NEW: Jungbunzlauer offers Citric Acid with Drug Master File (DMF)
Jungbunzlauer’s site in Ladenburg, Germany now offers a new specialty pharma grade citric acid. It is registered at the US Food and Drug Administration (FDA) with a Drug Master File (DMF) to fulfil stringent pharmaceutical requirements, especially when citric acid is used as Active Pharmaceutical Ingredient (API).
Jungbunzlauer operates the world’s largest citric acid plant in Pernhofen, Austria with a very strong focus on large scale output of high quality food grade citric acid. A second large scale food grade plant produces citric acid in Port Colborne, Canada, since 2002. In contrast to these plants, the Jungbunzlauer facility in Ladenburg Germany is focused on smaller specialty products. With regard to pharmaceutical applications, Ladenburg had been inspected by the FDA which affirmed its production to be compliant with current Good Manufacturing Practice (cGMP). The Ladenburg plant follows the ICH Q7A guidelines for API and is registered with the US FDA since May 2000 with Drug Master File (DMF) No. 14847 for the product tripotassium citrate.
Since October 2009, the Jungbunzlauer site in Ladenburg now also holds a Drug Master File for citric acid under No. 23078 as assigned by the FDA. With this, Jungbunzlauer is the only supplier world-wide offering citric acid with a US DMF. Additionally, a specific pharmaceutical service package for citric acid with DMF will support new drug applications or revisions with the authorities.
In order to keep the DMF active, its holders should update their DMF annually. An overview of the DMF in general and of the active status of Jungbunzlauer DMF No. 23078 in particular can be viewed at the following URL address: http://www.fda.gov/cder/dmf/
This new DMF is an important milestone for Jungbunzlauer and its Ladenburg site and shows both our commitment and our dedication to grow with specialty products and services for customers in the most demanding market segments.