1.

Introduction
1.1. Over view of Pharmaceutical products
Medicine is the science of diagnosing, treating, or preventing disease and other damage to the body or mind,
which includes vaccines. Pharmaceutical products are drugs which are made up of two components or
aspects. The first is the actual Active Pharmaceutical Ingredients, which is the central ingredient. The second
is known as an excipient (inactive substance). This refers to the substance inside the drug or tablet.
Excipients are the inactive or inert substances present inside a drug while the Active Pharmaceutical
Ingredients is the chemically active substance, which is meant to produce the desired effect in the body.
Active pharmaceutical ingredients are also known as API, Active Pharmaceutical Ingredients are portions
of any drug, which are active. Thus, depending on the drug’s administered dosage, the reactions and results
differ. Certain drugs are comprised of more than one kind of API.
Inactive Ingredients are components of a drug product that do not increase or affect the therapeutic action
of the active ingredient, which is usually the active drug. Inactive ingredients are added during the
manufacturing process of pharmaceutical products such as tablets, capsules, suppositories, and injections.
Inactive ingredients may also be referred to as inert ingredients or excipients, and generally have no
pharmacological effect. Examples of inactive ingredients include binding materials (which may be
excipients), dyes, preservatives, and flavoring agents. Agents that combine with active ingredients to
facilitate drug transport in the body are also considered inactive.
Antiadherents are used to reduce the adhesion between the powder (granules) and the punch faces and
thus prevent sticking to tablet punches. They are also used to help protect tablets from sticking. Most
commonly used is magnesium stearate.
Binders hold the ingredients in a tablet together. Binders ensure that tablets and granules can be formed
with required mechanical strength, and give volume to low active dose tablets. Binders are usually:
 Saccharides and their derivatives:
 Disaccharides: sucrose, lactose;
 Polysaccharides and their derivatives: starches, cellulose or modified cellulose such as microcrystalline
cellulose and cellulose ethers such as hydroxypropyl cellulose (HPC);
 Sugar alcohols such as xylitol, sorbitol or maltitol;
 Protein: gelatin;
 Synthetic polymers: polyvinylpyrrolidone (PVP), polyethylene glycol (PEG)...

1
 Binders are classified according to their application:
 Solution binders are dissolved in a solvent (for example water or alcohol can be used in wet
granulation processes). Examples include gelatin, cellulose, cellulose derivatives,
polyvinylpyrrolidone, starch, sucrose and polyethylene glycol.
 Dry binders are added to the powder blend, either after a wet granulation step, or as part of a direct
powder compression (DC) formula. Examples include cellulose, methyl cellulose,
polyvinylpyrrolidone and polyethylene glycol.
Tablet coatings protect tablet ingredients from deterioration by moisture in the air and make large or
unpleasant-tasting tablets easier to swallow. For most coated tablets, a cellulose ether hydroxypropyl
methylcellulose (HPMC) film coating is used which is free of sugar and potential allergens. Occasionally, other
coating materials are used, for example synthetic polymers, shellac, corn protein zein or other
polysaccharides. Capsules are coated with gelatin. Enterics control the rate of drug release and determine
where the drug will be released in the digestive tract.
Disintegrates expand and dissolve when wet causing the tablet to break apart in the digestive tract,
releasing the active ingredients for absorption. They ensure that when the tablet is in contact with water, it
rapidly breaks down into smaller fragments, facilitating dissolution.
Examples of disintegrates include:
 Cross linked polymers: cross linked polyvinylpyrrolidone (crospovidone), crosslinked sodium carboxymethyl
cellulose (croscarmellose sodium).
 The modified starch sodium starch glycolate.
Fillers are sometimes called "bulking agents" or "diluents." Fillers add volume and/or mass to a drug
substance, thereby facilitating precise metering and handling thereof in the preparation of dosage forms.
Fillers typically also fill out the size of a tablet or capsule, making it practical to produce and convenient for
the consumer to use.
A good filler should typically be inert, compatible with the other components of the formulation, non-
hygroscopic, relatively cheap, compactible, and preferably tasteless or pleasant tasting. Plant cellulose (pure
plant filler) is a popular filler in tablets or hard gelatin capsules. Dibasic calcium phosphate is another
popular tablet filler. A range of vegetable fats and oils can be used in soft gelatin capsules. Other examples of
fillers include: lactose, sucrose, glucose, mannitol, sorbitol, calcium carbonate, and magnesium stearate.
Sometimes other noted kinds of excipients are in effect doubling in function as fillers.
Relatively new precision "micro-dosing" technologies have begun enabling small-scale production of drug
products without the need for fillers (or any excipient, if desired - and if otherwise acceptable), due to its

2
ability to handle and measure out appropriate quantities without bulking/dilution. Such technologies exist
for dispensing both solid and non-solid substances, though powder is most common currently.
Flavours can be used to mask unpleasant tasting active ingredients and improve the acceptance that the
patient will complete a course of medication. Flavourings may be natural (e.g. fruit extract) or artificial.
For example, to improve:
 a bitter product - mint, cherry or anise may be used
 a salty product - peach, apricot or liquor ice may be used
 sour product - raspberry or liquor ice may be used
 an excessively sweet product - vanilla may be used
Colors
Colors are added to improve the appearance of a formulation. Color consistency is important as it allows easy
identification of a medication.
Lubricants
Lubricants prevent ingredients from clumping together and from sticking to the tablet punches or capsule
filling machine. Lubricants also ensure that tablet formation and ejection can occur with low friction between
the solid and die wall.
Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid are the
most frequently used lubricants in tablets or hard gelatin capsules. Lubricants are agents added in small
quantities to tablet and capsule formulations to improve certain processing characteristics.
Glidants
Glidants are used to promote powder flow by reducing inter-particle friction and cohesion. These are used in
combination with lubricants as they have no ability to reduce die wall friction. Examples include fumed silica,
talc, and magnesium carbonate.
Sorbents
Sorbents are used for tablet/capsule moisture-proofing by limited fluid sorbing (taking up of a liquid or a gas
either by adsorption or by absorption) in a dry state. Materials used for enteric coatings include fatty acids,
waxes, shellac, plastics, and plant fibers.
Preservatives
Some typical preservatives used in pharmaceutical formulations are
• Antioxidants like vitamin A, vitamin E, vitamin C, retinylpalmitate, and selenium
• The amino acids cysteine and methionine
• Citric acid and sodium citrate[disambiguation needed]
• Synthetic preservatives like the parabens: methyl paraben and propyl paraben.

3
Sweeteners
Sweeteners are added to make the ingredients more palatable, especially in chewable tablets such as antacid
or liquids like cough syrup. Sugar can be used to mask unpleasant tastes or smells.
They are used to: -- treat and prevent many illnesses, may also use in conjunction with other treatments’
, must always be used with care can be obtained in different ways depending on their classification
1.2. Backgrounds of pharmaceutical industries in the world
Medicine has existed since the dawn of human civilization. Diseases were originally thought to be caused by
deities or supernatural forces. Various ancient civilizations, from the Egyptians to the Chinese, developed
their own unique systems for practicing medicine in the fields of herbalist, anatomy, public health, and
clinical diagnostics. Medicine was not practiced by physicians, but rather by the common people through
observation and empiricism. The great Greek poet Homer described Egypt as a land where “the earth, the
giver of grain, bears the greatest store of drugs” and where “every man is a physician”. Homer’s mythology
does have some truth to it. In the famous Ebers papyrus, dating back to 1550 B.C., the ancient Egyptians
describe more than 700 medicinal formulas; some were incantations and placebos that delivered their
therapeutic effects through spiritual healing.
The Development of the Pharmaceutical Industry, pharmaceuticals is described as having emerged from the
amalgamation of modern biology, synthetic organic chemistry, and American entrepreneurship. Once science
was applied to medicine, a new era of drug discovery arose, with chemistry and biology at its core.
Cell theory, or Rudolf Virchow’s biogenesis law, revolutionized biology by defining living systems in terms of
functioning cellular units. Louis Pasteur’s germ theory of disease and Robert Koch’s postulates, which
established criteria for establishing a causal relationship between a microbe and a disease, laid the
foundation for infection theory and immunology. Paul Ehrlich, who is recognized as the founder of
chemotherapy, studied the interaction between cells and synthetic dyes. He coined the terms “receptors” and
“magic bullets”, referring to the modern day equivalent of receptor-legend interactions in targeted drug
delivery.
Natural products derived from plants constitute the bulk of the chemicals used in the pharmaceutical
industry. These compounds typically have complicated molecular structures that are very difficult for even
the most experienced of chemists to synthesize. Doxorubicin and paclitaxel are two examples of natural
products with anticancer effects. The biosynthetic pathway that produces paclitaxel in E. coli involves several
inefficient steps, making synthesis very challenging. Biologics, which includes human growth hormone,
insulin, vaccines and antibiotics, is another major category of large molecules produced by living organisms.

4
However, biogenetics are inherently more difficult to accurately replicate than conventional drugs and
require more extensive clinical trials and observation, which hamper their push to market.

1.3. HISTORICAL DEVELOPMENET OF PHARMACEUTICAL INDUSTRY IN

ETHIOPIA
Ethiopia is classified as one of the world’s poorest country. Poverty and low education levels serve as
contributing factors to the country’s health burden. The major health problems of the country remain largely
preventable communicable diseases and nutritional disorders.
Although traditional medicine plays an important role in Ethiopian society, knowledge about the extent and
characteristics of traditional healing practices and practitioners is limited and has frequently been ignored in
the national health system. There are a number of traditional medicinal practices that reflect the diversity of
Ethiopian cultures. Ethiopian traditional medicine is concerned not only with the curing of diseases but also
with the protection and Promotion of human physical, spiritual, social, mental and material wellbeing. The
many categories of traditional medicinal practices dealing with these different aspects of health include:
spiritual healing, prevention, as well as curative and surgical practices. The health and drug policies of the
Ethiopian Ministry of Health recognize the important role traditional health systems play in health care.
Unfortunately, little has been done in recent decades to enhance and develop the beneficial aspects of
traditional medicine including relevant research to explore possibilities for its gradual integration into
modern medicine.
Ethiopia is one of the most populous countries of Africa with a high demand for pharmaceutical products.
The manufacturing of pharmaceutical products in Ethiopia, however, is quite small. Currently, the industry
consists of 17 pharmaceutical and medical supply manufacturers and the country produce only between 10
and 20% of consumption of pharmaceuticals.
Ethiopian pharmaceutical manufacturing and Addis pharmaceutical factory are the largest and oldest firms,
and produce various medicines in relatively large quantities. The first pharmaceutical factory in the country
is Ethiopian pharmaceutical manufacturing (EPHARM), which was established in 1972 as a public company
by the Ethiopian government and investors from England. The firm is located in Addis Ababa& employs
about 570 employees up to 2005-2010. It has eight product lines & produces 50 products.

5
Table 1.1: Manufacture of pharmaceuticals, medicinal chemicals& botanical products
Production
of major 2005/06 2006/07 2007/08 2008/09 2009/10
products
Capsules 370,445 389,997 275,781 206,085 991,731
Tablets 602,887 573,412 501,758 462,519 505,022
Antibiotics - - 25 66 7,144
Syrup 191 1,638 1,653 2,534 1,444
Ointment 55 45 52 83 37
Injection of 4,481 4,277 2,731 25,578 9,464
100A

2005/06 2006/07 2007/08 2008/09 2008/10

Number of 4 6 7 8 11
Establishments
Numbers of 1,091 1,184 1,293 1,441 2,076
Employees
Wages and 17,907 25,297 29,908 32,759 56,151
Sales Paid (in
birr)
Gross Value of 216,395 257,064 311,711 498,749 682,979
Production(in
birr)
Ratio of 0.911 0.980 0.964 0.697 0.719
Imported to
Consumed
Total Raw
Material
Source: CSA (2011) Large and Medium-Sized Manufacturing Industries survey

6
Out of the total firms in the pharmaceutical industry, about 10 produce pharmaceuticals while the rest are
engaged in producing medical supplies such as syringes, absorbent, cottons & lab equipment. More than 100
types of medicines, mainly generic, are produced in Ethiopia.

2. Statement of problem
The pharmaceutical sub sector contribution to the overall economy (contribution ton GDP, foreign exchange,
employment) is minimal. For long period, the pharmaceutical industry was monopolized by one government
organization till the current government regime come to power with free market economy. However, the sub
sector is still highly underdeveloped and dominated by few manufacturers and depends on imported
products. However, the pharmaceutical industry is one of the sectors which the government is giving
attention in order to enhance the local pharmaceutical industries so that they can produce a substantial
portion of the pharmaceutical and medical supplies required for domestic consumption and for export.
Health care is the basic right of all citizens and the pharmaceutical manufacturing industry is pivotal to the
medical and pharmaceutical sectors of our country apart from its critical importance to the national
economy. The strengthening of local production capacity of pharmaceutical at affordable price is an essential
component of health care system. The health services rendered to date do not meet to the health care needs
of the great majority of the population and it is imperative that the local production of quality
pharmaceuticals should increase to a greater extent According to the government plan the availability of
locally produced essential drug will cover about 50percent of the annual national drug demand by the year
2014/15 so each of pharmaceutical industry found in Ethiopia should meaningfully contribute their part in
the attainment of this noble cause. The low health status of the people demands the provision of quality, safe
and effective drug within the reach of the broad masses. As compared to the population density of the
country, the local industries are insignificant in terms of addressing the public demand. Currently the local
pharmaceutical manufacturing industries consists of two state run companies and eleven private owned
pharmaceutical companies engaged in the production of human and veterinary drugs. They are mainly
involved in the manufacturing of tables, capsules, syrup, oral powders, dry powder parenteral, and
Intravenous (IV) fluids. And these industries are operating way below capacity due to several factors mainly
shortage of finance.
At present Ethiopia may not be known internationally as a major production location for pharmaceuticals.
However it might be one of the upcoming emerging markets in this sector. A market of currently 80million
people in Ethiopia and 320milion people in East Africa, as well substantial effort by the Ethiopian
government and the international donor community to rich the millennium development goals makes
Ethiopian an interesting investment location.

7
Market situation
The market for pharmaceutical and medical supplies is obtained either through imports or from local
manufacturers. Domestic market is highly dependent on imports as the local manufacturing units cover only
a small portion of the requirement for domestic needs. Drug manufactured locally only cover 15 percent of
the national demand, 85 percent of the demand is filled through import. Present local manufactures on
average only produce 23 million birr worth of products there is a huge market gap in pharmaceutical
products i.e. not all essential drugs for the country is currently produced or is under served by the local
pharmaceutical and medical supply industry.
Ethiopia as an investment location and its advantage
 Experienced manufacturers with state of the art technical equipment
 Very attractive level of production costs and excellent price performance
 Production of generic with large flexibilities regarding international patent right until 2016.
 Great market potential with 320millions in east Africa.

Objective of the study

 to assess different types of pharmaceutical products found in Ethiopia
 To identify pharmaceutical product which are highly demanded
 To identify the raw materials used to produce the highly demanded product (imported or local).
 to select raw materials which can be produced locally

8
3. Methodology
Different methods were applied to collect data.
 Interview among different pharmaceutical factory owners;
 Questioner to industry owners and ministry of trade,
The questionnir paper will prepare as follows

 The objective of this project is identifying raw materials that are used in the manufacture of
medicine and pharmaceutical objects in Ethiopia and, to reduce the import of these raw materials
and instead to replace them with materials produced here.
QUESTIONARY
 What are the pharmaceutical products that are produced in your factory?
 Among those produced products which of them are highly demanded?
 What are the raw materials required to produce these demanded products?
 Are these raw materials imported or locally produced? If they are imported, in what state & their
country of origin?
 What is the main difference between Ethiopian and abroad pharmaceutical products?
 What is the cost of these imported raw materials?
 What is the annual quantity of raw material required for one day production, and the recorded
production rate data of each year?
 Are the raw materials differentiated whether they are used as an active or non- active
pharmaceutical ingredient?

9
  Using internet accesses

4.Findings and Discussion

4.1. Imported Pharmaceutical Raw Materials

Throughout the year the imported pharmaceutical raw materails are almost increased linearly because of
the pharmaceutical industries are increased due to the rise of consumption.From this reason the
increanment of the imported pharmaceutical raw materails are increased futurely.
From the Fig.1 imported raw materials we can show the progress of the imported raw materials from 1997-
2007.

10
 Imported pharmacetiucal raw materials (1997 -2012) from
ministry of trade in Kg
16000000

14000000

12000000

10000000

8000000

6000000

4000000

2000000

0
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 year

Imported pharmacetiucal raw materials (1997 -2012) from ministry of trade in Kg

Fig.1 Imported raw materials in K.g from 1997-2012

4.2. Local Pharmaceutical products producers
Seventeen pharmaceutical factories were identified in Ethiopia as shown in Table 1.1. Out of these
seventeen factories only thirteen factories are currently operational while four factories have been closed
due to financial problem and most of the existing companies are manufacturing below the installed capacity
and produce a limited number of products. But from 2012-2013 all pharmaceutical Industries are in
operation by the assistant of government.

11
 Identified pharmaceuticals
Table 1.1 List of local pharmaceutical manufacturing companies
No. Factory Product Type Ownership Location
1 Addis Pharmaceutical factory Human Public Enterprise Tigray
pharmaceutical
2 Ethiopian pharmaceuticals Pharmaceuticals and Public Enterprise Addis Ababa
manufacturing (Epharm) medical supplies
3 Cadila pharmaceuticals Human Private Limited Oromia\Gelan
(Ethiopian) PLC pharmaceuticals Company
4 RX Africa PLC Human Ethio – American Addis Ababa
pharmaceuticals Joint Venture
5 Fawes Pharmaceuticals PLC Medical Supplies Private Limited Addis Ababa
company
6 East African pharmaceuticals Human & veterinary PLC/British Addis Ababa
pharmaceutical Sudanese Joint
Venture
7 National Veterinary Veterinary Public Enterprise Bishuftu\Debre-
Medicine/vaccine/ Zeit
8 PharmacureP.L.C Large Volume (IV) Private Limited Addis Ababa
Fluid Company
9 Sino Ethiopian Associate (Africa) Pharmacuetical raw Ethio Chinese Joint Addis Ababa
PLC material /Hard Venture
Gelatin Capsule/
10 Medsol pharmaceuticals Addis Ababa
11 Julphar Ethiopia Human Addis Ababa
pharmaceutical
12 Asmi Industry Surgical dressing Private limited Addis Ababa
and antiseptic company
disinfectants
13 Fanus Med Tech PLC Tigray
14 MOAB Medical Supplier Private limited Addis Ababa
/Sanitary towels, company
napkins & cosmetics

12
15 ARFAB Engineering Addis Ababa
16 Sa-med pharmaceuticals Addis Ababa
17 Access Bio Engineering Addis Ababa

13
Major Producing Industries

S/N Name of company Annual sales in birr (2011-2013 E.C)

2011 2012 2013

1 ADDIS PHARMACIUTICAL S.C 324,456,566.80 191,230,155 550,000,000

(APF)

2 ETHIOPIAN PHARMACIUTICAL 153,292,105 152,269,896 221,000,000

MANUFATURING S.C(EPHARM)
3 SINO-ETHIOP ASSOCIATE AFRICA 19,181,942.75 10,217,000.00 24,661,365.20

4 NATIONAL VETERNARY 50,908,743.06 51,040,715 83,085,067.82

INISTITUTE
5 FAWS PHARMACIUTICAL PLC 9,810,117.95 10,726,832.52 16,000,000

6 PHARMACURE PLC 16,205,631.80 20,262,262.70

7 RX AFRICA 7,353,624.19 7,183,862.50

8 ACCESS BIO * 179,084.36

-
-
9 ASMI 10,000,000

10 EAST AFRICAN PHARMACIUTICALS 11,532,172 7,769,250.90 20,535,054.61

11 CADILA PHARMACIUTICAL PLC 54,411,474.75 107,506,383.5 158,119,675

Table 1.3 the top producer pharmaceuticals indusrties

14
Addis pharmaceutical factory (APF) was established in 1992 as a share company in Adigrat, 120 KM north of
Mekelle or 898KM north of Addis Ababa. The firm produces various types of tablets, capsules, vials,
ampoules, syrup, suspensions, elixirs& dermatological preparations. It has about 600 employees.
From these pharmaceutical factories the top producers are: Addis pharmaceutical, Ethiopian pharmaceutical
cadila, National veterinary institute, Sino-Ethiopian Associates, East Africa, Fawes and Asmi as shown in the
above table. The rest of the firms in the pharmaceutical industries fall in the midsize category with numbers
employed ranging from 50 to 150. This include East African Pharmaceuticals (EAP)plc ,a wholly owned
British –Sudanese joint venture ;Sino Ethiopia Associate (Africa) plc-established in 2001 as strategic
partnership between two chines companies (china Associate Group & the Dandong JINWAN group) and an
Ethiopian company ,ZAF pharmaceuticals plc ;Asmi pharmaceuticals plc –established in1995 by Asmelash
Gebre ,Who also acts as a general manager.
As shown from the figure 2 thus pharmaceutical factories contribute large amount of income to the country.

600,000,000

500,000,000

400,000,000
Annual sale

300,000,000

200,000,000 2012/13
100,000,000

Name of Industries

Fig.2 Pharmaceutical Industries in their Annual sale

15
4.3 Pharmaceutical Data for Selected Industries

4.3.1. RX AFRICA (ETHIOPIA) PLC

RX Africa[Ethiopia]PLC procuces human drugs.the installed capacity of the factory is 80,000,ooo
capsules/year.it uses four tablets comparissions technologies.

Table 1.4 Annual Quantity of Starting Material for RX AFRICA PLC

Pharmaceutical
No Product Name Material Description Annual Quantity (kg)
Category
Ciprofloxacin HCl API 27,984.00
Maize Starch IPI 4,800.00
Sodium Starch glycolate IPI 1,680.00
Ciprofloxacin 500mg
1 PVPK-30 IPI 288.00
tablet
Aerosil IPI 240.00
Magnesium Stearate IPI 192.00
White Coating powder IPI (Ready - Mix) 720.00

Norfloxacin API 24,000.00

Maize Starch IPI 2,160.00
Dextrin IPI 720.00
Norfloxacin400mg Sodium Starch glycolate IPI 1,440.00
2
tablet Microcrystalline Cellulose IPI 720.00
Sucrose IPI 1,800.00
Magnesium Stearate IPI 288.00
White Coating powder IPI (Ready - Mix) 720.00

Tinidazole API 24,000.00

Tinidazole 500mg Maize Starch IPI 2,160.00

3
tablet Dextrin IPI 2,160.00
Sodium Starch glycolate IPI 2,160.00

16
 Microcrystalline Cellulose IPI 1,776.00
Sucrose IPI 2,880.00
Magnesium Stearate IPI 336.00
Yellow Coating powder IPI (Ready - Mix) 360.00

Sulphamethoxazole API 28,800.00

Trimethoprim API 5,760.00
Co - trimoxazole 480 Sodium Starch glycolate IPI 1,440.00
4
mg tablet Maize Starch IPI 2,016.00
Microcrystalline Cellulose IPI 1,440.00
Magnesium Stearate IPI 216.00
Cimetidine API 28,800.00
Maize Starch IPI 1,152.00
Sodium Starch glycolate IPI 748.80

Cimetidine 400mg PVPK - 30 IPI 864.00

5
tablet Microcrystalline Cellulose IPI 4,896.00
Magnesium Stearate IPI 288.00
Talc IPI 576.00
Green Coating Powder IPI (Ready - Mix) 1,008.00
Tetracycline HCl API 15,000.00
Talc IPI 600.00
Maize Starch IPI 600.00
Tetracycline 250mg
6 Sodium Starch glycolate IPI 180.00
capsule
Microcrystalline cellulose IPI 192.00
Magnesium Stearate IPI 48.00
EHGC for Tetracycline IPI (Ready Made) 63,000,000.00 Pcs

Metronidazole API 12,000.00

Maize Starch IPI 384.00
Metronidazole 250mg
7 Sodium Starch glycolate IPI 384.00
capsule
Microcrystalline cellulose IPI 1,632.00
Magnesium Stearate IPI 96.00

17
 EHGC for Metronidazole IPI 50,400,000.00 Pcs

Doxycycline Hyclate API 6,900.00

Talc IPI 3,036.00
Doxycycline 100mg
8 Maize Starch IPI 2,940.00
capsule
Magnesium Stearate IPI 331.20
EHGC Doxycycline IPI (Ready Made) 63,000,000.00 Pcs

Omeprazole 20mg Omeprazole 8.5% pellets API 18,224.00

9
Capsule EHGC for Omeprazole IPI 63,000,000.00 Pcs
Pharmaceutical
No Product Name Material Description Annual Quantity (kg)
Category
lbuprofen 75% directly
API 38,400.00
10 Ibuprofen 400mg tablet compressible granules
Pink coating powder IPI (Ready Mix) 720.00
Ethanol 96% IPI 2640.00 lt

Fluconazole API 6,000.00

Maize Starch IPI 6,000.00
Microcrystalline Cellulose IPI 5,400.00
Fluconazole 100mg
11 Sodium Starch glycolate IPI 360.00
capsule
Magnesium Stearate IPI 120.00
Talc IPI 180.00
EHGC for Fluconazole IPI (Ready Made) 63,000,000.00 Pcs

Acronyms
API = Active Pharmaceutical Ingredient
IPI = Inactive Pharmaceutical Ingredient

18
4.3.2. ETHIOPIAN PHARMACEUTICALS MANUFACTURING (EPHARM)
EPHARM was established as a joint venture in 1964 by the Ethiopian government and a British company,
smith and nephew. In 1971, a change in its ownership occurred consequently, one of the partners, smith and
nephew, was superseded by Teva Jerusalem of Israel.

Few years later, In December 1975, the company was fully nationalized by the state. In 1994,based on council
of minister regulation No.167/1994, it was established as a public enterprise since January 2002, it was be
recognized as Ethiopian pharmaceuticals manufacturing share company with paid up a capital of birr
122,963,000.

EPHREM’s motto “Quality is over most important product” which prevailed since its inception is not a mere
slogan of advertisement as the firm practically proved its sincere service to its customers and end user in its
49 years of existence. The customer and the public at large have already associated the name “EPHREM”,
with quality ,efficiency& safe pharmaceutical in that it produce wide range of product categories ,viz,
capsules, tables, vials(sterile powders), ampoules(small volume injectable),I.V.fluids syrups, ointments and
oral powders.

In order to improve its productivity and operation system, the company is implementing holistic
improvement works. Achievement of such improvement was the development and implementation of
ISO9001:2008 based Quality Management system. EPHARM has been audited by ISO QAR and obtained QMS
certificate. It has also conducted the study of Business process reengineering (BPR) for each functional unit
and currently performing its operational activities in accordance with the re-engineered process. In addition,
cognizant to the increasing worldwide concern about the environment, actual and potential effects of its
business on the future of the environment EPHARM implemented ISO 14001:2008 Based Environmental
Management System (EMS) since March 2007 and adheres cleaner’s production techniques.

19
EPHARM has fledged production facilities with the most modern technology to manufacturing various types
and form of pharmaceutical formulations. EPHARM’s vision and major mission are beyond making huge
profits. Is is devoted to satisfy the public and alleviate the country’s healthcare problem to the best of its
capacity.

EPHARM products are the highest selling products in the country due to user’s preference. Of course this
acceptance is the result of reliability of the firm’s drug with regard to Quality, Potency and Safety. This the
main reason for EPHARM’s steady sales and profit growth since the year of its establishment.

Ethiopian Pharmaceuticals Manufacturing S.C (EPHARM) produces human drugs.the installed capacity of the
factory is 600,000,000 tablates/year, 380,00 litters/year, 350,000,000/year etc.

Table 1.5 Annual Quantity of Starting Material for EPHARM

No Major raw Material Product name Annual quantity Unit price Total price
(kg)
1 Amoxycillline trihydrate Amoxacilline 46,000 692 31,832,000
2 Ampicilline trihydrate Ampicilline 29,500 650 19,175,000
3 Ascorbic acid gran.90% Vitamin B 7,450 3,350 24,957,000
4 Benzathine penicilline Benzathine 2,800 1,174 3,287,200
penicilline
5 chloramphenicol Chloramphenicol 4,200 1205 5,061,000
6 Cholquine po4 tablet Chloquine 10,200 423 4,314,600
7 Cloxacilline sodium Cloxacilline 16,000 727 11,632,000
8 Ciprofloxacin Ciprofloxacin 7,600 693 5,266,800
9 Flucinaloneacetonide Dermalar 4,000 1,792 7,168,000
10 Dextromethorphan Ephadex 225 6,702 1,507,950
11 Mebendazole Mebendazole 3,000 995 2,985,000
12 paracetamol Paracetamol 73,480 98.25 7,219,410
13 Prednisolone Prednisolone 250 25,162 6,290,500
14 Procaine penicilline Procaine penicilline 16,100 630 10,146,220
15 Tinidazol Tinidazol 4,700 456 2,143,200

20
4.3.3. Cadila pharmaceutical factory
Cadila pharmaceutical factory produce human drugs.the installed capacity of the factory based on 8 hrs shift
is 390 million tablets/year, 165 million capsules/year, 1.44 million litters/year.the products are listed in the
following table.

Table 1.6 Cadila pharmaceuticals (Ethiopia) plc.

CIPRODAC-500mg (45 Batch/year)

No Product Name RAW Materials Description Standard Qty (1 Annual

Batch,kg) Quantity(Kg)
1 Ciprofloxacin hydrochloride USP 273.140 2291.3
2 Microcrystalline cellulose**BP 51.000 2295.0
3 Colloidalsilicondioxide(aerosil)UNSF 3.150 141.75
4 Isopropyle alcohol***BP 54.00 2430
5 Sodium starch glycolate( type A)BP 6.750 303.75
6 CIPRODAC-500mg Magnesium stearate BP 2.700 125.50
7 Purified talc BP 5.985 269.32
8 Hypermellose(hydroxyl propyl 5.470 246.15
methyl cellulose )(5cps)UNSF
9 Benzyl alcohol BP 0.547 24.615
10 Polyethylene glycol(PEG6000)UNSF 0.273 12.285
11 Titanium dioxide (C.L:77891)BP 1.094 49.230

(CADPRIM ) 112 batch/year

No Product Name Raw Materials Description Standard Qty Annual
(1 Batch,kg) Quantity(Kg)
1 Sulphamethoxazole BP 200 22400
2 Trimethoprim BP 40 4480
3 Sucrose (sugar)IH 1500 168000
4 CADIPRIM Methyl hydroxybezoate Methyl 10 1120

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 paraben BP
5 Propyl Hydroxybenzoate (propyl 2.5 280
paraben)BP
6 Sodium Benzoate BP 10 1120
7 Xanthan Gum USNF 10 1120
8 Sodium Carboxymethyl Cellulose USP 15 1680
9 Polysorbate-80(Tween-80) BP 12.5 1400
10 Activated 4 448
polydimethylsiloxane(simethicone)USP
11 Color Carmosine supra FCFIH 0.5 56
12 Flavor Anise No.1 IH 2.5 280
13 Flavor for CadilaIH 2.5 280

(IBUNATE) 84Batch /year

No Product Name Raw materials Description Standard Annual
Qty (1 Quantit
Batch,kg) y(Kg)
1 Ibuprofen BP 164 13776

2 Maize starch BP 9.00 756

3 SodiumMethylParaben(Nippagi 0.20 16.8

Ibunate-400 n Sodium) BP

4 Sodium Propyl paraben(Npasol 0.04 3.36

Sodium) BP

5 CollidialSilicon Dioxide (Aerosil) 8.56 719.04

6 Magnesium Stearae BP 1.00 84

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 7 Hydroxy Propyl Methyl Cellulose 6.40 537.6
5 cps USNF

8 Erythrosine Lake Colour IH 0.52 44.352

9 Titanium Dioxide BP 0.16 13.44

10 Polyetylene Glycol-400 BP 1.12 94.0

11 Aspartam BP 0.20 16.8

12 Flavour Strawberry No1 1.60 134.4

(BBA)IH

13 Isopropyl Alcohol BP 64.0 5376

14 Dichloromethane BP 96.0 8064

15 Microcrystalline Cellulose BP 20.0 1680

16 Pregelatinzied Starch BP 6.00 504.0

4.3.4. APF –Addis Pharmaceutical Factory PLC

Addis Pharmaceutical Factory produces human drugs.AS the data from the campany profile indicates APF
produce 92 products: tablets, capsules, vials, ampoules, syrups ,suspension, elixirs and dermatological
preparations.the production capacity by product line is:- Tabletes: 140,000 – 420,000 T/hr, General capsules
252,000 capsules/hr, B-loctam capsules 138,000 capsules/hr etc. In this time of year(2012/13) APF has the
highest capacity.

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 No_ Product Name Raw material Standard Qty Annual
Description (tablets/hr) Quantity(tablets/hr)
1 Amoxacilline Amoxycillline 138000 662,400,000
trihydrate
2 Ampicilline Ampicilline 138000 662,400,000
trihydrate
3 Paracetamol Paracetamol 138000 662,400,000

4.4 Highly demanded pharmaceutical products

Pharmaceutical supply and fund agency:

Adequate and sustainable availability of safe, effective pharmaceutical grade drugs is vital to the success of
any health care system. The key logistic roles of the PFSA include health care commodity procurement and
distribution, management of the national health commodity fund, building the logistics capacity at hospitals
and health centers, coordinating health care commodity forecasting efforts, and improving evidence-based
and rational use by providers. The PFSA works closely with the USAID Deliver project. The lack of availability
of essential drugs on a sustainable basis has been a major limitation. The PFSA is addressing this through a
partnership with US-AID. 150 so-called “Special Pharmacies” have been created in public health facilities
across the country to increase access and affordability. Initial studies suggest there has been reduction in
costs and increased access in the special pharmacies as compared to the traditional model.
There are many pharmaceutical products produced in the Ethiopian pharmaceutical industries. From those
products forty highly demanded products are selected based on the data of 2012-2013 obtained from
Pharmaceutical Fund and Supply Agency (PFSA).These highly demanded products are selected by their
annual sale.

Pharmaceutical products Annual sale of 2012/13 (in

birr) Drug types
1,Ciprofloxacin 121,369,080 Antibiotic
2,Amoxacillin 114,784,535 Antibiotic
3,Ampicilin 57,059,300 Antibiotic
4,Sulphamethoxazole+trimethoprim 43,508,405 Antibiotic

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5,Ethromyain stearate 32,300,000 Antibiotic
6,cloxacillin 30,327,080 Antibiotic
7,chloramphenicol 26,651,115 Antibiotic
8,Ringer lactate injection with 26,625,000 IV infusion
giving set
9,Normal saline 0.9% injection with 19,125,000 IV infusion
giving set
10,chloroquine 15,784,901 Anti-malaria
11,O.R.S 13,520,000 Rehydration
12,Dextromethophen 12,959,895 Cough syrup
13,Methronidezole 12,375,000 Antibiotic
14,Paracetamol 11,570,550 Anti-pain

140,000,000
120,000,000
Annual sale [birr]

100,000,000
80,000,000
60,000,000
40,000,000
20,000,000
0

products

Highly demanded pharmacetiucal products in Birr

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4.5 Raw material used to produce the selected pharmaceutical products

No Product Name Material Description Pharmaceutical Standard

Category Composition
1 Ciprofloxacin Ciprofloxacin HCL API 77.94%
500mg tablet
Maize starch IPI 13.36%
Sodium Starch IPI 4.67%
glycolate
PVPK-30 IPI 0.8%
Aerosil IPI 0.66%
Magnesium Stearate IPI 0.53%
White Coating Powder IPI 2%

No Product Name Material Pharmaceutical Standard

Description Category Composition
2 Amoxicillin Amoxicillin API
500mg capsule trihydrate
colloidal API
anhydrous Silica
Gelatin IPI
Tartrazine IPI
Sunset yellow IPI
Carmosine IPI
Brilliant blue IPI
Titanium dioxide IPI
Magnesium API
stearate

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No Product name Material Pharmaceutical Standard
Description Category Composition
3 Ampicillin Ampicillin API 6.25%
500mg capsule Trihydrate
Carboxy Methyl API 1.83%
Cellulose sodium
Aerosil IPI 0.75%
Tartrazine IPI Quantity
Sufficient(q.s)
Sodium Benzoate IPI 0.45%
Sugar (Sucrose) IPI 90%

N Product name Material Description Pharmaceutica Standard

O l Category Compositio
n
4 Sulphamethoxazole Sulphamethoxazole
+Trimethoprim(400mg+80mg
) tablet
Trimethprim
Sugar(sucrose)
Methyl hydroxybenzoate methyl
paraben
Propyl hydroxybenzote
Sodium benzate
Xanthan gum
Sodium carboxymethyl cellulose

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 polysorbate
Activated
polydimethylsiloxane(simethicone)US
P
Color carmosine
Flavor anise
Flavor forcadilalh

4.6 Raw Material Demand Assessments

i. Ciprofloxacin 500mg Tablet
 Ciprofloxacin HCL is needed annual quantity of 26,499.6 kg to produce this product.
 Maize Starch is also needed annual quantity of 4,542.4 kg to produce this product.
ii. Ampicillin 500mg Capsule
 Ampicillin Trihydrate is needed annual quantity of 6,137.5 kg to produce this product.
 Sucrose is also needed annual quantity of 88,380 kg to produce this product.
Those raw materials are selected based on the highliy demanded products that produced in the top
producers industries that uses almost the same raw materials to those products. The annual imported
quantity is taken by multiplying by the annual quantity of their products from Pharmaceutical Fund And
Supply Agency(PFSA) that uses those raw materials.

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 Limitations
Information’s are not collected as desired because of different reasons. Some of them are:-
 Shortage of time- because some factory’s don’t give the information at hand; and we say we need time.
Therefore you have to return back.
 Misunderstanding of our objective.
 Some information are taken as secret by the company ownership due to this, they are not willing to give the
data.
 In some factory’s they don’t enter even to the factory i.e. The security guard return back from outside.

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 Conclusion
Out of seventeen pharmaceutical factories, only thirteen factories are currently operation. From those
thirteen factories we select the four pharmaceutical factories depending on the questionnaires, based on:-
 the availability of data
 the demand of the product they produce and
 Local annual requirement in quantity (from 2012-2013) from Pharmaceuticals Fund and Supply Agency
(PFSA).
And also their high annual production rate, their high annual quantity being produced, and their high sales in
Ethiopian market. In addition to this those products are being produced by most of pharmaceutical
industries found in Ethiopia. For this reason, the selected products are Amoxicillin, Ampicillin, Ciprofloxacin,
Sulphamethoxazole +Trimethoprim and the inactive pharmaceuticals ingredients are sucrose, Aerosol, Maize
starch, sodium starch glycolate.

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REFERENCE
1. Ministry of trade
2. Ethiopian pharmaceuticals manufacturing (EPHARM)
3. Cadila pharmaceuticals (Ethiopia) plc.
4. Rx Africa (Ethiopia) plc.
5. Addis pharmaceutical s.c (APF)
6. Mekelle-Pharmacetical- Manufacturing- Investment- profile
7. Ministry of Indusrty
8. Pharmaceutical Supply and Fund Agency (PSFA).
9. A profile of Ethiopian Pharmaceutical Manufacturers.

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