Granules India gets USFDA’s nod for Gabapentin Tablets

29 Mar 2023 Evaluate

Granules India has received approval from US Food & Drug Administration (US FDA) for 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.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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