Granules India receives USFDA approval for generic gabapentin tablets

Pharmaceuticals firm Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic gabapentin tablets indicated for management of postherpetic neuralgia in adults. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Gabapentin tablets of strengths 600 mg and 800 mg, Granules India said in a regulatory filing.

These tablets are bioequivalent to the reference listed drug product, 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 generalisation, in adults and pediatric patients aged 3 years and older with epilepsy, the company added.


Gabapentin tablets had annual sales of approximately USD 145 million in the US, it said citing IQVIA/IMS Health January 2023 data.

Granules now has a total of 55 ANDA approvals from USFDA with 53 final approvals and two tentative approvals, it added.