Lupin gets EIR from USFDA for Pithampur facility unit

Image
Press Trust of India New Delhi
Last Updated : Dec 10 2018 | 3:00 PM IST

Drug firm Lupin 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.

Disclaimer: No Business Standard Journalist was involved in creation of this content

*Subscribe to Business Standard digital and get complimentary access to The New York Times

Smart Quarterly

₹900

3 Months

₹300/Month

SAVE 25%

Smart Essential

₹2,700

1 Year

₹225/Month

SAVE 46%
*Complimentary New York Times access for the 2nd year will be given after 12 months

Super Saver

₹3,900

2 Years

₹162/Month

Subscribe

Renews automatically, cancel anytime

Here’s what’s included in our digital subscription plans

Exclusive premium stories online

  • Over 30 premium stories daily, handpicked by our editors

Complimentary Access to The New York Times

  • News, Games, Cooking, Audio, Wirecutter & The Athletic

Business Standard Epaper

  • Digital replica of our daily newspaper — with options to read, save, and share

Curated Newsletters

  • Insights on markets, finance, politics, tech, and more delivered to your inbox

Market Analysis & Investment Insights

  • In-depth market analysis & insights with access to The Smart Investor

Archives

  • Repository of articles and publications dating back to 1997

Ad-free Reading

  • Uninterrupted reading experience with no advertisements

Seamless Access Across All Devices

  • Access Business Standard across devices — mobile, tablet, or PC, via web or app

More From This Section

First Published: Dec 10 2018 | 3:00 PM IST

Next Story