Aurobindo Pharma gets US FDA approval for Pioglitazone Tablets

14 Feb 2013 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) 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 Center 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 about $2.8 billion for the twelve months ending September 2012.

Aurobindo now has a total of 177 ANDA approvals (152 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

Aurobindo Pharma Share Price

1177.60 -39.85 (-3.27%)
08-Dec-2025 15:31 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1790.05
Dr. Reddys Lab 1272.70
Cipla 1498.90
Zydus Lifesciences 920.90
Lupin 2061.50
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×