Unichem Laboratories 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.
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 commercialised from Unichem’s Goa plant. Active pharmaceutical ingredient i.e., Amlodipine Besylate used for this ANDA is also made in house at Roha plant, in Maharashtra.
Currently, there are six to seven companies who are dominating the US market. The current market size is around $ 45~50 million.
EP News Bureau – Mumbai