Granules India’s arm gets USFDA’s nod for Methylphenidate Hydrochloride Extended-Release capsules
27th May 2019

Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc has received approval from US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride Extended-Release capsules for 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, bioequivalent to the reference listed drug product (RLD), Ritalin LA Extended-Release Capsules, 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg, of Novartis Pharmaceuticals Corporation (Novartis). Methylphenidate Hydrochloride Extended-Release Capsules are used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Till date Granules Pharmaceuticals, Inc. had submitted total 19 ANDAs and the current approval is the third ANDA approval for the entity. Approvals for the balance 16 ANDAs are awaited.

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).