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The unsuccessful U.S. Food and Drug Administration compliance leading to official action indication, warning letter had adversely impacted the prospective business for Indian pharma companies focussing on the U.S. generics.
Recent instances of Import alert have intensified the regulatory risk significantly on the ongoing base business in the U.S. market.
Interestingly, the timeline for the escalated action by the U.S. FDA has shortened considerably adding further risk to the U.S. generics business.
Halol is the second instance, wherein, the official action indication classification has been escalated to import alert over past six months by the U.S. FDA. The import alert implies that a company would not be able to supply products from this site to the U.S. market, until the facility becomes compliant.
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