Noramco LLC
Noramco is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company supporting the advancement of opioid and non-opioid products across various therapeutic applications. Founded in 1979 and headquartered in Delaware, Noramco specializes in controlled substance development and manufacturing, providing DEA-compliant security, high-purity controlled substances, and formulation-friendly particle sizes. The company is a trusted partner in addiction treatment, abuse prevention, and comprehensive ADHD technology, with operations worldwide including facilities in the US and Switzerland, and agricultural access in Tasmania. Noramco is committed to quality, innovation, and expanding its portfolio of APIs and reference standards to meet industry needs.
Industries
Nr. of Employees
large (251-1000)
Noramco LLC
Wilmington, Delaware, United States, North America
Products
High-purity cannabinoid APIs and analogs
Synthetic cannabinoid active ingredients and analogs (including cannabidiol and dronabinol formats) produced as crystalline powders or in solution forms for pharmaceutical use.
Opioid-antagonist and addiction-treatment APIs
High-purity opioid-antagonist and addiction-treatment active ingredients produced with controlled impurity profiles and available in multiple particle-size grades to meet formulation requirements.
Stimulant APIs for ADHD therapeutics
cGMP-manufactured stimulant APIs (e.g., methylphenidate-related chemotypes and prodrugs) produced at multimetric-ton scale with customized particle sizes.
Analytical reference-standards catalogue
Catalog of highly characterized analytical reference standards and impurity materials spanning cannabinoid, opioid, and other controlled-substance chemotypes for use in validation, stability, and routine testing.
High-purity cannabinoid APIs and analogs
Synthetic cannabinoid active ingredients and analogs (including cannabidiol and dronabinol formats) produced as crystalline powders or in solution forms for pharmaceutical use.
Opioid-antagonist and addiction-treatment APIs
High-purity opioid-antagonist and addiction-treatment active ingredients produced with controlled impurity profiles and available in multiple particle-size grades to meet formulation requirements.
Stimulant APIs for ADHD therapeutics
cGMP-manufactured stimulant APIs (e.g., methylphenidate-related chemotypes and prodrugs) produced at multimetric-ton scale with customized particle sizes.
Analytical reference-standards catalogue
Catalog of highly characterized analytical reference standards and impurity materials spanning cannabinoid, opioid, and other controlled-substance chemotypes for use in validation, stability, and routine testing.
Services
Contract manufacturing of controlled-substance APIs
cGMP production and scale-up of controlled-substance and high-potency APIs for clinical and commercial supply.
Custom synthesis and process development
Custom synthesis, small-volume high-containment production, and process development for parenteral and high-potency controlled APIs.
Analytical reference standards and impurity standards supply
Production and secure distribution of highly characterized analytical reference standards and impurity materials for method development, validation, and stability studies.
Clinical-supply support and provision of clinical samples
Supply of GMP clinical samples and clinical-scale API production to support bioequivalence and therapeutic-equivalence studies.
Formulation-package development and dossier creation
Collaborative development of finished-dosage formulation packages and technical dossiers for out-licensing to manufacturers, integrating API and excipient expertise.
Analytical method development and validation services
Development of rapid, sensitive analytical methods for detecting genotoxic and related impurities, and method validation to support in-process monitoring and regulatory compliance.
Contract manufacturing of controlled-substance APIs
cGMP production and scale-up of controlled-substance and high-potency APIs for clinical and commercial supply.
Custom synthesis and process development
Custom synthesis, small-volume high-containment production, and process development for parenteral and high-potency controlled APIs.
Analytical reference standards and impurity standards supply
Production and secure distribution of highly characterized analytical reference standards and impurity materials for method development, validation, and stability studies.
Clinical-supply support and provision of clinical samples
Supply of GMP clinical samples and clinical-scale API production to support bioequivalence and therapeutic-equivalence studies.
Formulation-package development and dossier creation
Collaborative development of finished-dosage formulation packages and technical dossiers for out-licensing to manufacturers, integrating API and excipient expertise.
Analytical method development and validation services
Development of rapid, sensitive analytical methods for detecting genotoxic and related impurities, and method validation to support in-process monitoring and regulatory compliance.
Expertise Areas
- Controlled-substance API development and manufacturing
- Cannabinoid API synthesis and scale-up
- Analytical reference standards and impurity standards
- Analytical method development for impurities and genotoxic compounds
Key Technologies
- cGMP API manufacturing
- Synthetic cannabinoid chemistry
- Spectroscopy and mass spectrometry for material characterization
- High-containment processing for OEL-controlled compounds