Drug firm Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for a unit of its Pithampur facility in Madhya Pradesh.
The company received the EIR for unit 3 of the facility. The site was inspected from June 12-16, 2017, Lupin said.
“This was a pre-approval inspection for Albuterol Sulfate inhalation product,” it said in a BSE filing.
Lupin’s Pithampur facility manufactures dermatological products, dry product inhalers, and metered dose inhalers, the company said.
“The receipt of the EIR for our Pithampur unit 3 is an encouraging development. This is a validation of our commitment to maintain the highest standards in quality and compliance across our facilities,” Lupin MD Nilesh Gupta said.
The US Food and Drug Administration (USFDA) issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.
Stock of Lupin was trading at Rs 824.15 on BSE, down 1.88 per cent from its previous close.