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Alkem Laboratories Ltd Gets 3 observations from USFDA for API Manufacturing Facility

Alkem Laboratories Ltd Gets 3 observations from USFDA for API Manufacturing Facility

The US FDA had conducted an inspection at Alkem Laboratories Limited's API manufacturing facility located at Mandva. At the end of the inspection, the Company has received Form 483 with three (3) observations. There is no data integrity observation.

This Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations.
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More news about: global pharma | Published by Manvi | December - 05 - 2023 | 755

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