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)
Bionova Scientific
United States
Bionova Scientific is a US-based biologics CDMO (part of Asahi Kasei Group) focused on the development and GMP manufacturing of monoclonal antibodies and other therapeutic proteins using mammalian cell culture processes. They offer cell line development, upstream/downstream process development, formulation development, pilot production, GMP manufacturing, and process characterization. Expanding into plasmid DNA (pDNA) manufacturing with a new facility in The Woodlands, Texas.
Biologics Drug SubstanceBiologics Drug ProductFormulation Development
Biophore India Pharmaceuticals
India
Biophore India Pharmaceuticals Pvt. Ltd. is a Hyderabad-based research-driven pharmaceutical company specializing in the development and manufacturing of niche active pharmaceutical ingredients (APIs) for global markets. Focus areas include oncology, contrast agents, peptides, injectable APIs, and orphan drugs. They have 110+ US DMFs, 150 global DMFs, 20+ CEPs, and 4 US FDA and EU approved manufacturing facilities. FDA-registered with 5 approved products (capsules, tablets). Partner relationships include Oakrum Pharma.
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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