Alembic Pharmaceuticals receives USFDA approval for Tretinoin Cream USP
Tretinoin cream USP, 0.025%, has an estimated market size of US$ 94 million for twelve months ending June 2025 according to IQVIA.
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2 days ago
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Alembic Pharmaceuticals receives USFDA approval for Tretinoin Cream USP
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.025%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Tretinoin cream USP, 0.025%, has an estimated market size of US$ 94 million for twelve months ending June 2025 according to IQVIA.
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Alembic Pharma secures USFDA nod for generic acne cream
Alembic Pharmaceuticals said on Friday it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.025%. The product is therapeutically equivalent to Bausch Health's Retin-A Cream, 0.025%, and is indicated for the topical treatment of acne vulgaris. The cream has an estimated market size of $94 million for the 12 months ended June 2025, according to IQVIA. With this nod, Alembics cumulative ANDA approvals now stand at 224, including 202 final and 22 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research-driven company that manufactures and markets generic medicines globally. The company's consolidated net profit jumped 14.18% to Rs 156.63 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024.
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