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MyBiotech GmbH vs Rotop Pharmaka GmbH

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CategoryMyBiotech GmbHRotop Pharmaka GmbH
Listed sitecdmocdmo
SummaryGermany-based CDMO specializing in nanoparticle formulation, process development, GMP manufacturing, and aseptic fill-finish for nanomedicines and advanced drug delivery products.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
  • Formulation Development
  • Process Development
  • CMC Analytical Development
  • Stability Testing & Storage
  • Quality Control Testing
  • Lyophilization (Freeze Drying)
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Technology Transfer
  • CMC Regulatory Submission Support
  • 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
ModalitiesData not yet provided.
  • Radiopharmaceutical
IndicationsData not yet provided.
  • Oncology
  • Cardiovascular
  • Nephrology
Locations
  • Headquarters, Überherrn, Saarland, Germany
  • Headquarters, Dresden, Saxony, Germany
  • Manufacturing Campus, Dresden-Rossendorf, Saxony, Germany
CertificationsData not yet provided.Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.