NSEPress Release3h ago · 3 Oct 2026, 05:03 pm

Press Release

Aurobindo Pharma Limited · AUROPHARMA

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Aurobindo Pharma receives USFDA Final Approval for Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg, with an estimated market size of US$ 67 million for the twelve months ending August 2026.

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Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10

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Aurobindo Pharma Limited has informed the Exchange regarding a press release dated October 03, 2026, titled "Aurobindo Pharma receives USFDA Final Approval for Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg".

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October 3, 2026 To To Listing Department, The Corporate Relations Department NATIONAL STOCK EXCHANGE OF INDIA LIMITED BSE LIMITED Exchange Plaza, Bandra Kurla Complex,Bandra (E), Phiroz Jeejeebhoy Towers, 25th floor, Dalal Street, MUMBAI -400 051 MUMBAI -400 001 Company Code No. AUROPHARMA Company Code No. 524804 Dear Sir/ Madam, Sub: Press Release - Aurobindo Pharma receives USFDA Final Approval for Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg We enclose a copy of the Press Release that is being issued by the Company in connection with receipt of USFDA Final Approval for Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. Please take the information on record. Thanking you, Yours faithfully, For AUROBINDO PHARMA LIMITED B. Adi Reddy Company Secretary Encl: as above Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India. Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044. Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038, Telangana., India. Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833 Email: info@aurobindo.com Website: www.aurobindo.com Press Release Hyderabad, India, October 3, 2026 Aurobindo Pharma receives USFDA Final Approval for Perampanel Tablets, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg Aurobindo Pharma Limited is pleased to announce the 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 US$ 67 million for the twelve months ending August 2026, according to IQVIA MAT. Aurobindo Pharma 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. About Aurobindo Pharma Limited Aurobindo Pharma Limited (www.aurobindo.com), (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS, Bloomberg: ARBP IN) is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The Company has 30+ manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s robust product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti- Allergic, supported by a strong R&D set-up. Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India. Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044. Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038, Telangana., India. Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833 Email: info@aurobindo.com Website: www.aurobindo.com To know more, please log on to www.aurobindo.com For further information or queries, please contact: Investor Relations | Corporate Communications Phone: +91 40 66751211 | 66725000 Email: ir@aurobindo.com Disclaimer: This press release contains statements that may constitute “forward looking statements” including and without limitation, statements relating to product characteristics and uses, sales potential and target dates for product launch, implementation of strategic initiatives, and other statements relating to our future business developments and economic performance. While these forward-looking statements represent our judgment and future expectations concerning the development of our business, a number of risks, uncertainties and other factors could cause actual developments and results to differ materially from our expectations. The Company undertakes no obligation to publicly revise any forward-looking statements to reflect future events or circumstances and will not be held liable for any use of this information. Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India. Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044. Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038, Telangana., India. Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833 Email: info@aurobindo.com Website: www.aurobindo.com