Alembic Pharmaceuticals

Alembic Pharmaceuticals has received approval from the United States Food and Drug Administration for a cancer treatment, marking another milestone in the company’s expanding oncology portfolio. The regulatory clearance allows Alembic to market the drug in the United States, the world’s largest pharmaceutical market. The approval underscores the company’s growing capabilities in complex generics and regulated markets.

Alembic Pharmaceuticals has received approval from the U.S. Food and Drug Administration (USFDA) for its latest dermatology product, a generic version of an acne treatment, marking another milestone in the company’s growing international portfolio. The clearance strengthens Alembic’s position in the U.S. generics market, where demand for cost-effective dermatology solutions continues to expand. The drug, used in the treatment of acne vulgaris, opens new revenue opportunities for the firm while reaffirming its regulatory and manufacturing capabilities on the global stage.

Alembic Pharmaceuticals has achieved a significant milestone by obtaining final approval from the US Food and Drug Administration (USFDA) for its generic formulations of amlodipine and atorvastatin tablets, key treatments for hypertension and cardiovascular health. The approval covers a wide range of dosage strengths, positioning Alembic to compete directly with branded products like Caduet in the lucrative U.S. market.

Alembic Pharmaceuticals has secured final approval from the U.S. Food and Drug Administration (USFDA) to market its generic version of Ticagrelor Tablets, 90 mg, and a tentative approval for the 60 mg dosage. The drug, a therapeutic equivalent to AstraZeneca's Brilinta, is prescribed to lower the risk of cardiovascular death, heart attack, and stroke in patients with acute coronary syndrome. With an estimated combined U.S. market size of over USD 1.3 billion, this approval enhances Alembic’s presence in the U.S. generics market.