BASEL, Switzerland— Jungbunzlauer announced its production facility in Ladenburg was pronounced GMP (good manufacturing practice) compliant again, following a site inspection by FDA officials. The four-day inspection covered the production, warehouse and quality control departments, as well as the facility’s overall quality management, covering Jungbunzlauer offerings produced in the Ladenburg facility, including citric acid, tripotassium citrate, trimagnesium citrate, tricalcium citrate, calcium lactate gluconate, CITROFOL® (citric acid esters) and other specialty products.
Jungbunzlauer’s Ladenburg facility has been certified compliant by FDA since 2001. The compliance is part of the company’s PharmaChoices@Jungbunzlauer platform strategy, designed to strengthen its position in the pharmaceutical markets. Focal points of the recent inspection were the products holding Drug Master Files (DMF), namely tripotassium citrate (DMF No. 14846, registered since May 2000) and citric acid (DMF No. 23078, registered since August 2009).
