Alembic Pharmaceuticals said that its joint venture (JV) Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its ANDA for Mupirocin Cream USP, 2%.
The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham (Cork), Ireland.
Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions due to susceptible . strains of S. aureus and S. pyogenes.
Mupirocin Cream USP, 2% has an estimated market size of US$ 28 million for twelve months ending Jun 2021 according to IQVIA.
Aleor has been granted a competitive generic therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved applicant.
Alembic has received year to date (YTD) 13 approvals (10 final approvals and 3 tentative approvals) and a cumulative total of 152 ANDA approvals (133 final approvals and 19 tentative approvals) from USFDA.
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Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
The drug maker's consolidated net profit dropped 49.22% to Rs 169.29 crore on a 11.31% fall in sales to Rs 1,292.32 crore in Q2 FY22 over Q2 FY21.
The scrip rose 0.19% to currently trade at Rs 788.25 on the BSE.
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