US FDA Approves Granules India’s Gabapentin Tablets


After Granules India received FDA approval for Gabapentin Tablets, the company’s share price fell slightly in early trading on March 29, 2023. In its exchanges filing, Granules India stated that the US Food and Drug Administration (US FDA) had approved its abbreviated new drug application (ANDA) for Gabapentin tablets USP, 600 mg and 800 mg.

Adult postherpetic neuralgia is indicated for treatment with gabapentin tablets; furthermore, as an adjunctive treatment in the treatment of fractional beginning seizures, with and without optional speculation, in grown-ups and pediatric patients 3 years and more established with epilepsy.

According to Granules, gabapentin is bioequivalent to Neurontin Tablets, 600 mg and 800 mg, an RLD manufactured by Viatris Specialty LLC. There are currently 55 ANDA approvals for granules from the USFDA, consisting of 53 final approvals and 2 tentative approvals.

Gabapentin tablets currently sell for approximately USD 145 million annually in the United States. Granules India’s stock was trading at Rs 270.35 at 09:22 p.m. on the BSE, down 0.65 percent or Rs 0.65. On November 4, 2022, the share reached a 52-week high of Rs 381.25 and a 52-week low of Rs 227, respectively. Currently, it is exchanging 29.09 percent underneath its 52-week high and 19.1 percent over its 52-week low.

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