Sun Pharma Pauses US Shipments From Mohali Facility
India's largest drugmaker Sun Pharmaceutical on Sunday intimated stock exchanges that it has been directed by the United States Food and Drugs Administration (US FDA) to take corrective actions at its Mohali facility before releasing any more final product batches into the US.
The corrective actions include retaining an independent current good manufacturing practice (CGMP) expert to conduct batch certifications of drugs manufactured at the Mohali facility.
"The Company has received a letter titled 'Consent Decree Correspondence/Non-compliance Letter' from the US FDA. US FDA has directed the Company to take certain corrective actions at the Mohali facility before releasing further final product batches into the US," Sun Pharma said in an exchange filing.
US FDA inspected Sun Pharma's Mohali facility between 3-12 August 2022 and classified the inspection as Official Action Indicated (OAI).
The plant was already under OAI status, which is expected to impact approvals pending for products, but does not impact the current business from the facility.
Last November, Sun Pharma said that the OAI status is not likely to have any material adverse impact on the current business from the facility. It continued to manufacture and distribute existing products for the US market.
Sun Pharma added that though they are taking the required corrective steps, there will be a temporary pause in the release of batches from Mohali until the US FDA-mandated measures are implemented.
Once these measures are in place, the US shipments from Mohali will resume.
