The company will be engaging with the agency and are fully committed in resolving this issue at the earliest. The Company is also committed in maintaining the highest standards of compliances and quality manufacturing across all its facilities.
The Company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility.
Shilpa Medicare currently has three manufacturing facilities approved by USFDA - One formulation facility and two API facilities. None of these facilities except Jadcherla has any outstanding issues with the USFDA at this point of time.
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