Shilpa Medicare gets USFDA clearance for analytical services division; Stock up ~2%

This is the first USFDA inspection of this facility.

September 23, 2022 11:06 IST | India Infoline News Service
Shilpa Medicare Limited's Analytical Services Division situated at Nacharam, Hyderabad, Telangana has received US FDA clearance (EIR) for the inspection performed during April 26, 2022 to April 29, 2022.

As per the said filing, 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", the company said.

At around 11:05 AM, Shilpa Medicare Ltd is currently trading at Rs392.90 per share up by Rs7.25 or 1.88% from its previous closing of Rs385.65 per share on the BSE.

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