Cipla Ltd. received an 'Official Action Indicated' classification from the U.S. FDA, during the routine current Good Manufacturing Practices inspection at the Pithampur manufacturing facility.
The establishment has not met regulatory requirements and may be subject to further action, the company said in an exchange filing on Saturday.
The 'Official Action Indicated' status may cause delay and withholding of pending product approvals.
"We do not see material risk to our existing commercial product portfolio. The company is in the process of executing derisking plan for its new products," it said in the exchange filing. "The company will work closely with the U.S. FDA and is committed to address these within the stipulated time."
Shares of Cipla closed 3.53% higher on Friday, as compared with a 0.7% gain in the benchmark Nifty 50.
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