Aurobindo Pharma Limited, a Hyderabad-based global pharmaceutical company, has announced that it has received final approval from the US Food & Drug Administration (USFDA) for the manufacture and marketing of Perampanel Tablets. These tablets will be available in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, and are bioequivalent and therapeutically equivalent to Catalyst Pharmaceuticals’ Fycompa® Tablets.
The production of these tablets will take place at APL Healthcare’s Unit-IV, a wholly-owned subsidiary of Aurobindo Pharma. The company plans to launch the product in the third quarter of the fiscal year 2027. According to IQVIA MAT data, the approved product has an estimated market size of USD 67 million for the twelve months ending August 2026. This approval adds to Aurobindo Pharma’s extensive portfolio of 599 ANDA approvals from the USFDA, which includes 574 final approvals and 25 tentative approvals.
Perampanel Tablets are indicated for the treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged four years and older. Additionally, they are indicated as adjunctive therapy for primary generalised tonic-clonic seizures in patients aged 12 years and older. This approval marks a significant step for Aurobindo Pharma in expanding its central nervous system (CNS) therapeutic offerings.
Aurobindo Pharma Limited is a prominent player in the global pharmaceutical landscape, with a presence in over 150 countries. The company boasts more than 30 manufacturing and packaging facilities, which are approved by leading regulatory agencies, including the USFDA, UK MHRA, and Japan PMDA, among others. The company’s robust product portfolio spans major therapeutic areas such as CNS, anti-retroviral, cardiovascular, antibiotics, gastroenterological, anti-diabetics, and anti-allergic medications, supported by a strong research and development infrastructure.
Analysts view this approval as a positive development for Aurobindo Pharma, potentially enhancing its market share in the CNS segment. The USFDA approval is anticipated to contribute to the company’s growth trajectory, reinforcing its position in the competitive pharmaceutical market.
