Indian pharma companies filed 269 DMFs in US during the first nine months ended September 2012. The major companies like Hetero Drugs, Emcure Pharmaceuticals, Aurobindo Pharma, Dr Reddy's Laboratories, Lupin, Macleods Pharmaceuticals filed more than 8 DMFs. Further, Hetero Labs, Unimark Remedies, Neuland Laboratories, MSN Laboratories, Alembic Pharmaceuticals, Apotex Pharmachem India Pvt Ltd and CTX Life Sciences Pvt Ltd filed 5-7 DMFs during the first nine months of 2012. The total DMFs filed by the Indian companies stood at 404, 311 and 271 during the year 2011, 2010 and 2009 respectively. This shows that the investments in R&D and facilities started yielding results and Indian companies have able to file higher numbers of DMFs.
India's API manufacturers have maintained momentum of filing Drug Master Files (DMFs) in US with higher investments in cGMP facilities, research and development and talent pool during last couple of years. The major factors like better infrastructure, cost-effectiveness, contract research and manufacturing services and tie-ups with international players assisted well to these API players. India remains one of most favored API destinations globally. Despite several odds like stiff competition, slowdown in world economy, cost-cutting measures in highly regulated market and adverse foreign exchange rates, Indian API players dominated market share after China. Indian producers are well set to grab future opportunities up coming from expiration of patents in next few years.
The API forms the most vital part of any finished dosage product. The overall API market was valued at US$101 billion in 2011, and is expected to grow at a CAGR of 7.9 per cent from 2011 to 2016.
APIs are extensively used in many therapeutic segments such as cardiovascular, central nervous system disorder, oncology, gastrointestinal, etc with low profit margins as compared to formulation products. The over capacity and presence of many players putting pressure on bottom line of API manufacturers. The patent expiration to the tune of US$85 billion in next couple of years will give necessary boost for the growth in API segment. Further, worldwide growth in biotech segment may offer additional push for API growth. The Indian API market is highly fragmented with presence of major players. The contract research and manufacturing services (CRAMS) offered by major Indian companies is also providing strong support.
With low margins in APIs business due to competition, several Indian players moved in formulation manufacturing backed by investments in R&D during last couple of years. These players are using APIs to cater captive consumption and filing own dossiers with regulatory authorities. The Indian companies focus continued on developing commercially viable and novel (non-infringing/patentable)process know-how for APIs. Considering the growth potential, many players are proposing expansion of the API manufacturing in the country.
DMFs filed during Jan-Sept 2012