US FDA Inspection of Shilpa Medicare Limited, Unit VII, Analytical Services Division

Shilpa Medicare Limited's recently started Analytical Services Division situated on first Floor of Unit 7, Nacharam, Hyderabad, Telangana was inspected by US FDA during 26 Apr 2022 to 29 Apr 2022.

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 US FDA 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.

Shares of Shilpa Medicare Limited was last trading in BSE at Rs. 457.50 as compared to the previous close of Rs. 457.20. The total number of shares traded during the day was 20895 in over 960 trades.

The stock hit an intraday high of Rs. 472.70 and intraday low of 453.00. The net turnover during the day was Rs. 9650020.00.

Source : Equity Bulls

Keywords

ShilpaMedicare INE790G01031 AnalyticalServicesDivision USFDA Inspection