Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Warns Lupin Again About Poor Batch Failure Investigations

Executive Summary

Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.

You may also be interested in...



The Quality Lowdown: Alvotech, Lupin, Cipla, Lilly, Rentschler Inspection Findings And Akorn Recall

US FDA finds flawed data integrity, investigations, aseptic practices and more at range of foreign and domestic drug product manufacturing facilities, while a bankruptcy leads to a massive drug recall.

The Quality Lowdown: Key Inspection Findings At Glenmark, Centrient, Lupin, Aurobindo, Mac-Chem

US and EU drug GMP inspections at API and drug product manufacturing sites in India found fault with investigations, process validation, data integrity and contamination prevention.

Lupin Appoints New Compliance Manager As More Deficiencies Found

Lupin has named a new head of compliance, emphasizing the importance of achieving the highest quality standards just weeks after the FDA notified the firm of observations following an inspection at its Indian facility in Tarapur.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140950

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel