Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
Profile
ABX Advanced Biochemical Compounds GmbH, based in Radeberg, develops, synthesises and manufactures radiopharmaceuticals as well as precursors, active pharmaceutical ingredients and reference standards, including under contract manufacturing arrangements (CDMO/CMO), and supplies them worldwide.
Services
Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.
| Service | Status | EvidenceQuote from the company’s website (German) |
|---|---|---|
| API manufacturing Manufacturing |
Evidenced |
„From custom synthesis of precursors, APIs, and standards to cold kits and GMP manufacturing, we deliver tailored solutions“ Source · 10 Nov 2026 ↗ |
| Analytical method development and validation Testing and analytics |
Evidenced |
„Development of analytical methods based on CQA including a dedicated HPLC method being able to separate all radiochemical impurities“ Source · 10 Nov 2026 ↗ |
Official credentials
Manufacturing authorisation
The competent authority of the federal state authorises the site to manufacture, test or import medicinal products (Section 13 of the German Medicinal Products Act, AMG). Without this authorisation it may not do so.
DE_SN_01_MIA_2026_0040
Radeberg
DE_SN_01_MIA_2022_0020
Radeberg
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗GMP certificate
The authority has inspected the site and confirmed that it complies with Good Manufacturing Practice (GMP).
DE_SN_01_GMP_2025_0041
DE_SN_01_GMP_2026_0055
Radeberg
DE_SN_01_GMP_2026_0056
Radeberg
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Pillnitzer Strasse 1-7
01454 Radeberg
Heinrich-Glaeser-Strasse 10-14
01454 Radeberg
Heinrich-Gläser-Straße 10-14
01454 Radeberg