US FDA EIR to Lupin for Nagpur facility

 

Lupin Limited received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Nagpur facility. Inspection of the facility was done by the US FDA between August 5, 2019 and August 8, 2019.

The oral solid facility at Nagpur was inspected and was closed without any Form 483 observation. Lupin’s largest facility is Nagpur facility which has the most advanced oral solid dosage facility and has developed a solid track record of compliance through years.

As stated by the, managing director, Nilesh Gupta that an Excelling at Quality and Compliance is one of their top priorities and they remain faithful to meeting and exceeding standards set by regulatory agencies globally.