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Halol Plant Approvals Still On Hold As Sun Responds To Lengthy FDA Inspection Report

 
• By Bowman Cox

After years of pandemic-related delays, US FDA reinspects key Sun plant in Halol, India, hit with “official action indicated” inspection findings that tabled approvals just before COVID-19 impeded travel. However, new findings are generating further discussions.

Pharma plant
more inspection findings to address at halol • Source: Shutterstock

Sun Pharmaceutical Industries Ltd. last month finally got the US Food and Drug Administration inspection it was awaiting to lift the agency's December 2019 “official action indicated” classification that suspended approvals of additional drugs slated to be manufactured at its Halol, India, plant for the US market.

The plant was one of many stuck in OAI limbo with the FDA’s inspectorate largely grounded during the COVID-19 pandemic.

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