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17th November 2021, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mupirocin Cream USP, 2%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bactroban Cream, 2%, of SmithKline Beecham(Cork) Ltd, Ireland (SmithKline). Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes. 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.
Mupirocin Cream USP, 2% has an estimated market size of US$ 28 million for twelve months ending Jun 2021 according to IQVIA.
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.