Granules India gets USFDA’s approval for Acetaminophen Extended Release Tablets
18th Apr 2019

Granules India has received approval from US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Acetaminophen 650 mg Tablets, Extended Release, bioequivalent to the reference listed drug product (RLD), Tylenol 650mg tablets, Extended Release. The ANDA was filed by Granules Pharmaceuticals Inc., a wholly owned subsidiary of the company.

Acetaminophen 650 mg extended release tablets are used primarily for temporary pain management including arthritis relief.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).