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.
India
Getwell Pharma (India) Pvt Ltd is an Indian pharmaceutical company and a leading player in the oncology finished dosage formulation segment for more than 3 decades. The company manufactures and supplies anti-cancer drugs from its state-of-the-art manufacturing facility. Getwell holds FDA registration and has a global presence across multiple countries.
Poland
Gofarm Sp. z o.o. Sp.k is a Polish CDMO providing contract development and manufacturing services for pharmaceutical products, dietary supplements, and cosmetics. The company offers formulation development, analytical testing, stability studies, and commercial manufacturing for oral solid dosage forms, liquids, and semi-solid products. It operates from EU GMP-compliant facilities in Poland.
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