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Akums Drugs and Pharmaceuticals Ltd. vs Rotop Pharmaka GmbH

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CategoryAkums Drugs and Pharmaceuticals Ltd.Rotop Pharmaka GmbH
Listed sitecdmocdmo
SummaryIndia's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance.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
  • Technology Transfer
  • CMC Regulatory Submission Support
  • CMC Analytical Development
  • Stability Testing & Storage
  • Quality Control Testing
  • Oral Solid Dosage Manufacturing
  • Ophthalmic Manufacturing
  • Inhalation & Nasal Dosage Manufacturing
  • Topical & Semi-Solid Manufacturing
  • Vial Filling
  • Lyophilization (Freeze Drying)
  • Sterile Fill-Finish & Aseptic Manufacturing
  • API Synthesis & Manufacturing
  • 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
  • Biologics (Other)
  • Radiopharmaceutical
Indications
  • Respiratory
  • Dermatology
  • Ophthalmology
  • Oncology
  • Cardiovascular
  • Nephrology
Locations
  • Sterile Manufacturing Facility, Haridwar, India
  • Headquarters, Dresden, Saxony, Germany
  • Manufacturing Campus, Dresden-Rossendorf, Saxony, Germany
Certifications
  • WHO · Identifier: WHO-GMP
  • FDA · Identifier: USFDA
  • EMA · Identifier: EU-GMP
  • TGA · Identifier: TGA
Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.