Panacea Biotec Pharma Limited (PBPL), a wholly owned subsidiary of Panacea Biotec Limited, has received a communication from the United States Food and Drug Administration (USFDA) for its Baddi facility indicating the inspection classification as Official Action Indicated (OAI).

On June 9, 2022, PCBL received eight observations from the United States Food and Drug Administration for its Baddi facility which are related to improvements in existing procedures and are addressable.

PBPL is working closely with the USFDA to close these observations and the closure of warning letters issued by the USFDA earlier on September 24, 2020.

The company is committed to patient safety & quality and takes quality & compliance matters seriously and stands by its commitment to fully comply with the cGMP quality standards.

PBPL continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility.