Panacea Biotec Pharma's Baddi plant classified as OAI by USFDA

9 Sep 2022 , 09:18 AM

Panacea Biotech Limited’s material wholly-owned subsidiary Panacea Biotec Pharma Limited (“PBPL”) has now received a communication from the USFDA indicating the inspection classification as “Official Action Indicated” (OAI). 

The OAI classification implies, that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.

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

“The company is committed to patient safety & quality and take these matters seriously and fully stand by its commitment to comply with the cGMP quality standards’, said Panacea Biotech in a regulatory filing.

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 this facility.

The United States Food and Drug Administration (“USFDA”) had inspected Panacea Biotec Pharma Limited’s facility at Baddi, Himachal Pradesh, India from May 30 to June 08, 2022 and issuance of Form-483 by USFDA with eight (8) observations which are related to improvements in existing procedures and are addressable.

At around 9:18 AM, Panacea Biotech was trading at Rs141 per share higher by 1.81% on the BSE.

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