Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Desonide Cream, 0.05%.

The ANDA was filed by Aleor Dermaceuticals Limited (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05%, of Padagis US LLC. Desonide Cream, 0.05% is a Low potency corticosteroid indicated for the relief of inflammatory and Pruritic manifestations of corticosteroid-responsive dermatoses.

Desonide Cream, 0.05%, has an estimated market size of US $12 million for twelve months ending Sep 2022 according to IQVIA. Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.

Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's 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 marketing team of over 5,000 are well recognized by doctors and patients.