Alembic Pharmaceuticals Limited receives USFDA Final Approval for Valganciclovir for Oral Solution, 50 mg/mL.

27th 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 Valganciclovir for Oral Solution, 50 mg/mL. 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 Valganciclovir for Oral Solution, 50 mg/mL. A press release being issued in this regard is enclosed herewith. 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 27th October, 2026 Vadodara, India Alembic Pharmaceuticals Limited receives USFDA Final Approval for Valganciclovir for Oral Solution, 50 mg/mL. 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 Valganciclovir for Oral Solution, 50 mg/mL. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Valcyte for Oral Solution 50 mg/mL of CHEPLAPHARM Arzneimittel GmbH (CHEPLAPHARM). Valganciclovir for oral solution is indicated for: 1) treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), and 2) prevention of CMV disease in kidney, heart, or kidney-pancreas transplant patients at high risk. Refer label for a detailed indication and usage. Alembic has a cumulative total of 247 ANDA approvals (227 final approvals and 20 tentative approvals) from the 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