Indian generic drug maker Wockhardt has been hit by a U.S. import alert for the second time this year. The U.S. Food and Drug Administration (FDA) has imposed a ban on the company's manufacturing facility, located in Chikalthana, Maharashtra, prohibiting U.S. sales of drugs manufactured there.
This time the consequences for the manufacturer might be serious because the facility is one of the biggest revenue sources for Wockhardt, contributing about a quarter of its $1 billion revenue in the last financial year.
Earlier this year, in May, Wockhardt was dealt another blow from the FDA when the U.S. agency banned sales in the United States of products manufactured at its facility in the city of Aurangabad, the Financial Times reported.
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In July the FDA sent a warning letter to Wockhardt, explaining that inspectors were not allowed into the facility and that, when eventually they got in, they could not properly perform their duties. The FDA stated that unlabeled production was found in the plant and when inspectors asked a worker about the vials, the employee tried to dispose of their contents.
As the number of generic drugs distributed on the U.S. market increases, the FDA is trying to make sure that all products meet the highest industry standards. Imports from India have been on the rise and at present India accounts for the second-largest share of imported drugs in the United States.
