Sun Pharma pauses production at Mohali facility to implement US FDA corrective actions

Sun Pharma said that US shipments from the Mohali facility will resume once these measures are set in place.

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26 Aug, 2025 12:21

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Pharmaceutical major Sun Pharmaceutical Industries said on April 23 it will temporarily halt production at its Mohali manufacturing unit to implement corrective measures as guided by the US Food and Drug Administration.

This comes after the drugmaker's Mohali facility was flagged as 'Official Action Indicated' (OAI) by the US FDA in connection with its inspection between August 3 to August 12, 2022, Sun Pharma said in an exchange filing. In a recent letter issued by the US FDA, titled Consent Decree Correspondence /Non-Compliance Letter, the health regulator guided Sun Pharma to take certain corrective actions at the Mohali facility before releasing further final product batches into the US.

The corrective actions include retaining an independent CGMP (Current Good Manufacturing Practice) expert to conduct batch certification of drugs that are manufactured at the unit. "The company is taking required corrective steps, but there will be a temporary pause in release of batches from Mohali until US FDA mandated measures are implemented. US shipments from Mohali will resume once these measures are in place," Sun Pharma said in the filing.

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After the US FDA inspects a manufacturing facility, it puts the facility under question in one of the three categories- No Action Indicated, Voluntary Action Indicated, or Official Action Indicated.

An OAI is the strictest of the three classifications and is issued when the US health regulator is not satisfied with the response of the company in connection to the observations it issued for the facility under inspection.

After evaluating the situation, the health regulator has the authority to determine appropriate measures for the plant, which may range from a prompt reinspection to delayed approvals, including a warning letter or an import alert. Generally, plants that have received OAI status must undergo a reinspection by USFDA officials to ensure compliance.