Last Updated on October 15, 2024 by The Health Master
Maharashtra: Pharma major Sun Pharmaceutical Industries Limited has recently announced that the company has received a communication from the US Food and Drug Administration (USFDA) determining the inspection classification of the Mohali (Punjab) facility as “Official Action Indicated” (OAI).
Official Action Indicated
Official Action Indicated (OAI) means regulatory and administrative actions will be recommended.
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, so the facility is unlikely to have a material negative impact on current business.”
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 in a BSE filing.
The medical dialogue team had earlier reported that the US Food and Drug Administration (USFDA) had concluded an inspection with six observations at Sun Pharma’s Mohali manufacturing facility.
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra.
The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies.
It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), active pharmaceutical ingredients (APIs), and intermediates.
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