Lupin said it does not believe that the observations will have an impact on disruption of supplies or the existing revenues from operations of this facility
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, it added. Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control
AuroLife Pharma, a wholly-owned step-down subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (USFDA) for its oral solid manufacturing facility situated at Dayton
The company has received final approval from the US Food and Drug Administration (USFDA) for the medication in 300 mg strength, Zydus Cadila said in a statement