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The US health regulator has provided its approval to Sharon Bio-Medicine for its API plant at Taloja in Maharashtra.
However, the company has said that it cannot start supplying to the US market as its payment for generic drug user fee is pending.
Sharon Bio Medicine has said in a BSE filing that it has “received the Establishment Inspection Reports from the US Food and Drug Administration (USFDA).”
It further said that the inspection was conducted during June 29, 2015 to July 7, 2015 at the Taloja plant.
The company has said that “The API ( active pharmaceutical ingredients) is now approved by USFDA.”
