| Listed site | cdmo | cdmo |
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| Summary | 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. | Sterile injectable CDMO specializing in formulation development, lyophilization, fill/finish, and ADC manufacturing with cGMP-compliant facilities in the U.S. and Germany. |
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| 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
| - Formulation Development
- Lyophilization (Freeze Drying)
- Technology Transfer
- Sterile Fill-Finish & Aseptic Manufacturing
- CMC Analytical Development
- CMC Regulatory Submission Support
- Prefilled Syringe (PFS) Filling
- Vial Filling
- ADC (Antibody-Drug Conjugate) Manufacturing
- Vaccine Manufacturing
- HPAPI Manufacturing (High-Potency)
- Biologics Development & Manufacturing
- Stability Testing & Storage
- Bioconjugation Services
- Process Development
- Quality Control Testing
- Small Molecule Development & Manufacturing
- API Synthesis & Manufacturing
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| Modalities | - Small Molecule
- Biologics (Other)
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Antibody-Drug Conjugate (ADC)
- Vaccine
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| Indications | Data not yet provided. | Data not yet provided. |
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| 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
| - Bloomington, Bloomington, Indiana, USA
- Halle/Westfalen, Halle, Westfalen, Germany
- Bloomington, Bloomington, Indiana, United States
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| 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
| - ISO · Identifier: ISO 14001
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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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