Granules Pharma Gets USFDA Nod For ADHD Capsules

Granules Pharma, in its press note to the exchanges on Monday, informed that  the USFDA has given nod 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).

The Abbreviated New Drug Application (ANDA) for the drug has been filed by Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary of Granules India Limited.

Methylphenidate Hydrochloride Extended-Release Capsules are used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), the company said in a press note to the exchanges on Monday.

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, the company added.

Granules India Ltd’s share price ended at Rs110.60, up by Rs3.55 or 3.32%, from its previous close of Rs107.05 on the BSE.

The scrip opened at Rs107.10 and touched a high and low of Rs113 and Rs107.05, respectively. A total of, 59,938 (NSE+BSE) shares have traded on the counter. The current market cap of the company is Rs2,811.98cr. – India Info Line