Capability
Formulation Development CDMOs
Compare CDMOs with formulation development expertise for oral, injectable, topical, and inhalation dosage forms. Filter by technology platform, therapeutic area, and regulatory support.
621 companies listed
Is your molecule barely soluble? You're not alone. Most new chemical entities in the pipeline are, and formulation is where that problem gets solved or shelved. Formulation development takes an API and makes it stable, absorbable, and manufacturable at scale. It starts with pre-formulation (solubility, stability, excipient compatibility), and it sets the ceiling on your drug's clinical performance. Get it wrong and a promising molecule stalls. The capability that separates a real formulation CDMO from a general one is bioavailability enhancement. Ask what enabling platforms they run in-house: spray-dried dispersions, hot melt extrusion, nano-milling, lipid-based systems, cyclodextrin complexation. One platform isn't enough, because the right approach depends on your compound's physicochemistry. Engage early, ideally in late discovery. Late-stage formulation changes are expensive, and they eat months. 621 CDMOs here offer formulation development. Compare them by platform, dosage form, and therapeutic area.
About Formulation Development
Formulation development transforms an API into a stable, bioavailable, and manufacturable dosage form. It begins with pre-formulation studies (solubility, stability, compatibility) and progresses through prototype development, optimization, and scale-up. The formulation defines the drug product's clinical performance, and poor formulation choices can doom an otherwise promising molecule.
Bioavailability enhancement is the fastest-growing formulation challenge. An estimated 70-90% of new chemical entities in development pipelines have poor aqueous solubility. CDMOs with expertise in enabling technologies -- amorphous solid dispersions (spray drying, hot melt extrusion), lipid-based drug delivery systems, nanoparticle milling, and complexation -- can rescue molecules that would otherwise fail.
Companies (621)
Porton Pharma Solutions
China
Porton Pharma Solutions is a global CDMO headquartered in China with over 4,300 employees and operations in the US, Europe (Slovenia), and China. They offer end-to-end services across small molecules, tides (peptides/oligonucleotides), biologics and conjugates (ADCs), and advanced therapy medicinal products. Technical solutions include crystallization, bio catalysis, metal catalysis, flow chemistry, preparative chromatography, milling, and chemical engineering. FDA-registered with 4 FEI numbers for API manufacture, they have 3 FDA inspections with clean outcomes (1 NAI, 2 VAI).
Small Molecule APISmall Molecule Drug ProductOral Solid Dose
Prahem Laboratories LLP
India
Prahem Laboratories LLP is an Indian pharmaceutical company and sister company of Sneha Medicare Pvt Ltd (established 1985). Based in Mumbai, they operate as a CMO/CDMO with capabilities in development, production, and marketing of specialty medicines, generic medicines, OTC products, and new therapeutic development. Listed on CPHI Online as CMO/CDMO with distributor/import-export and generics/biosimilars manufacturing capabilities. Their business verticals include APIs, finished dosage forms (including oncology and contrast media), and export to LATAM, CIS, and Southeast Asian markets.
Frequently Asked Questions
When should you engage a CDMO for formulation development?+
Ideally during late discovery or early pre-clinical development. Engaging a formulation CDMO early allows: optimization of the dosage form for clinical studies, identification of formulation risks before IND/CTA filing, and alignment between the clinical formulation and the commercial dosage form strategy. Late-stage formulation changes are expensive and time-consuming.
What bioavailability enhancement technologies do CDMOs offer?+
Common technologies include: spray-dried dispersions (SDD), hot melt extrusion (HME), nano-milling / nano-suspension, lipid-based drug delivery systems (SEDDS, SMEDDS), complexation with cyclodextrins, co-crystals, and amorphous solid dispersions. Each technology has different applicability depending on the compound's physicochemical properties. CDMOs with access to multiple platforms can select the optimal approach.
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