAMAZEPINE
Manufacturing Process :
Charge Methanol, Iminostilbenecarbonyl chloride, ammonia & purified water in to
reactor, stir & heat the content to desired temperature. After completion of
reactioncentrifuge the reaction mass followed by washing the wet cake with purified
water. Charge Acetone, Hyflo, wet cake, activated carbon in to another reactor & heat
the content up to desire temperature. Cool the reaction mass and filter it through
sparkler followed by micron. Transfer the filtrate in to another reactor, stir & cool the
content. Centrifuge the reaction mass followed washing of wet cake with acetone and
then lastly dry the product in fluid bed drier.
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Chemical Reaction: Carbamezapine, stage-Final
OCl
Formula Weight: 258.74
Molecular Formula: C16H15ClO
Iminostilbene carbonyl chloride
Formula Weight: 35.03
Molecular Formula: NH4OH
Aq. ammonia
ONH2
Formula Weight: 239.31
Molecular Formula: C16H17NO
Carbamezapine, Stage-Final
HCl
Hydrochloric acid
Molecular Formula: HCl
Formula Weight: 36.5
NH4OH
H2O
Water
MF:H2OFW:18
+
++
Flow diagram:
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NEBIVOLOL
Manufacturing Process :
STAGE-1
To stirred solution of 6-fluoro-3,4-dihydro-�-hydroxy]-2H-2-[1] benzopyran
Ethanamine and 6-fluoro-3,4-dihydro[tert-butyldimethylsilyl) oxy]-2H-2-[1]benzo
pyran Acetaldehyde in THF and methanol sodium cyanoborohydride is added and
stirred it for 14 h at rt. If reaction is incomplete SECOND lot of sodium
cyanoborohydride was added and stirred for 18 h at rt. Reaction was poured into
NaHCO3 and extracted with ethyl acetate. After evaporation solid wa found and
recrystalise further into DCM and methanol mixture.
STAGE-2
To a stirred solution of stage-5 in THF and methanol mixture was heated to 70°C in
acidic condition for one hrs. Sodium hydroxide solutions are added to reaction
mixture and extract it with ethyl acetate. The ml was concentrated to get the oil. Yield
97%.
STAGE-3
The oil was taken in methanol solution and mixed with 2N solution of HCl in diethyl
ether and allowed to stand at –20°C for crystallization. Later it was purified in
methanol. Yield 32 %.
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Chemical Reaction:
O
F
OHC
OSi
CH 3
C H 3
C H 3
C H 3
CH 3
O
F
O H
N H 2
+
N a+
N BH 3THF/Methanol/EtOAc
6-f luoro-3,4-dihydro-[tert-buty ldim ethylsily l) oxy]-2H-2-[1]benzo pyran
Acetaldehyde
6-f luoro-3,4-dihydro-hydroxy]-2H - 2-[1] benzopyran E thanam ine
OF O H
N H
O
F
O Si
C H 3
CH 3
C H 3
C H 3
C H 3
6N HCl/Methanol
O
F
O H
N H O
F
O H
O
F
O H
N H O
F
O H
HCl
HClMethano l
Formula Weight = 324.46Formula Weight = 211.23
62.84
Formula Weight = 519.69
Formula Weight = 405.43
Formula Weight = 441.89
Nabivolo l H ydrochlo ride
+ NaOH + N BH 2
40 38.84
+ C l S i
C H 3
CH 3
C H 3
C H 3
C H 3
150.72
36.5
36.5
Stage-1
Stage-2
Stage-3
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Flow Diagram
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BRONOPOL (BP):
Manufacturing Process :
Charge methanol in Reactor then charge formaldehyde charge caustic lye slowly to the mixture.
This is maintained for 3 hours at 200C, after that charge bromine and maintain for 4 hours at
60oC, then methanol is recovered.
After total methanol recovery, charge water& Carbon this is then stir for 1 Hr. Then carbon is
filtered & water is distilled. The reaction mixture is chilled to 100C & centrifuge & dry. Ml is
sodium bromide solution & is collected separately.
Chemical Reaction:
CH 3NO2 + 2 HC HO HOCH2CH CH 2OH
N O2 NaO H (M W. 40)Br2(M W.1 60)N O2 HOCH 2 C - C H 2 OH + Na Br + H2O(M W. 61 ) ( MW. 60) (MW. 1 21 )
Br(MW. 200 ) (M W. 1 0 3 )
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Flow diagram:
2-MERCAPTO BENZIMIDAZOLE:
Manufacturing Process :
Orthophenylene diamine (OPDA), water and Sodium sulphide (as catalyst) are charged into a
reactor and then carbon disulphide is slowly added to the reaction mass, which gives 2 Mercapto
Benzimidazole. This is then slightly heated to drive out the Hydrogen sulphide gas generated
which
is absorbed in a scrubber containing sodium hydroxide to give sodium hydrosulphide. The solids
are separated by filtration and the mother liquor is recycled in next charge. The product dried &
packed. The mother liquour after 20 charges cycles is sent to ETP.
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Chemical Reaction:
Flow Diagram
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TBHQ (Tertiary Butyl Hydroquinone)
Manufacturing Process :
• Charge Water, Phosphoric Acid, Toluene and Hydroquinone in the reactor.
• Slowly start addition of Tertiary Butanol (TBA) at 1020 C.
• After completion of reaction settle down the reaction mass.
• Collect the lower aqueous layer as phosphoric acid, which is going to be reuse in next
batch.
• Now do the filtration and get the filtrate as toluene (reuse) and get the Wet Cake.
• Take the wet cake in another reactor and add 20 times water at 950
C.
• After an hour cool down the mass and do the filtration.
• Get the filtrate as Di-Butyl Hydroquinone and take wet cake for centrifuge.
• Remove the water and go for drying and packing.
Chemical Reaction:
OHOH + CH3 C OH CH3 CH3 OHOH CH 3CH3 C CH3
+ H 2OH 3 PO4 To l ue n e1 02o C MW. 1 10 M W. 7 4 M W. 1 6 6 MW.1 8
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Flow Diagram
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ANNEXURE VII
DETAILS OF WATER CONSUMPTION
DETAILS OF WASTE WATER GENERATION
Note: * Zero Discharge Unit.
Domestic waste disposed off through soak pit/ septic tank.
Category As per CTE No. 70101
Water Consumption
(KL/Day)
For Proposed Project
Water Consumption
(KL/Day)
Domestic: 2.5 10
Industrial:
Process 3.0 102(fresh) +63(Recycle)
Boiler 2.0 40(Recycle)
Cooling 0.5 35
Washing 00 5(fresh)+25(recycle)
Other 2.0 5(recycle)
Total (Industrial) 7.5 132 (fresh)+133(recycle)
Total
Domestic + Industrial)
10.0 142 (fresh)+133(recycle)
Category As per CTE No. 70101
Waste Water
Generation (KL/Day)
For Proposed Project
Waste Water
Generation (KL/Day)
Domestic: 1.5 7
Industrial:
Process 00 155
Boiler 00 10
Cooling 00 5
Washing 00 3
Other 00 0
Total (Industrial) 00 * 173
Total
(Domestic + Industrial)
1.5 180
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Water Balance:
Domestic
10
Soak Pit
7
Total water consumption
142(fresh) +133(recycle)
Process
102(fresh) +63(Recycle)
Boiler
20
Cooling
5(fresh)+ 25(recycle)
Gardening
5(recycle)
Effluent from
Process
155
Boiler blow
down
5
Cooling blow
down
3
Effluent Treatment Plant
173
RO Plant
173
RO Reject
70
RO Permeate
103
Evaporator
45
Condensate
30
Reject
10
To NCTL
25
Loss
10
Loss
15
Loss
25
• All quantity is in KL/Day
Washing
40 (recycle)
Loss
30
Loss
5
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ANNEXURE-VIII
EXISTING EFFLUENT TREATMENT PLANT
There is no requirement of ETP.
PROPOSED EFFLUENT TREATMENT PLANT
Effluent coming from various streams is passed through Oil & Grease separator and
then collected in existing collection tank no.1. Then that effluent transfer to new ETP
equalization tank.
After that effluent transfer to neutralization tank where pH is maintained by dosing of
lime / alum. After ensuring pH, effluent is transferred to the primary clarifier tank.
Sludge settled at bottom of the clarifier is transferred to the sludge drying beds.
Over flow of primary clarifier effluent will goes in Aeration Tank, where continue air
is supplied by means of diffused Aeration System for biodegradation of organic
matters. Nutrients are added as per requirement. The overflow is goes to Secondary
Clarifier's, where settlement of biomass takes place. Some biomass is recycled in the
aeration tank by circulation pump and partly biomass wasted in to sludge drying bed
& sludge from decanter is stored in Hazardous Waste Storage Area, having
impervious layer and leachate collection system. Finally, stored hazardous waste
disposed off to government approved land filling site.
Over flow of secondary clarifier sent to intermediate tanks where sodium hypo
chloride added. Then effluent is passed through Activated carbon filter.
After filtration waste is transferred to final treated tank. Treated effluent from the final
collection tank is transferred to RO plant. RO permeate is reuse and rejected is sent to
evaporator. The evaporate permeate is used in cooling tower and gardening purpose.
PARTICULARS OF EFFLUENT TREATMENT PLANT
Sr.
No.
Description Size (L*W*D) Nos. Capacity
1 Equalization tank 4.5*6*4 1 108 m3
2 Neutralization tank 2.3*2.3*3 1 16 m3
3 Lime soln preparation tank 300 lit 1 0.3m3
4 Alum soln preparation tank 200 lit 1 0.2m3
5 Primary clarifier 2.5 M dia*2.5 1 51.3 m3
6 Aeration tank 7*6*4 1 168m3
7 Secondary clarifier 2.5 M dia*2.5 1 51.3 m3
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8 Filter Foundation 6*3 1 18 m2
9 Storage tank 7*5*5 1 35m3
10 RO Shed 7*9 1 63m2
11 RO rejection tank 4.2*4.3*4 1 72.24m3
12 RO permeate tank 5.1*5.1*4 1 104.04m3
13 Sludge sump 2*2*3 1 12m3
14 Sludge drying bed 2*1.5*3 1 9m3
15 Evaporator 45m3
16 Condensate 30m3
17 Operator room 3*6 1 18m2
18 Hazardous Waste area 3*4 1 12m2
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FIGURE -4
FLOW DIAGRAM OF ETP
Primary
Clarifier
Secondary
Clarifier
Carbon
Filter
column
Evaporator
RO
Column
RO Reject
RO
Permeate
Condensate Reject
Equalization
Tank
Neutralization
tank
Aeration Tank
Sludge Drying Bed TO TSDF
Sludge
Sludge
S
l
u
d
g
e
Activated Sludge
Storage
Tank
Effluent
Reuse
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ANNEXURE-IX
DETAILS OF HAZARDOUS WASTE
Sr.
No.
Name of
Waste
Categ
ory
(As per
CTE No.
70101)
Quantity
for EC
Treatment & Disposal
1 Process
Organic
residue
28.1 0 77.32 Collection, storage for Onsite
Distillation
OR by
authorized other vendor OR Sale to
authorized recycler
2 Solvent
Residue
28.1 0 131.17 Collection, storage, transportation &
disposal by incineration at CHWI or
send for co‐processing in cement
industries
3 Process
Inorganic
Residue
28.1 0 25.85 Sent to TSDF
4 Spent
charcoal and
hyflo
28.2 0 38.47 Collection, storage, transportation &
disposal by incineration at CHWI or
send for co‐ processing in cement
industries
5 Spent
Organic
28.2 0 889.50 Collection, storage, transportation &
disposal by incineration at CHWI or
send for co‐ processing in cement
industries
6 Spent
Inorganic
28.2 0 145.00
Sent to TSDF
7 Spent
Solvents
20.2 0 114.00 Collection, storage, transportation &
disposal by incineration at CHWI or
send for co‐processing in cement
industries
8 ETP Sludge 34.3 0 5 Collection, storage, transportation &
disposal to TSDF
9 Discarded
Container/
Bags/liner
33.3 40 Nos.
200Nos.
50 Nos.
300 Nos.
After detoxification sent
to Authorized agencies
10 Used Oil 5.1 0.012 MT 1KL/Mon
th
After detoxification sent
to Authorized agencies
11 Spent Mother
Liquor
28. 4 0 1874.63 Collection, storage, onsite treatment in
MEE Dryer & incineration OR
transportation & disposal by
incineration at CHWI or send
for co‐ processing in cement industries
12 Process
Waste
34.3 8.334 0 Sent to TSDF site of M/s. BEIL,
Ankleshwar
13 Gypsum
Sludge
-- 10 0 Sent to TSDF site of M/s. BEIL,
Ankleshwar OR Brick manufacturer
14 Briquette -- 18.334 10 Sold to Brick
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Sr.
No.
Name of
Waste
Categ
ory
(As per
CTE No.
70101)
Quantity
for EC
Treatment & Disposal
Ash manufactures
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ANNEXURE X
ENERGY AND FUEL CONSUMPTION DETAILS
Sr.
No.
Particulars Requirement Remark
Electricity
Electricity 125KVA DGVCL
Fuel
Bio-Coal 300 tonne From local supply
• There is no change in energy and fuel consumption.
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ANNEXURE XI
FLUE GAS EMISSION
PROCESS EMISSION
Sr.
No.
Stack
Attached
To
Stack
Height
Fuel
Consumptio
n
Air
Pollution
Control
System
Type
of
Emission
Permissible
Limit
As per CTE-70101
1.
IBR
Boiler
( 2TPH)
11 m
Wood:- 700
Kg/Day Or
Baggase:-
700Kg/Day
Multi
Cyclone +
Bag Filter
+ Water
Scrubber
PM
SO2
NOx
150mg/NM3
100 PPM
50 PPM
For Proposed Project
1.
IBR
Boiler
( 2TPH)
11 m
Wood:- 700
Kg/Day Or
Baggase:-
700Kg/Day
Multi
Cyclone +
Bag Filter
+ Water
Scrubber
PM
SO2
NOx
150mg/NM3
100 PPM
50 PPM
Sr.
No.
Stack
Attached
To
Stack
Height
(m)
Stack
Diamete
r
(m)
Air Pollution
Control System
Type of
Emission
Permissible
Limit
1.
Reactor
Vessel
25 0.5 Water Scrubber +
Alkali Scrubber
HBr
SO2
HCl
20 mg/Nm3
40 mg/Nm3
20 mg/Nm3
2. Reactor
Vessel
25 0.5 ---- CO2
H2O
• This is no any process gas emission in due to existing product.
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DETAILS OF AIR POLLUTION CONTROL SYSTEM
Working:
As the contaminated fumes with particles, coming from bag filter and goes to
water scrubber. Water is sprayed from the top of the nozzle, which washes the large
particle from the contaminated fumes and settles down to the bottom.
Upper water from the bottom of the scrubber is circulating through the pump
to spraying nozzle. Solid particle is accumulating at the bottom of the scrubber which
is giving to the BEIL.
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ANNEXURE XII
PROCESS DESCRIPTION
A solvent recovery system comprises of two stage heat exchangers. Cooling
tower water is circulated in primary heat exchanger and in secondary heat
exchanger chilled water circulation is done. The uncondensed solvent after the
secondary heat exchanger will be diverted to water scrubber the traces of
solvent will get dissolved in water. On getting saturation, the solvent mix
water will be subjected for recovery of solvent (if feasible) and/or water will
be diverted to ETP plant for further treatment the process will ensure no VOC
emission from solvent recovery system.
FIGURE: 3
SOLVENT RECOVERY SYSTEM
Reactor
Primary
Condenser
Cooling Tower Line
Secondary
Condenser
Chilled Water
Circulation Spray
Water Tank
Receiver
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ANNEXURE XV
LIST OF HAZARDOUS CHEMICAL
Sr. No. Raw Material
1 1,1-dimethyl ethyl -6-(2-aminoethyl)
2 4-Fluoro -2-methyl-1-oxopropyl
3 Cyclohexane
4 Iso propyl alcohol(IPA)
5 Hydrochloric acid
6 Acetonitrile
7 Sodium hydroxide
8 Calcium acetate
9 Hyflow
10 4(S)-4-hydroxy-6-sulfonamide dioxide
11 Methane sulfonic anhydride
12 Ethyl amine
13 Aq.Ammonia
14 Pyridine
15 Tetra Hydrofuran(THF)
16 Sodium bicarbonate
17 Carbon
18 2-(5-bromo-2-methyl benzul)-5-(4-flurophenyl)thiophene
19 Silyl D-gloconolactone
20 Methanol
21 Acetone
22 Potassium carbonate
23 2,3-di-o-acetyl-5-deoxy-5-fluorocytidine
24 n-Pentyl Chloroformate
25 Methylene Chloride(MDC)
26 Ethyl Acetate
27 Activated Carbon
28 RS-a-Sulfophenyl acetic acid
29 (S) –a- Methyl benzyl amine
30 1-Hydroxy benzotriazole
31 Methane sulphonyl chloride
32 Hexane
33 7-Amino cephalosporic acid
34 Boron trifluride etherate
35 Tert-butyl acetate
36 Zinc chloride
37 Triethyl amine
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38 Di isopropyl ether(DiIPE)
39 Pyridine-4-carboxamide
40 Sodium iodide
41 Dimethyl formamine
42 Ethanol
43 Sodium acetate
44 3-[(1-Methyl-2-{[4-(5-oxo-4,5-dihydro-[1,2,4]oxadiazol-3-yl)-
phenylamino]-methyl)-1Hbenzoimidazole-5-carbonyl)-pyridin-2-yl
amino]-
propionic acidethyl ester
45 P-toluene sulphonic acid
46 Acetic acid
47 Hexa chlorofomate
48 �-(dimethylamino) benzenepropanol
49 1-fluoronaphthalene
50 Dimethyl sulfoxide(DMSO)
51 n-Propanol
52 (3R,3as,4aR)-hexahydrofuro[2,3-b]furan-3-ol
53 4-Amino-N-(2R,3S)(3-amino-2-hydroxy-4-phenyl-butyl)-N-isobutyl
benzenesulfonamide
54 Disucinimidyl carbonate
55 Sulphuric acid
56 2-Methyl2-Butanol
57 2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethanesulfinyl]-
1H-benzoimidazole
58 L (+) Mandelic acid
59 Diethyl tartarate
60 Titanium isopropoxide
61 Triethyl amine
62 Aloe emodine
63 Sodium dichromate dihydrate
64 Propionic anhydride
65 Toluene
66 Acetic anhydride
67 N-Methyl pyrrolidone
68 Celite
69 (±)-Trans-5,6-dihydro-4H-4-Ethyl amino-6-methylthieno[2,3-
b]thiopyran-2-sulfonamide-7,7-dioxide
70 n-Butanol
71 (-)Di-para-toluoyl-Ltartaric acid monohydrate
72 Intermediate-I
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73 Intermediate-II
74 n-butyl lithium in THF
75 Triethyl tin hydride
76 Trifluro borate-etharate
77 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]thio]-1H-
benzimidazole
78 Hydrogen Peroxide
79 Vanadium acetyl acetonate
80 Ammonia liquor
81 Magnesium Chloride
82 (S)-(-)-1,1-Bi-2-Naphthol
83 2-butyl-1,3-diazaspiro[4,4]non-1-ene-4-one hydrochloride
84 5-[4'-(bromomethyl) biphenyl-2-yl]-1-trityl-1Htetrazole
85 Methanolic HCl
86 Methylene Methylene
87 30% sodiumhydroxide lye
88 2-[2-[3(S)-[3-[2-(7-Chloro-2-quinolinyl)-ethenyl]phenyl]-3-
hydroxypropyl]phenyl-2-propanol
89 2-[1-(Sulfonyl methyl)cyclopropyl]acetic acid
90 N,N-Diisopropylethylamine
91 N-{4-[4-(4-Hydroxyphenyl)-piperazin-1-yl]-phenyl}-carbamic acid
phenyl ester
92 Formic acid N'-(2-benzyloxy-1-ethyl-propyl)-hydrazide
93 (5R-cis)-5-(2,4-difluorophenyl)-5-(1,2,4-triazol-1-
ylmethyl)tetrahydrofuran-3-methanol tosylate
94 methanol tosylate
95 2,3,4,6,7,8,9,10-Octahydro pyrimido[1,2-a]azepine
96 Formic acid
97 Dimethyl Sulfoxide
98 Palladium
99 Dibenzo-(1,4)-thiazepine-11(10H)-one
100 2-(2-(piperazin-1-yl)ethoxy)ethanol
101 Thionyl chloride
102 3- Pyridyl Acetic Acid
103 Diethyl carbonate
104 Methane sulfonic Acid
105 1H-Benzimidazole-2npropyl-4-methyl-6-(1-methyl benzimidazole-2yl]
106 4-methyl-(bromomethyl) bi phenyl carboxylate
107 Methyl Iso Butyl Ketone (MIBK)
108 5-{4-[4-(5-Cyano-1H-indol-3-yl)-butyl]-piperazin-1-yl}-benzofuran-2-
carboxylicacid methyl ester
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109 PHBA
110 MONO ETHYLENE GLYCOL
111 2-METHOXY-5-SULPHOMYL METHYL BENZOATE
112 S-1-ETHYL-5-AMINOMETHYL PYROLLIDINE
113 HEXA METHYL DI AMINE
114 SODIUM DI CYNAMIDE
115 TRI ETHYL AMINE
116 SODIUM HYDROXIDE FLAKES
117 PCA HCL
118 1-H-1,2,4-trizole
119 Epoxy comound
120 2-chloro 2,3 dimethoxy pyridine
121 5-dithiomethoxymenzimidazole
122 TEBA
123 sodium hypochlorite
124 sodium thiosulphate soln.
125 IPE
126 2-methoxy-ethyl-(3-nitro benzylidine)acetoacetate
127 3-amino crotonic acid cinnamyl ester
128 Benzo Pyran Acetaldehyde
129 Benzo Pyran ethelamine
130 Sodium Cyano borohydried
131 diethyl Ether
132 4-Methyl 2-Nitro Anisidine
133 Sodium hydro Sulfide
134 Carbon disulfide
135 Benzyl amine DPTT
136 Cerric Ammonium nitrate
137 NaBH4
138 4,6‐Dichloro‐5‐(2‐Methoxyphenoxy)‐2,2‐Bipysimidine
139 4‐Tert‐Butylbenzene Sulfonamide
140 Sodium Tert Butoxide
141 (4‐4‐Aminophenyl)‐morpholin‐3‐one
142 Glycidyl Phthalimide
143 4‐Dimethylaminopyridine(DMAP)
144 CDI
145 5‐Chlorothiophene‐2‐cacoxylic acid
146 Oxalyl Chloride
147 Aq. Methyl Amine
148 KSM
149 Isobutyl Bromide
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150 Ammonium Hydroxide. HCl
151 2‐(7‐methoxy‐1‐napthyl)Acetonitrile/ Agomelatine
152 Hydrogen Gas
153 Isopropyl Alcohal HCl
154 S(+)-2 amino butyramide hydrochloride
155 4-chloro butyryl chloride
156 Nitro Methane
157 Formaldehyde
158 Bromine
159 ODPA
160 Hydroquinone
161 Tertiary Butanol (TBA)
162 Iminostilbenecarbonyl chloride
163 Octylbenzene
164 Aluminium chloride
165 Bromoacetyl bromide
166 Diethylacetamido malonate
167 Triethylsilane
168 TiCCl4
169 Maleic acid
170 Ethyl acetate for washing
171 N,N-Dimethylacetamide
172 4-(Dimethylamino)pyridine
173 1-hydroxybenzotriazole
174 Dimethylformamide
175 Ethoxy phenoxy ethyl bromide
176 Cetyl Chloride
177 Pyridine
178 Methyl ethyl ketone
179 Lauryl Chloride
180 Acefilline
181 Ambroxol Base
182 Anisol
183 3,5 Dribromo Acetophenone
184 Nicotonic acid
185 Fresh Benzene
186 Chlorine gas
187 Furfuraldehyde
188 2,3 Dichloro Aniline
189 Fresh orthoxylene
190 Bis Salt
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191 Hydrazine Hydrate
192 Meta Di Chloro benzene
193 Imidazole
194 ISO Nicotinamide
195 Paraformaldehyde
196 DMA HCl
197 Acetophenone
198 Catechol
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Hydrazine Hydrate
Meta Di Chloro benzene
ISO Nicotinamide
Paraformaldehyde
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ANNEXURE XIV
CTE
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