ACKNOWLEDGEMENT First of all, I would like to express my deep gratitude to Allah the Almighty for giving me the opportunity to perform and successfully completing the term paper. I acknowledge my heartiest due to our honorable course instructor Md. Khairul Islam, Assistant Professor, Department of Business Studies, Dhaka International University for giving me the opportunity to carry out this report. His valuable advice and guideline helped me a lot in preparing this report successfully. Otherwise the task of preparing this report would have been harder in part.
Secondly, I like to convey my gratitude and thanks to the Personnel of Incepta Pharmaceuticals Ltd. for providing me the required data, support and suggestions regarding this Report. Executive Summary This report details about a leading Pharmaceutical company of Bangladesh named Incepta Pharmaceuticals. The report outlines the background of the company with the production and marketing practices. Incepta Pharmaceuticals is one of the renowned companies in Bangladesh. It starts it work from 1999 and till the company is in the leading position.
The company has a clear vision and its mission is to fulfill their vision. The company has level of management and these different level managers work together to improve the present condition of the company. Incepta produces various kinds of medicines and now the company is exporting medicines to 35 countries. Incepta also maintain their social responsibilities for the betterment of Bangladesh. Objectives of the Report The main objectives of the study are to learn how to prepare a report. Our honorable course teacher assigns us to prepare this report so that in the ob market we can perform effectively and efficiently and also enlighten the goodwill of our university as well as our teachers. Other objectives of this report are: • To share the lesson learns. • To inform about the progress. • To analyze the inputs against the outputs. • To communicate the changes. • Analyze the recommendations. • Risk reduction preparation. • To plan accordingly for up-coming period. • To take quick decisions. Methodology of the Report For smooth and accurate study everyone have to follow some rules & regulation. The study impute were collected from two sources.
The sources are i. Primary sources ii. Secondary sources Primary sources: Primary sources of information are those that provide first-hand accounts of the events, practices, or conditions. In general, these are documents that were created by the witnesses or first recorders of these events at about the time they occurred. These information are collected from: • Practical desk work • Face to face conversation with the officer • Direct observations • Face to face conversation with the client Secondary sources: Second-hand, published accounts are called secondary sources.
They are called secondary sources because they are created after primary sources and they often use or talk about primary sources. Secondary sources can give additional opinions on a past event or on a primary source. Secondary sources often have many copies which we collected from: • Annual report of companies • Various publications of companies, • Website Limitations of the Study The study is mainly based on secondary data. The study is confined to only one manufacturing firm that is categorized into miscellaneous manufacturing firm. The study is limited to corporate firms as treated as a case study.
In the absence of more reliable and available data, this study is under taken only for short periods. This study leaves a short-run coverage of periods sample for want to studying the immediate impact of changes in companies as it was intended for long-run analysis. Review of Related Literature Analysis of Data About 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.
The company specializes in value added high technology dosage forms like sustained release tablets, quick mouth dissolving tablets, effervescent tablets, barrier coated delayed release tablets, prefilled syringe products, Insulin and Insulin analogue and biological products, among others . It has established a modern research and development laboratory for the development of new, advanced dosage forms for various drugs and devices like poorly soluble drugs, dry powder inhalers, coated pellets, modified release products, taste masked preparation etc.
Incepta has a very competent sales team, which promotes the specialties throughout the country. The company virtually covers every single corner of the rural as well as urban area of Bangladesh. It has its own large distribution network having 18 depots all over the country. The company has a clear vision to become a leading research based dosage form manufacturing company with global presence within a short period of time. With this view in mind the company started to expand its business in overseas markets.
Currently Incepta exports to 33 different countries around the world. With hundreds of brands registered in different countries, and many more in the pipeline, Incepta is gradually expanding its global footprint across all the continents. Vision We want 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 those improve the quality of life of people around the world. And contribute towards the growth of our Nation.
The main theme of the company is, “Innovation into practice. ” 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 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. 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 1998-99 • 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. 2000 • 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. 2001 • There was massive restructuring throughout the company. Sales, Distribution, Marketing Strategy Department, and Factory; all were reorganized. • A total of 18 new generics with 37 presentations were launched this year. 1 of these generics were first ever in Bangladesh. • By the end of the year Incepta was ranked the 12th company of the country. The company had a phenomenal growth of 448% over the previous year (IMS). 2002 • A total of 32 new generics with 49 presentations were launched. 14 of these generics were first ever in Bangladesh. • Massive expansion project of the factory was envisioned. New office for the sales and distribution operation was also taking shape. • 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). 003 • 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. • The new office (Dhanmondi) for the sales and distribution operation was inaugurated. • The company registered an excellent growth of 28. 5% over the previous year (IMS). • By the end of the year Incepta was ranked the 8th company of the country (IMS). 2004 • A total of 17 new generics with 32 presentations have been launched. 6 of these generics were first ever in Bangladesh. The company maintained an excellent growth of 48. 2% over the previous year (IMS). • 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). 2005 • We 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. We started to supply life saving drugs to UNICEF from March, 2005. • A total of 27 new generics with 76 presentations were launched. 2 of these generics were introduced first time ever in Bangladesh. • The company maintained an excellent growth of 34. 8% over the previous year (IMS). • The company was ranked 3rd largest with the highest growth among the top five (IMS). 2006 • 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. • A total of 25 new generics with 82 presentations were launched. of these generics were first ever in Bangladesh. • The company maintained an excellent growth of 31. 26% over the previous year (IMS). • The company maintained the ranking of 3rd largest (IMS). 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. • 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. • 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. • The company maintained a growth of 12. 93% over the previous year (IMS). • The company held the 3rd largest ranking (IMS) among the companies. 008 • 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”. • 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. • The company maintained a growth of 12. 10% over the previous year (IMS). The company became the 2nd largest (IMS) among the companies operating in Bangladesh. 2009 • 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. • The company maintained an excellent growth of 27. 71% over the previous year (IMS). • The company maintained the 2nd largest (IMS) position in 2009. 2010 • 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 Cephalosporin). • Incepta launched 56 product presentations. 0 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). 2011 • 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 35 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. Incepta’s Growth in Comparison with Local Pharma Market (IMS* Data) [pic] Beginning in 2000, Incepta has been launching new and innovative products at a faster pace than its competitors.
Up to June 2011 it has already launched more than 317 generics with a total of 624 presentations. The company produces a wide variety of dosage forms covering nearly all the major therapeutic classes. During the last 11 years of operation Incepta launched as many as 118 new generics for the first time ever in Bangladesh. High focus on quality and timely introduction of much needed essential medications previously unavailable in the country has enabled Incepta to become the second largest pharmaceutical company of the country. 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 roduction 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 GMP 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 GMP 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 the production site of Incepta Pharmaceuticals Ltd: 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, and Nasal Spray) Semisolid dosage forms (Creams, Ointments, and Gels) Solid dosage forms (Tablets, Capsules, Powders, and Granules) C. Biological Products: Aseptically prepared injectables: Erythropoetin, Enoxaparin, Insulin, Insulin Glargine (rDNA), Filgrastim D. Cephalosporins (Dedicated manufacturing facility): Solid dosage forms (Tablets, Capsules, and Powder) Sterile Powders (Aseptically filled vials) 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 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.
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.
Our 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.
Products are supplied on a daily basis to all the major cities and towns of the country. Remote areas are also supplied rhythmically to ensure timely availability of products to all customers. There is a large fleet of transport including refrigerator trucks for supplying temperature sensitive products to retail shops around the country. Cold chain system is employed to products which need strict temperature control. Storage of these products is also maintained using refrigerators with backup power supply to ensure maintenance of standardized environment.
Global Reach of Incepta: Incepta market their products in 35 countries of the world through their distribution partners. [pic] Asia: Afghanistan, Armenia, Bhutan, Cambodia, Georgia, Hong Kong, Laos, Maldives, Mongolia, Myanmar, Sri Lanka, Tajikistan, Turkey, U. A. E. Vietnam Africa: D. R. Congo, Ethiopia, Mauritania, Seychelles, Somalia, Swaziland, Togo, Kenya Europe: Finland, Ukraine North America: Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras South America: Guyana Oceania: Fiji 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 124 generics for the first time ever in Bangladesh pharmaceutical market. The company has successfully developed 639 dosage forms of 335 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 six years of starting export operations, Incepta now sells its products in 40 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.
UK MHRA, the regulatory authority of England has inspected the Zirabo plant of Incepta Pharmaceuticals Ltd in February 2011. Incepta received the GMP approval for its solid dosage form facility in July 2011 for its own formulated products allowing marketing in UK and other European countries. 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, UNDP, UNRWA and UNFPA.
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. • UK MHRA GMP Certificate • 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 • Republic of Sudan Incepta currently sells its product in many countries of Asia, Africa, Central America and has started to sell in Latin America and Europe.
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.