US FDA Advises Manufacturers To Test For Nitrosamines In All APIs, Drug Products
Guidance is FDA's latest action in response to findings that over time in storage, especially at higher temperatures, levels of the probable carcinogen NDMAincreases in some ingredients, including ranitidine available in OTC heartburn remedies.
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Perrigo Among Firms Requesting Delay In Conducting US Nitrosamine Risk Assessments
Perrigo, Pfizer want FDA to postpone its March deadline for conducting nitrosamine risk assessments. Generics executive cites “serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
FDA Warning Letter Blasts Mylan’s Continued Lax Impurity Controls for APIs
Concerned about another possible nitrosamine scare, US FDA warning letter to Mylan focuses on firm’s failure to control contamination risks of its APIs and its inadequate testing of reused solvents.
The EU's Top Valsartan Lesson: Closely Examine Active Substance Manufacturing Processes
EU report on “lessons learnt” from the valsartan crisis calls for tighter GMP controls on API suppliers.