18th October, 2025 Vadodara, India

ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Date: 18th October, 2025 To, The Manager, Department of Corporate Services, BSE Limited P. J. Towers, Dalal Street, Fort, Mumbai – 400 001 BSE Scrip Code: 533573 To, The Manager, Listing Department, National Stock Exchange of India Ltd. ‘Exchange Plaza’, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051 NSE Symbol: APLLTD Dear Sir/Madam, Sub: Alembic Pharmaceuticals Limited receives USFDA Final Approval for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL (Single-Dose and Multiple-Dose Vials) With reference to the captioned subject, this is to inform the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL (Single-Dose and Multiple-Dose Vials). Please find enclosed herewith our press release. We request you to kindly take the same on record. Thanking you, Yours faithfully, For Alembic Pharmaceuticals Limited Manisha Saraf 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 : [email protected] ● CIN : L24230GJ2010PLC061123 PRESS RELEASE 18th October, 2025 Vadodara, India Alembic Pharmaceuticals Limited announces USFDA Final Approval for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL (Single-Dose and Multiple-Dose Vials). 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) Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL Single-Dose Vials, 200 mg/5 mL and 400 mg/10 mL (40 mg/mL) Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Kenalog-40 Injectable Suspension, of Bristol- Myers Squibb Company. Triamcinolone Acetonide Injectable Suspension USP is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible. Refer label for a detailed indication. Alembic has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA. Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, has an estimated market size of US$ 96 million for twelve months ending June 2025 according to IQVIA. 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: Ajay Kumar Desai Phone: +91 22-66953681 Email: [email protected]

The release as fetched from its publisher. alembicpharmaceuticals.com ↗