Assignment On Strategic Analysis of Incepta Pharmaceuticals Ltd SIM: 501 (Fundamentals of Strategic Management)

Submitted to:
Dr. M A Mannan Professor

Submitted by:
Md. Shahidul Islam Id: 210, Stream: SIM MBA, 13th Batch

Department of Management Studies University of Dhaka

Date of Submission: February 4, 2012

Table of Contents

1. Profile of Incepta Pharmaceuticals Ltd------------------------03 2. Vision -------------------------------------------------------------03 3. Mission ------------------------------------------------------------03 4. History of Incepta ------------------------------------------------04 5. Chronology of Events -------------------------------------------04 6. Quality Management Systems ----------------------------------07 7. Production facilities ----------------------------------------------08 8. Research & Development facilities ----------------------------10 9. GMP compliance -------------------------------------------------11 10. Marketing, Sales & Distribution -------------------------------12 11. International Marketing -----------------------------------------12 12. Strategic Environmental Analysis -----------------------------14

Profile of 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, value-added products that improves 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.
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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 44.8% 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 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. 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 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.

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 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, percipients, 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 is 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, and 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-ofthe-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.
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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.

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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.

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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. 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.

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 Strategic Environment Analyses

The General Environment Analysis:
The general environment includes the distant factors in the external environment that are general or common in nature. Its impact on the operation of the firm, its competitors and customers make its analysis imperative. For the identification and analysis of the factors in the general environment is used PESTLED model. These are as followsPolitical Environment: The import policy for pharmaceuticals is flexible and less hassle free. The Drug policy of 2005 has encouraged entrepreneurs to establish more pharmaceuticals company. The competitive situation is dominating by the large national and multinational companies. Strong competition exists in the market. The government has reduced export charge to expedite exporting more pharmaceuticals products in different countries especially European and American countries. Government has made some bilateral agreements with potential large economic countries to expand the business of the country. The economic condition of the country is in recession The inflation rate is high that is 11.68% for the last few months The share market of the country is not good The economic policy is not standard consistent with the economic cycle The deficiency rate of liquidity in banks Purchasing power of people is declining The customers are getting health conscious Huge population made large prospective market Attitudes of people has expanded Life style gets new dimensions Creating various social organizations such as club, gymnasium etc very rapidly Information technology is advancing very quickly More latest machines are inventing rapidly Internet users are increasing very fast Information technology can transfer easily from one place to another

Economic Environment

Sociocultural Environment

Technological Environment

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Legal Environment

The Industrial Relations Ordinance has some leakage The industries regulatory activities are not available There is no sufficient protection for employees rights. Brand name is somewhat vulnerable The market entry policies has set of complex formalities Raw materials are not available in the country. Most of the materials are imported from abroad. The Government has made some policies protecting natural environment. High changes in the cost of energy Levels of environment pollution is increasing day by day The population of the country is increasing very rapidly. It creates huge demand of medicine. The number of population is 14.24 million. The population growth rate is 1.34 The average age of the people has increased. The rate of urban migration is increasing quickly There are small ethnic communities available Some less developed areas of country has been made city corporation that will gradually develop Education level of people is increasing. The present literacy rate is 56%

Natural Environment

Demographic Environment

Internal Environment Analysis:

The internal environment of an organization consists of the conditions and forces that exist within the organization. Internal environment portrays an organizations in-house situations. An organization has full control over these situations. Strengths It has core competencies in producing new and innovative products. In 2011, it produced 625 number of products in which 7 were first ever products It has adequate financial resources, experienced human resources, state of the art physical resources and strong information systems. It has a clear vision
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Weaknesses It has few proprietary products in the market. The organizational culture is not sound Marketing strategy is not aggressive comparatively others The products are not throughout the country available

It has satisfactory growth rate. In 2010, its growth rate was 34.97%. It has strong positive brand image in the market It does good management practices It is the 2nd position of pharmaceuticals companies in Bangladesh It is research based company It has economic of scale in producing its production because it has a big factory. It has 20% Bangladesh market share in

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