Sun Pharma’s Mohali plant to have temporary hold on batch release till US FDA-mandated measures are implemented

On Sunday, April 23, Indian multinational pharmaceutical company Sun Pharmaceutical Industries Limited said that there would be a temporary suspension of batch releases from its Mohali (Punjab) plant until US FDA-mandated measures are implemented. Sun Pharmaceutical Industries Limited is India’s largest pharmaceutical company and the world’s fourth largest specialty generic drug company.

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Sun Pharmaceuticals Industries has been directed by the US FDA to take corrective action at its Mohali (Punjab) facility before releasing final product batches in the US. “Corrective actions include retaining an independent cGMP expert to perform batch certification of manufactured drugs and US shipments from Mohali will resume once these measures are in place”, the company said.

The US FDA had inspected the Mohali facility of Sun Pharmaceuticals from 3rd to 12th August 2022. Sun Pharmaceutical Industries Limited manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in more than 100 countries around the world.

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