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.
Italy
Doppel Farmaceutici Srl is an Italian CDMO operating since 1994, specializing in contract manufacturing and packaging of finished dosage forms for pharmaceutical companies. The company offers formulation development, R&D, manufacturing of soft and hard gelatin capsules, tablets, oral liquids, and semi-solids, along with full packaging services.
United States
Enteris BioPharma (now MOD3 Pharma, acquired by Aptar Pharma) was a US-based CDMO specializing in the development and manufacture of difficult-to-formulate oral drug products. Operating from a 32,000 sq ft FDA-inspected, cGMP-compliant facility in northern New Jersey, the company offered custom formulation development and clinical trial manufacturing services.
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