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OUTSOURCING SUPPLY OPERATIONS


The lack of API manufacturing presence in the US is largely due to “the race to the bottom on pricing against global players, lower input costs, and lesser regulatory burdens” in overseas facilities, the report found. Anthony Sardella, a senior research advisor at CABI, previously told Pharmaceutical Technology that the US must build a diverse supply chain to secure its access to APIs. “It’s not all about moving everything to the US with new technology, but also diversifying and partnering with other countries that could be producers,” he said. “Having a more balanced, resilient,


 aspect for building resilience for the US supply chain and decreasing our vulnerabilities.” According to an analysis of the US Food and Drug Administration data last year, manufacturing delays accounted for 11% of all drug shortages in the US. Ingredient shortages were behind around 5% of the drugs reported to be in short supply. The Medicine Supply Vulnerability Insights


Series will examine the global distribution  drug classes to identify potential supply chain vulnerabilities that could impact the availability of critical medicines, the USP said in a statement. The organisation’s Medicine Supply Map will also be discussed in upcoming USP Convention  solutions for improving supply chain resilience, develop recommendations to ensure facilities are prepared to meet demand, and build on collaboration between supply chain partners such as governments and manufacturers. USP CEO Ronald Piervincenzi, PhD, said:


“USP’s Medicine Supply Map is an innovative early warning system to help identify ingredient  providers, manufacturers and governments can take actions to help prevent the shortage from occurring. “Without visibility into the medicine supply chain, preparing for the next crisis is not possible,” he added.


Clinical Trial Supply Handbook | 15


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