The Mumbai based Wockhardt has received US FDA approval to market ceftazidime injections containing 1 gm/vial, the generic version of GlaxoSmithKline's Fortaz.
Ceftazidime is used for treating various kinds of infections. Wockhardt is expected to launch the product in the US market shortly.
"Wockhardt is one of the only three companies to have received this approval," said Wockhardt chairman Habil Khorakiwala.
According to IMS, the total market for ceftazidime injections in the US is $42 million, of which the 1 gm/vial market has sales worth US$12.6 million. Ceftazidime is used in treating several kinds of infections and is one of the most potent, powerful and safe antibiotics.
The ceftazidime pentahydrate API is manufactured in the FDA approved API facility at Ankleshwar, Gujarat and the injections are manufactured at the US FDA certified formulation plant at Waluj, Maharashtra.
Wockhardt has 11 approvals from the US FDA for its sterile products including cephalosporins. Currently, the company markets over fifty five products in the US.