Panacea Biotech's US Facility Receives 'Official Action Indicated' Status from USFDA

2 Feb 2024 , 12:40 PM

Panacea Biotech disclosed to the exchanges that the United States Food & Drug Administration (USFDA) has labeled its Baddi facility in Himachal Pradesh as ‘Official Action Indicated’ (OAI).

In October, the drug regulator issued a form-483 to the facility, highlighting nine observations regarding necessary improvements in current procedures.

An OAI designation implies that the regulator anticipates further corrective measures and may withhold approval for pending product applications or supplements linked to this facility until the cited issues are resolved.

The company assured it is actively collaborating with the regulator to address these observations and resolve the warning letter issued by the USFDA in September 2020.

Emphasizing its commitment to patient safety and quality, Panacea Biotech underscored its dedication to complying fully with cGMP quality standards, aligning with USFDA regulations.

Despite the classification, the company affirmed its ongoing manufacturing and distribution of existing products for the US market, asserting that the status would not significantly impact current business operations.

Panacea Biotech’s shares have surged by 31% over the past 12 months; however, over a five-year period, returns have decreased to 16%.

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