top of page

FAQs

You will find the answers to the more common questions here. Feel free to reach out via our contact form for any other questions.

What is the EUMA cooperative and why is membership so limited?

EUMA is a private manufacturing cooperative created for a small group of qualified pharmaceutical companies that require direct EU market access. Each member receives dedicated capacity inside an EU-licensed facility and exclusive rights to manufacture up to ten EU drug-shortage molecules. Membership is strictly capped to protect capacity, quality, and commercial value. Once the cohort is full, no further companies are admitted until a future expansion phase.

Why does EUMA require members to be pre-qualified before joining?

Only companies with an existing cGMP licence from WHO, PIC/S, or their local health authority and a clean compliance record are allowed to join. No major non-compliances or critical observations are permitted. This safeguards the facility, protects EUMA’s regulatory reputation, and ensures patient safety. The cooperative is restricted to companies that can operate responsibly inside a shared EU environment.

Why is this faster than building my own EU site or using a CMO?

Members avoid the multi-year timeline and regulatory burden of constructing a European facility and bypass the capacity constraints faced at established CMOs. EUMA initiates construction only when the membership is fully subscribed, which locks the schedule and accelerates EU entry. Members gain rapid access to a licensed base of operation without taking on the build, licence, or inspection risk themselves.

What commercial return should I expect from joining?

Each member converts a fixed contribution into priority access to EU-demanded generic molecules and early product sales. With exclusive rights to ten shortage molecules, members enter the market with immediate demand and minimal competitive pressure. The cooperative model removes years of sunk cost and turns EU market access into a fast, predictable revenue opportunity.

Which types of products benefit most from the cooperative model?

Shortage-listed generics and high-demand molecules suitable for rapid activation deliver the strongest returns. Members use EUMA to commercialise these products quickly, while avoiding the high cost and operational complexity of running a standalone EU facility.

Why should I secure a membership slot now?

Slots are extremely limited and allocated to the first companies that pass qualification and commit capital. Early members secure their molecule exclusivities, preferred capacity, and most favourable entry terms. Once the cooperative reaches full membership, the window closes and late applicants must wait for the next build cycle, delaying EU revenue by several years.

bottom of page