United States Food and Drug Administration (USFDA) has classified Cipla’s Goa plant as 'Official Action Indicated', impacting product approvals from the facility meant for the US market. Official Action Indicated means ‘objectionable conditions were found and regulatory administrative sanctions by FDA are indicated’ during inspections.
The USFDA may continue to withhold product approvals from this facility till the outstanding observations are resolved. The company has an ongoing derisking plan in place for new product approvals. The Company will work closely with the USFDA and is committed to address these within the stipulated time.
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients.
