Drug firm Granules India on Thursday said it has received approval from the US health regulator for Acetaminophen tablets, used for temporary pain relief. The approved product is bio-equivalent to the reference listed drug product (RLD), Tylenol tablets, extended release.
The US Food and Drug Administration (USFDA) has approved its abbreviated new drug application (ANDA) for Acetaminophen 650 mg tablets, extended release, Granules said in a BSE filing. Acetaminophen 650 mg extended release tablets are used primarily for temporary pain management. “The addition of Acetaminophen 650mg, extended release tablets to our OTC portfolio leverages several components of our value proposition,” Granules India Chairman and Managing Director Krishna Prasad Chigurupati said.
At 11.25 am, the shares of Granules India were trading 0.83 per cent lower at Rs 113 apiece on BSE.