You are on page 1of 16

INTRODUCTION

COMPANY PROFILE Shasun Pharmaceuticals Limited (Formerly known as 'Shasun Chemicals and Drugs Ltd.,') was incorporated in 1976 and is headquartered in Chennai, India. It manufactures active pharmaceutical ingredients (APIs), their intermediates and enteric coating excipients with a significant presence in some key generics. Shasun has created a strong product portfolio, building on its R & D Expertise, regulatory capabilities and multi scale production capacities. Shasun has also emerged as a key player in various service segments in the pharmaceutical field besides APIs and intermediaries, and is strengthening its offer of contract research, custom synthesis, contract manufacturing and contract formulation services to clients. Today, Shasun is one of the largest producers of Ibuprofen worldwide. The company offers derivatives of Ibuprofen like Ibuprofen Sodium, Ibuprofen Lysinate and S+Ibuprofen. It is also one of the major producers of Ranitidine and Nizatidine in the world. Its products are exported to countries across North America, Europe, Asia and Latin America. Shasun in its endeavour to become a true one-stop shop for global pharma companies, is evolving its business model to become a complete service provider, offering services right from the discovery stage to manufacturing formulations. The company has recently added finished formulations capability as forward integration, and has invested in large facility to cater to the international regulated market. It has tied up with multinational companies in the formulations space wherein it will be developing and supplying products for the US market. The recent acquisition of the business and facilities of Rhodia Pharma Solutions by Shasun's wholly owned subsidiary Shasun Pharma Solutions Ltd (SPSL), UK equipped the company to evolve as a technology based service provider than as a contract manufacturing and research provider. Its services include innovative process

research and development, rapid response small scale manufacture for clinical trial supply and full scale commercial manufacture of advanced intermediates and APIs, all with seamless technology transfer with and without cGMP. The formulation unit at Puducherry has been approved by US FDA. By integrating its facilities in India and UK, the company is trying to offer the benefits of operations in both the countries to its clients. The company has aligned its facilities so that while research can be conducted in India, development and manufacturing in kilo labs and pilot plant can be conducted either in UK or India and the optimal mix could be decided based on the regulatory, IP and cost. The company is planning to set up a multi-product pilot plant facility at Vizag, Andhra Pradesh, focusing on Contract Manufacturing Services business. In FY06, CRAMS business revenue has reached INR 3430 million. S. ABHAYA KUMAR S .VIMAL KUMAR R .SUNDARA RAJAN M .MOHAN S .DEVENDRA R .KANNAN N .SUBRAMANIAN Managing Director Whole Time Director Director Whole Time Director Whole Time Director Independent Director Independent Director

CORPORATE OVERVIEW

Today's new medicines are usually the result of collaborations between multiskilled teams involved in different parts of the drug life cycle. Modern Pharma or Biotech companies often partner with companies who specialize in these diverse activities including: cutting-edge research, medicinal chemistry and biotechnology, process development, production, validation and regulatory approval for both API and Drug Product. Rarely are these conducted by just one company. However Shasun has the ability to offer a wide range of these specialist activities thus allowing the innovative drug company to reach the market quicker and more cost effectively. Shasun is engaged in the manufacture of active pharmaceutical ingredients and drug products with a significant presence in the anti-inflammatory and anti-ulcerative therapeutic groups. In addition, the company has recently strengthened its offering in contract research, custom synthesis, contract manufacturing and contract formulation services through its acquisition of Rhodia Pharma Solutions and offers services and products to clients in US, Europe and Asia. Today Shasun exports products to countries across Europe, North America and others and a wide range of customers from the smallest Biotech to most of the world's largest Pharmaceutical giants. Shasun employs more than 1400 people in India, the UK and the US. Headquartered in Chennai ( India), Shasun operates world-class API facilities at Cuddalore and Puducherry in South India and Dudley in UK. In the last few years Shasun has added a state-of-the-art research center in Chennai and a world class solid oral dosage formulation facility in Puducherry. Shasun is publicly-held and listed on the National Stock Exchange and the Bombay Stock Exchange in India.

SHASUN'S HISTORY

From the modest beginning in 1976, Shasun has acquired a worldwide reputation for the manufacture of Active Pharmaceutical Ingredients (APIs) and their intermediates. The Companys products are exported to customers in countries across Europe, North America, Latin America and Asia. SHASUN is derived from the name of the founder, Late Shri. Shankarlal Jain and his wife Smt. Sundarbai. QUALITY POLICY We commit to meet National/International Standards and to manufacture and supply consistent quality Active Pharmaceutical Ingredients, Excipients, Intermediates and Pharmaceutical Dosage forms to achieve customer satisfaction. We care, to meet changing customer expectations, to enhance our employee contributions and to develop and retain our suppliers, in order to sustain our organizational performance. We accept responsibilities, to provide conducive work environment for our employees, to reduce problems and to desist from adversely impacting our surroundings.

ENVIRONMENT, HEALTH AND SAFETY POLICY

Shasun is committed to protecting the Safety, Health and well-being of its employees, the community in which we operate and the wider environment. In achieving this aim we will: Comply with all applicable legal and other requirements. Operate with the principles of Responsible Care and continually strive for excellence. Continually review and improve our processes, services and products to reduce industrial risk and impacts. Educate, train and motivate employees to conduct their activities in a safe and environmentally responsible manner. Use resources efficiently and minimize waste utilizing pollution prevention techniques. Work with suppliers and partners to mutually improve EHS performance. Integrate our sites effectively into their natural environment and local communities. INFORMATION SECURITY POLICY Shasun committed to protecting the confidentiality, integrity, and availability of information entrusted to itself by its staff, suppliers and other partners, as deemed necessary by privacy obligations, regulatory compliance or contractual obligation. To meet this vision we will develop, implement, and maintain most current information security standards, procedures, and best practices. The objectives of the organization towards Information Security are:

Set direction in achieving safe and secure environment and security of information to users. To maintain the Confidentiality, Integrity and Availability of the information.

To manage Shasuns Information security using Risk Management framework with a criteria for evaluating the risk based on the impact on confidentiality, integrity and availability. To maintain high awareness levels of security policies as applicable to various roles, through training and awareness campaigns. Comply with legislative and contractual requirements. Security incident management and prevention. Continuous improvements in security management through Security Forum. Protect Shasuns Intellectual property rights and proprietary information. Business continuity management through formulation and periodic testing of business continuity plans.

Shasun has selected to dovetail its strategic blueprint with the business growth being projected by its partners. It has extended this from a one-off instance to an ongoing commitment through the following priorities: An effective combination of scale, competence and costs in all business investments with the objective of achieving value-addition. An ongoing presence in regulated markets with the objective to enhance capability and profitability, setting off a virtuous cycle. A prudent leverage in organic synthesis, process development, supply chain and world-class facilities with the objective to emerge as a trusted outsourcing partner for key innovator companies. A focus on long-term relationships with the objective to grow customer accounts and generate attractive referral business. An emphasis on an increasingly professional management with the objective to scale up the business in a continuous way in response to growing opportunities. A stated non-competing approach with customers with the objective to enhance a sense of trust. QUICKER TURNAROUND TIME Shasun possesses the ability to extend projects from lab to validation within 12 months, and from shell to operations within six months. A judicious provision of buffer capacity permits the company execute critical projects with speed. COMPETITIVE PRICING Shasun enjoys Indias inherent advantage of low project and labour costs, leading to cost-effective customer solutions. This is reinforced by the capability of its development chemistry group to develop efficient alternative processes within costs and deadlines The companys experienced scale-up team helps migrate lab projects to successful product development

CORE STRENGTHS High quality, cGMP production. Continuous process innovation. Strong MNC relationships in API supply, contract manufacturing and contract research. Deep regulatory capability. Richly experienced and professional team. Successful R&D initiatives in the development of non-infringing processes for generic APIs and intermediates PHILOSOPHY
Research & Development for the Pharmaceutical Industry From Service

to Solution Provider
Shasun looking for long-term collaborations Shasun prefer to grow by adding value to collaborators

PRODUCTS
Carisoprodol Ketoprofen Sevelamer Hydrochloride Sevelamer Carbonate Methohexital Meprobamate Gabapentin Olanzapine Form-I Isradipine Quinapril Hydrochloride Colesevelam Hydrochloride Lacidipine Cycloserine Chlorphenesin Ranitidine Base Nizatidine Diphenhydramine citrate Z-L-Cyclohexylglycine Z-L-tert-Leucine (dicyclohexylammonium) salt

BRANDED FORMULATION

WARFEN WARFEN is used for the prophylaxis and or treatment of the thromboembolic complications associated with a trial fibrillation and or cardiac valve replacement. WARFEN is also used for the treatment of Venous Thrombo embolism and pulmonary embolism. WARFEN tablets are used to reduce the risk of death and recurrent myocardial infarction GLIMSEN GLIMSEN is indicated as an adjunct to proper dietary management, exercise and weight reduction to lower blood glucose in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise alone. GLIMSEN has low risk of hypoglycemic. GLIMSEN has potent blood -glucose lowering effect with less stimulation of insulin secretion, possibly due to more pronounced extra pancreatic effects. GLIMSEN has lower dosage, rapid onset and long duration of action GLIMSEN can be used in combination with Metformin, the thiazoliinodiones, alphaglucosidase inhibitors and insulin. FORMULATION Shasun Pharmaceutical Division develops and manufactures formulations for solid dosage products. The Division is a vertically integrated formulations partner for the pharmaceutical industry. Its services include formulation research and development activities, Analytical method development and validation, scale-up and technology transfer, clinical supplies manufacturing to full scale commercial manufacturing of oral solid dosage forms.

The formulation facility is located in Puducherry, in the south eastern coast of India. The site is located on a 14 acre campus with plenty of room for future expansion. It is a new facility completed in 2006 with 100,000 square feet of constructed space. It contains office areas, analytical laboratories, formulation development laboratories, a cGMP pilot plant and commercial manufacturing space. The facility is built to meet the regulatory requirements of the US FDA, Health Canada, MHRA in the U.K and other European Agencies. Some of the key features include separate air handling units with terminal mounted EU13 HEPA filters, to provide a class 100000 environment in the manufacturing areas. These are continuously monitored by a building automation system. Tablet compression areas have vertical material flow to avoid cross contamination. Automatic container cleaning system ensures validation of cleaning procedures. The facility has limited access controls and CCTV monitoring of man movement to various areas inside the facility, to avoid violation of current Good Manufacturing Practices (cGMP). CONTRACT FORMULATION Shasun Pharmaceutical Division contract manufactures finished oral dosage forms for a number of Pharmaceutical companies worldwide. These include film coated, sugar coated and enteric coated tablets as well as hard gelatin capsules Our granulation technologies include both low and high shear wet granulation processes as well as direct compression granulation. We use fluid bed granulators and driers to produce the granules. Tablet compression machines are capable of manufacturing single as well as bilayer tablets and our coating technology includes film, sugar and enteric coated tablets as well as pellets for encapsulation.

Our Packaging capabilities include bottle and blister packaging as well as bulk granules. Blisters can be packaged cold and hot form materials. The final finished product can be packaged and labeled as per regulatory requirements and ready for delivery to the customer. BIOTECHNOLOGY Shasun recognizes the role of biotechnology as the future of the global pharmaceutical industry in enhancing therapeutic effectiveness, improving lifestyle quality and strengthening corporate profitability. In view of this, the company is involved in the creation of significant biotechnology capabilities & capacities especially in the area of protein processing solutions to provide services for the biotech & pharmaceutical companies EMPLOYEE DEVELOPMENT Shasun is a FDA approved company for manufacture of bulk pharmaceuticals and hence the practices are equal to the best pharmaceutical companies in India and across the world. Being an ISO 9001:2000 certified company only supports the strength of our quality systems providing every employee with the best work standards. Shasun provides also congenial atmosphere to work, learn and grow. The company conducts various programmes to train their staff in the latest technologies and best management practices by organizing regular training classes keeping in mind the needs of each individual, and also encourages its employees to participate in industry events and trade shows. Shasuns R&D centre is a recognized the by Madras University as an institute for pursuing doctoral programme in chemistry. Young chemists are motivated to work on weekends on research projects, supervised by their guides, in subjects of their academic interest, which are discovery oriented and not purely commercial projects.

SHASUN CULTURE We are in transition from being a family owned and managed company to a organization run by qualified professionals. New leadership has taken charge within and the effect is a rejuvenated new culture. Every Shasun employee is today encouraged to become a leader by taking ownership for actions in their respective work areas. Cross-functional understanding and interaction within various departments and sites is required. TRAINING AND DEVELOPMENT Shasun is a FDA approved company for manufacture of bulk pharmaceuticals and hence the practices are equal to the best pharmaceutical companies in India and across the world. Being an ISO 9001:2000 certified company only supports the strength of our quality systems providing every employee with the best work standards. Our clientele is multi-national and hence more opportunities for travel, interaction, and understanding of international culture and standards involved is available to our employees, which groom them to become a world leader. Shasun provides also congenial atmosphere to work, learn and grow. The company conducts various programmes to train their staff in the latest technologies and best management practices by organizing regular training classes keeping in mind the needs of each individual, and also encourages its employees to participate in industry events and tradeshows. Shasuns R&D centre is a recognized the by Madras University as an institute for pursuing doctoral programme in chemistry. Young chemists are motivated to work on weekends on research projects, supervised by their guides, in subjects of their academic interest, which are discovery oriented and not purely commercial projects. SHASUN PH D PROGRAM In-house Ph D Program: Shasun R&D has been recognized for the Ph.d program of Madras University & Anna University. Shasun R&D centre has started recently an in-house PhD program to promote and enhance the capability of our scientists and to also get into basic research activities in related topics of interest of Shasun. One of our employee, Ms. Suman Meenakshi, have been registered with Anna

University for the Ph.D. program. Mr.Karthikeyan has registered for Ph D programme for Madras University. This year two more employees will be registered for the PhD program of Anna University. SRC intend to expand this program and extend it to more than one university in the future.

MILESTONES 1976-1990 Incorporated as a private limited company, Shasun Chemicals in Chennai First production facility established at Velachery, Chennai, for manufacture of Analgin (antipyretic). Second production facility was established at Puducherry for manufacture of Ibuprofen (anti-inflammatory) 1990-2000 Third manufacturing unit set up at Cuddalore to manufacture the anti-ulcerative Ranitidine HCI Shasun converted into a public limited company, incorporating its present name. US subsidiary, Shasun Inc., is established The company's shares were listed on Mumbai, Ahmedabad and Chennai stock exchanges. Technology and joint marketing agreement signed with Nagase & Co., Japan for S+Ibuprofen The company signed a technology agreement with Chircotech, UK, for S+Naproxen. The company signed a joint venture agreement with Austin Chemical Company, USA, 2000-2010 The company's exports exceeded Rs.100 cr.

Established a biotech laboratory in its R&D centre. Signed a letter of intent with Eli Lilly for supply and manufacture of an anti-TB drug. Multi Purpose Plant at Cuddalore was commissioned. Completed setting up its new Research Centre. Strategic partnership with Glenmark and Alpharma(now part of Actavis) for Development & Supply of Formulation products. Completed its first ever acquisition of Rhodia Pharma Solutions business marking its advent in the Global supply arena Successful maiden inspection of the formulation unit by US FDA authorities in Pondicherry (Puducherry). Successful completion of the US FDA inspection of its Cuddalore and UK facilities (Annan and Dudley). Received certi?cation of ISO 27001 (ISMS-Information Security Management Systems) by Bureau Veritas. Signed a licensing agreement with Gilead for manufacture of Viread to support the Clinton Foundation initiative Licensing of cross-coupling technology (Buchwald Technology) to H-Lundbeck A/S and Merck & Co. Inc. Setting up of Lab facility at Piscataway (New Jersey), United States to provide API development service in pre-clinical and clinical trial stages. Embarks on implementation of an enterprise resource planning (ERP) - SAP across all its locations. Successful completion of clinical trials of Streptokinase, a biotech product. Successful completion of US FDA re-inspection of formulation unit at Puducherry. Closure of Annan plant at Scotland, UK and operations consolidated at Dudley facility. Commercial Launch of Recombinant Streptokinase in the Indian Market in June 2009.

Initiation of Toxicity Studies with respect to GCSF and PEG-GCSF - biotech products. Received commercial order of a leading API product from an Innovator Company (an anti depressant drug). Achieved leadership position in API product - Gabapentin (?nds application for anti epileptic cases). Finished Dosages sales has grown by 100% as compared to FY09 and has crossed Rs 50 crores in turnover in FY10. 2011 Formed 50:50 Joint Venture SHASUN NBI LLC in USA with Nanoparticle Biochem Inc. for development of proprietary process of nanoparticles used in therapy & medical diagnostics. Commercial launch of Olanzapine API in Europian and North American markets.