TERES · Production back to Europe – through a novel/green manufacturing process of TERbinafine API synthESis

Synthetics Int. AG is a Swiss company strongly R&D driven which holds a variety of IP/commercial processes in the chemical business focused on the custom manufacturing and multi-customer products for the fine chemical market and the supply of polyfunctional cross linkers, tailor made manufacturing equipment, and natural products for treatment of wood. With a consolidated 20 years of history, Synthetics is a reference in the fine chemistry market. Within this project, in order to improve the synthesis of one of the most efficient dermatologic antifungals in the market, Terbinafine Hydrochloride, Synthetics has developed TERES, an innovative manufacturing process for this API, achieving a cycle time reduction from 6 steps to 2 steps by using a clever catalyst in order to accelerate the reaction. This implies a lower operation time and, at the same time, raw materials savings and environmental costs reduction (water/air, energy, solvents and toxic products). In addition, a better impurity profile is achieved, what means less risk of side effects in the drug product and purifying costs reduction. Consequently, Synthetics can ease the move Terbinafine manufacturing back from India (currently 80% of production) to a manufacturing plant in Denmark with an extreme competitive pricing.