Sun Pharma halts shipments from Mohali facility
Sun Pharmaceutical Industries (Sun Pharma) said on Sunday that it will temporarily halt the delivery of final product batches from its Mohali manufacturing site until it implements US Food and Drug Administration (FDA) required procedures.
The business stated in its regulatory filing that it got a letter headed “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,” the firm stated.
“These actions include, among others, retaining an independent CGMP expert to conduct batch certifications of drugs manufactured at the Mohali facility,” it continued.
It also stated that the business is implementing the necessary remedial actions, however that there would be a temporary halt in the distribution of batches from Mohali until US FDA-mandated precautions are implemented.
As a result, once these precautions are implemented, US supplies from Mohali will restart.
Sun Pharma’s Mohali factory was inspected by the US authorities in August of last year, from August 3 to August 12, 2022. The inspections were labeled as “Official Action Indicated” (OAI) by the US FDA.