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


The Quality Lowdown: More Concerns Raised About API Plants, Data Integrity And Sterility Assurance

Executive Summary

Recent enforcement activities shed light on compliance challenges at ALI, UCB, Novo, Samsung, Nectar, Panacea and Beximco.

You may also be interested in...

US FDA’s OPQ Reshapes For More Nimble Approach To Drug Quality Reviews

Reorganization in January expected to leave CDER’s nine-year-old pharmaceutical quality assessment organization more adaptable to public health emergencies, new pharmaceutical technologies and market dynamics, while further blending approaches to new and generic drug reviews.

How Industry Would Reduce The Regulatory Burden For Fleets Of Mobile Manufacturing Units

Stakeholders propose centralized oversight approaches for managing quality of “like-for-like” fleets of self-contained manufacturing units that could roam the US – or the world. The US FDA shares the industry’s thinking on how best to adapt the site-focused regulatory scheme it enforces to the emerging variety of distributed manufacturing systems.

Supply Chain Confidentiality Doesn’t Stand 'Sunshine Test', Califf Says

US FDA commissioner takes aim at supplier confidentiality in remarks at ISPE annual meeting. But while greater transparency would help avert individual shortages, better economics for generic drugs are needed to solve the problem, he said.


Related Companies

Latest Headlines
See All



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