Aurobindo Pharma has received the US Food & Drug Administration's (FDA's) final approval to manufacture and market Pioglitazone tablets USP 15mg, 30mg & 45mg (ANDA 200268) and its earlier tentatively approved Pioglitazone Hydrochloride + Metformin Hydrochloride tablets, 15mg(base)/500mg & 15mg(base)/850mg (ANDA 200823). The products are ready for launch.

Pioglitazone tablets USP 15mg, 30mg, 45mg and Pioglitazone Hydrochloride + Metformin Hydrochloride tablets, 15mg(base)/500mg, 15mg(base)/850mg are the generic equivalents of Takeda Global Research Development Centre Inc’s Actos tablets 15mg, 30mg, 45mg and Actoplus Met tablets, 15mg (base)/500mg, 15mg (base)/850mg respectively. The products are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

The combined market size of the products is approximately US$ 2.8 billion for the twelve months ending September 2012 according to IMS.

Aurobindo now has a total of 177 ANDA approvals (152 final approvals including two from Aurolife Pharma LLC and 25 tentative approvals) from US FDA

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over six major therapeutic/ product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics, supported by an outstanding R&D set-up.