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Alembic Pharmaceuticals Limited’s joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US drug regulator, US Food & Drug Administration (USFDA), for an Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, the company informed.
Aleor is a 60:40 joint venture between Alembic Pharmaceuticals Limited and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) focused on commercialising dermatology products globally.
Alembic Pharma Q3 standalone net up 19% at ₹277 crore
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.A. Inc, an official statement said here.
Nystatin and Triamcinolone Acetonide Cream, USP 100,000 units/gram and 1 mg/gram, is indicated for treatment of cutaneous candidiasis.
It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Why you should hold the stock of Alembic Pharma
Market size
Nystatin and Triamcinolone Acetonide Cream, USP has an estimated market size of $19 million for twelve months ending December 2020, according to IQVIA.
Alembic has a cumulative total of 139 ANDA approvals, which includes 123 final approvals and 16 tentative approvals from USFDA.
Alembic Pharmaceuticals shares gained on Thursday to trade at ₹972.40 on BSE.
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