The Indian drug and active pharmaceutical ingredients (API) company announced the approval in a Bombay Stock Exchange (BSE) filing last Tuesday.
Wockhardt said the US Food and Drug Administration (FDA) had deemed its product to be therapeutically equivalent to the reference drug Zosyn, which is owned by Pfizer.
The claim fits with data available on the FDA website.
According to Wockhardt, the drug was developed by subsidiary of Germany-based Fresenius Kabi, which it refers to as “Fresinius Kabi, Italy (FKAI).”
Wockhart also states that the Zosyn generic will be made by FKAI at a facility in Mitim, Italy.
According to its website FKAI – Fresenius Kabi Anti Infectives – has manufacturing facilities in Rovigo and Taccona di Muggiò near Milan.
US FDA
The abbreviated new drug application (ANDA) approval comes hot on the heels of US criticism of Wockhardt’s drug production operations. The agency cited problems at seven of the firm’s facilities as an indication of its "inadequate oversight."
The decision also follows weeks after Ireland’s Health Products Regulatory Authority (HPRA) rejected Wockhardt’s claim it had recommended renewal of the good manufacturing practices (GMP) certificate for the firm’s plant in Shendra, Aurangabad.