Aleor Dermaceuticals receives USFDA Approval for Clobetasol Propionate Ointment USP 0.05%.

Deepthi | Myequity news | Date : 05-03-2019 16:55:00 IST

Alembic Pharmaceuticals Limited’s joint venture Aleor Dermaceuticals Limited (Aleor) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Ointment USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Temovate® Ointment USP, 0.05% of Glaxo Wellcome Inc. Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Clobetasol Propionate Ointment USP, 0.05%, has an estimated market size of US$ 63 million for twelve months ending December 2018 according to IQVIA.

About Alembic Pharmaceuticals Limited

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.

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