The pharmaceutical supply chain, which moves drugs from raw materials to patients, begins with Active Pharmaceutical Ingredients (APIs). With the majority of APIs manufactured primarily in China and India, domestic drug supplies remain vulnerable to single points of failure. Risks associated with sourcing APIs include geographic concentration and lack of transparency in upstream supply chains. Consequently, manufacturers are shifting from single-source models to localized or dual-sourcing models to mitigate supply chain risks and geopolitical disruptions.
This article explores the vulnerabilities associated with sourcing APIs and the strategies CDMOs leverage to address these challenges. Supply chain vulnerabilities range from geographic concentration to quality issues and regulatory challenges. According to industry experts, understanding the entire supply network and establishing risk mitigation strategies are essential for ensuring material availability without unnecessarily increasing working capital.
Strengthening visibility into a product’s network is key when exploring secondary suppliers. Companies can qualify and onboard secondary sources while evaluating disruption scenarios. A structured supply-chain risk assessment should identify critical APIs and starting materials, helping to build proportionate mitigation strategies. Ultimately, integrating supply resilience into development and manufacturing strategies early can help identify alternatives before products reach commercial scale.
Source: contractpharma.com · Image: High-Tech Devices Help Ensure Product Safety by The U.S. Food and Drug Administration, Public domain, via Wikimedia Commons
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