Product news

Basel, 11 March 2013

Jungbunzlauer Ladenburg GmbH has been granted a CEP for Tripotassium Citrate

Jungbunzlauer Ladenburg GmbH has been granted a Certificate of Suitability to the monographs of the European Pharmacopeia (CEP) for the Active Pharmaceutical Ingredient (API) Tripotassium Citrate by the European Directorate for the Quality of Medicines (EDQM) in October 2012. Jungbunzlauer is the first company that will offer Tripotassium Citrate as API under CEP (No. R0-CEP 2011-388-Rev 00) and holds in addition an US FDA Drug Master File (DMF # 14847). This certificate represents another milestone in our commitment to establish Jungbunzlauer Ladenburg as a high quality API manufacturing facility.

Tripotassium Citrate is established in the therapy for urinary disorders since many years. It functions as API to prevent recurrent kidney stone formation by keeping the urine alkaline. Alongside this traditional medical usage field, potassium by itself moved into the spotlight as an important nutrient that has opened up new application areas. According to the World Health Organization (WHO) most people do not consume adequate amounts of potassium in their diets even though potassium is readily available in many foods. Unbalanced diets, including high sodium- and processed food intake, are risk factors for a reduced potassium consumption that has been associated primarily with hypertension, cardiovascular diseases, kidney stone formation and low bone-mineral density. [1] Tripotassium citrate is highly soluble and easily absorbed in the body. The fact, that the citrate is a good chelating agent leads to a maximum absorption of the potassium in the gastrointestinal tract. In this respect, Tripotassium Citrate has gained vast awareness as a potassium source in pharmaceutical as to tackle the problem of potassium deficiency and its side effects.

Tripotassium Citrate is produced in Jungbunzlauer’s Ladenburg, Germany plant according to cGMP guidelines as well as the principles and guidelines of GMP laid down in Directive 2003/94/EC and the principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC.

[1] WHO. Guideline: Potassium intake for adults and children. Geneva, World Health Organization (WHO), 2012 (http://apps.who.int/iris/bitstream/10665/77986/1/9789241504829_eng.pdf).