Granules gets USFDA approval for Methylphenidate Hydrochloride ER Tablets

Granules India announced that USFDA has approved the ANDA filed by Granules Pharmaceuticals Inc., subsidiary of Granules India, through its US agent First Time US Generic 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, Inc. shall market and distribute the product shortly.

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