24 Aug 2022 , 02:33 PM
According to the OAI classification, the USFDA may suspend approval of any pending product applications or supplements filed from this facility until the outstanding observations are rectified.
The company added that this further announcement is in continuation of its announcement dated May 20, 2022, regarding USFDA inspection at Glenmark’s Monroe, North Carolina (USA) facility from April 4 to May 19, 2022, and issuance of Formâ€483 with 17 observations.
The Company voluntarily recalled all of its items from this site in August 2021 and has not commercialized any products from this site since then.
Glenmark continues to work with the US FDA and is dedicated to taking all necessary efforts to resolve their concerns as soon as possible, stated the company in its filing.
Related Tags
IIFL Customer Care Number
(Gold/NCD/NBFC/Insurance/NPS)
1860-267-3000 / 7039-050-000
IIFL Securities Support WhatsApp Number
+91 9892691696
www.indiainfoline.com is part of the IIFL Group, a leading financial services player and a diversified NBFC. The site provides comprehensive and real time information on Indian corporates, sectors, financial markets and economy. On the site we feature industry and political leaders, entrepreneurs, and trend setters. The research, personal finance and market tutorial sections are widely followed by students, academia, corporates and investors among others.
Stock Broker SEBI Regn. No: INZ000164132, PMS SEBI Regn. No: INP000002213,IA SEBI Regn. No: INA000000623, SEBI RA Regn. No: INH000000248
This Certificate Demonstrates That IIFL As An Organization Has Defined And Put In Place Best-Practice Information Security Processes.