USFDA has approved Alembic Pharmaceutical's ANDA
Alembic Pharmaceuticals announced that its joint venture named Aleor Dermaceuticals received approval for Desonide Ointment, 0.05 per cent from USFDA.
The approved Abbreviated New Drug Application (ANDA) Desonide Ointment, 0.05 per cent is a low potency corticosteroid helpful for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. The ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Ointment, 0.05 per cent, of Perrigo New York, Inc. The estimated market size of Desonide Ointment, 0.05 per cent, is US$ 13 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 105 ANDA approvals (93 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It is engaged in manufacturing of markets generic pharmaceutical products. Alembic's state-of-the-art research and manufacturing facilities are approved by the regulatory authorities of many developed countries including the USFDA. Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd focusing on commercialising dermatology products globally.
On Thursday, the stock of Alembic Pharmaceutical opened at Rs. 545 per share and made an intraday high and low of Rs. 547.95 and Rs. 543.90, respectively on the BSE. At 11.50 am the stock was trading at Rs. 544, up by 1.27 per cent.