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


FDA Cracks Down On Unregistered Foreign Pharmaceutical Manufacturers

This article was originally published in The Pink Sheet Daily

Executive Summary

The agency has sent 11 warning letters for failure to register and list as importers of drugs into the U.S. since the beginning of the year.

You may also be interested in...

Generic Drug Facilities Guidance Details Who Self-Identifies, And Who Pays Fees

An FDA draft guidance defines which generic drug manufacturers and other entities must self-report under the new user fee law and which must pay facility fees. It also outlines practical steps companies should take now to meet requirements by deadline.

User Fee Bill Puts Industry, FDA to Work on Supply Chain Risks

The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.

FDA Pinpoints Culprit In Bad Heparin

Over-sulfated chondroitin sulfate named as adverse-events link, but China disagrees.


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