Syngene International
Integrated CRDMO from discovery to commercial supply with 5,200+ scientists and 50,000L bioreactor capacity.
Listed on cro.directory
Innovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S. Headquartered in Bangalore, India.
Phases
Indications / Therapeutic Areas
Services
- Discovery Research
- Medicinal Chemistry
- Computational & In-Silico Drug Discovery
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- Safety Pharmacology
- GLP Toxicology
- Analytical Method Development & Validation
- Formulation Development
- Process Development
- CMC Analytical Development
- Small Molecule Development & Manufacturing
- API Synthesis & Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Prefilled Syringe (PFS) Filling
- Cell-Line Development
- Recombinant Protein Manufacturing
- Monoclonal Antibody (mAb) Manufacturing
- Biologics Development & Manufacturing
- Upstream Processing
- Downstream Processing
- Bioanalysis
- Peptide Manufacturing
- Oligonucleotide Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- Cell Therapy Manufacturing
- mRNA Manufacturing
- Translational Research
- High-Throughput Screening
- Genetic Toxicology
- Preclinical In Vitro Studies
- Preclinical In Vivo Studies
- In Vivo Efficacy Models
- In Vivo PK / PD Studies
- Carcinogenicity Studies
- DART (Reproductive & Developmental Toxicology)
- Specialized & Large-Animal Models
- LC-MS Bioanalysis (Small Molecule)
- Ligand-Binding Bioanalysis (Large Molecule)
- Immunogenicity Assays (ADA / NAb)
- Biomarker Assays
- Flow Cytometry Services
- Clinical Trial Services
- Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- Phase IV / Post-Marketing
- Clinical Operations
- Data Management & eClinical
- Biostatistics & Statistical Programming
- Pharmacovigilance & Drug Safety
- Medical Writing
- Central Laboratory Services
- Clinical Imaging Core Lab
- Regulatory Affairs
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- China NMPA Regulatory Strategy
- ICH Stability Studies
- Companion Diagnostics Development
- Microbiology Services
- Virology Services
- Immunology & Inflammation Services
- Oncology Specialty Services
- CNS Specialty Services
- Cardiovascular & Metabolic Specialty Services
- Pathology & Histology Services
- Genomics & Sequencing Services
- Proteomics Services
- Bioinformatics & Data Science
- Device & Combination Product Services
- HPAPI Manufacturing (High-Potency)
- Controlled Substance Manufacturing
- Flow Chemistry & Continuous Manufacturing
- Solid-State Chemistry & Polymorph Screening
- Microbial Fermentation
- ADC Payload & Linker Synthesis
- Bioconjugation Services
- Viral Vector Manufacturing
- AAV Manufacturing
- Lentiviral Vector Manufacturing
- Autologous Cell Therapy Manufacturing
- Allogeneic Cell Therapy Manufacturing
- Lipid Nanoparticle (LNP) Formulation
- Vaccine Manufacturing
- Microbiome / Live Biotherapeutic Manufacturing
- Cartridge Filling
- Lyophilization (Freeze Drying)
- Oral Solid Dosage Manufacturing
- Topical & Semi-Solid Manufacturing
- Inhalation & Nasal Dosage Manufacturing
- Ophthalmic Manufacturing
- Technology Transfer
- Quality Control Testing
- Stability Testing & Storage
- Extractables & Leachables Studies
- Secondary Packaging & Labeling
- Serialization & Track-and-Trace
Modalities
Technical specifications & accreditations
Accreditations
Infrastructure
About this organization
Overview
Syngene International is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services spanning early discovery to commercial supply. The organization serves top 20 pharma and biotech companies through customized end-to-end solutions that move beyond traditional service outsourcing into true collaborative partnerships.
Service Capabilities
Discovery Services span the entire spectrum of early-stage research from target identification onward.
Development Services encompass activities from preclinical through clinical trials, including regulatory support and quality control.
Manufacturing Services include cGMP-compliant facilities for clinical supplies and registration batches, with recent expansion of biologics manufacturing capacity.
Dedicated Centers offer dedicated multidisciplinary scientific teams supporting specialized research and development programs.
Infrastructure & Scale
Syngene operates world-class R&D and manufacturing facilities with 5,200+ scientists and multiple million square feet of infrastructure. The organization recently announced a new biologics facility in the U.S. designed to increase total single-use bioreactor capacity to 50,000 liters, supporting mid-to-large-scale clinical and commercial biologics manufacturing.
Recognition
Ranked #1 in India's pharma and biotech sector for sustainability, Syngene is recognized by TIME Magazine and Statista as one of the "World's Most Sustainable Companies, 2025."
Locations
Headquarters
Bangalore · Karnataka · India
U.S. Biologics Facility
United States
U.S. Biologics Facility
San Diego · California · United States
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