Rotop Pharmaka GmbH
Profile
ROTOP Pharmaka GmbH, based in Dresden-Rossendorf, manufactures radiopharmaceuticals and cold kits for nuclear medicine and also offers these services as a contract development and manufacturing organisation (CDMO) partner for clients.
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 |
„Präkursor-Synthese/ API-Synthese“ Source · 10 Nov 2026 ↗ |
| Biologics and ATMP Manufacturing |
Unclear |
„Entwicklung von Theranostika und Cold Kits“ Source · 10 Nov 2026 ↗ |
| Stability testing Testing and analytics |
Evidenced |
„Qualitätskontrolle & Stabilitätstests“ Source · 10 Nov 2026 ↗ |
| External QP and batch certification Release and quality |
Evidenced |
„QP-Dienstleistungen (Qualified Person)“ Source · 10 Nov 2026 ↗ |
| Qualification and validation Engineering and validation |
Unclear |
„Prozess-Skalierung und cGMP-Herstellung (klinische Prüfpräparate und kommerzielle Produkte)“ Source · 10 Nov 2026 ↗ |
| GDP transport and storage Logistics |
Unclear |
„Globale Logistik“ 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_2024_0025
Dresden
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_0057
Dresden
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Bautzner Landstrasse 400
01328 Dresden