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18th Aug 2025 · SEBI-Registered Analyst

APLLTD
gets USFDA nod for Tretinoin Cream USP, 0.025%📈

Alembic Pharmaceuticals (

APLLTD
) has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.025%, which is therapeutically equivalent to Retin-A Cream 0.025% (Bausch Health US, LLC). 🔹 Indication: Topical treatment of acne vulgaris (refer label for detailed use). 🔹 Market Size: ~$94 million (12 months ending June 2025, IQVIA). 🔹 Alembic’s ANDA Track Record: 224 approvals (202 final, 22 tentative). With this, Alembic continues to strengthen its US generics portfolio, reaffirming its position as a research-driven, vertically integrated pharmaceutical company that has been serving global healthcare since 1907.

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