Drugmaker Cipla said the United States Food and Drug Administration (USFDA) had inspected InvaGen Pharmaceuticals Inc’s site in the US and made five regulatory observations.
InvaGen Pharmaceuticals is a wholly-owned subsidiary of Cipla, and the latter’s shares were down over 2 percent on BSE, Thursday, at ₹1,213.25 (at 13.10 hrs), following the development.
“The inspection was a routine current Good Manufacturing Practices (cGMP) inspection and a Pre-Approval Inspection (PAI) for a site transfer product within InvaGen. On conclusion of the inspection, InvaGen has received 5 inspectional observations in Form 483,” Cipla told the stock exchanges. The US site inspection was from September 11th to 19th, 2023.
There are no repeat or data integrity observations, it said, adding that they were working with the USFDA to address the issue.
Cipla is presently in the news on reports that its promoters were looking to sell their stake in the company, and interested parties included fellow-drugmaker Torrent Pharmaceuticals.