Alembic Pharmaceuticals’ joint venture gets USFDA Final Approval for Metronidazole Gel

06 Sep 2021 Evaluate

Alembic Pharmaceuticals’ (Alembic) joint venture Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole Gel USP, 1 %. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel Gel, 1 %, of Galderma Laboratories LP (Galderma). Metronidazole Gel USP, 1 % is indicated for the topical treatment of inflammatory lesions of rosacea. Aleor had previously received tentative approval for this ANDA.

Metronidazole Gel USP, 1 % has an estimated market size of $ 29 million for twelve months ending June 2021 according to IQVIA.

Alembic has a cumulative total of 149 ANDA approvals (132 final approvals and 17 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.


Alembic Pharma Share Price

843.15 -9.15 (-1.07%)
29-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1717.50
Dr. Reddys Lab 1268.60
Cipla 1494.40
Zydus Lifesciences 904.00
Lupin 2079.50
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×