NSEPress Release26 Jun 2026 · 26 Jun 2026, 07:10 pm
Press Release
Alembic Pharmaceuticals Limited · APLLTD
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Alembic Pharmaceuticals Limited has received USFDA Final Approval for Dapsone Gel, 5%, a topical treatment for acne vulgaris.
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Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated Jun 26, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Dapsone Gel, 5%.".
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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 Dapsone Gel, 5%.
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 Dapsone Gel, 5%.
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 Dapsone Gel, 5%.
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) Dapsone Gel, 5%. The approved ANDA is therapeutically equivalent to the reference
listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC. Dapsone Gel is indicated for the
topical treatment of acne vulgaris. Refer label for a detailed indication.
Alembic has a cumulative total of 244 ANDA approvals (224 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