USFDA concludes pre-approval inspection at Alkem Laboratories’ USA facility

16 Sep 2022 Evaluate

U.S Food and Drug Administration (USFDA) has concluded pre-approval inspection at Alkem Laboratories’ manufacturing facility located at St. Louis, USA, conducted during September 06, 2022 to September 14, 2022. At the end of the inspection, the company has received Form 483 with two observations. There is no data integrity observation.

This Pre-Approval 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.

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

5499.75 -35.25 (-0.64%)
29-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1717.50
Dr. Reddys Lab 1268.60
Cipla 1494.40
Zydus Lifesciences 904.00
Lupin 2079.50
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.

×