Lupin announced the completion of United States Food and Drug Administration (US FDA) inspections carried out at its Mandideep location. Lupin's Mandideep location houses the company's cardiovascular "Pril" API facilities, Cephalosporin API facilities and Cephalosporin Solid Oral Dosage Form facility.
These inspections were carried out between 26 November and 04 December 2018.
The inspection at Unit-2, the Cardiovascular "Pril" API facilities closed with 4 observations.
The inspection at Unit-I, the Cephalosporin facilities closed with 10 observations for the Cephalosporin API facilities and 8 observations for the Cephalosporin Solid Oral Dosage Form facility.
The observations are largely procedural in nature with some gaps identified in the aseptic processing areas of the Cepha losporin API block and the company is confident of addressing them satisfactorily.
As a company, Lupin has committed to an enhanced Quality Management System and Compliance Sustainability Plan. The Lupin Mandideep site is already executing the plan, which also serves to address some of the concerns raised during this inspection.
There are no new DMF and ANDA applications pending for review or approval from Lupin's Mandideep facilities.
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