Thursday, November 29, 2012

BWI: Unichem Laboratories Receives ANDA Approval from USFDA for Tizanidine Tablets

Press release from Business Wire India
Source: Unichem Laboratories Limited
Thursday, November 29, 2012 02:41 PM IST (09:11 AM GMT)
Editors: General: People; Business: Business services, Healthcare, biotechnology & pharmaceutical; Technology; Healthcare
Unichem Laboratories Receives ANDA Approval from USFDA for Tizanidine Tablets

Mumbai, Maharashtra, India, Thursday, November 29, 2012 -- (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 Tizanidine Tablets.

Tizanidine Tablets USP 2mg and 4mg are therapeutically equivalent to ZANAFLEX® Tablets 2mg and 4mg from Acorda Therapeutics.

Tizanidine tablets belong to a group of medicines called skeletal muscle relaxants. Tizanidine Tablets is used to help relieve, although not cure, muscle spasms caused by medical conditions such as multiple sclerosis or injuries to the brain or spine.

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

Currently, there are 9 generic approvals, while only 3 companies are dominating the market. The current market size is US$ 70 Million growing at 5% in value terms and 10% in volume.

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

BSE: 506690; NSE: UNICHEMLAB; Reuters: UNLB.BO; Bloomberg: UN@IN

Mr. K Subharaman, Unichem Laboratories Limited, +91 (22) 66888404 / +91 9833031121,
Mr. Rakesh Parikh, Unichem Laboratories Limited, +91 (22) 66888414 / +91 9892925555,
Mr. M Gundu Rao, Unichem Laboratories Limited, +91 (22) 66888380 / +91 9820228944,


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