Alembic Pharma Gets USFDA Nod for Amlodipine & Atorvastatin Tablets in Multiple Strengths

Alembic Pharmaceuticals gets USFDA nod for Amlodipine and Atorvastatin Tablets USP Alembic Pharmaceuticals Limited has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Amlodipine and Atorvastatin Tablets USP. The approval covers a number of strengths: 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.

This product is a therapeutic equivalent to the reference listed drug (RLD), Caduet Tablets, of Pharmacia and Upjohn Co. LLC.

Therapeutic Indication

The authorized tablets are for patients who need both amlodipine and atorvastatin. The compound therapy is useful for diseases which requires a calcium channel blocker and statin therapies simultaneously. Specific therapeutic use should be based on the product label.

Regulatory Milestone

With this, Alembic now has total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from USFDA.”Alembic effectively operates with a strong regulatory version in the U.S. generics market.

About Alembic Pharmaceuticals

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, was established in 1907. It is a market leader in India for its platform products and services it operates through owned and licensed infrastructure. The group runs ultra-modern research and manufacturing facilities in compliance with stringent global health standards, including USFDA. The Company has a strong and well-connected field force of over 5,200 representatives that continue to ensure its strong presence at the global as well as local levels.

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