Non-Controlled API

Molecule-agnostic APIs at Any Scale

Purisys has more than 40 years of experience in commercial pharmaceutical production. We are building on that experience to better serve the market by offering CDMO services, Purisys combines deep knowledge of pharmaceutical API synthesis and manufacturing with an intense focus on quality and regulatory oversight. We have the knowledge and experience you need—whatever your project, and wherever you are in your journey to market.

Purisys offers a fully operational global supply chain and exports to more than 40 countries –with full international regulatory compliance.

From our US-based flagship, 17,000-square-foot innovation center and manufacturing facility, we offer decades of experience in complex, high-barrier custom synthetic chemistry and manufacturing of a wide range of APIs.

Our API CDMO offering effectively integrates end-to-end project management, process development services, analytical services, regulatory support, and cGMP manufacturing of custom psychedelic compounds to rapidly advance your API to the clinic.

At a Glance

  • Phase-appropriate GMP manufacturing and commercial process validation
  • Process development with consideration of scale up and compliance
  • Process optimization or route redesign
  • Scientist-driven project management
  • Complete analytical testing
  • Reference standard synthesis and qualification
  • Analytical method development, optimization, validation, and method transfer
  • High-potency API manufacturing and testing
  • Non-sterile, parenteral processing and milling
  • Specialized equipment for handling labile APIs
  • Product design and development following QbD principles
  • Pre-formulation development and testing
  • Lyophilization, milling and custom packing

The experience our team has enables us to deliver exceptional efficiencies to your product development. Purisys’ skilled teams can perform all analytical testing and stability studies in-house and handle high-potency API manufacturing and commercial-scale, air-sensitive compounds. We can help you succeed through our:

  • Foresight – We know the long-term goals of a project, and we strive to develop processes that are suitable for downstream applications to avoid route redesigns.
  • Experience – We have an extensive catalogue of commercial APIs. We know what needs to be done because we’ve done it for more than 40 years, and we are here to help you.
  • Understanding – We are experts in every phase of a project, and what tasks are appropriate for each phase, so we don’t do things that we don’t need to do.
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