newINTRODUCTORY PAGEnew

ASSIGNMENT OF ENTREPRENEURSHIP

BYENTREPRENEURES

HARIS AHMED BUTT (1432-111026)

LIAQAT ALI KHAN (1432-111124)

HAFIZ MAZHAR SIDDIQ (1432-111016)

M.ZUBAIR KHAN (1432-111021)

Mentor: HUMAYUN SHUJA SATTI

1/13/2012

INTRODUCTORY PAGE:

Name of Business:

D.M.D PHARMACUETICAL (PVT) LTD.

Addresses of Business:

Head Office & Plant:

PLOT # 78, phase 3, HATTAAR, HATTAAR INDUTRIAL ESTATE HARIPUR KPK PAKISTAN

PHONE: +92 (995) 6172003-7 (5 LINES)

FAX: +92 (995) 6172008

UAN: 111-000-007

WEB ADD: www.dmd-pharma.com.pk

E-MAIL: [email protected]

D.M.D PHARMACUETICAL (PVT) LTD Reserves the Copy Rights.

mailto:[email protected]

Names and Addresses of Principal:

Mr. HARIS AHMED BUTT (CEO/EXECUTIVE DIRECTOR-MANAGING, MARKETING & FINANCE) HOUSE # I/244 MOHALLAH QUTB-UD DIN MURREE ROAD RAWALPINDI REGISTRATION # 1432-111026PHONE: +92 (995) 6172007FAX: +92 (995) 6172008CELL: +92 (333) 5528464E-MAIL: [email protected] ;

[email protected]

Mr. LIAQAT ALI KHAN (CHAIRMAN-EXECUTIVE DIRECTOR-QUALITY OPERATION-R&D)HOUSE #256 STREET 124 SECTOR G-9/3 ISLAMABAD REGISTRATION # 1432-111124PHONE: +92 (995) 6172006FAX: +92 (995) 6172008CELL: +92 (345) 8552110E-MAIL: [email protected] ;

[email protected]




Mr. HAFIZ MAZHAR SIDDIQ (EXECUTIVE DIRECTOR-SUPPLY CHAIN, LEGAL & REGULARITY AFFAIRS) HOUSE # 147 STREET NUMBER 4, SINGAM TOWN, ISLAMABAD REGISTRATION # 1432-111016PHONE: +92 (995) 6172005FAX: +92 (995) 6172008CELL: +92 (345) 99500281E-MAIL: [email protected] .pk;

[email protected]

Mr. MUHAMMAD ZUBAIR KHAN(EXECUTIVE DURECTOR-PRODUCTION)HOUSE # 24, STREET # 501, NASEERABAD, RAWALPINDI.REGISTRATION # 1432-111021PHONE: +92 (995) 6172004FAX: +92 (995) 6172008CELL: +92 (333) 5535042E-MAIL: [email protected] ;

[email protected]





Nature of Business:

Establish a Pharmaceutical Company for Diagnosis to Management of Diabetes

Finances Required

To Establish ONE ACRE Locally Industry along with other accessories, a Total of Rs.100 M would be required (for detail of finance please see back ground of entrepreneurs)

Confidentiality Report

This Report is Highly Confidential and should not be transmitted to any Person not authorized to Read it. D.M.D PHARMACUETICAL (PVT) LTD. Reserves the Copy Rights.


INDUSTRY ANALYSISMacro Environment:

Economy:

Pakistan’s economy like other developing countries is in recession and investment in any field

requires very calculated steps after thorough deliberations Pakistan is a poor country and its

economic outlook is bleak. It relies heavily on foreign loans and grants, and debt obligations take nearly 50 percent of the government's expenditures. The average per capita income per person in Pakistan is estimated at $460 (U.S.). A large number of Pakistanis, estimated at 35 percent, live below the poverty line.

Culture:

A very few areas of Pakistan are in this business, however this idea may be taken by the other companies but they not yet used it. At least 95 percent of the Pakistani population is Muslim; there are two food customs that are followed almost universally. One is that Muslims do not eat pork (therefore beef, chicken, lamb, and fish are the basic foods), and the other is that during the month of Ramadan, fasting is a daily activity.Spices and curry are an essential part of any Pakistani recipe. The most prevalent spices include chili powder, tumeric, garlic, paprika, black and red pepper, cumin seed, bay leaf, coriander, cardamom, cloves, ginger, cinnamon, saffron, nutmeg, and poppy seeds, among others. Using yogurt to marinate meats is another typical recipe. Because of the use of spices and curry for the main dish, the usual side dish is plain rice. Lentils are another common specialty. The food in the south is more exotic and highly spiced, while that in the north often features plain barbecued meat as the main dish. Usually any meat, fowl, or seafood is curried, and frying is the typical method of cooking. Ghee, which is clarified butter, is another commonly used recipe item and is often used for frying. Wheat and flour products are considered mainstays of the daily diet and the use of pickles, chutneys, preserves, and sauces along with curried meats, seafood, vegetables, and lentils and are why Pakistani cuisine has such a unique flavor.Green tea is the typical drink served at all meals.

Technology:

Imported technology would be costly therefore reliance on local made structure will have to be made.


Legal:

Copyright Amendment Ordinance, 2000.

Registration of layout Designs of integrated Circuits Ordinance, 2000.

Industrial Designs Ordinance, 2000.

Patents Ordinance, 2000.

The trade marks ordinance, 2001

Specific Industry Environment:

Future Outlook:

Pakistan’s Pharmaceutical Market is small and equally split between multinational and domestic companies. By 2016, Pakistan will be the 11th largest Pharmaceutical Market which dominated by locally manufactured pharmaceuticals, predominantly generic drugs, which meet around 90% of country’s needs

Trend of Industry:

Pakistan Pharmaceutical Industry is currently undergoing a transition where it needs to anticipate and adapt to the challenges & opportunities within this evolving landscape to ensure the uninterrupted supply of innovative medicines through research and development.

Growth Rate:

Pharmaceuticals: PKR152.78bn (US$1.79bn) in 2010 to PRK172.86bn (US$1.98bn) in 2011; +13.1% in local currency terms and +10.6% in US dollar terms.

Healthcare: PKR398.06bn (US$4.67bn) in 2010 to PKR456.48bn (US$5.24bn) in 2011; +14.1% in local currency terms and +12.0% in US dollar terms. Medical devices: PKR29.87bn (US$351mn) in 2010 to PKR35.48bn (US$407mn) in 2011; +18.8% in local currency terms and +16.1% in US dollar terms.

Overall growth rate of Industry is +15.5%

Government Policies:


THE DRUGS ACT 1976 (SALIENT FEATURES):

An Act to regulate the import, export, manufacture, storage, distribution and sale of drugs.

It extends to the whole of Pakistan and Federally Administered Tribal Areas (Including Export Processing Zones).

The State of Azad Jammu and Kashmir has also adopted this Act and the jurisdiction of the Central Licensing and Registration Boards constituted under this Act is extended to the territory of A J & K

Drugs Act, 1976 is a Federal legislation with distribution of functions between the Federal Government and Provincial Governments as follows:-

Federal Government Provincial Government

Manufacture Sale

Registrations

Pricing

Import

Export

For the purpose of this Act a drug is defined in section 3 (g) and includes allopathic drugs, surgical ligature, sutures, bandages, absorbent cotton, disinfectants, adhesive plasters, etc. Under this Act, the Federal Government has laid down the following rules to carry out various functions entrusted to it under this Act:

The Drugs (Licensing, Registering and Advertising) Rules 1976.

The Drugs (Labeling and Packing) Rules, 1986.

The Drugs (Import and Export) Rules, 1976.

The Drugs (Appellate Board) Rules 1976.

The Drugs (Research) Rules, 1978.

The Drugs (Specifications) Rules, 1978.

The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976.


When a proposal is made for establishment of the a pharmaceutical unit, the following documents are requested: -

a. A copy of the National Identity Card of the applicant.

b. Deed / lease document of the land / plot, for its proper identification.

c. Information about the company/firm, its directors or partners.

d. Sketch of the proposed site.

2. Verification of the site.

3. Approval of the layout plan.

THE DRUG MANUFACTURING LICENSE FEE SCHEDULE 'F‘

Site verification Rs. 1000/-

Approval of the site Rs. 1000/ - layout plan per section

Revision/expansion Rs. 500/ - of lay out plan per section

Grant of License

Basic Rs.10,000/-

Semi basic Rs.10,000/-

Formulation Rs.35,000/-

Repacking Rs.20,000/-

REGISTRATION OF DRUG:

THE REGISTRATION FEE SCHEDULE IS AS UNDER:-

For grant of Registration

Type of Drug Fee

1. New Drug Molecule Rs.15,000/-

2. Any other drug for import Rs. 15,000/-

3. Any other drug for local

Manufacture including Glenicals Rs 8,000


For renewal of Registration

(i)If the application for renewal is made before the expiry of the validity of a certificate:

Type of Drug Fee

1. Drug for import Rs. 7,500/-

2. Drug for local manufacture Rs. 4,000/-

including galenicals

(ii) If the application for renewal is made within sixty days after the

expiry of the validity of a certificate:

Type of Drug Fee

1. Drug for import Rs.15,000/-

2. Drug for local manufacture Rs. 8,000/-

including galenicals

Other Government Policies are as follow:

ALLOCATION OF CONTROL SUBSTANCES.

THE DRUGS APPELLATE BOARD

QUALITY CONTROL

DRUG PRICING

RESEARCH AND DEVELOPMENT

BULK RAW MATERIAL MANUFACTURE

Market Segmentation and Target Market

Pakistan alone currently counts 6.2 Million People with Diabetes and Estimated figures for 2025 suggest that this will almost double and reach 11.6 Million People.

Our Target Audience will be as follow:

Endocrinologist

Diabetologists


Physician

Nephrologists

Cardiologists

General Practitioner (G.Ps)

RMOs (Medicine)


DESCRIPTION OF VENTUREMission Statement:

“DIAGNOSIS TO MANAGING DIABETES”

History of Venture:

There are four Entrepreneur joining hand to establish

D.M.D PHARMACUETICAL (PVT) LTD.

Mr. Haris was work as a Product Specialist in Pharmaceutical Company. For his up keeping and growing in profession he starts MBA. His company think that his study plan will affect the effectiveness and efficiency of work, so they asked him to focus on the job.

Being Entrepreneur he decided to left job and start his own business with new idea. He shared his idea with his friends (Liaqat,Mazhar and Zubair), because his friends were having vast experience of R&D, Production, Quality Control and Administration.

They like his idea and make plan to start the business by putting their part of the assets. The idea is that “We manufacture and market diabetes products because Pakistan alone Currently counts 6.2 Million People with Diabetes and Estimated figures for 2025 suggest that this will almost double and reach 11.6 Million People. And captured 0.3 – 0.5 Million People with diabetes for our business”

Location and Size OF the Business:

They select HATTAAR (PLOT # 78, HATTAAR ROAD, ISLAMABAD) due to government relief in Taxes sand various relevant facilities for industrial sites.

The size of the business ONE ACRE Locally Industry along with other accessories

Products:

The ADA Clinical Practice Recommendations now recommend using HbA1c to diagnose diabetes, for this purpose we have


“Hba1c Device by the name of NOW+”

For Type-1 patient we have

Insulin glargine, is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystal’s that slowly release insulin, giving a long duration of action of 18 to 26 hours. Pharmacokinetically, it resembles basal insulin secretion of non-diabetic pancreatic beta cells.

“Insulin Glargine by the name of GLARIN”For Type-2 patients we have:Sitagliptin (is an oral antihyperglycemic (antidiabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. This enzyme-inhibiting drug is used either alone or in combination with other oral antihyperglycemic agents (such as metformin or a thiazolidinedione) for treatment of diabetes mellitus type 2.

Metformin is an oral antidiabetic drug in the biguanide class. It is the first-line drug of choice for the treatment of type 2 diabetes, in particular, in overweight and obese people.For alone treatment we have

“Sitagliptin by the name of SIPTIN” For Combination treatment we have

“Sitagliptin+Metformin by the name of SIPTIN+”


Office Equipment and Personnel:

For office equipment we required following

Furniture

Laptop 1

Desktop 10

And personnel are

Production supervisor 1

Production 18

R&D supervisor 1

R&D staff 6

Sales manager 3

DFM 5

Doctor 5

Sales Persons 18

Stock and storage 1

Supervisor

Electrician 1

IT manager 1

Genitor 1

Peon 2

Security Guard 2


Backgrounds of Entrepreneurs:

HARIS AHMED BUTT

Qualification B.Sc, having 7.5 year Experience of Sales and Marketing in Pharmaceutical Company

LIAQAT ALI KHAN

Qualification B.Sc Electronics Engineering, having experience of R&D for 11 years , quality control & production for 10 years and Marketing for 4 years

M.ZUBAIR KHAN

Qualification B.A, having experience of production officer for 6 year.

HAFIZ MAZHAR SIDDIQ

Qualification B.Sc, having experience of admin 1.5 year and sales of 2.5 year


PRODUCTION PLANFor Hba1c device we follow following steps in manufacturing process.

The test strip is preferably a porous membrane in the form of a non-woven, a woven fabric, a stretched sheet, or prepared from a material such as polyester, polyamide, polyolefin, polysulfone, or cellulose.

A test strip is manufactured by mixing 40 g of an anionically stabilized (3.8 parts by weight sodium lauryl sulfate and 0.8 parts by weight dodecyl benzene sulfonic acid) water-based hydroxyl elastomer, containing about 5% by weight colloidal silica and 5 g of finely ground titanium dioxide. Then I g of tetramethylbenzidine, 5,000 units horseradish peroxidase, 5,000 units glucose oxidase, 0.12 g tris, and 10 g of water (hydroxymethyl) aminomethane (buffer) are mixed into the batch.

After mixing to ensure a homogeneous blend, the batch is cast onto a polyethylene terephthalate sheet for added structural integrity in a carrier matrix, and dried at 122°F (50°C) for 20 minutes.

Next, 100 mg of 3-dimethyl amino benzoic acid, 13 mg of 3-methyl-2-benzothiazolinone hydrazone, 100 mg of citric acid monohydrate-sodium citrate dihydrate, and 50 mg of Loval are added in dry form to a 50 ml tube.

These dry materials are mixed with a spatula, then 1.5 g of 10% water solution of carboxymethylcellulose is added and mixed thoroughly with the above solids.

Next, 2.1 g of dialyzed carboxylated vinyl acetate ethyl copolymer latex is added and thoroughly mixed.

The latex copolymer had been dialyzed (separation of larger particles from smaller particles) by placing about 100 g of carboxylated vinyl acetate/ethylene copolymer emulsion into a membrane tubing. The filled membrane was soaked in a water (distilled) bath at 68°F (20°C) for 60 hours to allow low molecular weight particles, unreacted monomer, catalyst, surfactant, etc. to pass through the membrane. During the 60 hours the water was continuously changed using an overflow system. The remaining dialyzed emulsion was then used in preparing the reagent layer.

Then 0.18 ml of glucose oxidase is pippeted to the tube as a liquid. Next, peroxidase is pipeted as a liquid to the tube and tartrazine is pipeted to the tube. The resulting mixture is mixed thoroughly. This mixture is allowed to stand for approximately 15 minutes.


A polished-matte vinyl support prior to being coated with the above solution was cut to form cell rows and then wiped clean with methanol. The mixture is pulled into a 10 ml syringe and approximately 10, 6 mm drops are placed on each cell row. The coated cell row is heated in an oven at 98.6°F (37°C) for 30 minutes followed by 113°F (45°C) for two hours. This process of coating and spreading the mixture is repeated for each cell row. The cell rows were then cut into strips of the desired size.

These strips were packaged with absorbent packs of silica gel and dried overnight at approximately 86°F (30°C) and 25 mm/Hg vacuum

For insulin Glargine we follow following steps in manufacturing process.

Human insulin is grown in the lab inside Escherichia coli, a common bacteria. Though it is by far the most widely used type of bacterium, yeast can also be used as a substitute. The human protein that produces insulin, is obtained through an amino-acid sequencing machine that synthesizes the DNA

Manufacturers input insulin's amino acids (the exact number of which is known to the manufacturers), and the sequencing machine connects the amino acids together. Large tanks (fermentor) are needed to grow the bacteria and also to synthesize insulin.

For Sitagliptin and Sitagliptin+Metformin we follow following steps in manufacturing process.

These days, the majority of medications are in the form of pills, tablets, caplets, capsules or softgels. In the case of tablets, manufacturers have standard size molds for the precise size of their pill. During the manufacturing process, in addition to the active ingredients, the manufacturer will generally add a variety of excipients (other ingredients) to take up space (fillers), hold the ingredients together (binders), and assist


in disintegration (disintegrants). It may even be necessary to coat the tablet so that the taste and odor are masked (coatings). Fillers are necessary for the manufacturing process, but do nothing more for the pill itself than take up volume. The pill must be large enough for human fingers to readily handle. Even some small pills are quite a bit larger than the active ingredients they contain. Some common fillers are lactose (milk sugar), microcrystalline cellulose, corn starch, sugars (including sucrose, mannitol, sorbitol, fructose, dextrose), whey and yeast

Binders are used to make the components stick together when the ingredients are compressed to make the pill. Some common binders are povidone, xanthan gum and Carbopol (an acrylic resin). Some fillers may also act as binding agents and are referred to as filler/binders. Disintegrants facilitate the break-up of the tablet in the stomach. Some commonly used disintegrants are crospovidone, croscarmellose sodium and gellan gum.Coatings help to prevent the tablet from dissolving too soon, thus breaking up in your mouth. They may also keep you from tasting or smelling the active ingredients. A common coating is shellac - the same as used on wood floors and boats!Time-release capsules contain a variety of micro-pills that are designed to disintegrate in the stomach at different times. Each micro-pill has a little bit of active ingredient and fillers coated with a mixture of shellac and other compounds. The precise nature of the chemicals used in the coating controls the time the micro-pill takes to dissolve in the stomach .Colorants or pigments include titanium dioxide (white) and iron oxides (red or yellow). Plasticizers are used to improve the flexibility of coatings so that they don't crack or chip. (You've probably noticed how small amounts of material will rub or chip off uncoated tablets, simply through handling of the pill bottle.)

Physical Plant Layout:


Machinery and Equipment:

Making Machine Single Stroke to make Small Size Tablets as well as Large Sizes Tablets Like Round Square Rectangular, Oval, Hexagonal, Capsule Shape or any other Shapes. Tablet Making Machines are useful for Pharmaceutical Industries.

Technical Data

MODEL Heavy Duty

Output Per Hour 3600-36000(According to Number of

Punches and Size of Tablet)

Maximum Running Pressure (App.)

6 Tone

Maximum Tablet Dia 6 Tone

Power Required 1 H.P

Net. Weight 485 Kg

Dimensions (L X B X H) 100 X 71 X 155

Tray Dryer is used for the best drying results in conventional process. It is a double walled cabinet with one or two doors. The gap between two walls is filled with high-density fiber glass wool insulation material to avoid heat transfer. Doors are provided


with gaskets. Aluminum trays are placed on the Channels fitted in the dryer. (Stainless steel trays are available) Dynamically balanced axial flow type blower fans are provided for uniform air circulation in the drying chamber during process. Machine is provided with control panel board with process timer, digital temperature controller cum indicator etc

Technical Data

Application To Dry Raw material before use

Capacity(Available) 12,24,36,48,72,96

Trays

Tray Capacity 3.5 kg

Tray Size (L X B X H) 80 X 40 X 3.2 cms.

Type Electric

Power required 6.375 KW

Net. Weight (According to Capacity)

Dimensions 1270 X 1370 X 1240 (According


to Capacity)

Revolving Polishing Pan is for Polishing Pharmaceutical Tablets after Sugar Coating or without Sugar Coating Tablets

Technical Data

ApplicationPolishing Pharmaceutical

Tablets

Available 36" Inch

Pan's RPM 22 R.P.M

Motor 1 H.P. III PH / 440V/AC

Pan Mounting Angle Standard Angle 600

Nett Weight 250 Kg


ApplicationPolishing Pharmaceutical

Tablets

Available 36" Inch

Fermentor: Human insulin is grown in the lab inside Escherichia coli, a common bacteria. Though it is by far the most widely used type of bacterium, yeast can also be used as a substitute. The human protein that produces insulin is obtained through an amino-acid sequencing machine that synthesizes the DNA.

Manufacturers input insulin's amino acids (the exact number of which is known to the manufacturers), and the sequencing machine connects the amino acids together. Large tanks are needed to grow the bacteria and also to synthesize insulin.

By :

Zhejiang DaYu Light Industrial Machinery Co., Ltd(CHINA). is a rising comprehensive and professional manufacturer, being integrating in design, developing, manufacturing, installation, selling and after-sales service of pharmacy machine

For Hba1c device we required following machinery,


which are manufactured by Rotech Pharmaceutical Engineering Co., Ltd.(US FDA,EU cGMP&WHO Accept Manufacture, ISPE Member) follows the principle of "having competitive price while maintain superior quality in our equipment processing and packaging". Rotech has a constant commitment to customer satisfaction which is the base for our fast development, taking a preferential position as a supplier for the pharmaceutical, cosmetic, nutraceutical and natural industries throughout the world


OPERATIONAL PLANRaw Material:

Raw Material for Device we get from Rotech Pharmaceutical Engineering Co., Ltd.(US FDA,EU cGMP&WHO Accept Maufacture, ISPE Member) Shanghai China follows the principle of "having competitive price while maintain superior quality in our equipment processing”

Raw Material for Sitagilptin and Metformin we get from AFINECHEM Co.,Ltd Hangzhou Honor: Top 100 Imp & Exp enterprises of Hangzhou in 2009

Top 100 innovation- oriented export enterprises of Hangzhou in 2008 They supply good service, good quality and competive prices. They have great enthusiasm and patience, we are conscientious and responsible. 4 years exporting experience in chemicals, pharmaceuticals, intermediates. Strong in Optical Brightener /Fluorescent brightener (OBA) for polyester, cotton, paper, plastics, and detergent, pigments, dyestuffs, carbon black and pharmaceuticals, intermediates. We have successful experience in international market , such as India, Pakistan, Europe, USA, Africa, North America, South America, South Asia, South-east Asia, Japan, Korea, and Hong Kong

Raw Material For Insulin Glargine we get from Maya High Purity Chemical Industry Shanghai China

Raw Material Companies Quality Control Department transfers sealed shipping cartons maintained at 2 to 8 degree

Raw Material are Shipped via from China To Islamabad , Pakistan


Temperature is monitored at all step from airport to D.M.D pharmaceuticals in house cold storage by Data Loggers (Temperature Monitoring Device).

Downloading from container to specific warehouse Passing through computer control zone, where its quantity automatically senses , count

and loading in the computer software

The stock is transfer to relevant production areas through conveyor belt. Again the stock will be sense , count and subtracted from existing storage software.

Order will be placed automatically when the stock goes below the set limits GLARIN and NOW+ stocks are transferred to the Distributor (VIKOR) warehouse (as per

inventory) through refrigerated transport at 2 to 8 degree centigrade SIPTIN and SIPTIN+ stocks are transferred to the Distributor (VIKOR) warehouse (as per

inventory) through transport at controlled temperature


GLARIN stock are transport at 2 to 8 degree centigrade from Distributor (VIKOR) through refrigerated delivery to pharmacies where it is stored in refrigerators and then delivered to patients

SIPTIN and SIPTIN+ stocks are transport from Distributor (VIKOR) to pharmacies where it is stored and then delivered to patients

APPENDIXD.M.D PHARMACUETICAL (PVT) LTD Reserves the Copy Rights.

Diabetes Atlas Second Edition, International Diabetes Federation 2003

Adapted from Lebovitz H.Diabetes Rev. 1999;7:139-153,UKPDS Group (UKPDS 16).Diabetes. 1995;44:1249-1256

Adapted from : UKPDS Study Group 1998

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