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Amneal Pharmaceuticals vs Rotop Pharmaka GmbH

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CategoryAmneal PharmaceuticalsRotop Pharmaka GmbH
Listed sitecdmocdmo
SummaryU.S.-based biopharmaceutical company offering oral solid dosage, injectables, and API manufacturing with FDA-approved facilities across the U.S. and India, including advanced capabilities in lyophilization, aseptic processing, and oncology formulations.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
  • Oral Solid Dosage Manufacturing
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Vial Filling
  • Lyophilization (Freeze Drying)
  • API Synthesis & Manufacturing
  • Process Development
  • Formulation Development
  • Quality Control Testing
  • 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
  • Radiopharmaceutical
Indications
  • Oncology
  • Ophthalmology
  • Oncology
  • Cardiovascular
  • Nephrology
Locations
  • Rajoda, Ahmedabad, Gujarat, India
  • Matoda, Ahmedabad, Gujarat, India
  • Pipan, Ahmedabad, Gujarat, India
  • Palli, Ahmedabad, Gujarat, India
  • Raks, Dahej, Gujarat, India
  • Raks, Vizag, Andhra Pradesh, India
  • Commercial Offices, Mumbai, Maharashtra, India
  • Oncology Injectables, Hyderabad, Telangana, India
  • Administrative Offices, Ahmedabad, Gujarat, India
  • 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.