Alembic JV receives USFDA nod for Clobetasol Propionate shampoo

Alembic Pharmaceuticals Limited informed the bourses on Tuesday that its joint venture, Aleor Dermaceuticals Limited has received approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Clobetasol Propionate shampoo, 0.05 per cent.

The approved ANDA is therapeutically equivalent to the reference-listed drug product, Clobex shampoo, 0.05 per cent, registered under Galderma Laboratories. The product is indicated for the treatment of moderate to severe forms of scalp psoriasis in people of 18 years of age and older.

Clobetasol Propionate shampoo, 0.05 per cent, has an estimated market size of US$ 28 million for twelve-months ending December 2019, according to IMS Health and Quintiles (IQVIA). Alembic has a cumulative total of 122 ANDA approvals (109 final approvals and 13 tentative approvals) from US regulator.

Alembic Pharmaceuticals Ltd is a multinational pharmaceutical company headquartered in Vadodara (Gujarat). It is involved in the manufacturing of pharmaceutical products, substances and intermediates.

At 1.30 pm on Tuesday, the stock of the company was trading at Rs 871.45, down by 1.02 per cent or Rs 8.95 per share. The 52-week high is Rs 900 and the 52-week low is Rs 435.10 on BSE.