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.
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.
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.
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.
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