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ORIGINAL PUBLICATION: May 13, 2025

Every manufacturer faces supply chain risks, but pharmaceutical companies have the ability to mitigate some of these challenges by working with an established contract development and manufacturing organization (CDMO).

Building a robust network of raw material suppliers —carefully vetted for quality, technical responsiveness, and reliability—lays the foundation for supply chain resilience. A CDMO strengthens this framework by forging long-term strategic relationships with suppliers. Rather than simply fulfilling orders, these partners collaborate closely, sharing technology such as synthesis routes, impurity profiles, and analytical methods. When supply shortages arise, they can work proactively to develop solutions, whether by identifying alternative sources or leveraging new production capabilities that enhance ingredient purity.

What’s more, a U.S.-based CDMO is well positioned to prioritize a domestic supply chain and ensure reliable access to essential raw materials, specialty chemicals, and solvents. Investing in vertical integration for critical raw materials—such as regulatory starting materials (RSMs) and intermediates—further enhances supply chain security. While certain ingredients require sourcing abroad, partnering with a U.S.-based company that owns its manufacturing assets allows for direct oversight of product quality and supply reliability.

With a manufacturing footprint entirely within North America, domestic supply chain, and deep in-house expertise, Grace’s FCMS can mitigate supply chain problems and potential regulatory issues, while delivering high-quality products at any scale.

Implement Strong Supplier Relationships and Critical Risk Management Strategies

Here are some more ways a CDMO can deliver supply chain resilience and quality assurance in the face of complex and ever-changing global developments:

Maintaining safety stock to ensure sufficient quantities of raw materials to support production continuity and prevent supply disruptions.
Qualifying alternate suppliers as options if a primary provider is unable to meet increased demand.
Communicating frequently and establishing forecasts so that the CDMO and its suppliers are aligned to ensure continuity of supply when a plant is shut down for annual maintenance.
Engaging in formal contracts in particularly critical cases to guarantee regular deliveries at a set price.

Beyond supply stability, working with a U.S.-based CDMO provides distinct advantages:
Working with a manufacturer where FDA requirements are embedded both in the culture and daily operations provides a standard of quality that might not be guaranteed outside the U.S.
Domestic locations make conducting in-person audits more convenient.
The proposed Biosecure Act would ban U.S. companies from working with certain Chinese firms, but the risk extends beyond the organizations on that list. On-shoring helps reduce the risk of pharmaceutical IP theft or replication, including molecules, formulations, technologies, and processes.

Beyond supply stability, working with a U.S.-based CDMO provides distinct advantages:

Working with a manufacturer where FDA requirements are embedded both in the culture and daily operations provides a standard of quality that might not be guaranteed outside the U.S.
Domestic locations make conducting in-person audits more convenient.
The proposed Biosecure Act would ban U.S. companies from working with certain Chinese firms, but the risk extends beyond the organizations on that list. On-shoring helps reduce the risk of pharmaceutical IP theft or replication, including molecules, formulations, technologies, and processes.

Securing the supply chain remains a top priority in the pharmaceutical industry. By partnering with a reputable U.S.-based CDMO, pharmaceutical sponsors can gain the confidence needed to maintain resilient operations and ensure uninterrupted delivery of life-saving medications—regardless of global uncertainties.

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With a manufacturing footprint entirely within North America, domestic supply chain, and deep in-house expertise, Grace’s FCMS can mitigate supply chain problems and potential regulatory issues, while delivering high-quality products at any scale.

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