Selecting A CDMO Partner For Controlled Substance Oral Solid Dosages: A Guide To Reducing Risk Across Development And Manufacturing

Demand for controlled substance therapies is projected to nearly double in the US over the next decade, and oral solid dosages account for a large share of that volume. Yet a DEA registration says little about whether a CDMO can carry a program from development to commercial supply.

This guide separates basic compliance from true readiness across four areas: regulatory standing, accountability for every gram of material, formulation expertise that anticipates scale-up, and supply planning shaped by DEA quota requirements. Each section pairs its analysis with specific questions and factors to bring into partner evaluations, from inspection history to who owns quota management.

Explore the framework to sharpen how you assess prospective partners before commitments are made.