Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated November 07, 2025, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.".
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Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its generic Dasatinib Tablets in six strengths — 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. Dasatinib is used in the treatment of certain types of leukemia (chronic myeloid leukemia and acute lymphoblastic leukemia). With this approval, Alembic is now eligible to manufacture and market the generic version of this oncology drug in the US market. The approval adds to the company's growing portfolio of US generic filings and strengthens its presence in the oncology segment.
Positive for shareholders — this approval allows Alembic to tap into the US generic oncology market, potentially adding to its US revenue stream. However, pricing pressure in US generics means the actual revenue contribution may be moderate unless the company secures meaningful market share.