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| ECONOMIC PERFORMANCE |
| AFFORDABLE & INNOVATIVE MEDICINE |
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| Pharmaceutical Services and Active Ingredients |
| Accessibility is as crucial as affordability, when it comes to unmet needs. We put impetus on finding innovative solutions to address these needs. One of the solutions is to leverage our strengths in process chemistry and provide a range of services that help innovator pharmaceutical companies take their innovations to the market faster, more efficiently and to wider geographies. |
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| Active Pharmaceutical Ingredients |
Our Active Pharmaceutical Ingredients (API) Business caters to leading innovator
and generic companies across the US, Europe, Latin America, Japan, Korea and
other emerging markets. Over the years, we have developed deep technical
strengths in the development of complex APIs, such as steroids, peptides,
complex long chain synthesis and oncology. Our expertise in intellectual property
and regulatory issues helps us to consistently deliver the highest quality APIs that
meet or exceed regulatory standards. At the same time, our agility enables our
customers be the first-to-market by providing offerings ranging from intermediates
to end formulations. |
We produce and market more than 100 different APIs in numerous markets. We
export API to developed markets as well as many other key markets, covering
more than 80 countries. Our principal overseas markets in this business segment
include North America (the United States and Canada) and Europe. |
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| Infrastructure |
| The infrastructure for our API segment consists of eight U.S. FDA-inspected plants (six of which are in India, one in Mexico and one in Mirfield, United Kingdom) and four technology development centres (two of which are in Hyderabad, India, one in Cambridge, United Kingdom and one in Leiden, the Netherlands as a result of our acquisition of Netherlands-based specialty pharmaceutical company OctoPlus N.V.). |
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| DMF Dashboard |
| FY14 |
| During the year ended March 31, 2014, we filed 61 Drug Master Files (DMFs) worldwide, of which 12 were filed in the United States, 13 were filed in Europe and 36 were filed in other countries. |
| Cumulatively, our total DMFs filed worldwide as of March 31, 2014 were 631, including 196 DMFs filed in the United States. |
| FY15 |
| During the year ended March 31, 2015, we filed 77 Drug Master Files (DMFs) worldwide, of which 12 were filed in the United States, 16 were filed in Europe and 49 were filed in other countries. |
| Cumulatively, our total DMFs filed worldwide as of March 31, 2015 were 735, including 219 DMFs filed in the United States. |
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| Market Reach |
| Based on the barriers of entry and regulatory requirements, the global API market can broadly be divided into emerging and developed markets. With IPR, facility approvals and other regulations in place, the developed markets with high entry barriers also offer greater stability of sales and prices, with premium on quality, and vice versa for the emerging markets. |
| Developed Markets |
| Our principal overseas markets are the United States and Europe. In these geographies, we have invested in newer technologies and platforms, focussing on building long-term relationships with the customers, and are also pursuing a partnership model to enable our customers to reach more markets faster and efficiently by leveraging our cost leadership and presence across the globe. |
| FY14 |
| Our sales to these markets for the year ended March 31, 2014 accounted for 54% of our PSAI segment's revenues for the year. |
| FY15 |
| For the year ended March 31, 2015, the developed market sales contributed 59% to our PSAI segment's revenues. |
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| Emerging Markets |
| India is an important emerging market where we sell our API products to Indian and multinational companies, many of whom are also our competitors in our Global Generics segment. The market in India is highly competitive, with severe pricing pressure and competition from lower cost foreign imports in several products. |
| FY14 |
| Our sales to Indian markets for the year ended March 31, 2014, accounted for 16% of our PSAI segment's revenues for the year. |
| FY15 |
| For the year ended March 31, 2015, the Indian market sales contributed 13% to our PSAI segment's revenues. |
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| Other Markets |
| Our other key markets include Brazil, Mexico, South Korea and Japan. Our focus is on building relationships with top customers in each of these markets and partnering with them in product launches by providing timely technical and analytical support. |
| FY14 |
| Our sales to all of the other key markets (excluding India) for the year ended March 31, 2014 accounted for 30% of our PSAI segment's revenues for the year. |
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| FY15 |
| For the year ended March 31, 2015, the other key markets (excluding US, Europe and India) sales contributed 28% to our PSAI segment's revenues. |
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| Custom Pharmaceutical Services |
| Bringing good health to the world is always a team effort. This is why we support innovator and generics companies worldwide, in their quest for bringing good health. Delivering rapid, innovative and cost-efficient results, our Custom Pharmaceutical Services (CPS) business unit provides third-parties with pharmaceutical development and manufacturing services, and solutions for starting materials, intermediates, active ingredients and finished dosage forms. |
| With respect to our custom pharmaceuticals business, we believe that contract manufacturing is a significant opportunity, based on our strengths of a skilled workforce and a low-cost manufacturing infrastructure. We distinguish ourselves from our key competitors by offering a wider range of cost-effective services spanning the entire pharmaceutical value chain. |
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| Growth in contract manufacturing is likely to be driven by increasing outsourcing of late-stage and off-patent molecules by large pharmaceutical companies to compete with generics. We expect India to emerge as an alliance and outsourcing destination of choice for global pharmaceutical companies. |
| Our contract research and manufacturing business is uniquely positioned in the market where it utilises assets (both in terms of physical assets and technical know-how) of a vertically integrated pharmaceutical company and combines this with the service model that we have built over the last few years. |
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| Infrastructure and Capabilities |
| For our contract research services, we have well-resourced synthetic organic chemistry laboratories, analytical laboratories and kilo laboratories at our technology development centres at Miyapur and Jeedimetla in Hyderabad, India. To complete the full value chain in development services, we also provide formulation development services. We now have facilities for pre-formulation and formulation development, analytical development, clinical trial supplies, pilot scale and product regulatory support. Larger quantities of APIs are sourced from our API plants in India and Mexico. |
| The Dowpharma acquisition continues to offer niche capabilities and opportunities to provide technology leveraged manufacturing services to innovators, including major global pharmaceutical companies. Another acquisition, OctoPlus N.V., has also developed significant in-house capability in R&D and creation of innovative solutions, even using patented technologies which requires significant expertise and experience. |
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