Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Five Years Later, Legacy Biologics Still Face ‘Next Heparin’ Risks

This article was originally published in The Gold Sheet

Executive Summary

Several factors continue to slow efforts to modernize legacy biologics’ compendial monographs against fake ingredients like the ones someone put in heparin in 2008. Hyaluronate, the ‘poster child’ for monograph modernization; New NDAs for pancreatin create new modernization challenges; Heparin maker vertically integrates to prevent adulteration.

You may also be interested in...



Shortcuts Pursued in Effort to Close Compendial Gaps

Officials with FDA, the U.S. Pharmacopeia and the pharmaceutical industry are looking for a quicker way to remedy a situation underscored by the 2008 heparin crisis: the need to update hundreds, perhaps thousands of the compendial standards that the U.S. Pharmacopeia developed and FDA enforces.

USP Adds Heparin, Glycerin Tests While FDA, Army Labs Try New Test Methods

New tests raise bar against adulterants, counterfeits as USP adds instrumental methods for heparin ID test and drops compromised sheep clotting assay, while revising the glycerin ID test to include a DEG limit and making overtures to FDA's incoming leadership to strengthen their partnership. Meanwhile, FDA's forensic lab gives some insight into its methods for catching drug counterfeiters, the agency's St. Louis lab explains how it found adulterants in ED supplements, and the Army shares its methods for spotting biowarfare pathogens.

Biden Launches Effort To Strengthen US Pharmaceutical Supply Chain

A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.

UsernamePublicRestriction

Register

ID1135947

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