Indian pharma companies like Hetero, Alembic, Lupin, Dr Reddy’s dominating US generic space



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

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