Compare CDMOs specializing in small molecule drug product formulation, tableting, encapsulation, and coating. Filter by dosage form, batch size, and regulatory approvals.
406 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.
Germany
Rommelag CDMO GmbH (Rommelag Pharma Service) is a German company that invented Blow-Fill-Seal (BFS) technology for aseptic packaging of liquid pharmaceutical products. The CDMO division provides contract filling services and product development support for liquid and semi-solid pharmaceutical products using BFS technology. Rommelag also manufactures the bottelpack BFS filling machines (up to 37,500 containers/hour) and provides comprehensive lifecycle services including qualification, validation, and factory planning.
United States
Seran BioScience is a US-based CDMO headquartered in Bend, Oregon, recognized as a world leader in drug delivery and formulation development. The company provides comprehensive drug development and clinical/commercial manufacturing services, specializing in spray drying and particle engineering, preformulation, dosage form development, and cGMP manufacturing. Seran recently secured $200M+ from Bain Capital to build a new 100,000 sqft commercial manufacturing facility for non-sterile oral solid dose pharmaceuticals.
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.