{"id":3684,"date":"2025-06-09T13:32:35","date_gmt":"2025-06-09T13:32:35","guid":{"rendered":"https:\/\/jbl-test.brandpie.com\/?post_type=ingredient&p=3684"},"modified":"2025-10-01T09:59:35","modified_gmt":"2025-10-01T09:59:35","slug":"active-pharmaceutical-ingredients-apis","status":"publish","type":"ingredient","link":"https:\/\/www.jungbunzlauer.com\/de\/ingredient\/active-pharmaceutical-ingredients-apis\/","title":{"rendered":"Active Pharmaceutical Ingredients (APIs)"},"content":{"rendered":"\n
\n\t
\n\n
API<\/strong><\/th>Registration status<\/strong><\/th>Applications<\/strong><\/th><\/tr><\/thead>
Citric Acid
Anhydrous<\/a><\/strong><\/td>		US DMF, USP
CEP, Ph. Eur.
GMP certificate<\/td>		Bowel and colon cleansing
Anti-heartburn (combination with sodium bicarbonate)
Citrat source
Acidifying agent
Blood treatment<\/td><\/tr>
Tripotassium Citrate
Monohydrate<\/a><\/strong><\/td>		US DMF, USP
CEP, Ph. Eur.
GMP certificate<\/td>		Renal tubular acidosis
Kidney-stone management
Electrolyte replenishment
Potassium deficiency (Hypocalemia)
Cystitis
Systemic alkaliser<\/td><\/tr>
Trimagnesium Citrate
Anhydrous<\/a><\/strong><\/td>		CEP, Ph. Eur.
GMP certificate<\/td>		Constipation
Magnesium deficiency
Muscle function normalisation
Laxative
Magnesium supplement<\/td><\/tr>
Trisodium Citrate
Dihydrate<\/a><\/strong><\/td>		US DMF, USP
CEP, Ph. Eur.
GMP certificate<\/td>		Rehydration solution
Electrolyte replenishment
Laxative
Acidifier<\/td><\/tr><\/tbody><\/table><\/figure>\n\n<\/div>\n<\/div>\n\n\n\n\n
\n\t
\n\n\n
\n\t
\n\n\t\t\t\t\t
\n\t
\n\t\t\n\t\t\t\t\t

\n\t\t\t\tQuality Management\n\t\t\t<\/h2>\n\t\t\n\t\t\t\t\t
\n\t\t\t\t

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.<\/p>\n\n\t\t\t<\/div>\n\t\t\n\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n<\/div>\n\t\t\n\t<\/div>\n<\/div>\n\n\n\n\n\n\t\n
\n\t
\n\n\t\t
\n\t\t\n\t\t\t\n\t\t\t\n\t\n\n
\n\n\n\t
\n\t\t\t\t\t

\n\t\t\t\tRegulatory Support\n\t\t\t<\/h3>\n\t\t\n\t\t\t\t\t
\n
\n
\n

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).<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t\t\t<\/header>\n\n\t\n<\/div>\n\t\t\n\t\t\t\n\t\t\t\n\t\n\n

\n\n\n\t
\n\t\t\t\t\t

\n\t\t\t\tTechnical Support\n\t\t\t<\/h3>\n\t\t\n\t\t\t\t\t
\n
\n
\n

With their expert knowledge, Jungbunzlauer\u2019s Technical Support 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.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t\t\t<\/header>\n\n\t\n<\/div>\n\t\t\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\n\t\n\n

\n\n\n\t
\n\t\t\t\t\t

\n\t\t\t\tAudits\n\t\t\t<\/h3>\n\t\t\n\t\t\t\t\t
\n
\n
\n

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.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\t\t\t<\/header>\n\n\t\n<\/div>\n\t\t\t\t<\/div>\n\n\t<\/div>\n<\/div>\n\n<\/div>\n<\/div>\n\n\n\n\n

\n\t
\n\n\n
\n\t
\n\n\t\t\t\t\t
\n\t
\n\t\t\n\t\t\t\t\t

\n\t\t\t\tQuality standards\n\t\t\t<\/h2>\n\t\t\n\t\t\n\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n<\/div>\n\t\t\n\t<\/div>\n<\/div>\n\n\n\n\n\n\t\n
\n\t
\n\n\t\t
\n\t\t\n\t\t\t\n\t\t\t\n\t\n\n
\n\n\n\t
\n\t\t\t\t\t

\n\t\t\t\tGMP\n\t\t\t<\/h3>\n\t\t\n\t\t\t\t\t

APIs are produced at the production site in Ladenburg, Germany which is registered with German authorities (\u00a767 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\u2019s cGMP requirements since 2001. GMP certificates for all four API\u2019s are available.<\/p>\n<\/div>\n\t\t\t<\/header>\n\n\t\n<\/div>\n\t\t\n\t\t\t\n\t\t\t\n\t\n\n

\n\n\n\t
\n\t\t\t\t\t

\n\t\t\t\tGDP\n\t\t\t<\/h3>\n\t\t\n\t\t\t\t\t

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.<\/p>\n<\/div>\n\t\t\t<\/header>\n\n\t\n<\/div>\n\t\t\t\t<\/div>\n\n\t<\/div>\n<\/div>\n\n<\/div>\n<\/div>\n\n\n\n

<\/div>\n
\n\t
\n\n\n
\n\t
\n\n\t\t\t\t\t
\n\t
\n\t\t\n\t\t\t\t\t

\n\t\t\t\tRelated documents\n\t\t\t<\/h2>\n\t\t\n\t\t\n\t\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n<\/div>\n\t\t\n\t<\/div>\n<\/div>\n\n<\/div>\n<\/div>\n\n\n\n
<\/div>\n
\n\t
\n\t\t\n\n\t\t\t\t
\n\t\t\t\t\t\t\t\n\n\n
\n\n\t
\n\t\t
\n\t\t\t\t
    \n\t\t\t
  1. \n\tFolder\n<\/li>\n\t\t<\/ol>\n\t\t<\/div>\n\n\t\t

    \n\t\t\tProduct Range\n\t\t<\/h3>\n\t<\/header>\n\n\t