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
Nr. of Employees
small (1-50)
Purisys LLC
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
Integrated route selection, process development, analytical development and cGMP manufacturing for clinical and niche commercial APIs, including controlled‑substance projects.
Flexible high‑containment GMP suites supporting small‑volume production with closed charging, lyophilization, milling and capability to scale as required.
On‑site analytical method development, validation, impurity and forensic testing, ICH‑compliant stability studies and method transfer for regulatory submissions.
Commercial catalog and custom synthesis of reference materials with structural elucidation and qualification packages for analytical use and regulatory filings.
Consultative CMC strategy, preparation and writing of submission documents and support through preclinical to post‑approval stages.
Integrated route selection, process development, analytical development and cGMP manufacturing for clinical and niche commercial APIs, including controlled‑substance projects.
Flexible high‑containment GMP suites supporting small‑volume production with closed charging, lyophilization, milling and capability to scale as required.
On‑site analytical method development, validation, impurity and forensic testing, ICH‑compliant stability studies and method transfer for regulatory submissions.
Commercial catalog and custom synthesis of reference materials with structural elucidation and qualification packages for analytical use and regulatory filings.
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
News & Updates
Announcement of attainment of ISO 17025 (testing and calibration laboratories) and ISO 17034 (reference material producers) to extend laboratory and reference material capabilities.
Press release describing strategic alignment to form an integrated North American API and drug product supply chain services provider (Noramco Group).
Announcement of submission/activation of a commercial DMF for nalmefene hydrochloride (DMF 39767) to support API referencing in regulatory filings.
News describing acquisition that expands drug product formulation development and clinical/commercial manufacturing options available to Noramco Group customers.
Whitepaper/blog announcing the regulatory testing deadline for nitrosamines and offering guidance to ensure compliance.
Announcement of a preferred‑supplier relationship with a pharmaceutical partner to support development and supply of cannabinoid‑containing pharmaceutical products.
Announcement of attainment of ISO 17025 (testing and calibration laboratories) and ISO 17034 (reference material producers) to extend laboratory and reference material capabilities.
Press release describing strategic alignment to form an integrated North American API and drug product supply chain services provider (Noramco Group).
Announcement of submission/activation of a commercial DMF for nalmefene hydrochloride (DMF 39767) to support API referencing in regulatory filings.
News describing acquisition that expands drug product formulation development and clinical/commercial manufacturing options available to Noramco Group customers.
Whitepaper/blog announcing the regulatory testing deadline for nitrosamines and offering guidance to ensure compliance.
Announcement of a preferred‑supplier relationship with a pharmaceutical partner to support development and supply of cannabinoid‑containing pharmaceutical products.