USFDA conducts inspection at Shilpa Medicare's analytical services division in Hyderabad; Stock down 1%

2 May 2022 , 12:56 PM

Shilpa Medicare Ltd has informed that the Company’s recently started Analytical Services Division situated on first Floor of Unit 7, Nacharam, Hyderabad, Telangana was inspected by USFDA during April 26-29, 2022.

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.