Every year roughly ten million Americans receive the blood-thinning drug heparin, however in 2008 contaminated heparin resulted in about 350 adverse events and 150 deaths in the United States alone. Since then, heparin has attracted increasingly stringent attention from the FDA. In 2009 the U.S. Food and Drug Administration (FDA) alerted healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin. The increased scrutiny of heparin coming into the United States has created a market where only suppliers who can reliably source high quality heparin while tracing its origin will be able to successfully and safely supply the U.S. market.
ChemWerth is leveraging its 34 years of strong compliance standards to bring the industry a heparin source that is high quality, reliable and traceable. Every step of the heparin process throughout the supply chain is now required to be documented. The tracking and traceability measures put forth by the FDA and other regulatory bodies around the world fall right into ChemWerth’s business model “one world, one quality.”
Through extensive compliance expertise, ChemWerth has once again pioneered a reliable supply chain to which the final product can confidently be tracked to the initial source while having full control and overseeing the process along the way.
About ChemWerth, Inc.
ChemWerth is a world leader in developing and supplying specialty Generic Active Pharmaceutical Ingredients for the human and animal health markets. The company continues to rank #1 in DMFs Available for Reference among all other peer active pharmaceutical ingredient companies. ChemWerth is the regulatory agent for numerous FDA approved facilities in China, the United States, Europe and India. The company sells to the top generic pharmaceutical companies in the industry and sells products in 38 countries around the globe. For more information about the company please visit chemwerth.com.
