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 Pressing Repackers To Disclose API Suppliers In Case Quality Issues Arise

Executive Summary

The FDA's Francis Godwin tells Pink Sheet of progress battling supply chain obfuscation, which could allow marketing of adulterated drugs; Yino warning letter is latest salvo.

You may also be interested in...



Data Integrity Remains Challenging For API Manufacturers

Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.

US FDA Says Data Integrity Remains Challenging For API Manufacturers

Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.

FDA Warning Letters Hit Three Repackers For Failing To Identify Original API Makers

The US FDA’s concerns about the transparency of the pharmaceutical supply chain surfaced in three recent drug GMP warning letters to drug repackers of active pharmaceutical ingredients who failed to disclose the names of the API manufacturers to their customers. Janet Woodcock, director of the agency's drug center, called such lack of transparency a "real threat" to public health that must be addressed quickly.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS140897

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