tag:blogger.com,1999:blog-8964719845369935777.post8479363394371235319..comments2024-03-29T09:05:29.819-04:00Comments on Chemjobber: Zantac recalled because of NDMA contaminationChemjobberhttp://www.blogger.com/profile/15932113680515602275noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-8964719845369935777.post-51276193647645709542019-09-24T13:55:59.439-04:002019-09-24T13:55:59.439-04:00If you read the PharmTech piece there does not app...If you read the PharmTech piece there does not appear to be instance with nefarious intentions by the suppliers (unlike cases of melamine additions) but more inadequate focus by both API manufacturers and Regulators in recognizing the probable risks plus use of detection methods specifically looking for the contamination. Although implication is that was an obvious finding I suggest that is oversimplification because performing process risks rely on ranking potential hazardous where combinations of chemistry and conditions leading to a bad by-product from a solvent decomp/impurity can be overlooked/scored low in the overall complexity with greater concerns being examined. Definitely unfortunate and a undesired learning in difficulties inherent in API manufacturing but to jump to shady operators seeking profits seems unreasonable from what I have read.Anonymoushttps://www.blogger.com/profile/13200240559284166060noreply@blogger.comtag:blogger.com,1999:blog-8964719845369935777.post-67418318340172761502019-09-23T20:06:40.098-04:002019-09-23T20:06:40.098-04:00Is this because profit margins on generics are so ...Is this because profit margins on generics are so small that only the shadiest operators will compete in the market?Anonymousnoreply@blogger.com