| Listed site | cdmo | both |
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| Summary | Fully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases. | Charles River Laboratories provides contract research, development, and manufacturing services across the full drug discovery and development continuum, supporting 80% of FDA-approved drugs over the past five years. |
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| Services | - API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Recombinant Protein Manufacturing
- Microbial Fermentation
- Upstream Processing
- Downstream Processing
- Biologics Development & Manufacturing
- Process Development
- Formulation Development
- Quality Control Testing
- Stability Testing & Storage
- CMC Analytical Development
- CMC Regulatory Submission Support
| - CMC Regulatory Submission Support
- Quality Control Testing
- Technology Transfer
- Formulation Development
- Process Development
- Cell Therapy Manufacturing
- Viral Vector Manufacturing
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- API Synthesis & Manufacturing
- Upstream Processing
- Downstream Processing
- CMC Analytical Development
- Stability Testing & Storage
- Cell-Line Development
- Microbial Fermentation
- Small Molecule Development & Manufacturing
- AAV Manufacturing
- Lentiviral Vector Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
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| Modalities | - Biologics (Monoclonal Antibodies)
- Biologics (Other)
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- AAV / Viral Vector Platform
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| Indications | - Oncology
- Immunology
- Metabolic
| - Oncology
- Immunology
- Neurology
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| Locations | - Headquarters, Bengaluru, Karnataka, India
- Manufacturing, Hyderabad, Telangana, India
- Manufacturing, Vizag, Andhra Pradesh, India
- Manufacturing, Johor, Johor, Malaysia
| - Headquarters, United States
- North America, North America, USA/Canada
- Europe, Europe, Multiple
- Asia, Asia, Multiple
- North America, North America
- Europe, Europe
- Asia, Asia
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| Certifications | - FDA · Identifier: US FDA
- EMA · Identifier: EMA
- PMDA · Identifier: PMDA, Japan
- Health Canada · Identifier: Health Canada
- COFEPRIS · Identifier: COFEPRIS, Mexico
- ANVISA · Identifier: ANVISA, Brazil
- MCC · Identifier: MCC, South Africa
- TGA · Identifier: TGA, Australia
- MFDS · Identifier: Ministry of Food and Drug Safety (MFDS), South Korea
- NPRA · Identifier: NPRA, Ministry of Health, Malaysia
| - FDA · Identifier: 100 IND submissions containing Retrogenix® platform data
- EMA · Identifier: 100 IND submissions containing Retrogenix® platform data
- PMDA · Identifier: 100 IND submissions containing Retrogenix® platform data
- EMA · Identifier: Retrogenix® platform data support
- PMDA · Identifier: Retrogenix® platform data support
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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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