Granules India has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg. It is bioequivalent to Viatris Specialty LLC’s Neurontin Tablets, 600 mg and 800 mg. Gabapentin Tablets are indicated for the treatment 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 paediatric patients 3 years and older with epilepsy.
Granules now have 55 ANDA approvals from the US FDA (53 Final approvals and 2 tentative approvals). Gabapentin Tablets have a current annual market value of approximately $145 million in the United States. Granules India is a pharmaceutical product manufacturer and supplier. Its products include active pharmaceutical ingredients (API) such as tablets and caplets, as well as rapid release, pharmaceutical, formulation intermediates (PFI), and finished dosages (FDs).