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Incepta Pharmaceuticals Ltd.

Incepta Pharmaceuticals Ltd. is a leading pharmaceutical company in Bangladesh


established in the year 1999. The company has a very big manufacturing facility located
at Savar, 35 kilometer away from the center of the capital city Dhaka. The company
produces various types of dosage forms which include tablets, capsules, oral liquids,
ampoules, dry powder vials, powder for suspension, nasal sprays, eye drops, creams,
ointments, lotions, gels, prefilled syringes, liquid filled hard gelatin capsules, lyophilized
injections etc. Since its inception, Incepta has been launching new and innovative
products in order to fulfill unmet demand of the medical community. The focus has always
been to bring new, more technologically advanced molecules and innovative dosage forms
to this country.

Vision
Incepta wants to become a research based global pharmaceutical company in addition to
being a highly efficient generic manufacturer. To discover and develop innovative, valueadded products that improve the quality of life of people around the world. And contribute
towards the growth of our Nation.

Mission
Provide people globally with high quality health care products at affordable prices in order
to improve access to medicine and to provide employees an enabling environment that
facilitates realization of their full potential.

History of Incepta
Incepta began its operation with a handful of highly skilled and dedicated professionals
guided by an able leadership. Proper strategic planning, technical excellence, swift and
timely decisions helped us achieve our objectives leading to much faster growth. Incepta
was able to anticipate the need of the market and provide the right product at the right
time. High focus on R&D investment from the very beginning made possible the
introduction of quality products ahead of its competitors in most cases.

Incepta Pharmaceuticals Ltd. is now the 2nd largest company of the country and
recognized as the fastest growing of the top five manufacturing company in the country.
Established in the year 1999, the company has come a long way. Currently the Zirabo
plant consists of several buildings with state of the art technology. Dedicated
cephalosporin manufacturing building, a specialized manufacturing building for the
production of lyophilized products, insulin and amino acids and newly built liquid and
semisolid manufacturing building and large warehouse is also in operation.
Another multipurpose building for housing the Research & Development operation along
with the canteen facility is also there. Currently all the products are coming from the plant
at Zirabo. The company now produces almost all types of dosage forms covering nearly all
therapeutic area.
Incepta now has one of the largest and competent sales force and large distribution
network of its own, operated from 18 different locations throughout the country. A most
dynamic skilled and dedicated marketing team comprising of pharmacists and doctors are
at the core of the marketing operation. These highly skilled professionals play a crucial
role in providing the necessary strategic guideline for the promotion of its product.

Chronology of Events

December 16th 1998, the construction of the factory began.

August 1999, office operations began.

December 1999, first batch of product Neodin S 150 (Ranitidine 150 mg tablet)
was produced.

January 2000, sales began formally.

February 2000, training of the first batch of medical representatives began.

April 2000, with the launching of Osartil (Losartan Potassium) the first prescription
product of Incepta was launched in the market. The company started off in a new
direction.

Several other first ever product, Celenta (Celecoxib), Rofenta (Rofecoxib) and
Omidon (Domperidone) followed in the footsteps of Osartil.

A total of 23 new generics with 35 presentations were launched this year. 4 of


these generics were first ever in Bangladesh.

By the end of 2000 Incepta was the number 31st company of the country.

In 2001,There was massive restructuring throughout the company. Sales,


Distribution, Marketing Strategy Department, and Factory; all were reorganized.

In 2001,A total of 18 new generics with 37 presentations were launched this year.
11 of these generics were first ever in Bangladesh.

By the end of the year 2001, Incepta was ranked the 12th company of the country.
The company had a phenomenal growth of 448% over the previous year (IMS).

In 2002,A total of 32 new generics with 49 presentations were launched. 14 of


these generics were first ever in Bangladesh.

In 2002,Massive expansion project of the factory was envisioned. New office for
the sales and distribution operation was also taking shape.

In 2002,The company registered an excellent growth of 55.85% over the previous


year. By the end of the year Incepta was ranked the 10th company of the country
(IMS).

In 2003,Incepta kept on introducing innovative and newer molecules to the local

market. A total of 32 new generics with 48 presentations were launched. 18 of


these generics were first ever in Bangladesh.

In 2003,The new office (Dhanmondi) for the sales and distribution operation was
inaugurated.

In 2003,The company registered an excellent growth of 28.5% over the previous


year (IMS).

By the end of the year 2003, Incepta was ranked the 8th company of the country
(IMS).

In 2004, A total of 17 new generics with 32 presentations have been launched. 6


of these generics were first ever in Bangladesh.

In 2004,The company maintained an excellent growth of 48.2% over the previous


year (IMS).

In 2004, The ranking went up again and the company was ranked the 5th largest
company of the country with the highest growth rate among the top five (IMS).

In 2005, Incepta thrived under challenge and excelled in venturing into unexplored
grounds and continued to satisfy our customers. Incepta was audited and accepted
as a supplier for UNICEF & UNDP.They started to supply life saving drugs to
UNICEF from March, 2005.

In 2005, A total of 27 new generics with 76 presentations were launched. 12 of


these generics were introduced first time ever in Bangladesh.

In 2005, The company maintained an excellent growth of 34.8% over the previous
year (IMS).

In 2005, The company was ranked 3rd largest with the highest growth among the
top five (IMS).

By 2006 Incepta had positioned itself as an innovative research oriented and


knowledge based pharmaceutical company specializing in analysis, design and
development of new products.

Incepta successfully started overseas marketing operation from May 2006.

In 2006, A total of 25 new generics with 82 presentations were launched. 9 of


these generics were first ever in Bangladesh.

In 2006, The company maintained an excellent growth of 31.26% over the


previous year (IMS).

In 2006, The company maintained the ranking of 3rd largest (IMS).

In 2007, Incepta pioneered the introduction of biotech products (Human Insulin)


and lyophilized products (Pantoprazole injection) in the Bangladesh pharmaceutical
market. This was the first time a local pharmaceutical company produced such
highly sophisticated technology product in the country.

In 2007, A total of 32 new generics with 82 presentations were launched. 4 of


these generics were first ever in Bangladesh.

Marketing, Sales, Distribution and Administration departments shifted to the fully


owned new office premises in Tejgaon, Dhaka. The international standard head
office of Incepta started operation in the new office premises on 1st October, 2007.

In 2007, A marketing and sales team was setup in Myanmar headed by a country
manager from the Marketing Strategy Team to promote the 35 products registered
with the Myanmar FDA.

Continued investment in our core strength that is our manufacturing plant led to
recognition from European authorities and on January 11, 2008 Incepta attained
European "Certificate of GMP Compliance".

In 2008, 40 new products with 86 presentations were introduced of which 10 were


first ever in Bangladesh.

The plant received GMP certification (General formulations and Cephalosporins)


from Kenyan Ministry of Health on January 21, 2008.

Incepta was also awarded GMP (Cephalosporins) from Ethiopian Ministry of Health
on July 22, 2008.

Incepta registered 51 products in Mongolia on September 26, 2008 (As first


Bangladeshi Company).

Incepta registered 3 products in Georgia on October 13, 2008 (As first Bangladeshi
Company).

In 2008 significant number of products got registration in different countries. 19


products from Democratic Republic of Congo, 20 products from Sri Lanka, 22
products from Togo, 8 products from Hong Kong, 20 products from Mauritania, 6

products from Vietnam, 1 product in Cambodia.

Incepta started venturing in the field of human vaccines and hormonal products.
Construction of the Vaccine & Hormones facilities started on 1st January 2009 and
8th November 2009 respectively.

Incepta became the first Bangladeshi Company to get GMP Compliance Certificate
from Turkey (Tablets, Capsules and Lyophilized products) on January 08, 2009.

Incepta achieved GMP certification from the Ministry of Health, Yemen on May 25,
2009 (Sterile and Non-sterile products).

Incepta launched 51 new products in 2009. 4 of these were first ever in


Bangladesh pharmaceutical market.

Incepta was accepted and became enlisted with the Copenhagen office of UNICEF,
UNDP and UNESCO as global supplier of medicine.

Incepta was awarded GMP certificate from Uganda, National Drug Authority on 5th
August 2010 (Sterile Products, Non-sterile products and Cephalosporins).

Incepta launched 56 product presentations. 10 of which were first ever in


Bangladesh market.

Incepta maintained the 2nd largest (IMS) position in Bangladesh pharmaceutical


market in 2010. The company showed the strongest growth among the top 10
companies with a growth rate of 34.97% (IMS).

Incepta is set to introduce Human Vaccines to the market and become the first
Bangladeshi vaccine manufacturing company.

Export has emerged as a focus area for Incepta. With over three hundred products
registered in different countries export is now set to play more important role in
the growth of the company. Currently the company exports to 33 countries of the
world with many more in the pipeline.

Since starting supply of medicine to UNICEF in Bangladesh, Incepta has remained


the largest supplier till today.

Up to June 2011 the company has launched 30 products, 7 of which are first ever
in Bangladesh market.

Quality Management System


The QMS of Incepta Pharmaceuticals Limited is established in a frame to describe its
operations in different documents and practices which is based on the principles of PICS
and WHO guidelines. The Quality Manual describes the Quality Policy of Incepta
Pharmaceuticals Limited.
The responsibilities for the technical aspects of Quality Assurance are defined in the
Quality Manual. It encompasses all activities necessary to generate, maintain and verify
the quality of drugs.
The Quality Assurance of Zirabo Plant consists of Quality Control, Quality Compliance and
Quality Surveillance. The main tasks and duties of Quality Control have been described in
the Quality Manual and relevant SOPs. The Head of Quality Assurance or his delegates are
responsible for releasing drug substances, excipients, dosage forms and packaging
materials.
Quality Compliance is responsible for IPC, GMP co-ordination and training. Performances
of routine GMP checks are done as per need. Monitors to respect GMP regulation in the
manufacturing by instant checks of Batch Record completion, visual checks of cleaning of
working place, line clearance, performance checks of balance & other equipment.
Quality Surveillance is responsible for the implementation of the Quality Management
System in different areas in collaboration with different departments. Quality Surveillance
play active role in conducting external and internal audits with their follow-ups.

Research & Development is responsible for formulation development and method


development, implementing technical transfer to Production and Quality Control, and also
covers process validation, cleaning validation, method validation and follow up stability.
The Quality Manual describes how testing instructions are established and used. The
testing instructions include the specifications and testing methods. The testing instructions
are binding for release testing and for follow-up stability testing.
A routine inspection is being done in the name of "Self Inspection" mainly concerned with
safety, sanitation and infra-structural facilities leading to GMP including documentation.
Supply of raw materials are mainly obtained from approved suppliers. We select and
evaluate the supplier as per procedures. This procedure is also applicable in case of supply
of Primary and Secondary Packaging Materials.

Production Facilities
At present Incepta has one fully operational plant at Zirabo, Savar, Dhaka (Zirabo plant)
and another at Dhamrai, Dhaka. The second site is currently under development and
several projects of finished formulation unit are being set up.
The Zirabo manufacturing plant is located about 35 Km north of Dhaka City and covers an
area of land about 15,000 m2. The total built up production area is about 300,000 square
feet. Currently the plant consists of a general purpose manufacturing building, a dedicated
cephalosporin manufacturing building, and a specialized manufacturing building for the
production of lyophilized products, insulin and amino acids in addition to several floors
dedicated to the production of solid dosage forms- tablets and capsules. A newly built
liquid and semisolid manufacturing building is also in operation at this site. The site also
houses a warehouse for raw, packaging and finished goods. To meet the increasing
demand from domestic as well as overseas markets, another warehouse is currently under
construction with three times the capacity of the existing one. A separate multipurpose
building houses the Research & Development lab along with the canteen facility. At
present all the products are coming from this plant at Zirabo.
Manufacturing and packaging operations are carried out according to the validated
methods through systematically qualified machines with full documentation at all stages
of operations.
The production sites follow the cGMP guidelines for environmental requirements of the
manufacturing and packaging area, as well as comply with the EHS requirements.
Highly sophisticated HVAC systems are used to condition, monitor and supply clean air to
the working zone according to the manufacturing zone concept, capture and control any
dust, vapor, gas or fume generated, as well as treat re-circulated and/or exhausted air.
Temperature and moisture level are maintained at the desired level through this system.
Design of the room and air-conditioning systems ensure:

Prevention of contamination of the product.

Protection of the environment.

Protection of people.

Prevention of the ingress of vermin, insects, birds etc.

There are different environmental zones maintained within the manufacturing area.
Training programs take place on a regular basis according to written plan. Personnel at all
levels undergo general cGMP and Technical Training appropriate to perform their job
satisfactorily.
Purified water and water for injection plant and distribution systems are designed to
maintain the water quality according to the relevant requirements and state-of-the-art
engineering design which include e.g. 24 hours run circulation loops, smooth interior
surfaces, adequate materials, minimum flow rates.
At the Zirabo plant the following activities are carried out

Pharmaceutical Manufacturing processing and packaging of pharmaceuticals to


supply to the local market and for Export to 3rd parties. Approved suppliers supply
the active substances used in manufacturing. Most of the auxiliaries used for
production are bought from approved third parties.

Logistics, Warehousing Storing of raw and packaging materials to meet the


requirements of production and also storing and dispatch of finished products as
per concept of Good Storage Practice of pharmaceuticals.

Engineering/Industrial Engineering In line with pharmaceutical production, health


safety and environmental protection, infrastructure maintenance, machinery and
other maintenance. Effluent treatment and safe disposal of pharmaceutical waste.

Quality Assurance/Quality Control Quality Control of pharmaceuticals, raw and


packaging materials, reagents and chemicals, plant and personnel hygiene,
method and process validation, and overall quality assurance of pharmaceuticals.

Research & Development Formulation development and adaptation for scale up


production with process validation, method validation in collaboration with QA/QC.
Stability study and shelf life determination of pharmaceutical products.
Reformulation/improvement of existing formulations in line with new/advanced
technology.

Plant HR/Administration Support different units of the plant for HR related issues,
general services, general logistics and administrative issues.

The following product forms are manufactured on site:

A. Sterile Products:

Liquid dosage forms (LVP & SVP, Terminally sterilized and aseptically filled
ampoule) Eye Drops

Solid dosage forms (Solid fill, Dry vials and Freeze-Dried Products)

B. Non Sterile Products:

Liquid dosage forms (Oral Liquid, Nasal Solution, Nasal Spray)

Semisolid dosage forms (Creams, Ointments, Gels)

Solid dosage forms (Tablets, Capsules, Powders, Granules)

C. Biological Products:

Aseptically prepared injectables: Erythropoetin, Enoxaparin, Insulin, Insulin


Glargine (rDNA), Filgrastim

D. Cephalosporins (Dedicated manufacturing facility):

Solid dosage forms (Tablets, Capsules, Powder)

Sterile Powders (Aseptically filled vials)

Research & Development Facility


Research is a critical thrust area for Incepta because it is the foundation upon which their
strategy to introduce new products and delivering quality products to customers' stand. As
a result of our efforts in R & D we have been successful in developing and introducing
quality products faster than their competitors. They have built up a sophisticated R & D
facility equipped with state-of-the-art equipment and facilities. Their R & D is a highly
experienced multidisciplinary team. The objective of this R & D strength is to develop new
drug delivery system and various dosage forms like controlled release, immediate release,
melt in the mouth, effervescent formulations, nasal preparations, cream & ointment
preparations, liquid injections like Insulin and large volume amino acid solution for
injection, powder filled vials, prefilled syringe injections, Depot injections, ophthalmic
products, lyophilized products in key therapeutic segments in addition to the conventional
dosage forms.

Formulation & Development at Incepta R & D ensures:

Pre-formulation studies to check bio-chemical action of ingredients.

Trials to assess efficiency and reproducibility of formulation (process validation)

Stability study following ICH guide-line to check physical, chemical, and


microbiological aspects of formulation. Standardize processes for uniform quality.

Transfer of technology to production department.

Analytical method validation.

Equipment Facilities for R & D


Incepta have a separate Galenical laboratory for R & D, equipped with all the necessary
machineries & equipments of GMP standard in small scale for the team to develop
products.
Analytical development is supported by our Quality Control Department. Quality Control
Department is equipped with highly sophisticated instruments like UPLC, Gas
Chromatography, Atomic absorption spectrophotometer, FTIR, etc. A dedicated team is
involved in the development and validation of methods of API, raw materials & finished
products. A highly sophisticated microbiology laboratory has been setup to cater to the
need for quality control of regular products as well as control of all the different biological
products that the company produces.
Their R & D team has pioneered the technology development and subsequent introduction
of 130 new products for the first time in Bangladesh market (up to December 2010).
Following are a few of this long list of products:

Losartan Potassium tablet

Pantoprazole Sodium delayed release tablet

Loratadine melt in the mouth (Flash) tablet

Verapamil hydrochloride SR tablet

Calcium with Vitamin C effervescent tablet

Multivitamin with multi-mineral tablet which contains 32 Vitamins & minerals

Insulin Glargine (rDNA) injection and other Insulin products

Prefilled injection technology products like Enoxaparin

Lyophilized injections of Pantoprazole, Esomeprazole and Omeprazole

Filgrastim injection

Erythropoetin injection

Zoledronic Acid injection

GMP Compliance
The Directorate General of Drug Administration, Ministry of Health & Family Welfare,
Government of the Peoples Republic of Bangladesh, has issued GMP certificate to Incepta.
The Drug Administration issues GMP certificates following inspections carried out
according to WHO prescribed standards.
Incepta Vaccine Limited, a sister concern of Incepta Pharmaceuticals Ltd recently received
GMP certificate, from the Directorate General of Drug Administration.
Incepta Pharmaceuticals Ltd has also been accredited with the European Union GMP
certification for its Solid Dosage form plant at Zirabo, Savar, in Bangladesh, a rare and
one of the most coveted certifications for regulated markets. The Solid Dosage Plant of
the company was inspected by the European authorities and found to be complying with
the Manufacturing and Quality Control Standards as per the European Good Manufacturing
Practices.
Very recently Zirabo, plant has been inspected by the UK MHRA , and the company is
awaiting approval from this esteemed regulatory authority.
Directorate General of Drugs and Pharmaceuticals, Ministry of Health of the Republic of
Turkey issued GMP certificates to Incepta Pharmaceuticals Ltd for Tablets, Capsules and
Lyophilized Products. Unlike single product GMP certificate which is the normal trend,
Incepta received GMP certificate for multiple full lines.
Incepta has received GMP certification from a number of other countries. The relevant
departments of the Health Ministry of these countries have issued these GMP certificates.
Incepta currently holds the following GMP certifications:

European Union GMP Certificate

Turkey GMP Certificate

Yemen GMP Certificate

Kenya GMP Certificate

Democratic Republic of Congo GMP Certificate

Ethiopia GMP Certificate

Uganda GMP Certificate

Marketing, Sales & Distribution


A complete and integrated Marketing, Sales and Distribution network is required to make
the information on products and services available to the customer.
To achieve our purpose and mission, we affirm our values of integrity, respect for people,
innovation, performance and leadership. Around 4000 individuals from diverse disciplines
including pharmacy, microbiology, MBA, Accounting, Engineering and Medicine are
working nationwide under the umbrella of Incepta. All the skilled and professional
personnel are set at their very appropriate responsible positions. Their sales team
comprising highly professional science graduate and post-graduate people are involved in
the timely and smooth promotion of our products for the benefits of our doctors, people
as well as the whole nation.
Incepta has its own large distribution network having 18 depots all over the country. They
make the products available in every single drug store of the country. The depots are
located in Dhaka, Chittagong, Rajshahi, Khulna, Sylhet, Barisal, Comilla, Noakhali,
Mymensingh, Magura, Bogra, Narayangonj, Rangpur, Dinajpur, Tangail, Jessor,
Moulovibazar and Cox's Bazar.

International Marketing
Incepta, a leading Pharmaceutical manufacturer in Bangladesh, continues its voyage
towards inherent dream to become a key contributor in the world Pharmaceutical market
by maintaining a constant commitment to research, developing innovative products and
quality management. Our unwavering determination to achieve excellence leads us to new
global benchmarks.
Incepta is guided by its export mission to improve the health and well-being of people
worldwide. Its corporate philosophy is to create new value around health-related products
through science and advanced technology.
Incepta has always given very high priority to its Research and Development activities.
This focus enabled Incepta to develop and market 118 generics for the first time ever in
Bangladesh pharmaceutical market. The company has successfully developed nearly 650
dosage forms of 300 plus generics in different specialties that are currently selling in the
local as well as international market.
Incepta is continuing to introduce new and technologically advanced molecules and
innovative dosage forms. These molecules and dosage forms have played key role
towards the rapid growth of the company in the last eleven years. Currently Incepta is the
second largest and fastest growing company among the top five companies of the
country.

The company is dedicating a significant percentage of its resources to strengthening its


technology including biotechnology, centered on Pharmaceuticals. Incepta currently
manufactures and sells several bio-tech products in the local market. In order to expand
its bio-tech business abroad Incepta has already established a state-of-the-art Human
Vaccine production facility which will go into production soon.
Within five years of starting export operations, Incepta now sells its products in 33
countries. This has become possible due to an intellectual pool of some of the best minds
in the country. Starting in 2006, Incepta already has registration of more than 300
products in different countries around the globe. Further negotiation with possible
business partners and product registration is going on to further the presence of the
company in many more countries.
In January 2008, the company received "Certificate of GMP compliance" from European
Union which basically opened the door to the European market for Incepta. In recent
times the UK MHRA authorities have also inspected the production facilities located at
Zirabo, Savar. The UK MHRA GMP compliance certificate is now under process.
In 2004 Incepta was inspected by UNICEF and UNDP and accepted as a potential supplier.
In 2005 Incepta started supplying products to UNICEF locally in Bangladesh. Subsequently
in 2010, Incepta was accepted by the global headquarters of UN agencies at Copenhagen,
Denmark and became enlisted as global supplier to UNICEF, UNESCO, and UNDP.
During the course of the last couple of years the company has received accreditation from
many other countries of the world and currently holds the following GMP certificates from
their respective Ministry of Health.

European Union GMP Certificate

Turkey GMP Certificate

Yemen GMP Certificate

Kenya GMP Certificate

Democratic Republic of Congo GMP Certificate

Ethiopia GMP Certificate

Uganda GMP Certificate

Incepta currently sells its product in many countries of Asia, Africa, Central America and
has started to sell in Latin America. Incepta is taking special efforts to ensure presence in
the rest of the globe. Currently the company is exploring distributorship, contract
manufacturing, in licensing, technology partnership and many other forms of cooperation.
Companies around the world can benefit from partnership with Incepta as the company
offers a very large portfolio of generic products to choose from. Focus on ensuring high
quality and cost effectiveness makes our portfolio more attractive to potential customers.