The global pharmaceutical supply chain is more fragile than ever. COVID-19, geopolitical tensions, raw material shortages, tarrifs and logistics disruptions have exposed vulnerabilities that can directly impact API availability and costs.
In this blog, we explore how to build a resilient API supply chain—and why proactive planning matters more than ever.
Key Strategies for API Supply Chain Risk Management
- Second-Source Preparation and/or Qualification
- Identify and potentially qualify alternate CMOs/CDMOs or internal manufacturing options.
- Maintain secondary supplier relationships even if unused.
- Raw Material and Critical Intermediate Security
- Dual-source high-risk starting materials and intermediates.
- Audit critical suppliers and establish backup plans.
- Inventory and Safety Stock Management
- Maintain phase-appropriate safety stocks at strategic points in the supply chain.
- Factor in lead time variability for critical materials.
- Business Continuity Planning (BCP)
- Develop site-specific and program-wide BCPs for manufacturing interruptions.
- Include scenarios like natural disasters, political events, and pandemic impacts.
- Regulatory Pre-Planning
- Understand regulatory filing requirements for site additions, process changes, and supplier variations.
Common Pitfalls
- Assuming “it won't happen to us”
- Relying on sole-source suppliers without risk assessments
- Neglecting to identify and/or qualify alternate sites or materials proactively
- Ignoring the regulatory timeline for post-approval changes
Key Takeaway:
In today's environment, API supply chain resilience isn’t optional—it’s a strategic imperative. Building proactive redundancy and contingency plans protects both product availability and business continuity.
Need help strengthening your API supply chain?
DS Inpharmatics offers expert risk assessments, second-source qualification support, and global regulatory strategy to protect your program’s success.
Meranda Parascandola
Meranda Parascandola is a member of the DSInpharmatics team and has written a variety of blog posts which you can read here.
