In response to the growing regulation of potential carcinogens in pharmaceutical ingredients and excipients, JMC has issued an announcement confirming the safety of our saccharin products.
Regulators such as the US FDA have recently begun regulating nitrosamines and nitrites in pharmaceuticals. In response, customers have been asking JMC to confirm the safety of our products and processes. In particular, customers have been asking whether JMC uses the Maumee process to produce Saccharin. Such questions are raised because there are concerns among customers who are aware that nitrites are used in the Maumee process. We hereby confirm to you that JMC’s Saccharin is manufactured by the Remsen & Fahlberg process, not the Maumee process. Therefore, we can also confirm that there are no concerns about nitrosamines or nitrites with JMC’s Saccharin products.
Please find below a document that details why JMC products are totally free from nitrites. We encourage you to share this with your quality team.
Please do not hesitate to contact us if you have any questions about this announcement.
