Carbogen Amcis vs Rotop Pharmaka GmbH

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Category	Carbogen Amcis	Rotop Pharmaka GmbH
Listed site	cdmo	cdmo
Summary	Full-service CDMO offering integrated drug substance and sterile drug product development and manufacturing from early phase through commercialization, with specialized capabilities in API synthesis, process development, analytical services, and stability testing across multiple scales.	ROTOP is a leading radiopharmaceutical CDMO based in Dresden, Germany, offering end-to-end development and cGMP manufacturing of cold kits and ready-to-use radiopharmaceuticals for diagnostic imaging and therapy, with over 25 years of expertise and distribution to 40+ countries.
Services	API Synthesis & Manufacturing Process Development CMC Analytical Development Formulation Development Stability Testing & Storage Quality Control Testing Technology Transfer CMC Regulatory Submission Support Lyophilization (Freeze Drying) Flow Chemistry & Continuous Manufacturing HPAPI Manufacturing (High-Potency) ADC Payload & Linker Synthesis Bioconjugation Services Vial Filling Sterile Fill-Finish & Aseptic Manufacturing ADC (Antibody-Drug Conjugate) Manufacturing Small Molecule Development & Manufacturing Solid-State Chemistry & Polymorph Screening	API Synthesis & Manufacturing Formulation Development Process Development Lyophilization (Freeze Drying) Vial Filling Sterile Fill-Finish & Aseptic Manufacturing Quality Control Testing Stability Testing & Storage CMC Regulatory Submission Support EU EMA Regulatory Strategy US FDA Regulatory Strategy
Modalities	Small Molecule Antibody-Drug Conjugate (ADC)	Radiopharmaceutical
Indications	Data not yet provided.	Oncology Cardiovascular Nephrology
Locations	Bubendorf (Headquarters), Bubendorf, Basel-Landschaft, Switzerland Aarau, Aarau, Aargau, Switzerland Neuland, Hunzenschwil, Aargau, Switzerland Vionnaz, Vionnaz, Valais, Switzerland France, France, France United Kingdom, United Kingdom, United Kingdom Netherlands, Netherlands, Netherlands China, China, China Headquarters, Bubendorf, Basel-Landschaft, Switzerland Switzerland, Switzerland, Switzerland UK, UK, United Kingdom France, France, France Netherlands, Netherlands, Netherlands Shanghai, Shanghai, Shanghai, China	Headquarters, Dresden, Saxony, Germany Manufacturing Campus, Dresden-Rossendorf, Saxony, Germany
Certifications	NMPA · Identifier: GMP NMPA · Identifier: GMP Compliance NMPA · Identifier: GMP compliant NMPA · Identifier: GMP Compliance (Shanghai site, unannounced inspection, no observations) CIA · Identifier: Chemical Industries Association Recognition	Data not yet provided.
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