Lupin has received 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.