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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

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US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

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• By Sue Sutter

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More from Compliance

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

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US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
• By Sue Sutter and Derrick Gingery

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