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.
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Growth Catalyst6/10
Governance Concern1/10
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Full Announcement
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