U.S. Food and Drug Administration (USFDA) has issued a Warning Letter to Morton Grove Pharmaceuticals, USA, a step-down Subsidiary of Wockhardt. This would mean that current portfolio of the Company will continue to be made available in the market. However, new approvals will be withheld till resolution. The company, with the help of the Consultants, has already initiated appropriate measures since last several months to address the issues raised by USFDA.
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.