Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated May 23, 2025, titled "Alembic Pharmaceuticals receives USFDA Final Approval for Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg".
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Alembic Pharmaceuticals has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Amlodipine and Atorvastatin Tablets in 12 different strength combinations, ranging from 2.5 mg/10 mg to 10 mg/80 mg. This combination drug, used for treating high blood pressure and high cholesterol, is a generic equivalent of Caduet Tablets marketed by Pharmacia and Upjohn Co. LLC. With this approval, Alembic's cumulative ANDA count from the USFDA rises to 223, including 199 final approvals and 24 tentative approvals. The approval enables Alembic to launch and sell this generic product in the lucrative US market.
This is a positive development for Alembic as it adds another product to its US generics portfolio, potentially opening a new revenue stream. Approval of a high-volume combination drug like Amlodipine and Atorvastatin (a common cardiovascular therapy) can contribute meaningfully to US business growth, though the exact revenue impact will depend on market share captured post-launch.