Granules India’s arm gets USFDA nod for ANDA
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 … Read more