"The company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darifenacin extended release tablets, 7.5mg and 15mg," Alembic Pharmaceuticals said in a BSE filing today.
The approved product is equivalent to Enablex of Allergan Pharmaceuticals.
Also Read
The company now has a total of 70 ANDA approvals from the USFDA.
The stock was trading at Rs 529, up 2.16 per cent, on the BSE.