Category
Small Molecule CDMOs
Compare small molecule CDMOs for API synthesis, drug product formulation, and finished dosage manufacturing. Filter by chemistry capabilities, scale, and regulatory approvals.
407 companies listed
About Small Molecule Manufacturing
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.
Companies (407)
Fisiopharma
Italy
Fisiopharma is an Italian CDMO established in 1989, dedicated to the development and manufacturing of injectable pharmaceutical products in the form of liquid, suspension, and lyophilized formulations. It offers CDMO services from first product development through to commercial manufacturing at its facility in Italy.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Galenicum Health
Spain
Galenicum Health is a Spanish specialty pharmaceutical company founded in 2003 in Barcelona, operating as a CDMO with a manufacturing facility near Madrid. The company produces finished dosage forms in multiple formats including liquids, ointments, creams, sachets, powders, nasal sprays, tablets, and capsules, with a production capacity of over 50 million packs per year. Galenicum operates in 58+ countries with 800+ employees and consolidated revenues of 213M EUR (2023).
Frequently Asked Questions
What is the difference between API and drug product manufacturing?+
API (Active Pharmaceutical Ingredient) manufacturing produces the chemical compound that provides therapeutic effect. Drug product manufacturing takes that API and formulates it into the final dosage form patients receive -- tablets, capsules, injectables, creams, etc. Some CDMOs handle both; many specialize in one.
How do you choose a small molecule CDMO?+
Match your project stage to the CDMO's capabilities. Early-phase needs: strong process chemistry and flexibility. Late-phase needs: validated manufacturing, regulatory filing support, and commercial-scale capacity. Check their experience with your reaction types (hydrogenation, cryogenic, high-pressure) and any special handling requirements (potent, controlled substances).
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