Alembic Pharmaceuticals Limited receives USFDA Final Approval for Ciprofloxacin and Dexamethasone Otic Suspension USP 0.3% / 0.1%

17th October, 2026 To, To, The Manager, The Manager, Department of Corporate Services, Listing Department, BSE Limited National Stock Exchange of India Ltd. P. J. Towers, Dalal Street, ‘Exchange Plaza’, Bandra Kurla Complex, Fort, Mumbai – 400 001 Bandra (E), Mumbai – 400 051 BSE Scrip Code: 533573 NSE Symbol: APLLTD Dear Sir/Madam, Sub: Alembic Pharmaceuticals Limited receives USFDA Final Approval for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. With reference to the captioned matter, this is to inform the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. Please find enclosed herewith the press release in this regard. We request you to kindly take the same on record. Thanking you, Yours faithfully, For Alembic Pharmaceuticals Limited Chirag K. Shukla Company Secretary Encl.: A/a. ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123 PRESS RELEASE 17th October, 2026, Vadodara, India Alembic Pharmaceuticals Limited receives USFDA Final Approval for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Ciprodex Otic Suspension, 0.3% / 0.1%, of Sandoz Inc. Ciprofloxacin and Dexamethasone Otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions: i) Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes, and ii) Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients. Refer label for a detailed indication. According to IQVIA, the estimated market size for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%, was US$110 million for twelve months ending June 2026. Alembic has a cumulative total of 246 ANDA approvals (226 final approvals and 20 tentative approvals) from USFDA. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a field force of over 5500 are well recognized by doctors and patients. Information about the Company can be found at www.alembicpharmaceuticals.com; (Reuters:ALEM.NS) (Bloomberg:ALPM) (NSE:APLLTD) (BSE:533573) For more information, contact: Isha Lamba Phone: +91 22-66951652 Email: isha.lamba@alembic.co.in ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123