Indian API players set to file more DMFs in 2011 with US FDA

摘要

The Indian active pharmaceutical ingredients (APIs) segment is moving ahead with new approvals from US authorities for their Drug Master Files (DMFs). Both listed and unlisted Indian pharma companies filed 90 DMFs with the US-FDA during the first quar- ter of 2011, as compared to 75 and 91 DMFs respectively during first quarter of 2010 and 2009. Indian pharma companies filed a total of 271 DMFs with US-FDA during 2009 and 311 DMFs in 2010.