API manufacturing secondary supply is not optional – it’s essential
A robust active pharmaceutical ingredient (API) manufacturing and supply chain strategy demands geographic and supplier diversity to reduce risk, increase resilience, and maintain continuity of care. When selecting a contract development and manufacturing organization (CDMO) for secondary supply, sponsors should prioritize:
Technical depth and scalable capacity
- Supply chain agility
- Cultural and operational alignment
At Sterling, we have extensive experience serving as a secondary API manufacturing supplier from our integrated network of sites across the US, UK, and EU. We collaborate seamlessly with internal manufacturing or external partners, flexibly integrating at any point in the supply chain, including upstream with key and regulatory starting materials (KSM and RSM).
With dual-site supply capabilities across distinct western geographies, combined with the convenience of a single central partner, we support our customers’ projects with seamless continuity, regulatory compliance, and agile delivery across global markets.
Approaches to API manufacturing and supply
Sterling tailors every secondary supply model to fit a sponsor’s operational structure, regulatory obligations, and risk appetite. Common scenarios include:
Sponsors with in-house API manufacturing often partner with Sterling to establish an offshore secondary site. This geographic diversity enhances business continuity and strengthens supply assurance.
Mid-sized and large pharma companies frequently work with two independent CDMOs to establish a dual-source strategy. This approach also increases redundancy and mitigates location-specific disruptions.
A preferred model for sponsors seeking efficiency without compromising resilience. Sterling offers multi-region API manufacturing under a unified quality system, making tech transfer, regulatory compliance, and logistics easier. This delivers redundancy within a single partner relationship, streamlining operations while diversifying risk.
Why one global partner simplifies API manufacturing
Coordinating multiple suppliers introduces complexity, cost, and potential gaps in quality. Sterling’s integrated global network provides:
- Multi-region manufacturing with centralized program management
Explore our API manufacturing capabilities and facilities
- Consistent quality systems across all sites
View our quality and regulatory credentials
- Faster tech transfer and regulatory alignment
Read more on tech transfer between our sites
- Supply assurance through site-to-site flexibility
Our US, UK, and EU presence enables us to perform seamless site transfer, dual concurrent validation approaches, and proactive mitigation of regional disruptions. Our global procurement model ensures uninterrupted access to raw materials and adaptive supply planning across your API’s lifecycle. Click to read more from Sterling’s Vice President of Global Procurement on supply chain.
Whether navigating launch, scale-up, or lifecycle management, Sterling brings the agility of a global network with the focus of a dedicated partner.
Ready to strengthen your API supply strategy with Sterling?
