Wockhardt gets USFDA approval to market generic version of Zosyn

22 Mar 2017 Evaluate

Wockhardt has received approval from US Food and Drug Administration (USFDA) to market generic version of Wyeth’s Zosyn, used for treating bacterial infections, in the American market. The abbreviated new drug application (ANDA) of Piperacillin and Tazobactam for Injection USP, 40.5 g/vial, pharmacy bulk package submitted by Wockhardt Bio AG, subsidiary of the company has been approved by USFDA.

Wockhardt’s ANDA was determined to be therapeutically equivalent to the reference listed drug (RLD) Zosyn for Injection 40.5g/vial, pharmacy bulk package of Wyeth Pharmaceuticals Inc. Wockhardt Bio AG had filed this ANDA in collaboration with Fresinius Kabi, Italy (FKAI), where the product development was completed. The ANDA will be manufactured commercially at FKAI, Mitim, Italy.

Wockhardt is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s, the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.


Wockhardt Share Price

1345.90 -17.25 (-1.27%)
23-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1631.65
Dr. Reddys Lab 1235.15
Cipla 1314.85
Zydus Lifesciences 881.95
Lupin 2137.15
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×