Scrip 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

Heparin Scare Drives Call For API Sources On Drug Labels

This article was originally published in PharmAsia News

Executive Summary

Some physicians and consumers in the United States are urging the FDA to require drug labeling that discloses the origins of the product. The reaction is in response to announcements of deaths that may be connected with heparin blood-thinner made from imported ingredients from China. The pro-labeling groups note that fruits and other commodities are labeled by source, while even a look on drug Web sites usually does not identify the source of drug ingredients, either active or inactive. The FDA requires the name and address only of the manufacturer, packer or distributor, but not the API source, which is treated as confidential. Drug makers say good manufacturing practice requirements, if followed, handle those concerns. (Click here for more - a subscription may be required

Latest Headlines
See All
UsernamePublicRestriction

Register

SC068148

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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