Alembic Pharma's Aleor Dermaceuticals gets USFDA nod for generic product

Drug firm Alembic Pharmaceuticals on Wednesday said its joint venture firm Aleor Dermaceuticals has received approval from the US health regulator to market a generic product, which is used to treat various skin conditions, in the American market.

The company said its joint venture firm Aleor has received final approval from the US Food and Drug Administration (USFDA) to market its abbreviated new drug application (ANDA) Clobetasol Propionate Cream in the US market.

The approved product is generic version of Fougera Pharmaceuticals' Temovate Cream which is indicated for relief of inflammatory and pruritic manifestations.

According to IQVIA, the Clobetasol Propionate Cream USP (0.05 per cent) had an estimated market size of USD 57 million (about Rs 405 crore) for the 12-months ending September 2019.

Alembic now has a cumulative total of 118 ANDA approvals from the USFDA.

The company's shares on Wednesday ended 0.41 per cent higher at Rs 634.30 on the BSE.



Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel