Granules India Ltd received ANDA Approval for Gabapentin Tablets

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg. It is bioequivalent to the reference listed drug product (RLD), Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.

Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

Granules now have a total of 55 ANDA approvals from US FDA (53 Final approvals and 2 tentative approvals).

The current annual U.S. market for Gabapentin Tablets is approximately $145 Million, according to MAT Jan 2023, IQVIA/IMS Health.

Shares of Granules India Limited was last trading in BSE at Rs. 271.00 as compared to the previous close of Rs. 284.10. The total number of shares traded during the day was 54175 in over 1881 trades.

The stock hit an intraday high of Rs. 284.15 and intraday low of 270.50. The net turnover during the day was Rs. 14921062.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 Pharmaceuticals USFDA Approval ANDA GabapentinTablets