Sharon Bio-Medicine today said it has received approval from the US health regulator for its API plant at Taloja in Maharashtra.
The company, however, said it cannot start supplying to the US market as its payment for generic drug user fee is pending.
In a BSE filing, Sharon Bio Medicine said it has “received the Establishment Inspection Reports from the US Food and Drug Administration (USFDA)”.
The inspection was conducted during June 29, 2015 to July 7, 2015 at the Taloja plant, it added.
“The API (active pharmaceuticals ingredients) is now approved by USFDA,” the company said.
It may be noted that the payment for Generic Drug User Fee is pending and therefore supply to the US cannot be done unless pending arrears are cleared, it said without disclosing details.
Shares of Sharon Bio Medicine were trading at Rs 10.16 in the afternoon trade, up 19.95 per cent on BSE.