Your Health isOur Passion!

APIs and Intermediates catalogue

Company Profile• Located 25 km of Riga, Latvia• Company established in 1972 • Olainfarm is an innovative manufacturer of Finished dosage forms, Original and Generic APIs, API

intermediates, Specialty organic chemicals• Site area 430 000 sq. meter, multipurpose plant• Full cGMP compliance• Products offered in gram to tons quantities

Research and Development• Synthetic route scouting• Technology optimization/upscale• Development and Validation of analytical methods• Determination and characterization of impurities• Degradation studies and stability testing

Our Chemistry Know-how• Quinuclidine chemistry• Adamantane chemistry• Chiral amino acids• Hydrogenations• Handling of hazardous chemicals• Metalorganic chemistry

Contract Manufacturing• APIs and Intermediates manufacturing

We offer full cycle API and Intermediates development/upscale/manufacturing under cGMP

QC/QA and Regulatory Documentation Support• Compilation of Active Substance Master File (ASMF) and Dossiers in CTD and eCTD formats• Qualification and Validation (facility, equipment and process validation)• Conducting internal audits as part of self-inspection program to ensure compliance to GMP standards

and also vendor audits• Preparation of Quality Reviews (PQR)• Change control, deviation investigation and handling of market complaints • QC of Raw materials, in-process samples and finished products

Equipment1. HPLC/UPLC (UV, MS, LSD, RI) 2. GC, GC-MS3. Particle size analysis4. IR, UV, Optical rotation, mp, XRPD, NMR5. Solubility determination6. Automatic titrators

Kilo Lab/Pilot plant/Production plant• Plant area — 45000 sq. meters• Operating volume — 219 000 liters• Operating temperature — -10 to +200 deg. C (-50 to +200 deg. C for the Kilo lab)• Operating vaccum — 3–5 mBar

No. Chemical name Structural formula Molecular formula

Key use StageCAS No.

1. 1– Adamantyl methyl ketone(1– Acetyladamantane)

C12H18O Rimantadine hydrochloride

C[1660 – 04 – 4]

Adamantane derivatives

Intermediates

2. 2 – Adamantanone C10H14O C[700 – 58 – 3]

3. 2 – Adamantanol(2 – Hydroxyadamantane)

C10H16O P[700 – 57 – 2]

4. 1,3 – Dimethyladamantane C12H20 C[702 – 79 – 4] Memantine hydrochloride

6. 3 – Amino – 1 – hydroxy – adamantane

C10H17NO C[702 – 82 – 9] Vildagliptin

9. 1 – Chloro – 3,5 – dimethyladamantane

C12H19Cl C[707 – 36 – 8] Memantine hydrochloride

10. 1 – Hydroxy – 3,5 – dimethyladamantane

C12H20O C[707 – 37 – 9] Memantine hydrochloride

15. 1 – Acetylamido – 3,5 – dimethyladamantane

C14H23NO L[19982 – 07 – 1] Memantine hydrochloride

17. (2S) – [(tert – Butoxycarbonyl)amino](3 – hydroxyadamant – 1 – yl)ethanoic acid

C17H27NO5 L[361442 – 00 – 4] Saxagliptin

14. 1 – Adamantaneethanol[2 – (1 – Adamantylethanol)]

C12H20O P[6240 – 11 – 5]

13. 1 – Adamantanemethanol(1 – Adamantylmethanol)

C11H18O P[770 – 71 – 8]

12. 1 – Adamantaneacetic acid(1 – Adamantylacetic acid)

C12H18O2 P[4942 – 47 – 6]

11. 1,3 – Dihydroxyadamantane(1,3 – Adamantanediol)

C10H16O2 L[5001 – 18 – 3]

8. 1 – Acetylamidoadamantane C12H19NO L[880 – 52 – 4]

7. N – (2 – Adamantyl) – N – (4 – bromophenyl)amine

C16H20BrN P[87913 – 26 – 6]

5. 2 – Aminoadamantane hydrochloride

C10H17N .

HCl P[10523-68-9]

16. 3 – (Hydroxy – methyl)adamant – 1 – ol

C11H18O2 L[38584 – 37 – 1]

CH3

O

CH3

CH3

NH2

ClH

NH

Br

NHCH3

O

CH3 CH3

Cl

CH3 CH3

OH

NHCH3

CH3

CH3

O

OH

OH

O

NHBoc

O

OH

NH2

OH

OH

OH

OH

O

OH

OH

OH

OH

No. Chemical name Structural formula Molecular formula

Key use StageCAS No.

18. Dimethyl-5-hydroxy-1,3-Adamantane dicarboxylate

C14H20O5 P[213274-64-7]

Adamantane derivatives

Intermediates

19. S-Rimantadine C12H21N P[887336-06-3]

20. R-Rimantadine C12H21N P[887336-05-2]

OH

COOMeMeOOC

CH3NH2

CH3NH2

1. 1 – Aminohydantoin hydrochloride C3H5N3O2 ⋅ HCl C[2827 – 56 – 7] Dantrolene Nitrofurantoin

No. Chemical name Structural formula Molecular formula

Key use StageCAS No.

Miscellaneous

NHN

O

O

NH2 • HCl

C – Commercial, P – Pilot, L – Laboratory

No. Chemical name Structural formula Molecular formula

Key use StageCAS No.

1. 3-Quinuclidinone hydrochloride

C7H11NO .

HCl Aceclidine Azasetron Cevimeline Clidinium MequitazineQuifenadine

C[1193

[50790-85-7]

– 65 – 3]

Quinucilidine derivatives

Intermediates

2. 3-Carbethoxy-dehydro-quinuclidine hydrochloride

C10H15NO2.

HCl C

3. 3-Carbethoxyquinuclidine C10H17NO2 C[6238 – 33 – 1]

4. 3-Quinuclidinol C7H13NO C[1619 – 34 – 7] AceclidineClidiniumQuinupramineAclidinium

Quifenadine

6. R – ( – ) – 3 – Quinuclidinolee 99.9%

C7H13NO C[25333 – 42 – 0] SolifenacinAclidinium

9. S – ( – ) – 3 – Aminoquinuclidine dihydrochlorideee 99.5%

C7H14N2 .

2HCl C[119904 – 90 – 4] Palonosetron

10. 3 – Quinuclidine carboxylic acid hydrochloride

C8H13NO2 .

HCl L[6238-34-2]

[79221-75-3]

Free base[138874-55-2]

Free base[88644-21-7]

[865887-14-5]

15. S-3-aminomethyl-quinuclidine dihydrochloride

C8H16N2 .

2HCl L

14. 3-aminomethyl-quinuclidine dihydrochloride

C8H16N2 .

2HCl L

13. S-3-hydroxymethyl quinuclidine hydrochloride

C8H15NO .

HCl L

12. R-3-hydroxymethyl quinuclidine hydrochloride

C8H15NO .

HCl L

11. 3-hydroxymethyl quinuclidine hydrochloride

C8H15NO .

HCl L

8. R – (+) – 3 – Aminoquinuclidine dihydrochlorideee up to 99.5%

C7H14N2 .

2HCl C[123536 – 14 – 1]

7. 3 – Aminoquinuclidine dihydrochloride

C7H14N2 .

2HCl C[6530 – 09 – 2]

5. S – (+) – 3 – Quinuclidinolee 99.5%

C7H13NO C[34583 –34–1]

16. R-3-aminomethyl-quinuclidine dihydrochloride

C8H16N2 .

2HCl L

N

O

• HCl

N

OH

N

OH

N

OH

N

NH2

• 2HCl

N

NH2

• 2HCl

N

NH2

• 2HCl

N

COOH

• HCl

N

OH• HCl

N

OH• HCl

N

OH• HCl

N

NH2

• 2HCl

N

NH2

• 2HCl

N

NH2

• 2HCl

C – Commercial, P – Pilot, L – Laboratory

N

O

OEt• HCl

N

O

OEt

Drug substances (APIs):

No. Product Therapeutic category Pharmacopoeia StageCAS No.

C – Commercial, P – Pilot, L – Laboratory® - Registered Trademark in Republic of Latvia

Generics

1. Amantadine hydrochloride(ASMF available)

Antiviral (Influenza A); antiparkinsonian; treatment of drug-induced extrapyramidal reactions

Ph, Eur.USP

[665 – 66 – 7] C

2. Amantadine sulphate Antiviral (Influenza A); antiparkinsonian Non – pharmacopoeial

[31377 – 23 – 8] P

3. Anagrelide hydrochloride(ASMF available)

Platelet-reducing agent USP [58579 – 51 – 4] C

4. Chlorobutanol hemihydrate (ASMF and CEP available)

Analgesic (dental) Ph. Eur. (CEP) [6001 – 64 – 5] C

5. Furazidin (Furagin®)(ASMF available)

Antimicrobials Non – pharmacopoeial

[1672 – 88 – 4] C

6. Memantine hydrochloride(ASMF available)

Anti-Dementia Drug USP [41100 – 52 – 1] C

7. Nitrofurantoin monohydrate(ASMF available)

AntibacterialVet: Antibacterial

USP [17140 – 81 – 7] [monohydrate]

C

8. Nitrofurantoin Macrocrystalline(ASMF in development)

AntibacterialVet: Antibacterial

USP [67 – 20 – 9] [anhydrous]

C

9. Phenazepam(ASMF in development)

Tranquillisers Non – pharmacopoeial

[51753 – 57 – 2] C

10. Rimantadine hydrochloride(ASMF available)Pure enantiomers available

Antiviral USP [1501 – 84 – 4] [hydrochloride]; [13392 – 28 – 4] [base]

C

11. Thalidomide(ASMF available)

All other antineoplastics USP [50 – 35 – 1] C

12. Lenalidomide(ASMF available)

All other antineoplastics Non – pharmacopoeial

[191732 – 72 – 6][base]

C

13. Lenalidomide Hydrochloride(ASMF available)

All other antineoplastics Non – pharmacopoeial

[1243329 – 97 – 6] P

14. R-(+)-Phenibut Non – pharmacopoeial

[35568 – 36 – 6] P

15. R-Phenylpiracetam Non – pharmacopoeial

[949925 – 07 – 9] P

17. R-Baclofen(Technical package available)

Non – pharmacopoeial

[69308 – 37 – 8] C

No. INN Therapeutic category Structural formula ASMF available

CAS No.

1. CevimelineHydrochloride

And free base

Q4 2015[153504-70-2][107233 – 08 – 9]

[274901 – 16 – 5]

In development

Drug substances (APIs):

2. Vildagliptin Q2 2015

3. Saxagliptin Q2 2016[361442 – 04 – 8]

4. Glycopyrrolatebromide

Q2 2016[596 – 51 – 0]

5. Ivabradine hydrochloride

Antianginal

ATC: C01EB17

Antispasmodic; Anticholinergic; Antimuscarinic

ATC: A03AB02

Antidiabetic

ATC: A10BH03

Antidiabetic

ATC: A10BH02

Parasympatho – mimetic

ATC: N07AX03

Q2 2016[148849 – 67 – 6]

6. Aclidinium bromide Bronchodilator

ATC: R03BB05and R03AL05

2017[320345-99-1]

7. Umeclidinium Bromide Bronchodilator

ATC: R03BB07 and R03AL03

2017[869113-09-7]

8. Pomalidomide All other antineoplastics

ATC: L04AX

Q4 2015[19171 – 19 – 8]

N

O

ON

OO

O

• HCl

N

NH

O

O

O

O

NH2

9.

S

O

N• HCl

NH2

NO

HH

CN

OH

N+

O

O

S

SOH

O Br

Apremilast Antipsoriatic

ATC: L04AA32

2017[608141-41-9]

N

O

ONH

O

S

O

O

O

O

OH

NH

N

O

CNH

N+

O

OH

Br

O

O

OH

N+ Br

Address: 5 Rupnicu Street, Olaine, LV-2114, LatviaPhone: (+371) 67013705Fax: (+371) 67013777E-mail: olainfarm@olainfarm.lv

www.olainfarm.com

Certificates• EU GMP for APIs and FDFs• US cGMP for certain APIs (FDA)• TGA for FDFs (Australia)• ISO 14001 Environmental Management System• ISO 17025 Laboratory Management System

YOUR HEALTH IS OUR PASSION SINCE 1972Olainfarm is the leading manufacturer in the chemical and pharmaceutical sector of the Baltic States with more than 40 years of experience.

Export to more than 40 countries