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 with us to get further information or to get a personal quote for one of our APIs.

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    APIRegistration statusApplications
    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.

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    Active Pharmaceutical Ingredients and Excipients

    Explore our comprehensive library of technical articles, applications cards, and other literature.

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