NSEPress Release26 Jun 2026 · 26 Jun 2026, 10:31 am

Press Release

Alembic Pharmaceuticals Limited · APLLTD

✦ AI Summary▲ PositiveOrder Win

Alembic Pharmaceuticals Limited has received USFDA Final Approval for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, with an estimated market size of US$ 27 million.

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Earnings Impact8/10
Growth Catalyst6/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10

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Full Announcement

Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated Jun 26, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL.".

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APLLTD_26062026103102_Intimation_to_SE_Press_Release_FA.pdf

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Date: 26th June, 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 Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. 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 Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. 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 : alembic@alembic.co.in ● CIN : L24230GJ2010PLC061123 PRESS RELEASE 26th June, 2026 Vadodara, India Alembic Pharmaceuticals Limited announces USFDA Final Approval for Oseltamivir Phosphate for Oral Suspension, 6 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) Oseltamivir Phosphate for Oral Suspension, 6 mg/mL. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tamiflu Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc. Oseltamivir Phosphate is an influenza neuraminidase inhibitor (NAI) indicated for: i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and ii) Prophylaxis of influenza A and B in patients 1 year and older. Refer label for a detailed indication. Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, have an estimated market size of US$ 27 million for twelve months ending March 2026 according to IQVIA. Alembic has a cumulative total of 243 ANDA approvals (223 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: Ajay Kumar Desai Phone: +91 22-66953681 Email: ajay.desai@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