Pharma companies will lose sleep over the IRA “The Inflation Reduction Act will keep pharmaceutical company leaders up at night in 2024. Medicare drug price negotiation will impact more than just the 10 drugs on the current negotiation list by creating competition in those therapeutic categories and could force price adjustments, including higher commercial drug […]
WHO issues guidance on nitrosamine controls in drug manufacturing World Health Organization logo (Source: iStock) The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing practices (GMP) for the prevention and control of contamination of nitrosamines, which are a probable human carcinogen. The new GMP guideline applies to all manufacturers of excipients, […]
The emergence of nitrosamine impurities In June 2018, regulatory authorities worldwide became aware of the presence of the nitrosamine N-nitrosodimethylamine (NDMA) in valsartan, an active pharmaceutical ingredient (API) manufactured by a specific producer. Subsequently, another nitrosamine, N-nitrosodiethylamine (NDEA), was also detected in valsartan and other sartan-containing APIs from additional manufacturers. NDMA and NDEA are classified as probable human carcinogens, and their unexpected […]
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