Small Molecule Drugs
ScinoPharm, a supplier to the global API market, can provide services in API process development and chemical organic synthetic route design. We have complete R&D capabilities that range from the synthesis of new chemical entities at the early stage of drug development to commercial production. Because of our solid R&D and technical competencies, ScinoPharm can develop its own manufacturing processes without infringing on existing patents. This approach allows us to secure orders from major pharmaceutical companies in a highly competitive global market and be active in both new drug and generic drug markets.
ScinoPharm’s R&D department can design and improve production methodologies and processes applicable to medium- and large-scale production. Furthermore, we have expertise in molecular structure differentiation and thus can address issues encountered during synthesis or production. ScinoPharm can provide to our customer's services including R&D of manufacturing processes, improvement or modification of existing manufacturing processes, the discovery of new process methodologies to produce products, preparation of APIs, process development, and production of single-isomer molecules, and development of practical purification techniques for the abovementioned products.
Regarding ScinoPharm’s analytical chemistry services, in addition to the testing and determination of a chemical’s purity, development and validation of analytical methods, and stability tests, ScinoPharm provides legal services such as preparing an application to the regulatory authority and authoring of chemical manufacturing control, test documents, and technical reports. Furthermore, because FDA’s cGMP guidelines require that all newly developed and marketed drug products must be supported and verified by chemical analysis, we provide services in analytical chemistry to help ensure the compliance of our customers’ products.