Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Perampanel Tablets in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg. The approved product is bioequivalent and therapeutically equivalent to Fycompa® Tablets of Catalyst Pharmaceuticals, Inc, the reference listed drug. The tablets will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma, and are scheduled to be launched in the third quarter of FY27.
According to IQVIA MAT data, the approved product had an estimated US market size of $67 million for the 12 months ended August 2026. The approval adds another product to Aurobindo Pharma’s portfolio of generic medicines in the US market. With this approval, Aurobindo Pharma’s cumulative number of ANDA approvals from the USFDA has reached 599, comprising 574 final approvals and 25 tentative approvals.
Perampanel Tablets are indicated for the treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged four years and older. The medicine is also indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.
The latest approval strengthens Aurobindo Pharma’s presence in the central nervous system (CNS) segment and expands its portfolio of products supplied to the US pharmaceutical market. The company has a broad generic pharmaceutical portfolio across several therapeutic categories, including central nervous system, anti-retroviral, cardiovascular, antibiotics, gastroenterology, anti-diabetic and anti-allergic products. Its product portfolio is supported by research and development capabilities and manufacturing facilities serving regulated and emerging markets.
Aurobindo Pharma is an integrated pharmaceutical company headquartered in Hyderabad, India. It develops, manufactures and commercialises generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients (APIs). The company markets its products in more than 150 countries and operates more than 30 manufacturing and packaging facilities. These facilities have approvals from regulatory agencies including the USFDA, UK Medicines and Healthcare products Regulatory Agency, European Directorate for the Quality of Medicines, Japan’s Pharmaceuticals and Medical Devices Agency, World Health Organization, Health Canada, South Africa’s Medicines Control Council and Brazil’s ANVISA.
The company continues to expand its generic product portfolio through regulatory filings and approvals across major global pharmaceutical markets. The Perampanel approval is expected to support the company’s product expansion in the US and add to its existing portfolio of approved generic medicines.
Aurobindo Pharma Limited is listed on the National Stock Exchange of India and BSE. The company operates across pharmaceutical development, manufacturing and commercialisation, with products spanning multiple therapeutic areas and markets.
