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Gland Pharma Limited vs Rotop Pharmaka GmbH

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CategoryGland Pharma LimitedRotop Pharmaka GmbH
Listed sitecdmocdmo
SummaryGland Pharma is a vertically integrated CDMO offering sterile injectable manufacturing across vials, lyophilized, prefilled syringes, and ophthalmic formats, with four cGMP-compliant formulation facilities and four API manufacturing units, supported by R&D capabilities in formulation, analytical, and process development.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
  • Formulation Development
  • CMC Analytical Development
  • Stability Testing & Storage
  • Vial Filling
  • Lyophilization (Freeze Drying)
  • Prefilled Syringe (PFS) Filling
  • Ophthalmic Manufacturing
  • Sterile Fill-Finish & Aseptic 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
IndicationsData not yet provided.
  • Oncology
  • Cardiovascular
  • Nephrology
Locations
  • Headquarters / Dundigal Formulation Facility, Hyderabad, Telangana, India
  • Pashamylaram Formulation Facility, Hyderabad, Telangana, India
  • Penems Formulation Facility, Hyderabad, Telangana, India
  • R&D Pilot Plant, Dundigal, Hyderabad, Telangana, India
  • Biotech Drug Substance Facility, Genome Valley, Hyderabad, Telangana, India
  • API Manufacturing Facility 1, Visakhapatnam, Andhra Pradesh, India
  • API Manufacturing Facility 2, Visakhapatnam, Andhra Pradesh, India
  • Oncology Facility, Visakhapatnam, Andhra Pradesh, India
  • Headquarters, Dresden, Saxony, Germany
  • Manufacturing Campus, Dresden-Rossendorf, Saxony, Germany
Certifications
  • FDA · Identifier: USFDA
  • MHRA · Identifier: MHRA
  • EMA · Identifier: EMA
  • ANVISA · Identifier: ANVISA
  • TGA · Identifier: TGA
  • BGV Hamburg · Identifier: BGV
  • WHO · Identifier: WHO
  • Health Canada · Identifier: Health Canada
  • MCC · Identifier: MCC
Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.