Capability
Small Molecule Drug Product CDMOs
Compare CDMOs specializing in small molecule drug product formulation, tableting, encapsulation, and coating. Filter by dosage form, batch size, and regulatory approvals.
407 companies listed
Small molecule drug product manufacturing turns your API into the tablet, capsule, or injectable a patient actually takes. The hard part isn't making one clinical batch. It's finding a partner who can carry the process from a 20,000-unit Phase I lot to a validated commercial line without a mid-program tech transfer that resets your timeline. Ask three things before you shortlist. Does the CDMO run your dosage form at both clinical and commercial scale under one roof? If your molecule is BCS Class II or IV, do they have real bioavailability-enhancement experience (spray drying, hot melt extrusion, amorphous solid dispersions), or just a brochure? And can they show a batch record and stability package that held up under an FDA pre-approval inspection? The CDMOs below list small molecule drug product as a core capability.
About Small Molecule Drug Product Manufacturing
Small molecule drug product manufacturing transforms the API into the final dosage form patients receive. This includes granulation, blending, compression (tablets), encapsulation, film coating, and packaging. Each step requires precise process control to ensure dose uniformity, dissolution performance, and stability.
Bioavailability enhancement is a growing need. Many new chemical entities have poor aqueous solubility (BCS Class II/IV), requiring advanced formulation technologies: spray drying, hot melt extrusion, nanoparticle milling, amorphous solid dispersions, and lipid-based drug delivery systems. CDMOs with these capabilities command premium positioning.
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 equipment is needed for oral solid dose manufacturing?+
Core equipment includes: high-shear granulators, fluid bed processors, roller compactors (for dry granulation), tablet presses (rotary for high-volume, single-station for development), capsule fillers, film coating systems (pan coaters), blenders, and packaging lines. For modified-release products, add multiparticulate processing equipment (pelletizers, coating systems for beads/pellets).
How do you select a drug product CDMO for clinical vs commercial?+
Clinical-stage needs: flexibility, small batch capability (5,000-50,000 units), fast turnaround, and regulatory filing support. Commercial-stage needs: high-throughput equipment, validated processes, supply chain reliability, and cost efficiency at scale. Some CDMOs cover both stages; others specialize. Plan your CDMO strategy to minimize tech transfers between clinical and commercial.
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