Lupin responds to US FDA’s OAI letter

In the wake of Lupin receiving a letter from the US FDA classifying the inspection conducted at the company’s Mandideep (Unit 1) facility in December 2018 as ‘Official Action Indicated’ (OAI), the pharamaceutical company has released a statement saying that there are no new DMF and ANDA applications pending review or approval from the Mandideep (Unit 1) facility and the company does not believe that this classification will have an impact on disruption of supplies or the existing revenues from operations of this facility.

The US FDA in its letter to Lupin had stated that this facility (OAI) may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed.

Lupin is in the process of sending further updates of its corrective actions to the US FDA and remains hopeful of a positive outcome.

Last year, the inspection at Unit-2, the Cardiovascular "Pril" API facilities had closed with four observations. The inspection at Unit-1, the Cephalosporin facilities closed with 10 observations for the Cephalosporin API facilities and eight observations for the Cephalosporin Solid Oral Dosage Form facility.

The observations were largely procedural in nature with some gaps identified in the aseptic processing areas of the Cephalosporin API block and the company was confident of addressing them satisfactorily.

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