"Good Manufacturing Practice" for Jungbunzlauer Ladenburg
Basel, April 1st, 2002 – US Food and Drug Administration finds production of Jungbunzlauer derivatives and specialties compliant with cGMP regulations.
FDA officials have confirmed Jungbunzlauer Ladenburg to be compliant with current Good Manufacturing Practice (cGMP) regulations. The recognition follows a three-day inspection of Ladenburg's production and warehouse management, as well as its quality control policy. cGMP compliance applies to all Ladenburg products, including tripotassium citrate, monosodium citrate, tricalcium citrate, potassium gluconate, sodium diacetate, Citro DC, CITROFOL and other specialty products.
"The successful FDA inspection underlines our top notch approach, which we pursue for our derivatives as much as for our main products. I am optimistic that the cGMP compliance for the Ladenburg products will further strengthen our position in the pharmaceutical market, in the United States like elsewhere", says Dr. Stefan Radi, VP Sales of the Jungbunzlauer Group.
The cGMP recognition comes one year after the FDA's registration of the Jungbunzlauer Ladenburg factory (Drug Master File DMF 14846). A specific Drug Master File was also submitted for tripotassium citrate (DMF 14847) last year. The cGMP recognition is valid for an indefinite length of time, but subject to regular control. The next FDA control is expected in 2003.
For further information please contact:
Jungbunzlauer Ladenburg GmbH
Dr. Gerhard Gerstner
Technical Service Manager