• Institute of Good Manufacturing Practices India
  • Global accredited training & certification provider
  • Approved by Quality Council of India (QCI) & Accredited Vocational Institution of Ministry of HRD, Government of India
  • Approved Training Institute of Food Safety and Standards Authority of India (FSSAI)
  • Recognized by Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India
  • An ISO 9001:2015 Certified Organisation registered under The Societies Registration Act,1860 Government of India
  • Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
  • Affiliated with Life Sciences and Food Industry Sector Skills Council (SSC) set up by National Skill Development Corporation (NSDC)
  • Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD & ASSOCHAM Services Excellence Award 2017

Trusted by organizations & training participants in over 30 countries
Training | Certification | Education | Research


USFDA EIR obtained by Lupin for unit 3 of the Pithampur facility

Updated: Dec 18, 2018

An EIR (Establishment Inspection Report) form the U.S regulator has been received for unit 3 facility in Madhya Pradesh of Lupin limited, which is a multinational pharmaceutical company based in Mumbai.

According to the accustomed sources, an inspection was carried out from June 12th till June 16th in the year 2017 for the unit 3 of Pithampur facility. It was stated by Lupin in a BSE filing that this was a preapproval inspection of a product called as Albuterol Sulfate Inhalation. "Receiving the Establishment Inspection Report (EIR) for Unit 3 facility of Pithampur is quite an inspirational development," said Nilesh Gupta, Managing director of Lupin limited. He also added that this is actually a confirmation that the company is devoted to maintaining the elevated standard in compliance and maintaining quality.

An establishment Inspection Report (EIR) is issued by U.S Food and Drug Administration (USFDA) to a facility that comes under the USFDA or during scrutiny by the contracted agency of FDA when it decides that the inspection will be closed. USDFA has given the term Establishment Inspection report (EIR) for the whole account of what has been done by the investigator of FDA in all the time spent in the organization, form the introduction period to the inspectional surveillance delivery.

By chance this happened a week before the completion of the inspection by USFDA at Mandideep location that serves as an organizer to the company’s solid oral dosage form facility and pril API facilities of Cardiovascular and Cephalosporin. The inspection has taken place from 26th of November till 4th December, 2018.

Lupin's stock was trading at 824.15 on BSE which was 1.88 % less from its previous close, despite receiving an EIR from FDA. The company is a manufacturer of dermatological products, metered dose inhalers, dry powder inhalers.