Alphora owned by Eurofins (an independent CDMO)Contract Development and Manufacturing Eurofins CDMO (Contract Development and Manufacturing Organization) provides integrated, end to end solutions for pre-clinical and clinical outsourcing services of both Drug Substance/Active Pharmaceutical Ingredient (API) and Drug Product for New Biologic Entities (NBEs) and New Chemical Entities (NCEs). Eurofins CDMO helps streamline the drug development cycles for pharmaceutical and biopharmaceutical companies to allow them to move rapidly from research stage of NBE/NCE development to clinical stages with integrated and time-efficient services. From formulation screening and development, analytical development, stability studies and preclinical safety assessment studies to sterile and nonsterile manufacturing, Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA) services, and Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) services, as well as clinical trial material including packaging and logistics. Eurofins has extensive capabilities in multistep syntheses, as well as the development of cytotoxic and highly potent Active Pharmaceutical Ingredients (APIs). With 13 state-of-the-art facilities in the US, Europe and India and global regulatory expertise, Eurofins CDMO provides high-quality, customized solutions for complex products and unique production processes, specializing in the development of innovative formulation technologies and solutions to enhance bioavailability and control drug release for difficult-toformulate drug candidates. To support early phase programs, including INDenabling projects, Eurofins can execute the following: Development of new, scalable API route options Route development and process safety assessment Current Good Manufacturing Practice (cGMP) compliance Starting material and other raw materials sourcing and development Polymorph screening & salt selection Analytical method screening and preliminary stability profile Pre-formulation and pre-clinical supply Our integrated group of companies provides a seamless transition for API and drug substances from the initial discovery stages of the program to commercialization and on-the-shelf.