Shilpa Medicare Limited's Analytical Services Division situated at Nacharam, Hyderabad, Telangana has received US FDA clearance (EIR) for the inspection performed during 26 Apr 2022 to 29 Apr 2022.
This is the first US FDA inspection of this facility. The facility is identified as testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited (Parent Organization) and its agreed parties. The FDA clearance on the facility will enable the company to test and release batches into US from this facility. This facility, after appropriate submissions, can also be used for testing and releasing batches into Europe and other markets of the world.
The facility is involved in analytical testing of drug products (Release & Stability), drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous analytical studies.