Purisys LLC
U.S.-based small-molecule CDMO and supplier of active pharmaceutical ingredients (APIs), reference standards, and analytical services. Operates an FDA‑inspected manufacturing and innovation facility in Athens, GA and provides cGMP development and manufacturing (milligram to metric‑ton scale), analytical development and testing, reference material production, process development, and regulatory/CMC support for clinical through niche commercial applications.
Industries
N/A
Products
Commercial reference standards catalog
Library of pharmaceutical reference standards with structural elucidation and analytical characterization for method calibration, QC and regulatory submissions.
Commercial Drug Master File (DMF) for nalmefene hydrochloride (DMF 39767)
Active pharmaceutical ingredient DMF submitted to the U.S. FDA to enable referencing of the API in regulatory filings.
Pharmaceutical‑grade cannabinoid APIs
Synthetic, cGMP cannabinoid APIs (major and minor cannabinoids, degradants, metabolites) produced with documented purity, stability and regulatory support; company maintains multiple commercial DMFs for cannabinoid APIs.
Commercial reference standards catalog
Library of pharmaceutical reference standards with structural elucidation and analytical characterization for method calibration, QC and regulatory submissions.
Commercial Drug Master File (DMF) for nalmefene hydrochloride (DMF 39767)
Active pharmaceutical ingredient DMF submitted to the U.S. FDA to enable referencing of the API in regulatory filings.
Pharmaceutical‑grade cannabinoid APIs
Synthetic, cGMP cannabinoid APIs (major and minor cannabinoids, degradants, metabolites) produced with documented purity, stability and regulatory support; company maintains multiple commercial DMFs for cannabinoid APIs.
Services
Custom API CDMO services
Integrated route selection, process development, analytical development and cGMP manufacturing for clinical and niche commercial APIs, including controlled‑substance projects.
Small‑scale and contained GMP manufacturing
Flexible high‑containment GMP suites supporting small‑volume production with closed charging, lyophilization, milling and capability to scale as required.
Analytical testing, method development and stability
On‑site analytical method development, validation, impurity and forensic testing, ICH‑compliant stability studies and method transfer for regulatory submissions.
Reference standards production and distribution
Commercial catalog and custom synthesis of reference materials with structural elucidation and qualification packages for analytical use and regulatory filings.
Regulatory CMC and filing support
Consultative CMC strategy, preparation and writing of submission documents and support through preclinical to post‑approval stages.
Custom API CDMO services
Integrated route selection, process development, analytical development and cGMP manufacturing for clinical and niche commercial APIs, including controlled‑substance projects.
Small‑scale and contained GMP manufacturing
Flexible high‑containment GMP suites supporting small‑volume production with closed charging, lyophilization, milling and capability to scale as required.
Analytical testing, method development and stability
On‑site analytical method development, validation, impurity and forensic testing, ICH‑compliant stability studies and method transfer for regulatory submissions.
Reference standards production and distribution
Commercial catalog and custom synthesis of reference materials with structural elucidation and qualification packages for analytical use and regulatory filings.
Regulatory CMC and filing support
Consultative CMC strategy, preparation and writing of submission documents and support through preclinical to post‑approval stages.
Expertise Areas
- API contract development and manufacturing (CDMO)
- Process development, route scouting and scale‑up
- Controlled‑substance and DEA‑regulated API handling
- Cannabinoid and psychedelic API synthesis for clinical use
Key Technologies
- cGMP manufacturing
- Design of Experiments (DOE) automation and reaction screening
- Process modeling and simulation
- HPLC / UHPLC