| Listed site | cdmo | cdmo |
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| Summary | Health Canada–approved and FDA-inspected cGMP contract manufacturer offering integrated drug discovery, development, and manufacturing services including custom synthesis, API production, formulation development, and sterile fill-finish for vials, syringes, and cartridges. | 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. |
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| Services | - CMC Analytical Development
- Formulation Development
- Process Development
- API Synthesis & Manufacturing
- HPAPI Manufacturing (High-Potency)
- Small Molecule Development & Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Cartridge Filling
- Sterile Fill-Finish & Aseptic Manufacturing
- Lyophilization (Freeze Drying)
- Stability Testing & Storage
- Extractables & Leachables Studies
- Quality Control Testing
- Flow Chemistry & Continuous Manufacturing
- Oligonucleotide Manufacturing
- Bioconjugation 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
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| Modalities | - Small Molecule
- Peptide
- Oligonucleotide
| - Small Molecule
- Biologics (Other)
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| Indications | | Data not yet provided. |
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| Locations | - Headquarters & Manufacturing, Toronto, Ontario, Canada
| - 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
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| Certifications | - Health Canada · Identifier: Health Canada Establishment License
- Health Canada · Identifier: Cannabis Analytical Test Licence
| - 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
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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