Shilpa Medicare Ltd gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

Shilpa Medicare Limited's Analytical Services Division situated at Unit 7, Nacharam, Hyderabad, Telangana has been inspected by US FDA during 08 Mar 2023 to 10 Mar 2023. This is a full GMP inspection.

The inspection is closed with 2 minor 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 will work towards implementing the corrective actions to address the observations.

This is the second US FDA inspection on the site. The initial inspection was done during Apr 2022, for which the GMP clearance (EIR) was issued in July 2022.

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 is involved in the testing of US/EU & other markets commercial batches.

Shares of Shilpa Medicare Limited was last trading in BSE at Rs. 268.85 as compared to the previous close of Rs. 281.05. The total number of shares traded during the day was 101669 in over 2726 trades.

The stock hit an intraday high of Rs. 274.00 and intraday low of 263.25. The net turnover during the day was Rs. 27204364.00.

Source : Equity Bulls

Keywords

ShilpaMedicare INE790G01031 Pharmaceuticals AnalyticalServicesDivision USFDA Inspection 2Observations