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
RNP Pharmachem is an Indian pharmaceutical company providing CDMO/CMO services and site transfer project activities. The company operates a Singapore EU-GMP approved manufacturing facility and has 51-200 employees. Limited information is available about the company's specific capabilities and therapeutic focus beyond its general CDMO/CMO service offering.
India
Elysium Pharmaceuticals Ltd. is an Indian pharmaceutical company based in Vadodara, Gujarat, with FDA-registered manufacturing facilities (1 FEI, 3 inspections including 1 NAI and 2 VAI). Limited public information is available due to website being down, but FDA registration and LinkedIn profiles confirm pharmaceutical manufacturing operations. Evidence of contract manufacturing is limited.
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