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How the Valsartan Contamination Happened: Its Context & Implications

Last year’s valsartan contamination and recall brought some surprising chemical synthesis issues to light in the pharma industry. While the reactions used in generic valsartan production are known to be…

Posted in FDA, generic, method development, process chemistry, QA/QC, Quality, synthesis | Tagged , , , , , | Comments Off on How the Valsartan Contamination Happened: Its Context & Implications

Pharma API Supply Chains: Mitigating Risk

The risks to pharmaceutical supply chains grow in parallel with the industry itself. As drug markets have become increasingly complex and global in nature, so – too – have drug…

Posted in APIs, Contract Manufacturing, generic, outsourcing, Quality, supply chain | Tagged , , | Comments Off on Pharma API Supply Chains: Mitigating Risk