BSECompany Update3d ago · 4 Nov 2026, 09:56 pm

Alembic Pharmaceuticals Limited receives USFDA Final Approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).

Alembic Pharmaceuticals Ltd · 533573

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Alembic Pharmaceuticals Ltd has received USFDA Final Approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC), a generic version of Pataday Once Daily Relief, with an estimated US$20 million market size in the United States.

Analysis Scores

Earnings Impact8/10
Growth Catalyst6/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment8/10

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Alembic Pharmaceuticals Ltd - 533573 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

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4th November, 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 Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). 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 its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). 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 4th November, 2026 Vadodara, India Alembic Pharmaceuticals Limited receives USFDA Final Approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). 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 for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pataday Once Daily Relief, 0.7%, of Alcon Laboratories, Inc. (Alcon). Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%, is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. Refer label for a detailed indication and usage. According to IQVIA, Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%, had an estimated market size of US$20 million in the United States for twelve months ending September 2026. This ANDA was developed in collaboration with Orbicular Pharmaceutical Technologies Pvt Ltd. Alembic has a cumulative total of 248 ANDA approvals (229 final approvals and 19 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 5,800 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