Sun Pharmaceutical gets "Official Action Indicated" from USFDA for Mohali facility
India Infoline News Service |
09 Nov, 2022 |
Sun Pharmaceutical Industries Limited had earlier announced regarding the USFDA inspection at the Company's Mohali (Punjab) facility from August 03 to August 12, 2022 and issuance of Form-483 by USFDA with 6 observations.
In addition to this, the Company has received a communication from the USFDA determining the inspection classification as "Official Action Indicated" (OAI).
Further, the communication states that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved and may initiate additional actions, if any, under the current Consent Decree.
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 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.
Sun Pharma remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.
At around 9:18 AM, Sun Pharmaceuticals Industries Ltd is currently trading at Rs1,034.55 per share up by Rs6.75 or 0.66% from its previous closing of Rs1,027.80 per share on the BSE.
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