Path to Market
Purisys is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry.
Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization – with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis. Our broad ranging, and often specialized, chemistry capabilities make us the partner of choice for technically intensive and complex projects. Purisys also has an industry-leading track record in compliance with US FDA cGMPs and other global regulatory bodies.
Global Leader in Complex Chemistry – Expertise in Cannabinoids
Purisys has a long track record in the custom cannabinoid space. Purisys currently produces all major and minor cannabinoids of clinical interest, as well as degradants, metabolites and analytical reference standards. Purisys has been manufacturing CBD via a patented process since 2016 (US commercial DMF filed in 2020) and has a Drug Master File for Δ9-THC in sesame oil (dronabinol) API since 2007.
The cannabinoids produced by Purisys are distinguished by their high purity, ultra-low THC concentration, exacting quality control and GMP production – as well as regulatory support services required for INDs and NDA/ANDAs.
Clinical Stage Custom CDMO Services
Purisys has a full suite of manufacturing and support services for companies conducting clinical trials or who have molecules in discovery entering Phase I, Phase II or later phase clinical development. Our resources are particularly well suited to complex chemistry, including high potency molecules and parenteral grade (NSP) APIs. In addition, Purisys can produce APIs under GMP for commercial orphan drug patient populations where other CDMOs can only provide non-GMP grades of material.
Purisys offers a full range of CDMO services for NCE (new chemical entity) pharmaceutical and biotech companies including reference and small-scale R&D and GMP manufacturing, process and analytical services, formulation support, and full regulatory filing capabilities.
Controlled Substance Excellence
Purisys personnel have a 40-plus year track record producing and managing controlled substance APIs for pharmaceutical production in accordance with international rules and global regulations. We offer one of the premiere reference standard catalogues and manufacturing capabilities in this market segment today. Our experienced team has worked to move pharmaceutical compounds globally and is comfortable navigating the regulatory and logistics associated with global shipments/permits.
Scientific Core Competency
After decades in the API market, Purisys has a highly experienced team of PhD scientists with diverse industrial/scientific backgrounds. This wide experience allows the Purisys team to effectively and efficiently execute projects while maintaining compliance and providing an excellent customer experience.