Drug firm Shilpa Medicare Ltd on Thursday said its analytical services division in Nacharam, Hyderabad, has received US Food and Drug Administration (FDA) clearance for the facility.
The inspection was performed from April 26, 2022, to April 29, 2022, and is the first US FDA inspection of this facility, the company said in an exchange filing on September 22.
The facility is identified as a testing laboratory in numerous Abbreviated New Drug Applications (ANDAs) filed by Shilpa Medicare Ltd and its agreed parties.
The FDA clearance on the facility will enable the company to test and release batches into the 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, it said.
The facility is involved in analytical testing of drug products (release and stability), drug substances, raw materials and packing materials. It is also engaged in analytical method validations, method transfers, and conduct of other miscellaneous analytical studies, it added.
