Eurofins CDMO Alphora Inc., operating as part of Eurofins CDMO, is a leading provider of Active Pharmaceutical Ingredient and Drug Product development and manufacturing services for complex small molecules, including highly potent compounds. As a campus style facility, we offer 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.
Our services include:
• Drug Substance/API Development
• Solid State Research & Development
• Drug Product Operations (Pre-Formulation & Formulation Development)
• Analytical Development & Validation
• Clinical Packaging and Logistics
• Project Management
• CMC & Regulatory Services
• Process Development
• DoE and QbD
• Stability Testing
• Gram to Kilogram Synthesis
• cGMP and non-cGMP
• High Potency
• Fast Track services
• Flow Chemistry