A private-label GMP line for Europe
A global, Japan-headquartered company wanted to launch a private-label product line for European customers - without building a plant. PAN-Celltech provided a tailored CMO/CDMO model: GMP (EU Annex 1) process development, customised single-use packaging and full QC/QA.
This story is published with the customer anonymised. It describes a real PAN-Celltech CMO/CDMO engagement; the customer's name is withheld.
A global brand entering Europe
A global, Japan-headquartered company set out to launch a private-label product line for European customers. Building a European facility, learning a new regulatory system and running production in-house would have turned a market-entry decision into a multi-year capital project.
Custom GMP products, fully compliant, fully integrated
They needed a European CMO/CDMO that could produce custom-formulated products under GMP (EU Annex 1), guarantee full regulatory compliance, and integrate seamlessly into their existing GMP production environments - so the private-label line could reach European customers without the build.
A tailored CMO/CDMO model
PAN-Celltech built a service model on flexibility, compliance and trust:
- GMP-compliant production-process development, for both new and existing products.
- Customised packaging formats in single-use bags or bottles, designed to fit the partner's GMP workflows.
- Full QC testing and QA documentation to meet European pharmaceutical standards.
- Delivery to the partner's designated EU production site.
Market access without building a plant
A flexible, compliant, trusted model let a global manufacturer put its own label on GMP products made in the EU - market access without building a plant. The engagement is an ongoing CMO/CDMO supply.
Frequently asked questions
How can a non-EU manufacturer produce a private-label GMP line in Europe without building a facility?
By partnering with a European CMO/CDMO that develops the GMP production process, manufactures to GMP in an EU Annex 1 facility, provides custom packaging and full QC/QA documentation, and delivers into the partner's EU site.
Can PAN-Celltech develop the GMP production process for both new and existing products?
Yes. The model includes GMP-compliant production-process development for new and existing products, plus customised single-use bag or bottle packaging designed to fit the partner's GMP workflows.
What quality documentation is provided?
Full QC testing and QA documentation to European pharmaceutical standards, with delivery to the partner's designated EU production site.
Keep reading
- Whitepaper: From Bench to GMP
- Whitepaper: Beyond Compendial - buffers & reagents
- Overview: The Open Downstream
- Service: Customized Solutions - CMO / CDMO
- ← All case studies