BWI: Unichem Laboratories Receives ANDA Approval from USFDA for Amlodipine Besylate Tablets

Press release from Business Wire India
Source: Unichem Laboratories Ltd
Thursday, October 24, 2013 06:23 PM IST (12:53 PM GMT)
Editors: General: Consumer interest; Business: Healthcare, biotechnology & pharmaceutical, Heavy industries, Major diversified industrial groups; Technology; Healthcare
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Unichem Laboratories Receives ANDA Approval from USFDA for Amlodipine Besylate Tablets


Mumbai, Maharashtra, India, Thursday, October 24, 2013 -- (Business Wire India) -- Unichem laboratories Limited are pleased to announce that it has received ANDA approval from the United States Food and Drug Administration (U.S. 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.

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




CONTACT DETAILS
M Gundu Rao, Unichem Laboratories Ltd, +91-22-66888 380, gundurao@unichemlabs.com
Rakesh Parikh, Unichem Laboratories Ltd, +91-22-66888 414, rparikh@unichemlabs.com
K Subharaman, Unichem Laboratories Ltd, +91-22-66888 404, subharamank@unichemlabs.com
Mr. Monish Shah, Unichem Laboratories Ltd, +91-22-66888 509, monish.shah@unichemlabs.com

KEYWORDS
CONSUMER, HEALTHCARE, HEAVY INDUSTRIES, GROUPS, TECHNOLOGY, HEALTHCARE

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