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Aurobindo Pharma gets USFDA’s final nod to manufacture, market Perampanel tablets
Oct-05-2026

Aurobindo Pharma has received receipt of final approval from the US Food & Drug Administration (USFDA) to manufacture and market Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, which are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fycompa Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, of Catalyst Pharmaceuticals, Inc.

The product will be manufactured at Unit-IV of APL Healthcare, a wholly-owned subsidiary of the company and will be launched in Q3FY27. The approved product has an estimated market size of $67 million for the twelve months ending August 2026. The company now has a total of 599 ANDA approvals (574 final approvals and 25 tentative approvals) from USFDA.

Perampanel Tablets are (i) indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older and (ii) indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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