Mumbai: India is playing a dominant role in the US generic pharma space, having cornered over half the certified dossiers filed globally for active pharmaceutical ingredients (API). Drug companies from India filed 51% of the overall global applications, also called drug master filings (DMF), in the US market during calendar year 2011. DMFs are essentially approvals to supply complex raw materials to all generic manufacturers servicing the US market, which is the most lucrative of all global markets.
Over the last three years, there has been a sustained increase in the trend of such applications from India. Of the global DMF filings in the US, India accounted for 45% in 2009, which increased to 49% in 2010 and 51% in 2011 (see chart).
Against this, China which is the leading API supplier in emerging markets, cornered only 18% of the total DMFs filed in the US in 2011, down from 20% in 2010. Interestingly, midrung companies like Hetero, and even smaller ones like USV, Nectar Life Sciences, Shilpa Medicare and Gland Pharma are now filing for such approvals from the US Food and Drug Administration.
Says Glenn Saldanha, chairman and MD, Glenmark Pharma, "Indian companies are playing a huge role in providing tangible, long-term value to generic players in the US market. US being the largest standalone generic market, continues to offer attractive partnership opportunities as most US dosage manufacturers (barring the top four or five) are not backward integrated."
Among the companies, Hyderabad-based Hetero had the maximum new filings at eight during the fourth quarter of 2011.Others like Alembic, Emcure and Gland have filed four DMFs each. Among large players, Lupin and Dr Reddy's filed three each, while Sun Pharma had two filings, and Cadila filed for one. Other significant filers were Jubilant, Aurobindo, Ipca (two each), while Orchid and Torrent filed for one each.
It was the first time that domestic players filed for 22 molecules during the quarter (higher than eight in 3Q11), of which the Prasugrel filing by Dr Reddy's may lead to a new chemical entity, according to a JM Financial analyst.
Says Sujay Shetty, partner, PwC India, "Domestic companies have moved up the value curve by filing complex certified dossiers. These filings are important for domestic as well as US companies, which are filing for approvals to launch generic drugs (abbreviated new drug application), and are truly indicative of the quality and regulatory compliance, which has become critical. Also, for Indian manufacturers in the US, sourcing APIs from Indian companies, lowers costs." Sales of APIs in the US have also started augmenting US revenues of these Indian companies .
In the past, industry experts say domestic companies targeted less-regulated markets for API and this space is now extremely competitive. So, many of them decided to make the transition of supplying APIs to regulated markets. And to do this they naturally had to build on their R&D capabilities to meet the stringent requirements of countries like the US.
"Basically, two aspects have emerged... Not only are Indian companies offering standalone APIs but are also increasingly offering finished dosages as part of vertically integrated partnership deals. This is most true for mid-rung players which presently do not have a direct presence in the US market ," adds Saldanha.
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