Pharmaceutical | Active Pharmaceutical Ingredients (APIs)

Active Pharmaceutical Ingredients (APIs)

Our API portfolio covers four different products which can be provided with access to our US drug master file (DMF) and/or certificate of suitability (CEP). Jungbunzlauer is constantly expanding its API portfolio according to the customers and markets needs. Please get in touch with us to get further information or to get a personal quote for one of our APIs.

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API	Registration status	Applications
Citric Acid Anhydrous	US DMF, USP CEP, Ph. Eur. GMP certificate	Bowel and colon cleansing Anti-heartburn (combination with sodium bicarbonate) Citrat source Acidifying agent Blood treatment
Tripotassium Citrate Monohydrate	US DMF, USP CEP, Ph. Eur. GMP certificate	Renal tubular acidosis Kidney-stone management Electrolyte replenishment Potassium deficiency (Hypocalemia) Cystitis Systemic alkaliser
Trimagnesium Citrate Anhydrous	CEP, Ph. Eur. GMP certificate	Constipation Magnesium deficiency Muscle function normalisation Laxative Magnesium supplement
Trisodium Citrate Dihydrate	US DMF, USP CEP, Ph. Eur. GMP certificate	Rehydration solution Electrolyte replenishment Laxative Acidifier

Quality Management

With our API products we provide detailed information and statements together with Regulatory Support, Technical Service as well as the option to perform Audits on a required basis.

Regulatory Support

Our experts in Regulatory Affairs are experienced in applying for and maintaining API registrations at the EDQM and the US-FDA and are currently expanding the API registrations outside Europe and the USA. We would appreciate to support your drug approval procedure with regulatory verified and up to date API documentation (CEP, US DMF).

Technical Service

With their expert knowledge, Jungbunzlauer’s Technical Service teams support our customers in resolving their commercial and technical challenges with solutions tailor-made to their individual requirements and with up-to-date technical information on our products.

Audits

Customer audits or third-party-audits can be arranged upon request. Our business partners can easily verify the high standards adherent to in our manufacturing processes.

Quality standards

GMP.

APIs are produced at the production site in Ladenburg, Germany which is registered with German authorities (§67 AMG) as an API manufacturer and is continuously found to be compliant to EU GMP Guide Part II and ICH Q7A (GMP) and US FDA’s cGMP requirements since 2001. GMP certificates for all four API’s are available.

GDP.

As an integral part of our GMP system in the production plant in Ladenburg, Germany, Good Distribution Practice (GDP) guidelines are followed for all APIs.