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)
NEON LABORATORIES LTD
India
Indian pharmaceutical company (established 1984) that emerged as a leader in anesthesia and critical care products. Manufactures 500+ products sold in 70+ markets. Multi-located manufacturing facilities including API and formulations. Started as contract manufacturer for anesthesia products (1992) and grew into branded generics. Major plant at Palghar with 460 million units capacity. Has dedicated manufacturing units for cephalosporins and oncology to avoid cross-contamination. 2000+ employees. FDA registered with 3 FEI numbers, 29 inspections (13 NAI, 15 VAI, 1 OAI). Began API production in 2008. Also has medical devices division (HOSPRO).
Small Molecule Drug ProductSterile InjectableFill/Finish (Vials)
O
Olon Ricerca Bioscience
United States
Olon Ricerca Bioscience is a US-based CRO/CMO subsidiary of Olon SpA, specializing in chemical development and API manufacturing for preclinical and clinical phases. Founded in 1986 and acquired by Olon SpA in 2017, the company provides integrated services from synthetic chemistry and process development through to cGMP kilo-lab manufacturing at its Concord, Ohio facility.
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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