The facility received the United States Food and Drug Administration (USFDA) clearance (EIR) for the inspection performed during 26 April 2022 to 29 April 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 (Parent Organization) and its agreed parties, the pharmaceutical company stated.

The drug maker said that 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, it added.

The company further said that 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 is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.

The company's consolidated net profit tumbled 46.5% to Rs 0.85 crore on 10% increase in net sales to Rs 261.16 crore in Q1 FY23 over Q1 FY22.