The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India’s subsidiary — Granules Pharmaceuticals, through its US agent First Time US Generics LLC, for Methylphenidate Hydrochloride Extended-Release Tablets USP, 10 mg and 20 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug ‘Ritalin SR Sustained-Release Tablets, 20 mg’ of Novartis Pharmaceuticals Corporation. Granules Pharmaceuticals shall market and distribute the product shortly.
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).