US FDA issues warning letter to Shilpa Medicare for Jadcherla facility, Telangana
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 has received a warning letter through email from the USFDA for its Jadcherla facility, Telangana.
The company has informed that it will be engaging with the agency and is fully committed in resolving this issue at the earliest.
“The Company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from operations of this facility”, informed Shilpa Medicare through a statement.
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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