US FDA halts imports of pharma co Viatris drugs made at its Indore unit
This story was originally published at 10:38 IST on 24 December 2024
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MUMBAI – Drug regulator US Food and Drug Administration has halted the import of 11 drugs manufactured at US-based Viatris Inc.'s Indore unit through the issuance of a warning letter and an import alert for the facility, the company said in a press release late Monday.
The missives were issued following an inspection by the regulator of the Viatris' oral finished dose manufacturing facility in Indore earlier this year. This import alert curbs the import of 11 actively distributed products into the US, until the warning letter is lifted. However, an exception has been made for four drugs, subject to certain conditions, based on concerns over shortages.
"There could be the potential for additional exceptions based on further discussions with the agency," Viatris said in the press release. The company said a comprehensive remediation plan is underway at the site. The company is currently in touch with third-party subject-matter experts to support this plan. Viatris is also taking corrective and preventive actions, including but not limited to, related personnel action, it said. End
Reported by Anand JC
Edited by Deepshikha Bhardwaj
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