USFDA concludes GMP inspection at Glenmark Pharmaceuticals’ USA manufacturing facility

18 Jun 2025 Evaluate

United States Food & Drug Administration (USFDA) has concluded GMP inspection at Glenmark Pharmaceuticals’ manufacturing facility situated in Monroe, North Carolina, USA. The inspection was conducted from June 09 to June 17, 2025.

At the end of the inspection, the Company was issued a Form 483 with five observations. All the observations are procedural in nature. There was no observation related to data integrity reported. The Company will work in close collaboration with the agency to address the observations and will respond to the USFDA within the stipulated timeline. 

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

Glenmark Pharma Share Price

2009.95 -9.60 (-0.48%)
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.

×