Jungbunzlauer Launches New Ingredients Platform
The portfolio stands for the excellence and sustainability of Jungbunzlauer’s products and services for the pharmaceutical industry which is reflected in the name, PharmaChoices@Jungbunzlauer Ingredients for high quality pharma products.
Oct 5 2010 --- To demonstrate our commitment as premium supplier for the pharmaceutical industry, Jungbunzlauer is officially launching a new ingredient platform, “PharmaChoices@Jungbunzlauer”.
With our unique range of products manufactured in plants in Europe and Canada, Jungbunzlauer can tackle three main pharmaceutical ingredient fields, namely excipients, intermediates and active pharmaceutical ingredients (API’s).
Top quality is first! Committed to our rigorous quality standards, the portfolio stands for the excellence and sustainability of Jungbunzlauer’s products and services for the pharmaceutical industry which is reflected in the name, PharmaChoices@Jungbunzlauer Ingredients for high quality pharma products.
API’s are produced at the cGMP production site in Ladenburg, Germany which is registered with German authorities (§67 AMG) as an API manufacturer and has continuously been found compliant with ICH Q7A and US FDA’s cGMP requirements since 2001.
As an additional PharmaChoices@Jungbunzlauer offering, the we can provide a “documentation & service package” for the specific regulatory needs linked to Jungbunzlauer’s products. These comprise open DMF in CTD format, stability data, letter of access to existing DMF and further services concerning change control and yearly updates.
Recent investments concerning API’s include the production of Citric Acid Anhydrous P250, a Ph.Eur./USP grade with US Drug Master File (DMF No. 23078) as well as the elaboration of an Active Substance Master File (ASMF) for the Ph.Eur./USP grade of Trimagnesium Citrate.
