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

FDA Sends Warning Letters To Two Chinese Producers Of Adulterated Heparin

This article was originally published in The Pink Sheet Daily

Executive Summary

Could prosecution be the next step? .

You may also be interested in...



Amphastar Lawsuit Over Heparin Shipments Suggests Lovenox ANDA Approval May Be Far Off

Allegations in Amphastar Pharmaceuticals’ lawsuit over FDA detention of heparin raw ingredient shipments suggest approval of its enoxaparin ANDA, the generic of Sanofi-Aventis’ low-molecular weight heparin Lovenox, is far from imminent.

Amphastar Lawsuit Over Heparin Shipments Suggests Lovenox ANDA Approval May Be Far Off

Allegations in Amphastar Pharmaceuticals’ lawsuit over FDA detention of heparin raw ingredient shipments suggest approval of its enoxaparin ANDA, the generic of Sanofi-Aventis’ low-molecular weight heparin Lovenox, is far from imminent.

USP Revised Heparin Testing Standards Take Effect Oct. 1

USP also establishes collaborative relationships with Chinese organizations following the adverse events from Chinese-sourced contaminated heparin.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS069327

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