Cipla gets USFDA OAI status for Goa facility
Mumbai: Pharma major Cipla has announced that the company has received a communication from the US Food and Drug Administration (USFDA) that the classification of Company's Goa facility continues to be as Official Action Indicated ("OAI"). Official Action Indicated (OAI) means regulatory and/or administrative actions will be recommended."USFDA may continue to withhold product approvals...
Mumbai: Pharma major Cipla has announced that the company has received a communication from the US Food and Drug Administration (USFDA) that the classification of Company's Goa facility continues to be as Official Action Indicated ("OAI"). Official Action Indicated (OAI) means regulatory and/or administrative actions will be recommended.
"USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved. The Company has an ongoing de-risking plan in place for new product approvals," the company stated in a BSE filing.
"The Company will work closely with the USFDA and is committed to address these within the stipulated time," Cipla further stated.
Read also: USFDA issues 6 observations for Cipla Goa plant
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.
Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.
Read also: Cipla gets CDSCO Panel nod to manufacture, market COPD drug combination Aerosol for inhalation
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