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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