CDMOs offering HPAPI Manufacturing (High-Potency) with Small Molecule

Matching companies

• Adragos Pharma

  Global CDMO headquartered in Munich offering end-to-end development and manufacturing for small molecules and biologics, including sterile/non-sterile liquids, solids, semi-solids, lyophilization, and prefilled syringes across seven facilities in Europe and Japan.

• Almac Group

  Global CDMO with 7,900+ employees across 18 facilities, offering integrated drug development and manufacturing services including analytical development, formulation, process development, fill-finish, and specialized chemistry capabilities.

• Ardena

  Ardena is an integrated CDMO and bioanalytical CRO specializing in advanced drug product development, nanomedicine, and bioanalysis for complex molecules including poorly soluble compounds, highly potent APIs, and controlled substances.

• Asymchem Laboratories

  Asymchem is a CDMO providing integrated API synthesis, drug product development, and biologics manufacturing with specialized capabilities in peptides, oligonucleotides, highly potent compounds, and flow chemistry.

• Axplora

  Global CDMO and API manufacturer specializing in complex small molecule development, ADC manufacturing, HPAPIs, and hazardous chemistry across ten production sites in Europe, India, and the US.

• BSP Pharmaceuticals

  BSP Pharmaceuticals is a CDMO specializing in development and manufacturing of cytotoxic oncology drugs, ADCs, peptides, proteins, and lipid-based formulations from preclinical GLP through commercial supply.

• BioVectra

  North American CDMO specializing in clinical-to-commercial biologics, small molecules, HPAPIs, and bioreagents with 50+ years of microbial fermentation and complex chemistry expertise across cGMP facilities in Canada.

• Bushu Pharmaceuticals

  Bushu Pharmaceuticals is a contract development and manufacturing organization (CDMO) specializing in pharmaceutical contract manufacturing with over 25 years of experience.

• CMC Pharmaceuticals, Inc.

  CMC Pharma provides integrated formulation development, analytical testing, stability studies, and cGMP manufacturing oversight for small molecule drug programs from preclinical through post-approval, with hands-on regulatory expertise and CMO management built in.

• Cambrex

  CDMO offering drug substance and drug product development, manufacturing, and analytical services across small molecules, peptides, and specialty chemistries.

• Carbogen Amcis

  Full-service CDMO offering integrated drug substance and sterile drug product development and manufacturing from early phase through commercialization, with specialized capabilities in API synthesis, process development, analytical services, and stability testing across multiple scales.

• CordenPharma

  Full-service CDMO offering cGMP development and manufacturing of APIs, lipid excipients, drug products, injectables, peptides, LNPs, oligonucleotides, and oral solid dose across 10 facilities in 6 countries with 3000+ employees.

• Curia

  Global CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.

• Dalton Pharma Services

  Health Canada–approved and FDA-inspected cGMP contract manufacturer offering integrated drug discovery, development, and manufacturing services including custom synthesis, API production, formulation development, and sterile fill-finish for vials, syringes, and cartridges.

• Divi's Laboratories

  World's largest API manufacturer and trusted CDMO partner for 25+ years, offering generic APIs, custom synthesis, peptides, and nutraceutical ingredients to 100+ countries with complete backward integration and green chemistry principles.

• J-STAR Research, Inc.

  Contract process R&D and cGMP manufacturing for small molecule pharmaceuticals, specializing in high-potent compounds, controlled substances, crystallization development, and analytical services across Phase 1–3 clinical programs.

• Micromacinazione

  Swiss-based CDMO specializing in particle engineering and micronization with over 50 years of experience. Offers micronization, milling, spray drying, solid-state characterization, and complementary processing services (classification, blending, cryogenic, co-micronization, conditioning) for APIs, HPAPIs, controlled substances, and excipients from early development to commercial GMP scale.

• Pharmaceutics International, Inc.

  Drug product CDMO specializing in aseptic injectables, oral solid dose, lyophilization, and prefilled syringes with 30+ years of experience in complex formulations and potent compounds; now part of Jabil.

• Pharmaron

  Premier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK.

• Quotient Sciences

  Integrated CDMO offering drug product formulation and manufacturing for small molecules and synthetic peptides, with 30+ years of experience and scalable capacity from clinical to 500 kg commercial batches across US and UK facilities.

• SK pharmteco

  SK pharmteco is a CDMO offering comprehensive drug development and manufacturing services.

• Siegfried Holding

  Global CDMO with 16 production sites across four continents, offering integrated development and manufacturing from early-phase to commercial scale for drug substance and drug product.

• Sterling Pharma Solutions

  Small molecule CDMO offering comprehensive API development and manufacturing from discovery through commercial cGMP production, with specialized expertise in complex and hazardous chemistries and ADC bioconjugation.

• Syngene International

  Innovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.

• UPM Pharmaceuticals

  Independent, family-owned CDMO specializing in oral solids, semi-solids, and controlled-substance manufacturing with 475,000 sq ft cGMP facility in Bristol, TN; over 80 products commercialized.