USFDA issues EIR for Alkem Laboratories’ API manufacturing facility at Mandva

28 Feb 2024 Evaluate

U.S Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Alkem Laboratories’ API manufacturing facility located at Mandva, Maharashtra. The inspection has been classified as Voluntary Action Indicated (VAI) and was closed accordingly.

Earlier, USFDA had concluded inspection at the company’s API manufacturing facility located at Mandva, Maharashtra. The said inspection conducted from November 27, 2023 to December 01, 2023. At the end of the inspection, the company has received Form 483 with three observations. 

Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical Ingredients (APIs) and nutraceuticals, which it markets in India and International markets.


Alkem Laboratories Share Price

5431.85 -65.55 (-1.19%)
20-Dec-2024 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1808.50
Dr. Reddys Lab 1342.45
Cipla 1472.45
Lupin 2147.55
Zydus Lifesciences 973.90
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.