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
