BWI: Unichem Laboratories Receives ANDA Approval from USFDA for Bisoprolol & Hydrochlorothiazide Tablets

Press release from Business Wire India
Source: Unichem Laboratories Limited
Tuesday, August 03, 2010 03:14 PM IST (09:44 AM GMT)
Editors: General: Consumer interest; Business: Advertising, PR & marketing, Business services, Financial Analyst, Healthcare, biotechnology & pharmaceutical, Stock exchanges; Healthcare
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Unichem Laboratories Receives ANDA Approval from USFDA for Bisoprolol & Hydrochlorothiazide Tablets


Mumbai, Maharashtra, India, Tuesday, August 03, 2010 -- (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 Bisoprolol & Hydrochlorothiazide Tablets.

Bisoprolol & Hydrochlorothiazide Tablets 2.5 mg/6.25 mg, 5 mg/6.25mg and 10 mg/6.25 mg are therapeutically equivalent to Ziac Tablets of Duramed Pharmaceuticals Inc.

Bisoprolol & Hydrochlorothiazide is widely prescribed antihypertensive drug.

The product will be now immediately commercialized from Unichem's Goa plant. Active pharmaceutical ingredient i.e. Bisoprolol & Hydrochlorothiazide used for this ANDA is also made in house at Roha plant. This ANDA approval will increase the presence of Unichem in US market. Unichem already has 8 other ANDA's duly approved and there are some more ANDA's in pipeline.

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 leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives. 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
Mr. M Gundu Rao , Unichem Laboratories Limited, +91 9820228944 / +91(22) 66888380 , gundurao@unichemlabs.com
Mr. Rakesh Parikh, Unichem Laboratories Limited, +91 9892925555 / +91 (22) 66888414, rparikh@unichemlabs.com
Mr. K Subharaman, Unichem Laboratories Limited, +91 9833031121 / +91 (22) 66888404, subharamank@unichemlabs.com

KEYWORDS
CONSUMER, MARKETING, BUSINESS SERVICES, Financial Analyst, HEALTHCARE, STOCK EXCHANGES, HEALTHCARE, UNICHEMLAB.BO, UNICHEMLAB.NS

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