Wockhardt has been issued an import alert from the US Food and Drugs Administration (USFDA) for its Ankleshwar plant for alleged violation of good manufacturing practices. This is the drug maker’s third plant to receive an import alert from the US drug regulator. The Ankleshwar unit manufactures active pharmaceutical ingredients (APIs) and was inspected last year by the US regulator.
The move is a setback to the company’s plans to revive its US business. The share of the firm’s US business in the total sales dropped to 22 percent in FY16 from 24 percent a year ago because of import restrictions. The Ankleshwar plant contributes 10-15 percent of the US sales (Rs 964 crore in FY16).
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.
