Cipla stock 3% down after 6 observations from USFDA for Goa plant

In an exchange filing on June 21, the pharma giant disclosed that it received six observations from the USFDA in Form 483 after an inspection of its manufacturing facility in Goa. The inspections were carried out between June 10 and 21. Cipla added that it's committed to addressing these observations comprehensively within the stipulated time.

A form 483 is an integral part of the regulatory process and consists of a list of observations made by the USFDA during the inspection. The form is issued once the inspection is finished.

It is to be noted that Form 483 does not represent a final FDA determination regarding the manufacturing facility’s compliance with Good Manufacturing Practices (GMP), as per the USFDA website.

Previously, in an exchange filing on June 18, Cipla announced that its wholly owned subsidiary in the United Kingdom, Cipla (EU) Limited will invest an additional EUR 3 million in Ethris GmbH. The company said the investment will be made through a convertible loan to accelerate Cipla’s participation in the messenger ribonucleic acid (mRNA) space. The pharmaceutical company had earlier invested EUR 15 million in Ethris in 2022.

Cipla and Ethris are working towards a long-term strategic partnership to fast-track innovative mRNA-based treatments, the pharma giant added in the filing.

The mRNA vaccines gained importance during the COVID-19 pandemic due to the first regulatory approvals for SARS-CoV-2. mRNA-based medicines have a lot of potential in several indications as infectious disease vaccines, therapeutic cancer vaccines, and protein replacement therapies, according to the release.

At 2:12 pm, Cipla shares traded at ₹1,507 apiece, down by 2.22% on the NSE.