Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and ...
Protheragen, an ISO9001 certified supplier of pharmaceutical ingredients and specialty chemicals, announces its expanded suite of end-to-end impurity solutions covering impurity synthesis & isolation, ...
The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, < ...
The FDA requires drug manufacturers to comply with the standards for elemental impurities. These impurities cover those that are added to the product during the process of manufacturing or those that ...
Smokers looking for Pfizer's cessation med Chantix may have a tough time finding the drug as the pharma giant has halted global distribution on impurity concerns. After finding unacceptable levels of ...
The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...
Two years after an independent laboratory began pushing the Food and Drug Administration to analyze various medicines for traces of carcinogens, the agency sent inspectors to the company and cited it ...
The list of potentially hazardous structural fragments was compiled from various literature sources and refined by analyzing their performance on data from different assays detecting point mutational ...
FILE PHOTO: A drone view shows the Eli Lilly logo on one of the company’s offices in San Diego, California, U.S., November 21, 2025. REUTERS/Mike Blake/File Photo WASHINGTON, March 12 (Reuters) - ...
Biologics Safety Testing Market · GlobeNewswire Inc. Dublin, April 22, 2026 (GLOBE NEWSWIRE) -- The "Biologics Safety Testing ...
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