Alkem Laboratories’ Indore plant gets one observations from USFDA

08 Jul 2022 Evaluate

United States Food & Drug Administration (USFDA) has issued Form 483 with one observation with respect to ANDA filed for the products to be manufactured for Alkem Laboratories’ manufacturing facility located at Indore. The USFDA had conducted a Good Manufacturing Practice (GMP) and pre-approval inspection from July, 1 2022 to July 7, 2022.

This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to USFDA within the stipulated timeline, a detailed response to close out the said observation.

Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products.

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