OVERVIEW: Established in the year 1978 as an exclusive facility for Small Volume Parenterals (SVPs), Gland Pharma has

developed into a progressive and quality conscious organization serving the pharmaceutical needs of diverse markets across the globe. The Company has world-class & world-scale facilities for injectables set up in collaboration with Vetter Group, Germany. The collaboration with Vetter provides Gland Pharma a technological edge in injectables and specifically in Pre Filled Syringes. The Company is constantly upgrading its operations and facilities to meet current Good Manufacturing Practice (cGMP) standards. It has earned a position of leadership in the country in injectables manufacture. Gland Pharma is a research-focused organization continuously developing niche products for the Indian and global pharmaceutical markets. It has pioneered Heparin technology in India and has a position of leadership in the GlycosAminoGlycans (GAGs) range of molecules. The company manufactures Active Pharmaceutical Ingredients (APIs) and injectable formulations for niche segments such as Osteoarthritis, Anti-coagulants, Gynaecology, and Ophthalmology. R&D: Gland Pharmas R&D focuses on two areas: Chemistry and Formulation development. This complements the Companys strength in injectables and its leadership in the GAGs range of molecules. The R&D is involved in developing generic pharmaceuticals encompassing small molecules, biologics and protein pharmaceuticals for the osteoarthritis, anti-coagulants, ophthalmology, gynaecology and anti-cancer segments. Most of the products are delivered as injectables. The R&D can over 150 highly skilled professionals working in complete synergy. The requisite support is extended by means of a well-equipped lab with modern infrastructure. The R&Ds focus on new products and formulations will make the company a significant player in the generics market worldwide. SERVICES: Overview: Gland Pharma provides wide Range of services that include Contract Manufacturing Product Development Contract Research

CONTRACT MANUFACTURING: Gland Pharma offers services for contract manufacturing of injectables ranging vials, ampoules, pre-filled syringes and lyophilized products. It provides value added total solutions in injectables for the global markets. PRODUCT DEVELOPMENT: Gland Pharma provides a complete range of solutions for Formulation Development of various injectables including biotechnology products. Gland Pharmas formulation scientists develop dosage forms and manufacturing processes for sterile products. The company utilizes project-specific protocols to ensure that all formulations meet or surpass the clients expectations. Gland Pharma offers its clients a full line of quality analytical and microbiological testing services to complement any project. Product development services include: Formulation Development Analytical Method Development Stability Testing Packaging Development Documentation Support INLICENSING: Gland Pharma's Product strategy is an integration of its strengths in GAGs and Pre-Filled Syringes. The Company has launched many niche molecules in the domestic markets and is also marketing the same in other near regulated markets. In keeping with the strengths, the company chooses products that fit into a common pattern: - Possibility for delivery in syringes or other injectables. - Application in niche segments of Cardiology, Anticoagulants, Anesthetics - Institutional products. Through its research, development and manufacturing, the company is committed to deliver products that consistently meet or exceed the expectations of its customers. It ensures this commitment through design of quality products, efficient production, quality assurance systems, reliable delivery, and continued service of its products. Gland Pharma has successfully launched several molecules for the first time in India for the Indian and global markets. Most of these APIs are low-volume (5-10 kg batch size)

products that are delivered in injectables, thus providing value addition to the companys core manufacturing strength. Product Development: Gland Pharmas formulation scientists develop dosage forms and manufacturing processes for sterile products. The company utilizes project-specific protocols to ensure that all formulations meet or surpass the clients expectations. Gland Pharma offers its clients a full line of quality analytical and microbiological testing services to complement any project. ACTIVE PHARMACEUTICAL INGREDIENTS Gland Pharma Limited supplies the Active Pharmaceutical Ingredients (APIs) and specialty drug intermediates produced in cGMP compliance Plants. In addition it has the capability to offer custom synthesis of the specialized products for Pharmaceutical use or for research studies viz. for clinical studies using the processes supported either by the customer or developed by us in our R&D Laboratories. All the APIs are produced in environmentally controlled and monitored facilities meeting the room classifications of class 10,000 standards in manufacturing suites. All the manufacturing suites are equipped with an independent air handling systems maintaining the required air changes. The purification rooms are provided with HEPA filters and positive room pressures are maintained between the adjacent rooms to ensure that there is no cross contamination of the products in our cGMP facilities. Our scientists and project team members are well qualified in respective disciplines viz. Organic Chemistry, Process Engineering and Pharmaceutical sciences etc. The technical team members have vast experience in the development of Synthetic Processes, Setting up Manufacturing Facilities, scaling up operations and adopting the good manufacturing practices. Gland Pharma Limited has been engaged in manufacturing injectable grade synthetic and biochemical molecules since three decades and has rich experience in manufacturing and testing of Active Pharmaceutical Ingredients. CONTRACT MANUFACTURING: Company has a state-of-the-art facility for Pre-Filled Syringes (PFS) set up in collaboration with Vetter, Germany. Gland Pharma has a variety of syringe filling options that utilize a fully integrated Groninger filling line. The syringe line capacity is up to 60,000 units per day for syringes ranging from 0.5 ml to 5 ml. The syringe line has been approved by the US FDA. Pharma has 2 filling suites to process vials in sizes ranging from 1 ml to 10. The vial lines are flexible and can accommodate filling of 3-piece plastic bottles (for eye/ ear drops). The total line capacity is 400,000 units per day covering a wide spectrum of

closures. Available vial-closure configurations include: Inert, surface-coated or standard stopper configurations Flip-offs or tear-away seals. The vial line has been approved by the US FDA. Ampoule The line capacity is up to 200,000 ampoules per day with fill volumes ranging from 1 ml to 5 ml. Infusions Filling A separate facility has been set up for filling infusions (50 ml 500 ml). The line capacity is up to 20,000 units per day. All the lines are interlocked with automatic controls and are designed for both aseptic filling and terminal sterilization. The vial and ampoule lines are integrated for washing, tunnel sterilization, filling and stoppering/ sealing operations INTERNATIONAL: The International Business Division of Gland Pharma was started in 2000. Regardless of its short history, the Divisions rapid growth contributes significantly to the companys bottom line. Gland Pharma currently sells its products to over 25 countries, adding new markets yearly. The facility has been audited and approved by the US FDA (2003, 2006), ANVISA, Slovakia, Tanzania, Columbia and many other regulatory bodies. The company holds 4 ANDAs and will submit an additional 4 dossiers to the US FDA before the end of the year. The International Business Divisions portfolio not only includes Glands 150+ products, but also is also responsible for the Contract Research opportunities. Domestic: Marketing operations-India Managed by a team of highly skilled and trained professionals, Glands key strengths come from its strong Manufacturing, Selling and Distribution, Presence in all major institutions and reputed hospitals across the country and brand building. Gland has gained a strong foothold in the domestic pharma market specializing in superspeciality injectable drugs. One of the most significant achievements for Gland Pharma was the launch of Cutenox, the first indigenous enoxaparin in all four strengths of 20, 40, 60 & 80 mg PFS, a cost effective alternative to the international imported brand of enoxaparin with comparable quality and efficiency. Gland has a strong presence in niche therapeutic segments such as Critical Cardiac care, Anesthesiology, Critical Care Medicine, Nephrology and Orthopedic products. While consolidating in the Cardiovascular and Anesthesiology segments, the company has ambitious plans to enter into Oncology segment and expand the product portfolio in Nephrology segment. For this, creation of specialized, highly dedicated and trained task

force is on the anvil. This team will comprise of Customer Relationship Managers (CRMs) who will concentrate their efforts selectively on the core doctors in the respective speciality. Gland has focused its attention on niche disease markets helping drive a more personalized approach to customer management. This has also helped us to spend more quality time with our key opinion leaders in the respective niche segments and derive the maximum business returns from them. We have an all India presence covering all major geographical markets in the country through our highly skilled and dedicated field force. This ensures a good coverage of all potential Cardiologists inclusive of Interventional cardiologists and Cardiothoracic surgeons, Intensivists, Physicians, Anesthesiologists, Orthopedicians and Nephrologists. Our field force ensures coverage of all major hospitals (both private and government), Intensive Care Units (ICUs), ICCUs, Neonatal ICUs and nursing homes. We also have a substantial business from large government tenders especially for our cardiovascular range of products. Other than doctors our field force meet the potential paramedical staff in hospitals inclusive of Nurses, Pharmacists, Dialysis Technicians, Anesthesia technicians and Catheterization laboratory assistants all of whom play a major role in driving our business. Our skilled and well-trained field force are continuously involved in activities to enhance knowledge about our products and related disease among physicians by organizing continuing medical education programs (CME programs), detection of undiagnosed diseases through special detection camps and enhancing patients' awareness about diseases by organizing several patient education programs. We invest in augmenting our field force to strengthen doctor coverage and sharpen key account management. We also invest a sizeable amount in CRM activities to help strengthen the bond between our field force and the corporate marketing team with the key customers. Our product range includes niche products in Critical Cardiac care inclusive of Anticoagulants, Antiplatelet, Anti-arrhythmic and Inotropic Drugs, Anesthesiology inclusive of Neuromuscular Blocking Agents, Orthopedics inclusive of chronic pain Management Drugs, Nephrology and Critical care antibiotics for the treatment of serious infections. VISION: To be recognized as a world class pharmaceutical company seeking a quantum growth to lead in niche therapeutic segments in the domestic market To provide superior service to our customers with Innovative, High Quality, Indigenous products at affordable cost To inculcate a work culture that encourages and values High Performance, People, Excellence and Innovation

MISSION STATEMENT: To be a global generic injectables player, providing value-added total solutions BACKGROUND: Established in the year 1978 as an exclusive facility for Small Volume Parenterals (SVPs), Gland Pharma has developed into a progressive and quality conscious organization serving the pharmaceutical needs of diverse markets across the globe. The companys facilities are approved by US FDA, and are the first liquid injectable facility in India approved by them. The Company has world-class & world-scale facilities for injectables set up in collaboration with Vetter Group, Germany. The collaboration with Vetter provides Gland Pharma a technological edge in injectables and specifically in Pre- Filled Syringes. The Company is constantly upgrading its operations and facilities to meet current Good Manufacturing Practice (cGMP) standards. It has earned a position of leadership in the country in injectables manufacture. Gland Pharma is a research-focused organization continuously developing niche products for the Indian and global pharmaceutical markets. It has pioneered Heparin technology in India and has a position of leadership in the GlycoAminoGlycans (GAGs) range of molecules. The company manufactures Active Pharmaceutical Ingredients (APIs) and formulations for niche segments such as Cardialogy, Anaesthesia Osteo arthritis, Anticoagulants and Gynaecology. Executive Summary: Gland Pharma is in the Pharmaceutical business for over 2 decades. Gland Pharma Limited is the first USFDA approved liquid Injectable facility in India. Started in 1978, Gland Pharma has been involved in manufacturing Heparin injections. Gland has pioneered Heparin in India, supplying this life saving drug to all the major Hospitals. 1979: Gland started Contract manufacture of Injectables for Multi-National Companies. Injectable manufacture in Vials and Ampoules was taken up. Gland continued to specialize in this field, and with the inputs provided by its MNC principals, has been a pioneer in Injectable manufacture in India. Over the years, the company has increased its manufacturing capacity, culminating in a major expansion during 1996-98, along with its

German partners, the Vetter group. 1987: aseptic technology had changed and clean room concepts were introduced. Glands Ameerpet facility was upgraded to conform to the latest concepts in Injectable manufacture. 1993: Glands capacity utilized completely, and another plant was envisaged. To be at an International level, its search for a foreign partner led to a partnership with the Vetter Group of Germany, world leaders in aseptic processing technology and specializing in Pre-filled Syringes. 1997-99: a new facility was designed and constructed. This comprised adding two new vial lines, one ampoule line and a Pre-filled Syringe line (for the first time in India). The expansion project has been carried out in a spacious new site, about 20-km from Hyderabad city. In keeping with its philosophy, the company has created state-of-the-art facilities, comparable with any facilities elsewhere in the world, at its new complex in Dundigal. The company has aimed, in its new facility, to Develop facilities conforming to the local, US and European standards for Injectable manufacture; Attract quality conscious customers from India, who are seeking high quality facilities and reliable long term manufacturing contracts; Cater to the export markets, both for contract manufacture as well as supply of products.

2000: Low Molecular Weight Heparins Enoxaparin: Gland for the first time in the country manufactured Enoxaparin in 2000. The product were launched in domestic market in 2000.Exports to near regulated markets commenced in 2002.Gland also have an agreement for co-marketing in India with couple of pharma majors in India . 2001: Apotex: The company formed a strategic alliance with one of the leading Generic companies in US and Canada. This has paved a way for the companys entry into the regulated markets. As per this arrangement Gland will toll manufacture some generic injectables for the customer for the US market. 2003: US FDA: Glands objective in setting up a new facility at Dundigal, near Hyderabad, has been to reach its goal of being an injectables manufacturer to supply world markets (including USA). The facility has been approved by USFDA in December 2003. The US FDA approval marks an important milestone in the companys long-term goals and opens up opportunities for the company in the regulated markets.

2004: Low Molecular Weight Heparins: Dalteparin & Nadroparin: Gland successfully developed two more Low Molecular Weight Heparins-Dalteparin and Nadroparin. These products were launched in domestic market in 2004. Gland also built an API plant, which became operational in April 2005. Gland has an agreement with leading North American generic major to market Dalteparin in USA. 2006: More partnerships: The company is in advanced stage discussions for strategic partnership with leading US generic companies for marketing products in USA. Similar model will be adopted for Europe and Gland is in discussions with couple of European generic players. Gland expects to sign agreements with at least 10 major generic players across the globe supplying generic products either developed by Gland or using outsourced APIs. GLAND VISION: VISION: Build state-of-the-art facilities Build organizational capability and technical competence through strategic alliances/ JVs Offer novel forms of drug delivery systems Cater to global market for pharmaceutical services all the way from R&D to production and marketing Expand, over a period of time, into manufacture of other dosage forms With focussed training, HRD strategies & inputs from its German partner Vetter, Gland will focus on achieving international standards and accreditations for its facilities at all times Gland Pharma will focus on providing value added services to its clients in the high tech area of injectables manufacture, including assistance in regulatory matters, validations, formulation development and other related areas of R&D Novel forms of injectables, such as PFS, cartridges shall be introduced into the market in India, to provide clients additional forms of drug delivery mechanisms, while at the same time adding to Glands profitability through such innovations R&D in formulation development, new molecular evaluation, synthesis and other services to make Gland a comprehensive service provider shall be a focus area and profit centre for the company. In formulation marketing, Gland shall focus on new, innovative products for niche markets that would enhance profitability and also draw upon in-house strengths of the company in terms of its strategic alliances manufacturing technology and R&D infrastructure. The formulation business shall also concentrate on exports of products to neighbouring countries through strategic alliances.

 To have relationships translating into commercial business with atleast 15 out of top 20 generic Pharma companies in regulated markets. Attain a position in top 3 in atleast 3 major key markets. Attain technological leadership in aseptic processing. To set up a school for aseptic technology. To have 40% market shares in PFS in India. To attain leadership in LMWHs market in India. GLAND MISSION AND FOCUS: The businesses of the company shall all be well defined and focused, working on the basis of profit centres. The specific mission and focus areas of these businesses shall be as under: Contract Manufacturing to Focus on Practicing all cGMPs Obtaining International certifications from global regulatory bodies Serving most of the Major players in Pharma industry

R&D to focus on Providing Customized services to clients Process development Formulation development Analytical method development Stability studies

Marketing to focus on Expand product range and presence Coverage from existing metropolitan cities to entire India Seek Joint Ventures (JVs) for products & markets Strategies to register and sell in countries SE Asia/ Middle East, CIS countries, Africa and South America.

BUSINESS STRATEGY: BUSINESS PHILOSOPHY: The Companys business philosophy is based on its strengths in Injectables manufacturing and R&D. In keeping with the strengths, the company chooses products that fit into a common pattern: Possibility for delivery in syringes or other injectables

Application in niche segments of Cardiology, Anticoagulants, Anesthetics Institutional products

Typically, products, which are off-patent or close to patent expiry are chosen for development. The companys approach is to gain initial experience in the domestic market, followed by less regulated markets. Simultaneously, dossiers and other documents are prepared for the regulated markets. Where the products are found promising, the company has set up US FDA class API facilities and work towards filing of ANDAs. BUSINESS FOCUS & BUSINESS MODELS: The Companys core business focus is in 4 different areas of activities:

INJ ECTABLES
Exports: Reg Markets: Future

Thrust Area

V lu $ a e

Contract Mfg:

Domestic Markets:

Core Activity

Niche Products

BUSINESS FOCUS: 1. Contract Manufacturing: This is the traditional business area for the Company. The main strengths in this activity are in terms of: Nearly Three decades of experience in contract manufacture of injectables World-class facilities and world-scale capacities Strength in PFS delivery systems since 1998 Integrated facility for all injectables ranging from ampoules, vials, PFS, lyophilized vials and infusions

2. Domestic Marketing Niche Products: Gland has begun marketing some of its own products for the past three decades. These new APIs have been developed in Glands in-house R&D. Gland has pioneered in Heparins in 70s and has expertise in this technology for nearly 25 years. Based on this expertise, Gland has now developed couple of Low molecular weight heparins like Enoxaparin, Dalteparin and Nadroparin. Gland also developed other products like Hyaluronic Acid and Chondroitin Sulphate in GAGs range. Another important segment developed by Gland is Anaesthesia products. Gland has specialised in manufacture of Nuero Muscular Blocking Agents like Vecuronium Bromide, Rocuronium Bromide, Atracurium and Cis Atracurium. API plant for these products has been built recently by Gland. Gland has been adopting a two-pronged approach in domestic sales. Apart from selling the products through its own marketing network and sales force of little over 100 people, Gland has been leveraging the marketing strengths of pharma majors in India by having marketing arrangements with them. Gland has signed co marketing agreements with several large domestic Pharma companies to sell the Niche products like Enoxaparin, Tirofiban etc. Under these agreements Gland manufacture these companies market these products under the brand names of these companies and the products. The products are transferred under a pre agreed transfer price. Gland has the agreements with the following companies for various products. S.No Company 1 Ranbaxy 2 Intas Product Flothin (Enoxaparin) Loparin (Enoxaparin) Terofib (Tirofiban - Agreement Signed) Daltepin (Dalteparin - Agreement Signed) 3 Nicholas Piramal LMWX (Enoxaparin) Aggribloc (Tirofiban) 4 Torrent Thrombiflo (Enoxaparin) Cardiforce (Dobutamine HCl) Aggritor (Tirofiban) 5 New Medicon Dobutin (Dobutamine HCl) Xaparin (Enoxaparin) 6 Micro Erkacin (Amikacin Sulphate) Enoxaparin (Agreement Signed) 7 Baxter India Acurium (Atracurium) 8 Raman & Weil Atrelax (Atracurium) 9 AstraZeneca Partocin (Oxytocin) 10 Yash Pharma Yavisc (HPMC) 11 JB Chemicals Aggrilek (Tirofiban) 12 Unisankyo Lipoxane (Enoxaparin)

13 14 15 16

Lupin USV Ajanta Dr Reddys

Tirofuse (Tirofiban) GPMax (Tirofiban) Noxprin (Enoxaparin) Enoxaparin

3. Exports Thrust Area: The company set up its new exports division during 200001 and has since seen considerable growth in its business in the global markets. The exports grew to Rs 36.00 Crores in 2005-06 from a modest figures of Rs 0.80 Crores in 2000-01. The export markets shall continue to be the thrust area and will lay the foundation for Glands entry into the regulated markets. Gland now sells its products in about 25 countries. The model adopted by Gland is to sell the product through local companies and use their marketing skills in their markets. Glands typically have contracts with couple of local companies who are in top five in that country and who are strong in selling to Hospitals and institutions. Gland has successfully implemented this model in most of the South American markets like Brazil, Chile, Venezuela, and Colombia etc. Gland has arrangements in place with couple of Europe based NGOs like IDA, Mission Pharma who supplies pharmaceuticals to Africa under the tenders floated by WHO, UNICEF etc. With the success in the less regulated markets Gland has gained the necessary experience and confidence to launch its products in the regulated markets. 4. Regulated Markets Generics (Future): The future for the Company lies in marketing its products in the high-value regulated markets of USA, Canada and Western Europe. Once again the company has chosen the partnership model and would like to leverage its manufacturing strengths with the partners marketing, regulatory and legal strengths. The company has completed tie-ups with some of the leading companies in US to market its products. The company needs to make adequate preparation in terms of investment in facilities, continuous up gradation conforming to International standards, and understanding on legal/ patent issues. The company is aggressively pursuing ANDA programme and has a rich pipeline of 30 products. The company has received approval for 4 ANDAs and expects to receive approval for 3 more products in next six months. The teams are in place for filing at least 24 ANDAs in next 24 months. The company plans to launch Dalteparin, a LMWH as its first product in the regulated markets. This will be followed by other LMWHs such as Enoxaparin, Nadroparin and other generics that will be chosen based on the companys business philosophy. BUSINESS MODELS:

Glands two pronged Business Model (Products & Services) has been designed to: Consolidate its core business focus: Contract Manufacturing and Domestic Marketing Focus on increasing value through phased entry into different global markets Export markets: Higher returns; lower gestation periods Contract Manufacturing for Regulated markets: Leads to optimal line utilization, keeping up with regulatory standards and gaining entry for generics marketing Generics: While products such as Oxytocin, Gentamycin etc (where APIs are not made by Gland Pharma) provide higher returns compared to contract manufacturing business, own products (Enoxaparin, Dalteparin etc) provide Gland the highest value addition. RELATED MARKET STRATEGY: The future for the Company lies in marketing its products in the high-value regulated markets of USA, Canada and Western Europe. For this the company needs to make adequate preparation in terms of investment in facilities, continuous up gradation conforming to international standards. The company is expected to launch Oxytocin in US markets in next six months. The Company plans to launch Dalteparin, in next 12 months as its first LMWH product in the regulated markets. This will be followed by other LMWHs such as Enoxaparin, Nadroparin and other generics that will be chosen based on the Companys business philosophy. The market dynamics of W. Europe and N. America are quite diverse. Hence it is important to gain a significant insight into the workings of these markets to establish and grow organically. The Dalteparin exercise will be the first step in this direction.

Formulation Dev. & M fg

Contract Manufacturing

Generics Business
The regulated markets generic business offers three different opportunities to Gland: 1. Contract manufacturing: This provides far greater profitability compared to contract manufacturing in the domestic markets; besides, it provides the route to access different large Generic customers for marketing Glands own products. 2. Formulation development & manufacturing: Here, Gland shall offer to develop formulations for some other generics, such as Oxytocin and Gentamycin. This will be a value-addition over the contract manufacturing services. Here, the APIs are sourced from other DMF approved suppliers. 3. Product Delivery: This is the higher end of the business, where Gland develops niche APIs and delivers them as finished formulations. These products (such as Dalteparin, Enoxaparin, Vecuronium, Atracurium etc) are either off patent or soon-to-be off-patent molecules, hence have a larger profitability. RELATED MARKET ISSUES: Understand Patent/ other legal issues: The implications of legal issues needs to be understood at all levels to provide the necessary confidence. This can be achieved through consultation with experts and support from strategic partners. The Company has undertaken a study of patent issues pertaining to Enoxaparin. Also, it is in consultation with a Patent Attorney for legal support. Forge Alliances: Gland has to further strengthen itself to enter the regulated markets. This can be achieved through strategic tie-ups with larger generic

asingSophistication Incre

Product Delivery
asingValue Incre

companies in these regions. This will provide Gland the necessary marketing muscle to penetrate these markets effectively Manufacturing solutions - Expand Syringe Filling Capacities: Glands current capacity for syringes meets its present requirements adequately. However, with its expanding product portfolio, entry into other markets, increasing volumes for contract manufacturing (biogeneric products), the requirements will exceed the available capacity. Hence, further world-scale capacity needs to be added.

MARKET OPPORTUNITIES: WORLD PHARMA MARKETSALES & GROWTH:

World Pharm a Market Grow th Rate 2003 14 12 10 8 6 4 2 0 North America Europe Japan RoW Total USA Europe Japan Rest of World 25% 51% 12% 12% World Pharma Market 2002 (US$ 400 bn)

GENERIC MARKET OPPORTUNITIES: GLOBAL PHARMACEUTICAL MARKET: WORLDWIDE GENERIC DRUGS MARKET, 1998-2003 ($ Million) Geographic Region U.S. Western Europe Japan Rest of the World 1998 11,150 6,250 4,860 4,920 2003 CAGR % 18,181 10.3 12,120 14.1 6,210 5.0 6,848 6.8 43,359 9.8

Total 27,180 Source: Business Communications Company, Inc.

Overall, the global generics market seems likely to increase at an annual rate of 10%15%. In the US, the value of the generics sector is predicted to rise to $18.5 billion. The dollar value of expiring patented drugs will increase significantly over the next five years,

as compared to the last 3 years. Warburg Dillon and Read, a brokerage firm, estimated that the value of sales of expiring patented drugs was only $1.1 billion in 1998 and $3.3 billion in 1999 compared with projected values of $6.5 billion, $6.7 billion, $2.8 billion, $6.0 billion and $3.5 billion for years 2000 - 2004, respectively. GENERICS GROWTH:
Share by Country
5%

15% 2%

51% 11% Canada Germany Spain France UK

8% 7% 1% Italy Japan USA

13% CAGR for Retail Generics to 2005 TOP GENERIC COMPANIES: S. No Company Name 1 Teva Pharmaceutical Industries 2 Alpharma Inc. 3 Watson Pharmaceuticals, Inc. 4 IVAX Corporation 5 Barr Laboratories 6 Mylan Laboratories Inc. 7 Andrx Corporation 8 Ranbaxy Laboratories 9 SICOR Inc. 10 KV Pharmaceutical Company Source: Datamonitor Report, 2002 ISSUES & CHALLENGES: A handful of major factors will have a powerful bearing on the size, growth and nature of the generics industry and market during the first five years of the new millennium. The cumulative effect of all factors is predicted to be vigorous growth in the generics sector. USD Million 2,500 1,238 1,220 1,200 1,190 1,100 771 764 456 204

THE TECHNOLOGY CHALLENGE: Biotechnology Surge - The first biotechnology products are now reaching the end of their patent-protected lives and will soon enter the generics arena. This is an opportunity for companies in the generics sector to enhance their profile as equals of R&D-based pharma companies by proving their competence in biotechnology products. But the technical challenges, in particular, are considerable. Bio equivalence Other than the regular pharmaceutical quality tests such as: Identification of the active ingredient Drug purity (no production related impurity/ no products of decomposition) Active ingredient content Uniformity of mass and content (homogeneity, accuracy of dosage) Pharmaceutical availability Stability

Increased Competition: The Hatch-Waxman Act -The Drug Price Competition and Patent Term Restoration Act of 1984 (the Waxman-Hatch Act) encourages generic competition. One of the provisions of this act is to permit generics companies to carry out preliminary development work on generic equivalents of branded products, even though patent protection on the original has not yet expired. Thus, the generic developer can plan to enter the market within days or hours of patent lapse. Partly as a result of changed public policy, generic competition has intensified. Government regulatory issues Impact of government intervention on industry operations Increasing market penetration of generic Rx products The Waxman-Hatch Act results in shorter product life cycles after patent expiration Government imposed price controls & increasing coverage by managed care organizations PRODUCT GROUP OPPORTUNITIES: HEPARIN RANGE: (Low Molecular Weight Heparins: LMWHs) INTRODUCTION: LMWHs are anticoagulants, defined as salts of sulphated GlycosAminoGlycans (GAGs) having an average molecular weight ranging between 4000 6000 Daltons. At least 60% of all molecules have a molecular weight of less than 8000 Daltons. Glycosaminoglycans (GAGs) are the most abundant Heteropolysaccharides in the body. These molecules are long unbranched polysaccharides containing a repeating disaccharide unit. There are five different types of GAGs occurring in the body:

Hyaluronates, Dermatan Sulphates, Chondroitin Sulphate, Heparin and Heparin Sulphates and Keratan Sulphates. Advances in cardiology and coronary artery diseases management have made LMWHs as the mainstay for prevention of myocardial infarction (heart attack). The chemical structure of LMWHs is related to that of parent drug heparin, also named UnFractionated Heparin (UFH). TYPES OF LMWHs: Based on their molecular weight, LMWHs are identified by the following names and are promoted for specific indications. LMWH Name Enoxaparin Dalteparin Nadroparin Tinzaparin INDICATIONS: LMWHs are indicated for both treatment and prophylaxis In cardiology: In preventing unstable angina. In reconstructive vascular surgery and peripheral arterial disease In angioplasty/ stenting and restenosis In acute coronary syndromes In acute stroke In prevention of postoperative deep-vein thrombosis, In renal and hepatic impairment: Treatment of deep vein thrombosis (DVT) In Oncological, Gynecological, Neurological and Orthopedic surgeries LMWHs MARKET POTENTIAL: GLOBAL ANTI-COAGULANTS MARKET: US Brand Lovenox (Enoxaparin) Fragmin (Dalteparin) Sales Forecast Position in 2008 Global market (USD Million) 2180 2 450 5 Brand Name Lovenox/ Clexane Fragmin Fraxiparine Innohep Marketed By Aventis Pharmacia Sanofi Synthelabo Bristol Myers Squibb Est. market in 2004 USD 2 Billion USD 400 Million USD 250 Million USD 125 Million

Innohep (Tinzaparin) 165 Fraxiparine (Nadroparin) 102 Total LMWHs Market 2897 Total Anti-coagulants market USD 9558 in FY 2008 GLOBAL LMWHs MARKET:
Global LMWHs Market FY2001

7 8

5 14

57 15

Lovenox

Fragmin

Fraxiparine

Innohep

Others

Source: Aventis Annual Report, 2001; Total market for anti-coagulants: USD 5 billion in FY 2004 ANAESTHETICS RANGE: (Muscle Relaxants/ Neuro-Muscular Blocking Agents (NMBAs)) DESCRIPTION: Vecuronium is an aminosteroidal non-depolarising NMBA. Presented in either 4 or 10 mg vials and is an agent of intermediate duration giving it considerable versatility. Atracurium is a benzylisoquinolinium non-depolarising NMBA. It has an intermediate duration of action with an onset similar to other non-depolarising agents. Cis-Atracurium is a benzylisoquinolinium non-depolarising NMBA. It is one of the stereoisomers of Atracurium. It is a NMBA of intermediate duration. MUSCLE RELAXANTS: MARKET POTENTIAL: Muscle spasms resulting from accidents, sports injuries, and other strenuous activities are common occurrences across all age groups. With over 30 million prescriptions written on an annual basis in the United States, cyclobenzaprine has been the most commonly prescribed therapeutic agent for the treatment of muscle spasms. Its side effects include drowsiness, dry mouth and dizziness. Sales of muscle relaxants in the United States were approximately $977 million in 2000. 2001 American City Business Journals Inc.

Vecuronium: The market for the manufacture and sale of Vecuronium in the United States is approximately $12 million. Baxter, which markets Vecuronium under an exclusive agreement with GensiSicor, is the leading supplier of the drug. Wyeth was the second-largest supplier, until it suspended production in 2001. Pancuronium: Pancuronium is a long-acting NMBA used to temporarily freeze muscles during surgery or for use with patients that are mechanically ventilated. According to the FTC, the market for the manufacture and sale of Pancuronium is highly concentrated. Baxter, Wyeth, and Abbott Laboratories (Abbott) are the only suppliers of Pancuronium in the United States, with Baxter - through its exclusive license with GensiaSicor - accounting for almost half of all U.S. sales. Source: Federal Trade Commission Press Release dated, December 20, 2002 CONTRACT MANUFACTURING OPPORTUNITIES: GLOBAL INJECTIBLES INDUSTRY OVERVIEW: As in India, globally there are a few companies that offer injectables manufacture as a contract service. However, the number of companies offering such services is not very large, as it is a niche area and requires considerable investments. Broadly, the contract injectables manufacturing businesses focuses on two types of customers: Big Pharma and the Generics companies. Big Pharma customers typically market their products on the primary basis of customer value, patent protection and therefore, at higher prices and margins, designed to recover investments and fund further development activity. Hence, they offer prices for contract manufacture of injectables that can sustain the larger investment and operating costs of contract injectables manufacturers in USA/ Europe. However, the generics businesses operate significantly on the price competitiveness of their products in the market. This has been a very fast growing component of the pharmaceutical markets in USA and Europe (40% of volume and USD 18 billion in value in USA in 2000). These players are seeking lower cost manufacturing bases, and Gland, one of the first INJECTABLES manufacturers in Asia seeking a US FDA clearance, therefore is in a position to provide the cost advantages they seek. Furthermore, Gland is seeking to add further value to its manufacturing strength through filling and marketing its own niche products such as Enoxaparin, for the regulated markets. Some of the important global injectables manufacturers (with US FDA approval) are: S.No Company Location Customers Web Address Products Name 1 Abbott USA Big Pharma & www.abbott.com

2 3 4 5 6 7 8

Laboratories Baxter Chesapeake Biological Labs Cardinal Health Bedford Labs Faulding Pharmaceutic als Akorn Inc Vetter Injectables

USA USA USA USA

contract mfg Big Pharma and contract mfg Contract Mfg Big pharma Contract Mfg Contract Mfg

www.baxter.com www.cblinc.com www.cardinalhealth.com www.bedfordlabs .com www.faulding.co m

Large and small volume Parenteral Hy Pak Syringes, Lyophilization, Cartridges, Vials Disposable ampoules (0.2mL to 2000mL capacity) Vials

USA Germany

Ampoules, Vials and Lyophilized vials Contract Mfg www.akorn.com Pre-loaded sterile syringes, ampoules & vials Big Pharma & www.pharmaturm PFS, Lyophilised Contract Mfg .com

INJECTIBLES INDUSTRY OVERVIEW: The Indian Pharma industry is about Rs.200 Bn of which 85% i.e., nearly Rs.170 Bn represents the formulations market. Out of this about 15% (Rs. 25.5 billion) represents the value of injectables in the market. Typically, 10% of this represents the value of contract manufacturing, which is assumed @ Rs. 1/- per vial/ ampoule on the average. Thus, it may be grossly projected that the number of injectables manufactured and sold in the Indian market could be in the region of about 2.55 billion nos (or 2550 million nos. p.a). (Source: India Infoline reports) INDIAN INJECTIBLES INDUSTRY OVERVIEW: S.No 1 2 3 4 5 Company Name Gland Pharma Global Parenteral Samrudh Reckon Strides Arco Labs Location Dundigal, Hyderabad Bangalore Bombay Bangalore Bangalore Products Ampoules, Vials, Pre-filled syringes & Large Volume Parenteral (100 Ml bottles) Vials, Ampoules Vials, Ampoules Large volume Parenteral (100 Ml bottles) Vials, Ampoules

CONTRACT MANUFACTURING MARKET POTENTIAL: Recent analyst surveys place the market for Parenteral dose contract manufacturing services around $1.2-1.5 billion, including vials, ampoules, syringes, bags and bottles. They also project an annual growth rate of 5-10%. Current Parenteral facilities will be inadequate to handle the needs of the large influx of biopharmaceuticals predicted to take place during the next few years (and beyond). Many providers (and pharma companies) have concluded that the sheer volume of biodrugs currently advancing through trials, nearly all of which need parenteral dose manufacturing warrants investment in manufacturing sites. In addition, these new drugs can be more complex and require more difficult and costly processing than existing products, raising the premium for parenteral manufacturing. (Source: Contract Pharma: Nov/ Dec 2002 issue - Parenteral Dose Manufacturing: By Gil Y. Roth) In conclusion, Worldwide capacities are needed for injectables manufacture. Due to higher sterility and accuracy of dosage, syringes are a preferred mode of delivery. Biogeneric for regulated markets are fast opening up opportunities for PFS delivery systems. Gland can capitalize on the above opportunities to enable it to reach its mission of being a global generic injectables player by providing: Generic products for the regulated markets Contract manufacturing services for the regulated markets Contract manufacturing services for biogeneric FINANCIAL HIGHLIGHTS: Particulars Income Profit before Interest, Depreciation & Taxes Interest Profit before Depreciation & Tax Depreciation Profit before Tax Provision for Taxation 2008 - 2009 1741.96 511.92 52.18 459.73 73.65 386.09 2007 2008 1216.28 428.79 68.40 360.39 62.29 298.10 (Rs. In Millions) 2006 - 2007 1032.34 283.22 49.59 233.64 54.52 179.12

Current Tax Deferred Tax Liability Profit After Tax Transfer to General Reserve Earnings Per Share (Rs.) OPERATIONAL PERFORMANCE: Particulars Net Sales Other Income Total Income EBIDTA Finance Charges Depreciation Profit before Tax Provision for Tax Deferred Tax Liability Profit After Tax Earnings Per Share (EPS) Debt-Equity Ratio Book Value per Share EXPENDITURE: Particulars Materials consumed Power & Fuel Staff Cost Other Expenses Finance Charges Depreciation Total

71.78 11.90 302.41 2.00 25.72

91.11 13.65 193.33 2.00 18.86

52.01 13.92 113.17 2.00 11.70 (Rs. In Millions) 2006 - 2007 1025.27 7.07 1032.34 283.22 49.59 54.52 179.12 52.01 13.92 113.17 11.70 0.84 93.25

2008 2009 1640.70 101.26 1714.96 511.92 52.18 73.65 386.09 71.78 11.90 302.41 25.72 0.21 206.11

2007 2008 1180.73 35.55 1216.28 428.79 68.40 62.29 298.09 91.11 13.65 193.33 18.86 0.31 179.38

2008 2009 709.19 66.13 206.25 248.47 52.18 73.65 1355.87

2007 - 2008 366.70 56.74 202.54 162.62 68.40 62.29 919.29