Aurobindo Pharma gets USFDA approval for Perampanel

Aurobindo Pharma Limited

has received final USFDA approval to manufacture and market Perampanel tablets in six strengths ranging from 2 mg to 12 mg. The product will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary, and is scheduled for launch in Q3 FY27. Aurobindo now has 599 USFDA ANDA approvals, including 574 final approvals and 25 tentative approvals. Perampanel is used for certain forms of epilepsy. The approval adds another product to Aurobindo’s US portfolio, while commercial contribution will depend on the launch and subsequent market uptake. The estimated US market size for the product was about $67 million for the 12 months ended August 2026, according to IQVIA data cited in industry reports. What I’m watching: Q3 FY27 launch execution, pricing and the initial contribution from the product. Stance: Tracking the commercial opportunity following regulatory approval. Disclosure: This post is for educational purposes only and is not investment advice or a buy/sell recommendation. Disclose any holding or interest before publishing.