Jungbunzlauer is pleased to inform you that a Certificate of Suitability to the monographs of the European Pharmacopeia (CEP) has been granted by the European Directorate for the Quality of Medicines (EDQM) for our Active Pharmaceutical Ingredient (API) Trisodium Citrate on 28 January 2020 (number: R0-CEP 2018-273-Rev 00 Sodium citrate).
Currently, Jungbunzlauer is the only company holding a CEP for Trisodium Citrate which is manufactured under GMP (Good Manufacturing Practice) at the Ladenburg site in Germany.
TSC is widely used in oral rehydration salts, cough syrup, antacid and laxatives and the availability of the CEP will further support the licensing activities of Jungbunzlauer’s pharma customers.
With the addition of TSC, Jungbunzlauer’s API portfolio now covers four different products which can be provided with access to our US drug master file (DMF) and/or certificate of suitability (CEP) and with a GMP certificate from local authorities. Jungbunzlauer is constantly expanding its API portfolio according to customer and market needs. Please visit our Pharma website to find an overview of our rapidly growing API and Excipient portfolio and contact us to get further information or a personal quote for our APIs.