Semi-synthesis is a type of a chemical synthesis that utilizes compounds isolated from natural sources as starting material, such as bacterial or cell cultures or plant material. These natural biomolecules are usually large and complex. Generally, semi-synthetic derivatives outperform original biomolecules with respect to potency, stability or safety.

Teva api’s semi-synthetic process development leverages our expertise in synthetic organic chemistry, downstream processing (DSP), and particularly purification by chromatography. The complexity of the compounds, the wide range of structural and optical isomers, and the relatively low stability of the natural biomolecules and/or their derivatives, require high-yield reaction conversion and cutting-edge purification techniques. Registration of semi-synthetic APIs also requires a special approach due to the potentially large number of impurities and exceptions from ICH standards

Teva api process development and production capabilities in semi-synthetic organic chemistry are increasing rapidly, and we are operating dedicated or multi-purpose production plants with 100 kg capacity. Because of the high product costs and relatively low capacity of semi-synthetic manufacturing, our knowledgeable production team works closely with our top R&D experts to carry out this important work. Teva api customers can look forward to newly-developed semi-synthetic APIs in the product pipeline in years to come.

Teva api’s products, which involve the use of semi-synthetic process expertise, are varied and include API products such as: Buprenorphine HCl, anidulafungin , Azithromycin dihydrate and more.