The US Food and Drugs Administration (FDA) has issued an import alert on Wockhardt’s 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 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 per cent in FY16 from 24 per cent a year ago because of import restrictions. The Ankleshwar plant contributes 10-15 percent of the US sales (~964 crore in FY16).
The US FDA had carried out an inspection at the Ankleshwar plant in November last year and issued adverse observations known as Form 483 for violating good manufacturing practices.
The Ankleshwar plant is used to make both formulations and active pharmaceutical ingredients and largely caters to domestic and European markets. However, it exports some formulations and active pharmaceutical ingredients (APIs) to Wockhardt’s US plant.
Wockhardt’s plants in Chikhalthana and Waluj in Aurangabad have import alerts against them. At present, the company is able to export only two products from Chikhalthana to the US. Other than this, Wockhardt serves the US market from its manufacturing plant in Chicago.
In January, the US FDA had issued adverse observations to the company’s Shendra plant. Wockhardt plans to use the Shendra facility to export oral solids and injectables to the US.
The mood in Wockhardt was upbeat after the US drug regulator closed inspections at Chikhalthana and Waluj plants recently without any adverse observations (Form 483). The company had also hired consultants and remedial measures were underway to address FDA concerns.