Contract Pharma published an article back in May discussing the issue of Nitrosamines uninvitedly found in drug products. The article’s author, Aloka Srinivasan, VP of Lachman Consultants, helps us better understand the presence of Nitrosamines and how to address them. Nitrosamines has recently re-surfaced in the pharmaceutical world due to FDA and other international agencies finding traces of these compounds in the angiotensin II receptor blockers (ARBs), commonly known as the “sartans.”
All pharmaceutical companies which have FDA approved “sartans” have been sent requests to evaluate the presence of nitrosamines in their products and communicate their findings to FDA.
For more information, read the full article here.