Lupin gets Establishment Inspection Report from USFDA for Pithampur facility unit; stock falls 1.88%
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.
New Delhi: 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 12-16 June, 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 percent from its previous close.
Shares of Sun Pharmaceutical Industries on Wednesday gained nearly 4 percent after the company received establishment inspection report (EIR) from the US health regulator for its Halol facility in Gujarat
The EIR report is given to an establishment after the completion of an inspection by the USFDA
Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., said on Thursday it has received the Establishment Inspection Report (EIR) from the USFDA (the United States Food and Drug Administration) for the pre-approval inspection at two of its biologics manufacturing facilities in Bengaluru