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.
