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MARKET INTEL by PharmaCompass
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By PharmaCompass
2019-04-25
Impressions: 113 Article
A month back, PharmaCompass had reported on two of Indian drugmaker Lupin Ltd’s manufacturing sites — one in India (Mandideep, Unit 1) and the other in the US (Somerset, New Jersey) — receiving ‘Official Action Indicated’ (OAI) letters from the US Food and Drug Administration (FDA).
An OAI letter means the facilities are considered to be in an unacceptable state of compliance with regard to current good manufacturing practice (cGMP).
This week, there is news that the company has received a letter from the FDA classifying the inspection conducted at its Pithampur (Indore) Unit-2 facility in January 2019 as Official Action Indicated (OAI), Lupin said in a regulatory filing.
The Form 483 issued to the facility had highlighted concerns over Lupin’s handling of OOS results. This has been a recurring problem at Lupin’s operations over the past few years. The FDA may withhold approval of any pending applications or supplements in which this facility is listed.
However, the company said it does not believe that the classification would have an impact on disruption of supplies or the existing revenues from operations of this facility. The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome, it added.
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