Lupin obtains USFDA EIR for unit 3 of the Pithampur facility

Lupin Limited, a transnational pharmaceutical company based in Mumbai, has reportedly received an Establishment Inspection Report (EIR) from the U.S. regulator for the unit 3 of the facility in Madhya Pradesh.

As per sources familiar with the knowledge of the matter, the unit 3 of Pithampur facility was inspected from June 12 till June 16, in the year 2017. Lupin also mentioned in a BSE filing that this was a pre-approval inspection of a product known as Albuterol Sulfate Inhalation.

Nilesh Gupta, Managing Director, Lupin Limited, said that receiving the Establishment Inspection Report (EIR) for the Pithampur unit 3 facility is a rather motivating development. He also added that this is indeed a proof of their commitment to maintain the highest standards in compliance and quality across their facilities.

For the record, the U.S. Food and Drug Administration (USFDA) issues an Establishment Inspection Report (EIR) to the facility that is the subject of a USFDA or inspection by an FDA-contracted agency when they decide to close the inspection. Establishment Inspection Report (EIR) is the term given by the U.S. Food and Drug Administration (USFDA) for the whole narration of what the FDA investigator or inspector did throughout the time spent in the establishment (i.e. a facility), from the period of introduction till the delivery of the inspectional observations.

Incidentally, the week before Lupin announced the completion of USFDA inspections at its Mandideep location that plays host to the company's Cephalosporin Solid Oral Dosage Form facility, and Cephalosporin and Cardiovascular Pril API facilities. The inspections took place from November 26 till December 4, 2018.

Ironically, despite receiving the EIR from the FDA, Lupin’s stock was trading at Rs 824.15 on BSE, down 1.88 percent from its previous close.

For the record, the company manufactures dry powder inhalers, dermatological products, and metered dose inhalers.