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USFDA Approves Lupins Generic Diabetic Drug

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Published on : Apr 10, 2014

The United States Food and Drugs Administration (USFDA) has finally approved Lupin Pharmaceuticals Inc (LPI), the American subsidiary of Indian drug manufacturers Lupin Ltd, to sell Pioglitazone Tablets in the U.S market. The approval has been granted first for fiscal 2015. 

Pioglitazone is a generic medicine used for managing diabetes and is a version of Actos tablets manufactured by Takeda Pharmaceuticals USA. Company sources reveal that marketing of the drug will soon begin for the drug, which would be available in variants of 15 mg, 30 mg and 45 mg strength.  

The IMS data gathered for December 2013 indicate that the annual sales of Actos generic in the U.S market were near to $236 million. Also, Actos is specified as an adjunct to exercise and diet in order to gain proper glycemic management in adults with type 2 diabetes mellitus. 

Till date, Lupin has successfully launched 17 products during the years 2013 and 2014. It has received approvals for 100 products from the US drug regulator. As of December, 2013 Lupin had collectively filed 186 Abbreviated New Drug Applications (ANDA) with the USFDA. 

Lupin is known in the global market as a producer and developer of a variety of generic and branded formulations as well as the manufacturer of various active pharmaceutical components. It is a significant player in the space of diabetology, pediatric, GI, anti-Infective, CNS, asthma and NSAID and holds global leadership in cephalosporin and anti-TB medicines. 

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