Jungbunzlauer Ladenburg GmbH receives certificate of GMP compliance
Jungbunzlauer Ladenburg recently received the certificate of GMP compliance of a manufacturer which was issued following an inspection according to Art. 111 (1) of Directive 2001/83/EC and corresponding German Drug Law (§64,1 AMG).
Active Pharmaceutical Ingredients (APIs) are produced at the Jungbunzlauer cGMP site in Ladenburg, Germany which has continuously been found compliant with ICH Q7A and US FDA’s cGMP requirements since 2001, based on FDA inspections and numerous third party pharma audits.
After a two-day inspection in May this year, the competent German authority concluded that Jungbunzlauer Ladenburg production site “complies with the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC and the principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC”.
The new GMP certificate resembles another milestone in Jungbunzlauer’s commitment as a premium supplier for the pharmaceutical industry within its ingredient platform “PharmaChoices@Jungbunzlauer” launched October 2010.
The inspection specifically focused on two API products, Tripotassium Citrate and Trimagnesium Citrate. With Tripotassium Citrate, Jungbunzlauer Ladenburg holds a Drug Master File (DMF #14847) and is registered with the US FDA since May 2000.
Further recent activities concerning APIs include the elaboration of a Certificate of Suitability (CEP) for the Ph.Eur. grade of Tripotassium Citrate which is scheduled to be filed by end of 2011.
For further information, please consult our dedicated PharmaChoices pages on our website or contact: