Granules India gets USFDA nod for Acetaminophen extended release tablets

The recently approved product, Acetaminophen 650 mg extended-release tablets are used primarily for temporary pain management. Granules also manufacture several off-patent drugs, including Paracetamol, Ibuprofen and Metformin.

New Delhi: 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.

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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.

Granules India Limited is a pharmaceutical manufacturing company based in Hyderabad. The Company manufactures tablets, Pharmaceutical Formulation Intermediates (PFIs) and active pharmaceutical ingredients (APIs) which are distributed in over 74+ countries.

Granules manufacture several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets.

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