USFDA nod to Granules India postherpetic neuralgia drug Gabapentin

The medicine is also indicated as 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.

Published On 2023-03-29 06:16 GMT   |   Update On 2023-03-29 06:16 GMT
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Hyderabad: Granules India Limited announced today 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.

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 the management of postherpetic neuralgia in adults. Postherpetic neuralgia is neuropathic pain that occurs due to damage to a peripheral nerve caused by the reactivation of the varicella zoster virus.

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The medicine is also indicated as 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.

Read also: Granules India, Greenko ZeroC ink pact to enable carbon free energy, green molecule solutions

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, according to MAT Jan 2023, IQVIA/IMS Health.

Read also: Granules India bags USFDA okay for hypertension drug Losartan Potassium

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The company manufactures high-quality API, FD, PFI and Speciality Products with a focus on customer centricity. Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK. The Company has 7 manufacturing facilities out of which 6 are in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

Read also: Granules Pharma bags USFDA nod for ADHD drug Amphetamine Mixed Salts ER

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