Granules India gets USFDA nod for Gabapentin Tablets; share price falls

Granules now have a total of 55 ANDA approvals from USFDA.

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Granules India’s share price dropped marginally in the early trade on March 29 after the company received USFDA approval for Gabapentin Tablets.

Granules India announced that the US Food & Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA) for Gabapentin tablets USP, 600 mg and 800 mg, the company said in the exchanges filing.

Gabapentin tablets are indicated for the 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.

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Gabapentin is bioequivalent to the reference listed drug product (RLD), Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC, Granules said.

Granules now have a total of 55 ANDA approvals from USFDA (53 Final approvals and 2 tentative approvals).

The current annual US market for Gabapentin tablets is approximately USD 145 million.

At 09:22 hrs Granules India was quoting at Rs 270.35, down Rs 0.65, or 0.24 percent on the BSE.

The share touched a 52-week high of Rs 381.25 and a 52-week low of Rs 227 on 04 November, 2022 and 20 June, 2022, respectively.

Currently, it is trading 29.09 percent below its 52-week high and 19.1 percent above its 52-week low.