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)
Orofino Pharmaceuticals Group
Italy
Orofino Pharmaceuticals Group (OPG), headquartered in Rome, Italy, is a group of companies specializing in third-party pharmaceutical manufacturing services. The group includes Biopharma (betalactam finished products), Injectalia (small sterile liquids including hormones, biologicals, heparins, vaccines), K24 Pharmaceuticals (chemical testing, EU release, secondary packaging), and Drug'On Pharma Switzerland (API manufacturing). Focused on sterile injectables and betalactam oral/injectable dosage forms.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Pace® Life Sciences
United States
DUPLICATE ENTRY -- This is the same company as 'Pace Analytical Services LLC (Pace Life Sciences)' (company index 10). Pace Life Sciences is the CDMO/CRO division of Pace Analytical. Same website content, same capabilities. See company index 10 for full profile.
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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