Cipla reported that its Pithampur manufacturing facility received an ‘Official Action Indicated’ classification from the USFDA, during its current Good Manufacturing Practices inspection.
The establishment has not met regulatory criteria and may face further action, according to a stock exchange filing on Saturday.
The ‘Official Action Indicated’ status may cause product approvals to be delayed or withheld.
‘We see no material impact of this on our current commercial product portfolio. The company is currently executing a derisking plan for its new products,’ it stated in an exchange filing.
The company will work closely with the USFDA and is committed to addressing these issues within the timeframe specified.
At around 10.38 AM, Cipla was trading 0.31% lower at Rs 1,206 per piece, against the previous close of Rs 1,209.75 on NSE. The counter touched an intraday high and low of Rs 1,221 and Rs 1,174.20, respectively.
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