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Granules India announced that the United States & Drug Administration (US FDA) has approved the Abbreviated New Drug
Application (ANDA) filed by Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary
of Granules India 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.
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