NEW DELHI, Apr 18: Drug firm Granules India Thursday said it has received approval from the US health regulator for Acetaminophen tablets, used for temporary pain relief.
The approved product is bioequivalent 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.