USFDA issues EIR to Alkem Laboratories’ Indore manufacturing facility

24 Feb 2023 Evaluate

U.S Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Alkem Laboratories’ manufacturing facility located at Indore which was inspected from July 01, 2022 to July 07, 2022. In response to Form 483 issued by the US FDA containing one observation, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the USFDA.

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

5535.00 -28.80 (-0.52%)
26-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1719.20
Dr. Reddys Lab 1269.05
Cipla 1505.05
Zydus Lifesciences 911.50
Lupin 2112.95
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×