Wockhardt gets QIDP status for two of its anti-infective drugs

01 Sep 2014 Evaluate

Drug maker Wockhardt has received Qualified Infectious Disease Product (QIDP) status from the US health regulator -- US Food and Drug Administration (USFDA) -- for two of its anti-infective drugs WCK 771 and WCK 2349. This is the first instance of an Indian pharmaceutical company receiving QIDP status.

These drugs will be entering their global Phase-3 clinical trials early next year. QIDP status is granted to drugs which act against pathogens which have a high degree of unmet need in their treatment and are identified by the Centre for Disease Control, USA, a top US government health and safety body.

WCK 771 is an intravenous (IV) drug while WCK 2349 is a solid oral tablet. Both act against Methicillin-resistant Staphylococcus Aureus (MRSA), which causes a range of diseases from skin infection to severe respiratory infections.

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.

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