Alembic Pharma Receives USFDA Approval for Generic Tretinoin Cream, Targets USD 76 Million US Market
New Delhi: Alembic Pharmaceuticals Limited (Alembic) has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Refer label for a detailed indication.
Tretinoin Cream USP, 0.05%, has an estimated market size of US$ 76 million for twelve months ending March 2026 according to IQVIA.
Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from USFDA.
Also Read:vAlembic Pharma Secures USFDA Tentative Nod for Generic Vitrakvi, Eyes 180-Day Exclusivity
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.
