Cipla Ltd., the pharmaceutical giant based in Mumbai, experienced a significant decline in its shares on Thursday, emerging as the top losers on the Nifty 50 index. This downturn followed the public disclosure by the United States Food & Drug Administration (USFDA) of a warning letter issued to Cipla’s Pithampur unit on November 20 (CNBC-TV18).
Accessed by CNBC-TV18, the warning letter highlights data integrity issues flagged by the regulatory authority, specifically concerning product complaints and microbial contamination. Furthermore, the communication notes similar and recurring observations at the Goa site, which is already under a warning letter from the USFDA. In response to these concerns, the USFDA has directed Cipla to engage third-party consultants to address the identified issues.
The scrutiny of Cipla’s Pithampur facility occurred during an inspection by the USFDA between February 6 and February 17, 2023. Subsequent to this inspection, a form 483 was issued, citing eight observations. It’s worth noting that this particular plant is responsible for manufacturing respiratory and oral products for the company.
As of 11:23 am, Cipla’s shares displayed a notable dip, trading at ₹1,189.00, reflecting the market’s response to the USFDA’s public revelation of the warning letter and the associated regulatory concerns.