Shilpa Medicare announced that the companys recently started Analytical Services Division situated on first Floor of Unit 7, Nacharam, Hyderabad, Telangana was inspected by US FDA during 26 April 2022 to 29 April 2022.
The inspection was triggered by Shilpas submission of applications for four ANDAs 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.
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.
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