"current Good Manufacturing Practice" for Jungbunzlauer Ladenburg
US Food and Drug Administration finds production of Jungbunzlauer derivatives and specialties compliant with cGMP regulations.
FDA officials have again confirmed Jungbunzlauer Ladenburg to be compliant with current Good Manufacturing Practice (cGMP) regulations. The recognition follows a four-day inspection of Ladenburg's production, warehouse and quality control departments, as well as its overall quality management. cGMP compliance applies to all Ladenburg products, including citric acid, tripotassium citrate, trimagnesium citrate, tricalcium citrate, calcium lactate gluconate, CITROFOL® (citric acid esters) and other specialty products.
The successful FDA inspection underlines our high quality approach, which we pursue for our derivatives as much as for our main products. The cGMP compliance for the Ladenburg products is part of our PharmaChoices@Jungbunzlauer platform strategy to strengthen our position in the pharmaceutical market, in the United States like elsewhere.
Jungbunzlauer Ladenburg continuously holds the cGMP status since the first FDA inspection in 2001. The cGMP recognition is valid for an indefinite length of time, but subject to regular control. Focal points of the recent inspection were the products holding Drug Master Files (DMF), namely tripotassium citrate (DMF 14847, registered since May 2000) and citric acid (DMF No. 23078, registered since August 2009).