Lupin gets EIR from USFDA for Nagpur facility

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Pharma major Lupin has announced the receipt of the Establishment Inspection report (EIR) post the completion of a Pre-Approval Inspection (PAI) for its Phenytoin Sodium Extended Release 100 mg capsules, carried out by the US FDA at its Nagpur facility in Maharashtra. The inspection conducted in September 2018 concluded without any observations.

Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage products. The site also houses Lupin’s state of the art injectable manufacturing facility.

Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “The receipt of the EIR for our Nagpur facility is a positive development as we continue our journey on meeting and exceeding global quality standards at all of our facilities.”