USFDA has classified Cipla’s Goa plant as an ‘Official Action Indicator’. file. , Photo Credit: Special Arrangement
Drug major Cipla on November 24 said the USFDA has classified its Goa plant as ‘Official Action Indicated’, affecting product approval from the facility for the US market.
According to the US Food and Drug Administration (USFDA) definition, Official Action Indicated (OAI) means “objectionable conditions were found during the inspection and regulatory administrative sanctions were indicated by the FDA”.
It states that an FDA inspection revealed significant objectionable conditions or practices and that action must be taken to address the issues.
“We would like to inform you that the company has received a notification from the USFDA that the classification of the said facility of the company as OAI continues,” Cipla said in a regulatory filing.
This facility allows the USFDA to withhold product approval until the outstanding objections are resolved.
The Mumbai-based drug major said the company has ongoing plans for new product approvals.
Cipla will work closely with the USFDA and is committed to resolving these within the stipulated time.
The USFDA had inspected the company’s Goa plant in August this year.
The company’s shares were trading at Rs 1,109.10, up 0.17%, on the BSE.