Company Description
Eurofins CDMO Alphora Inc., operating as part of Eurofins CDMO, is a leading provider of Active Pharmaceutical Ingredient (API) and Drug Product (DP) development and manufacturing services for complex small molecules, including highly potent compounds. As a campus style facility, Eurofins CDMO Alphora Inc. offers API and Drug Product Development services as a fully integrated solution or as stand-alone services.
As an FDA & Health Canada approved CDMO, we specialize in process chemistry, analytical method development and non-cGMP & cGMP API scale-up. Through the integration of synthetic Process R&D, Solid State R&D, and Formulation Development, we offer a full suite of drug development services and manufacturing capabilities to support pre-clinical to commercial success.
Our Drug Product operations can support development and clinical manufacturing of oral solid dosage forms and complements our existing API development & manufacturing services by providing enhanced quick-to-clinic drug product strategy designed to meet clients’ needs for Phase I and II products.
Company Background
Date Founded: 2003
Key Personnel:
- Geo Evans, President
- Cheryl Young, Vice President, Business Development and Project Management
- Elena Bejan, Vice President, Research and Development
- Kevin Rosenthal, Business Head, Drug Product Operations
Services & Capabilities
- API Development & Manufacturing: We support our clients from route selection to process and analytical development, to non-cGMP and cGMP scale-up and more.
- Solid State Research & Development: Our SSRD programs apply High-Throughput Screening Technology for expeditious discovery of new polymorphs, pharmaceutical salts, solvates, co-crystals & particle size engineering.
- Analytical Development & Validation: We focus on the development of analytical methods & phase appropriate specifications to ensure control of the synthetic process & quality of API throughout the program.
- Drug Product Development & Manufacturing: Our innovative pre-formulation & formulation development, state-of-the-art technologies and cGMP production facilities are specifically designed for quick-to-clinic small molecule drug development.
- API Development Services for Phytocannabinoids: We apply our rigorous API development expertise to produce well-characterized, pharmaceutical-grade phytocannabinoids of high purity that cannot be readily achieved through traditional extraction.
Facilities
Our facilities are located in Canada and centered within the North American Pharmaceutical Industry. Our fully equipped laboratories and manufacturing services include:
- Synthetic Organic Laboratories
- Non-cGMP & cGMP High Potency Laboratories
- Solid State R&D Laboratories
- cGMP Analytical Laboratories
- Pre-Formulation & Formulation Laboratories
- cGMP Kilo Laboratories
- cGMP Manufacturing Plant - DS & DP
- cGMP Warehouse
- cGMP Stability Chambers & Testing Services