Source: CNBCTV18
Panacea Biotech informed the exchanges that the United States Food & Drug Administration (USFDA) has classified the company’s Baddi facility in Himachal Pradesh as an “Official Action Indicated” (OAI). The facility was issued a form-483 by the drug regulator with nine observations in October, which were related to improvements in existing procedures.
An OAI status means that the regulator expects further corrective actions and may withhold approval of any pending product applications or supplements in which this facility is listed till the observations are resolved.
The company further said that it is working closely with the regulator to resolve these observations and achieve closure of the warning letter that the USFDA issued in September 2020.
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“We are committed to patient safety and quality and take quality & compliance matters seriously,” Panacea Biotech’s statement said. It further said that it is committed to fully comply with the cGMP quality standards, consistent with the USFDA regulations.
The company said that it will continue to manufacture and distribute existing products for the US market, and therefore this classification will not have any material adverse impact on current business.
Shares of Panacea Biotech have risen 31% over the last 12 months. If we take returns over a five-year period, that gains drop to just 16%.
