Unichem Laboratories Receives ANDA Approval from USFDA for Amlodipine Besylate Tablets
October 24, 2013 - Mumbai, Maharashtra, India
Amlodipine Besylate Tablets USP 2.5mg, 5mg and 10mg are therapeutically equivalent to NORVASC® Tablets 2.5mg, 5mg and 10mg from Pfizer Inc.
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.
About Unichem Laboratories Limited
Unichem Laboratories Limited is an International, integrated, specialty pharmaceutical Company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the Company is a leaded in niche areas of cardiology, neurology and other orthopadics and anti-infective. The Company has strong skills in product development, process chemistry and manufacturing of complex API as well as dosage forms.
More information about the Company can be found at www.unichemlabs.com
Source: Business Wire India