Cipla Ltd. said it has received a “warning letter” from the U.S. drug regulator for its formulations plant in Goa.
That comes after the U.S. Food and Drug Administration classified the plant as Official Action Initiated. The facility was inspected from Sept. 16-27 last year, according to an exchange filing by the drugmaker.
As per the warning letter, Cipla may continue to sell existing drugs from the facility but newer approvals will be held by the regulator if corrective measures are not taken by the company.
The plant, according to Kotak Securities, contributes around 30 percent to its U.S. sales. There won't be any major financial impact as no critical near-term filings from the facility are present, Chirag Talati, an analyst at the brokerage, wrote in a report.
Ankit Hatalkar, an analyst at Edelweiss Securities, said that most of the products from this site have filings from alternative sites and all the respiratory filings are from Indore facility, which has the U.S. FDA clearance.
Shares of Cipla fell for the fourth consecutive trading session. The stock fell as much as 4.7 percent, the most since October 2019, to Rs 405.80.
The drugmaker said that it remains committed to maintaining the “highest standards of compliance and will work closely with the agency to comprehensively address all the observations”.
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