Aurobindo Pharma receives USFDA approval for Repaglinide Tablets

23 Jan 2014 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration to manufacture and market Repaglinide Tablets USP 0.5mg, 1 mg and 2mg. The product is ready for launch. The market size of the product is estimated to be $274 million for the twelve months ending November 2013 according to IMS.

Repaglinide Tablets USP 0.5mg, 1mg and 2mg are the generic equivalent of Novo Nordisk Inc's Prandin Tablets USP 0.5mg, 1mg and 2mg and indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Aurobindo has a total of 189 ANDA approvals (164 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.

Aurobindo Pharma Share Price

1217.45 -6.20 (-0.51%)
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