CDMOs offering HPAPI Manufacturing (High-Potency) with Small Molecule in United States
16 matching organizations
HPAPI Manufacturing (High-Potency) with Small Molecule in United States is a frequent shortlist pattern for sponsors evaluating CDMO partners with regional footprint. This page lists organizations that map to all three dimensions so you can move from broad taxonomy browsing to a geography-aware candidate set.
Profiles emphasize fit-first discovery: review scope, regulatory posture, and provenance on each listing rather than treating this page as a single ranked recommendation.
When you need additional filters (indications, claim status, or free-text search), continue to the main search experience and layer criteria on top of this starting point.
Directory listings on this page are fit-first and provenance-backed; sponsors are labeled separately and do not alter organic ordering.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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