Alembic Receives USFDA Approval for Generic Epilepsy Drug

Alembic Receives USFDA Approval for Generic Epilepsy Drug

India Pharma Outlook Team | Monday, 28 July 2025

The US Food and Drug Administration have given Alembic Pharmaceuticals final approval to market its extended-release carbamazepine tablets in the US. Strengths of 100 mg, 200 mg, and 400 mg are covered by the approval.

In addition to treating nerve pain linked to trigeminal neuralgia, the medication is given to treat epilepsy. Alembic's version is a generic version of Tegretol-XR, a drug that Novartis first created. The company stated that the approved product serves a $71 million US market for the 12 months ending March 2025, citing IQVIA statistics.

This move brings Alembic's total number of USFDA-approved abbreviated new drug applications (ANDAs) to 225. This comprises 23 provisional clearances and 202 final clearances. On July 26, 2025, Alembic Pharmaceuticals' stock closed at ?999, a decrease of 1.91%. Alembic Pharmaceuticals' stock fell 17% during the past year, down 4.77% so far this year, and increased 3.77% in the most recent month.

Also Read: India Leads in Vaccine Production, Hosts 2nd Largest USFDA Plants

The headquarters of the global Indian pharmaceutical company Alembic Pharmaceuticals Ltd. are located in Vadodara.[2] It produces pharmaceutical intermediates, pharmaceutical ingredients, and pharmaceutical products. It is also referred to as the market leader in India for the macrolides class of anti-infective medications. Its Sikkim plant manufactures formulations for Indian and unregulated export markets, while its Panelav unit manufactures formulations and active pharmaceutical ingredients (APIs).

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