USFDA classifies Cipla Pithampur facility as OAI
Mumbai: Cipla has announced that the Company has received a communication from the United States Food and Drug Administration (USFDA) that the inspection classification of the Pithampur manufacturing facility is Official Action Indicated (“OAI”) as the establishment has not met regulatory requirements and may be subject to further regulatory action.
The OAI status may cause delay/withholding of pending product approvals.
"We do not see material risk to our existing commercial product portfolio. The Company is in the process of executing derisking plan for its new products," Cipla stated in a BSE filing.
"The Company will work closely with the USFDA and is committed to address these within the stipulated time," it further stated.
Medical Dialogues team had earlier reported that the USFDA had issued 8 inspectional observations in Form 483 after an inspection at the company's Pithampur manufacturing facility.
Read also: USFDA Inspection: Cipla Gets 8 Observations For Pithampur Facility
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.
The company specializes in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments. Cipla's 47 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to 86 markets.
Read also: Cipla arm gets zero Form 483 observations from USFDA for USA facility
