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The ANDA was filed by Aleor Dermaceuticals which was amalgamated with Alembic.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide cream of Padagis US LLC.
Desonide cream is a low potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
According to IQVIA, Desonide cream has an estimated market size of $12 million for twelve months ended 30 September 2022.
Alembic has received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
On consolidated basis, the company's net profit declined 18.7% to Rs 133.35 crore despite of 14.1% jump in revenue from operations to Rs 1,475.01 crore in Q2 FY23 over Q2 FY22.
The scrip declined 0.27% to currently trade at Rs 597.60 on the BSE.
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