Sun Pharma Halol facility gets OAI from USFDA
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New Delhi: Sun Pharmaceutical Industries Limited has announced that the Company has received a communication from the USFDA indicating the inspection classification of Halol at Gujarat facility as "Official Action Indicated" (OAI).
The OAI classification implies inter-alia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.
"The Company 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 Halol facility. Sun Pharma continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the Company's remedial action," the company stated.
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