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Granules India gets ANDA approval for Gabapentin tablets
29-Mar-23   08:19 Hrs IST
The US Food & Drug Administration (US FDA) has approved Granules India's Abbreviated New Drug Application (ANDA) for Gabapentin tablets USP, 600 mg and 800 mg.

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.

Hyderabad-based Granules India is a vertically integrated fast growing Indian pharmaceutical company. It is present in the manufacturing of entire value chain - from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs).

The company reported 23.24% jump in net profit to Rs 124.32 crore on a 15% increase in revenue from operations to Rs 1,146.12 crore in Q3 FY23 over Q3 FY22.

Shares of Granules India fell 4.61% to Rs 271 on Tuesday, 28 March 2023.

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