2 May 2022 , 12:56 PM
As per the filing, the inspection was triggered by Shilpa’s submission of applications for four ANDA’s to seek approval to use this site as alternate testing laboratory. The inspection has been closed with four observations, which are related to improvements in existing procedures and are addressable.
The Company will be submitting the responses to USFDA observations within stipulated timeline and implement the corrective actions to address the observations.
“This Analytical Services Division has started analytical testing operations from May 2021. This is the first US FDA inspection of this facility. The facility is involved in analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. This facility has not been used till now to test products for commercial dispatch into US/EU markets”, said company in a filing on Monday.
At around 12:59 PM, Shilpa Medicare was trading at Rs452.95 apiece down by Rs4.55 or 0.99% on the BSE.
Related Tags
IIFL Customer Care Number
(Gold/NCD/NBFC/Insurance/NPS)
1860-267-3000 / 7039-050-000
IIFL Capital Services Support WhatsApp Number
+91 9892691696
IIFL Capital Services Limited - Stock Broker SEBI Regn. No: INZ000164132, PMS SEBI Regn. No: INP000002213,IA SEBI Regn. No: INA000000623, SEBI RA Regn. No: INH000000248
ARN NO : 47791 (AMFI Registered Mutual Fund Distributor)
This Certificate Demonstrates That IIFL As An Organization Has Defined And Put In Place Best-Practice Information Security Processes.