The United States Food and Drug Administration (USFDA) issued a warning to drug producer Cipla on Saturday following an examination of the company's Pithampur facility in Indore, earlier this year.
In February, the plant was the subject of a regular examination by the American agency.
"We wish to inform you that on November 18, 2023, the company has received a warning Letter dated November 17, 2023 from [the] United States Food and Drug Administration (USFDA) for the routine current Good Manufacturing Practices (cGMP) inspection conducted at our Pithampur manufacturing facility between February 6-February 17, 2023," Cipla said in an exchange filing.
Advertisement
The complaint claims that the USFDA provided the medicine company with a thorough analysis of the shortcomings in the procedures used at the facility.
Cipla's new approvals from the site will be put on hold for now.
In the submission, Cipla also stated that it would be collaborating with the US government to guarantee that the issues at the Pithampur factory are resolved. The plant manufacturers respiratory and oral products for the company.
"The company will respond to the warning letter within the stipulated timelines and work closely with the USFDA to address the concerns in a holistic and timely manner to ensure sustained compliance," reads the filing.
Advertisement
"We uphold quality and compliance with utmost importance and remain committed to be compliant with the cGMP quality standards," Cipla added.
Cipla's shares were trading at Rs 1,247.85 at 12:10 pm, down by −1.70 rupees and 0.14 per cent. Cipla has also made headlines due to the possibility of its promoters selling a portion of their stake.
Just one email a week