Lupin Completes FDA Inspections

Lupin, a Mumbai, India-headquartered pharmaceutical company, has successfully completed good manufacturing practice (GMP) and prior approval inspections (PAI) carried out by the US Food and Drug Administration at two of the company’s facilities. 

The company completed the first inspection (a GMP inspection and PAI) was completed on July 28, 2017 at its manufacturing facility in Pithampur, India and was made without any observations. The other inspection (PAI) was completed on July 31, 2017 at its manufacturing facility in Aurangabad, India with one 483 observation. The observation was procedural in nature and corrected during the inspection itself, according to the company. 

Source: Lupin (Pithampur) and Lupin (Aurangabad)

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