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)
Tiefenbacher Group
Cyprus
Purpose-driven, family-owned healthcare company pioneering healthcare since 1963, headquartered in Cyprus. Delivers best-in-class solutions across the entire pharmaceutical value chain from API distribution through development, manufacturing, and registration of affordable medicines. 900+ employees, 400+ customers, 180+ finished dosage form products, serving patients in 80+ countries. Production capacity up to 3 billion units per year. Manufacturing sites in Cyprus (large-scale oral solid dose, SPC waiver site) and Hyderabad, India (specialized high-potent manufacturing block for oncology, FDA-inspected). Includes Tiefenbacher Laboratories (TBD Pharmatech) as API CDMO division. Offers ICH stability studies, technology transfer, analytical laboratory services, and EU batch testing/release.
Small Molecule Drug ProductOral Solid DoseSolid Dose Manufacturing
Tiofarma
Netherlands
Tiofarma is a Dutch CDMO specializing in complex semi-solid formulations (creams and ointments) and emergency nasal sprays, offering services from pre-formulation through commercial supply. The company operates an EU-GMP and FDA-licensed manufacturing facility in Oud-Beijerland, Netherlands, with in-house R&D and analytical laboratories.
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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