Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated January 12, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Tentative Approval for BosutinibTablets, 400 mg".
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Alembic Pharmaceuticals has received USFDA Tentative Approval for its Bosutinib Tablets, 400 mg, a supplemental ANDA therapeutically equivalent to PF Prism C.V.'s Bosulif Tablets. Bosutinib is a cancer drug used to treat chronic myeloid leukemia (CML) in adults. Alembic already has final USFDA approvals for the 100 mg and 500 mg strengths of this product, so this 400 mg approval completes its Bosutinib portfolio. The total US market for this product is estimated at US$ 251 million for the 12 months ending September 2025, according to IQVIA. The company now has a cumulative total of 232 ANDA approvals (212 final and 20 tentative) from the USFDA.
Tentative approval means Alembic can launch the 400 mg version in the US once patent or exclusivity barriers on the reference drug are cleared, adding a new revenue stream in a sizeable US$ 251 million market. This strengthens the company's US generics pipeline but is a portfolio addition rather than an immediate blockbuster catalyst.