Aurobindo Pharma receives five product approvals from USFDA including two Paragraph IV products

Posted AtPrdomain.com

Aurobindo Pharma Ltd is pleased to announce that it has received 5 product approvals from the US Food & Drug Administration since October 2007 for the US market. These approvals include two Paragraph IV products - Finasteride Tablets USP and Glyburide & Metformin Hydrochloride Tablets.

The product approved are as follows:

1. Glyburide Tablets USP - 1.25, 2.5 & 5mg
2. Torsemide Tablets - 5, 10, 20 and 100 mg
3. Finasteride Tablets USP - 5 mg
4. Atenolol Tablets USP - 25, 50 and 100 mg
5. Glyburide & Metformin Hydrochloride Tablets - 1.25/250, 2.5/500 & 5/500 mg

Aurobindo now has a total of 59 ANDAs approved by the USFDA.

About Aurobindo Pharma Limited:
Aurobindo Pharma Limited (www.aurobindo.com), headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company has received approvals for several facilities from leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics. The Company is marketing these products globally, in over 100 countries.

March 03, 2009