Shilpa Medicare’s Analytical Services division situated at Nacharam, Hyderabad, Telangana has received United States Food and Drug Administration (USFDA) clearance (EIR) for the inspection performed during April 26 2022 to April 29, 2022. This is the first USFDA inspection of this facility. The facility is identified as testing laboratory in numerous ANDAs filed by Shilpa Medicare 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.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.
