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Ascendiacdmo vs Gland Pharma Limited

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CategoryAscendiacdmoGland Pharma Limited
Listed sitecdmocdmo
SummaryAscendia is a specialty CDMO offering formulation development, analytical services, and cGMP manufacturing for small molecules, biologics, and gene delivery therapies, with proprietary nanotechnologies for solubility and bioavailability enhancement.Gland 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.
Services
  • Formulation Development
  • CMC Analytical Development
  • Stability Testing & Storage
  • Process Development
  • Technology Transfer
  • CMC Regulatory Submission Support
  • Oral Solid Dosage Manufacturing
  • Lyophilization (Freeze Drying)
  • Vial Filling
  • Sterile Fill-Finish & Aseptic Manufacturing
  • Prefilled Syringe (PFS) Filling
  • 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
Modalities
  • Small Molecule
  • Biologics (Other)
  • Gene Therapy
  • Small Molecule
  • Biologics (Other)
IndicationsData not yet provided.Data not yet provided.
Locations
  • Headquarters & Manufacturing, New Jersey, New Jersey, United States
  • 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
CertificationsData not yet provided.
  • 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
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.