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API


In 2012, contaminated medications from the New England Compounding Center (NECC) caused a meningitis outbreak, leading to tragedy when 64 patients were killed and 751 injured. Unsurprisingly, the pharmacy compounding industry has been under close scrutiny ever since. The FDA has now become the primary agency for regulating compounding pharmacies such as NECC. Historically, compounding[…]

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API Sourcing Challenges

Pharma and biopharmaceutical supply chains continue to grow more complex & global. The process of sourcing active pharmaceutical ingredients (APIs) and intermediates has also become more challenging. In 2018, ISR Reports looked at how experience and capacity impact small molecule API outsourcing. Among the findings, about 25% of respondents indicated their company lacked the capacity[…]

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