Historical trends have shown that the strategies for supplying APIs are inherently dynamic, influenced by factors such as regulations, costs, logistics, globalization, and geopolitical considerations. Comprehending this dynamism and the trends is essential for effective strategizing and for making proactive business decisions.
The number of API Drug Master File filings and the region of manufacturing have undergone significant changes between 2000 and 2023. This global trend in APIs introduces vulnerabilities and risks, including potential increases in government tariffs, higher costs, supply chain disruptions, challenges in meeting high-quality standards, and issues related to regulatory compliance. Therefore, pharmaceutical manufacturing companies that depend on high-quality API suppliers must maintain a robust business continuity plan that includes alternate high-quality suppliers.
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