Wockhardt US unit gets FDA warning note
Products of Wockhardt’s US unit Morton Grove Pharma will be available in that market but new approvals will be withheld until compliance issues are resolved
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Mumbai: Wockhardt Ltd’s step-down unit in the US, Morton Grove Pharmaceuticals Inc., has received a warning letter from the US Food and Drug Administration (FDA) for violation of norms. While the current product portfolio of the firm will be available in the US, new approvals will be withheld until compliance issues are resolved, Wockhardt said in a stock exchange filing on Wednesday. The company, with the help of consultants, has initiated steps to address issues raised by FDA, it said.
The company has been grappling with regulatory issues since 2013, which has hurt its earnings. The drug maker reported a loss of Rs53.91 crore in the quarter ended December, as against a net profit of Rs72.04 crore in the same period a year ago. This was its first quarterly loss in more than four years.
Three plants of Wockhardt in India are already under an import ban in the US. The company’s formulations units at Chikalthana and Waluj in Maharashtra have been under the US FDA’s import alert since 2013, while its bulk drug plant at Ankleshwar in Gujarat was issued an import alert in August.
The US regulator also observed deviations from norms at the company’s formulations plant in Shendra, Maharashtra, in early 2016.
According to Wockhardt’s annual report, Morton Grove Pharmaceuticals reported a net profit of Rs11.28 crore in financial year 2015-16.
Shares of Wockhardt ended almost flat at Rs751.10 on the BSE, while the benchmark Sensex closed up 0.84% at 28984.49 points on Wednesday.