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.
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.
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.
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