美國最大的非專利藥公司VTRS接到FDA的警告,要求停止在美國銷售11種印度製造的藥品

來源: 2025-01-05 09:19:32 [舊帖] [給我悄悄話] 本文已被閱讀:

Viatris receives FDA warning letter for 11 drugs made at India plant

The U.S. FDA is blocking imports of 11 drugs manufactured by Viatris (NASDAQ:VTRS) from an India facility following an agency inspection.

The imports of the medications will not be permitted again until the concerns are addressed. However, four of the drugs, which are in shortage, can continue to be shipped into the U.S., subject to certain conditions. 

Viatris said as soon as it was made aware of the issues, it "immediately implemented a comprehensive remediation plan at the site. The necessary corrective and preventive actions are well underway, including but not limited to related personnel actions. Additionally, we have engaged independent third-party subject matter experts to support the remediation plan."