Compare small molecule CDMOs for API synthesis, drug product formulation, and finished dosage manufacturing. Filter by chemistry capabilities, scale, and regulatory approvals.
406 companies listed
Small molecule manufacturing covers two distinct stages: active pharmaceutical ingredient (API) synthesis and drug product (DP) formulation. API work involves multi-step chemical synthesis, from kilo-lab through pilot-plant to commercial scale. Drug product work transforms the API into tablets, capsules, injectables, or other dosage forms.
Process chemistry is where projects succeed or fail. Look for CDMOs with strong route scouting and process optimization capabilities. A good CDMO can improve yields by 20-40% during scale-up, saving months of development time. Crystallization expertise is particularly critical for controlling polymorphic form and particle size distribution.
How does your CDMO handle potent compounds? Many oncology and hormonal APIs require OEB4 or OEB5 containment. Not every small molecule CDMO has the engineering controls for sub-microgram exposure limits. Verify containment capabilities early -- retrofitting is expensive and slow.
Germany
Rommelag CDMO GmbH (Rommelag Pharma Service) is a German company that invented Blow-Fill-Seal (BFS) technology for aseptic packaging of liquid pharmaceutical products. The CDMO division provides contract filling services and product development support for liquid and semi-solid pharmaceutical products using BFS technology. Rommelag also manufactures the bottelpack BFS filling machines (up to 37,500 containers/hour) and provides comprehensive lifecycle services including qualification, validation, and factory planning.
United States
Seran BioScience is a US-based CDMO headquartered in Bend, Oregon, recognized as a world leader in drug delivery and formulation development. The company provides comprehensive drug development and clinical/commercial manufacturing services, specializing in spray drying and particle engineering, preformulation, dosage form development, and cGMP manufacturing. Seran recently secured $200M+ from Bain Capital to build a new 100,000 sqft commercial manufacturing facility for non-sterile oral solid dose pharmaceuticals.
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