Shares of Wanbury Ltd surged 5% on 23 August after the company announced receiving an Establishment Inspection Report (EIR) with zero form 483 observations from the United States Food and Drug Administration (USFDA) for its manufacturing facility located at MIDC Industrial Area in Patalganga, Maharashtra.
In an exchange filing on Friday morning, the company announced that the US Federal Drug Administration agency’s inspection had been successfully concluded.
In a recent exchange filing, the company reported that the USFDA had classified the inspection of one of its facilities as ‘No Action Indicated’ (NAI). This means that the inspection concluded with no observations, as evidenced by the absence of any Form 483.
The corporation also stated that the facility is deemed to be in an acceptable state of conformity with current good manufacturing practice (CGMP) in light of this inspection.
The company, in an exchange filing, said, “The USFDA has issued an Establishment Inspection Report for the Company’s manufacturing facility located at MIDC Industrial Area, Patalganga, Maharashtra, India and the inspection has now been successfully closed by the USFDA.”
The company added, “USFDA has determined that the inspection classification of this facility is ‘No Action Indicated’ with zero 483 observations.”
In addition, the company’s manufacturing facility in Patalganga, Maharashtra, has won two awards. The first was for the greatest period of time without an accident, and the second was for the least amount of accidents on average.
At 11:36 am, the shares of Wanbury were trading 3:63% higher at Rs 216.78 on NSE.
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