BSECompany Update3h ago · 3 Oct 2026, 05:09 pm
Submission of 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.
Aurobindo Pharma Ltd · 524804
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Aurobindo Pharma Ltd has received USFDA final approval for 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 Fycompa Tablets. The product will be manufactured at Unit-IV of APL Healthcare and launched in Q3FY27.
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Aurobindo Pharma Ltd - 524804 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
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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