Dr Reddy’s Vizag plant gets USFDA nod

24 Nov 2009 Evaluate

The US drugs regulator, which recently inspected two manufacturing plants of Dr Reddy’s Laboratories Ltd (DRL) has cleared one plant and given a minor observation at the other. The team of inspectors from the US Food and Drug Administration (FDA) is also expected to inspect Lupin’s Mandideep facility in Madhya Pradesh and Ranbaxy’s Tonsa plant in Punjab by the end of this year.

 

DRL had eight ANDAs (abbreviated new drug applications—an application to market a generic drug only in the US) filed from this plant and FDA wanted to conduct a for-cause audit as DRL had recalled products from the US market. Following this visit, FDA has recommended for approval all eight ANDAs.

 

FDA has gradually become very stringent on GMPs and is routinely cracking down on companies and plants that are not up to its standards.

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