Pharmaceutical APIs

Start with us for our expertise.
Stay with us for our execution.

Today’s Purisys draws on a track record of more than 10 years producing cannabinoid APIs to help brand and generic pharmaceutical companies gain regulatory approval and bring new products to market. In our work with over 130 geographically diverse customers, Purisys supports a wide variety of therapeutic indications for approved and investigational formulations, many of which are not yet approved by FDA, including antimimetic, pain, anxiety/stress, neurological disorders and more.

Scientist with Dropper
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A Full-Spectrum Drug Development Partner

Purisys combines a wealth of intrinsic experience and institutional knowledge from process development, manufacturing and regulatory perspectives unique in the API business – and which is extremely difficult to replicate in any territory. Purisys has extensive capabilities in assisting pharmaceutical companies develop cannabinoid APIs for preclinical testing through commercialization.

Process & Analytical Services

  • Process Development
  • Analytical Development
  • Particle Size Development
  • Pre-formulation including Solid State Characterization
  • Structural elucidation
  • Excipient compatibility
  • Solubility determination
  • Automated DOE reaction screening
  • Stability
  • Reference Standards Catalog
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Ultra-pure Cannabinoid Materials

Purisys has been manufacturing CBD via a patented process since 2016. It currently produces at facilities in both the USA and Switzerland. Purisys’s focus to date has been on the pharmaceutical industry, where its ultra-high purity materials (0.001% THC) are attractive for drug development projects. Our experience in the pharmaceutical sector makes us an ideal partner for high quality consumer product development.

Two patents outline our differentiated processes to produce ultra-pure THC and CBD, US10059683B2 and US7923558B2. A variety of cannabinoids are produced in Europe, and domestically in the United States, in a range of quantities.

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DEA/Regulatory Compliance

By registering with FDA/DEA and operating GMP compliant manufacturing facilities, both within and outside of the United States, Purisys is uniquely positioned to service customers globally that wish to market their product in the US.

The Drug Enforcement Administration (DEA) is the Federal Agency that regulates controlled substance activity in the United States. By law, DEA permits imports of Schedule I and II substances only in specific situations (where competition is found to be inadequate, small quantities for analytical testing and, when a medical emergency exists). This restriction can prevent companies using foreign suppliers or dosage form manufacturers from entering the US market.

Purisys’s DMF (#33223) for CBD was filed in February 2019 includes substantial stability and purity information.

Regulatory Support

  • 40-year track record
  • Full regulatory filing capabilities
  • Thousands of DEA C-II pallet spaces
  • DEA Import / Export / Manufacturing / Distributor / Research Registrations
  • Licensed to ship to 48 US States (Manufacturer/Distributor/Wholesaler)
  • Exemplary FDA, EDQM, and DEA compliance records