Mumbai-based drugmaker Cipla Ltd.'s facility in Pithampur, Indore received a warning letter from the United States Food and Drug Administration, the company said in an exchange filing.
The warning letter is based on the inspection carried out between February 6 - February 17, 2023. The plant manufacturers respiratory and oral products for the company.
Cipla mentioned that the warning letter summarises contraventions regarding methods or controls followed at the facility which do not follow the Current Good Manufacturing Practices (CGMP).
The letter also contains directional guidance for necessary corrections. Cipla will respond to the USFDA within the stipulated time to ensure sustained compliance, the company said.
Cipla was issued eight observations by the US drug regulator for the inspection carried out earlier this year. In August, the facility was classified as Official Action Indicated (OAI).
Going by the US drug regulator’s classification, Official Action Indicated (OAI) generally means objectionable conditions were found and regulatory or administrative actions by USFDA are indicated during inspections.
This also means that new approvals from the site will be put on hold for now. The delay in Cipla's inhaler gAdvair is already factored into the consensus estimates and the stock price.
The company is already working on transferring the Advair generic to another site and is likely to be launched by early to mid-financial year 2025.
"The company doesn't comment on it, the promoters have not commented on it. We respond to what we do as a company through various statutory announcements, there have been none. As of two days back, we also opened the window for our employees. So I think people could infer, based on all of this, seems like it's business as usual," he said.
The brokerage expects a potential upside of 21% over the next 12 months for Cipla's shares.
Shares of Cipla ended 1% higher on Friday and have gained 17% so far in 2023.
(Edited by : Hormaz Fatakia)
