Unichem gets approval for Amlodipine Besylate Tablets

Unichem laboratories Limited are pleased to announce that it has received ANDA approval from the United States Food and Drug Administration (US FDA) for Amlodipine Besylate Tablets.

Amlodipine Besylate Tablets USP 2.5mg, 5mg and 10mg are therapeutically equivalent to NORVASC® Tablets 2.5mg, 5mg and 10mg from Pfizer Inc.

Also read: US showing good growth; EMs steady: Unichem Labs 

Amlodipine Besylate Tablet USP is a calcium channel blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

The product will be commercialized from Unichem’s Goa plant. Active pharmaceutical ingredient i.e., Amlodipine Besylate used for this ANDA is also made in house at Roha plant.

Currently, there are 6-7 companies are dominating the US market. The current market size is around US$ 45~50 Million.