BioDuro-Sundia, an Advent International portfolio company, is a trusted, leading contract research, development, and manufacturing organization (CRDMO).
Description
BioDuro, an Advent International portfolio company is a trusted, leading contract research development, and manufacturing organization (CRDMO) for 29 years. We provide our biotech and pharmaceutical partners with fully integrated services to support their efforts from target identification through to commercial drug product manufacturing. The company is based in the US with operations in China, totaling 2,000+ scientists and 7 global sites across 6 cities.
Core expertise includes small and large molecule discovery, development and scale-up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The one-stop-shop operation helps biotech and pharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes. We adhere to one global highest standard of compliance and business operation code. Science-driven, customer-oriented, flexible, people-focused culture enables us to provide top-tier integrated, fast and flexible tailored services to our customers to meet their unique needs and accelerate our development timeline.
For more information about BioDuro, please visit our website at www.bioduro-sundia.com
Type of Drugs Manufactured:
Small Molecule;Biologics
Which CDMO Services do you offer?:
Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Research & Development;Clinical Trials materials and logistics;Packaging;Regulatory Services;Analytical Development
No. of Manufacturing Facilities:
6-10
Please select any High Potent Products capabilities:
OEB 4-5
Facilities Locations:
North America;China
Regulatory Approvals for your facilities:
FDA (United States);ISO;GMP;NMPA (China)
Manufacturing Technologies:
Liquids;Semi-solids;Solids
Company Products and Services:
CMO/CDMO
Current Capacity:
Key starting materials and intermediates kg-t, API (up to 15 kg)
Certification
United States FDA, , GMP, ISO
Manufacturing Information
Drug Type
Small Molecule, Biologics
Capabilities
- Accelerated Stability Studies
- ADMET
- Analytical Services
- Animal Health
- Animal Model Services
- API Solubilization Technologies
- APIs (Active Pharmaceutical Ingredients)
- Assay Development
- Bioanalytical Services
- Bioavailability Studies
- Bioequivalence
- Biologics
- Blending
- Capsule
- cGMP Synthesis
- Chemistry (CMC)
- Chiral Separations
- Chromatography
- Cleaning Equipment
- Clinical Dose
- Clinical Packaging
- Clinical Studies
- Clinical Trial Materials
- Clinical Trials
- Combinatorial
- Computational
- Containment
- Contract Development
- Contract Development and Manufacturing (CDMO)
- Contract Research (CRO)
- Contract Sales
- Controlled Release
- Cytotoxic & High Potency Compounds
- Dissolution Testing
- Documentation Support Services
- Dosage Form Development
- Dose Form
- Drug Delivery Devices
- Drug Development
- Drug Screening
- Encapsulation
- Filling
- Finished Dosage Forms
- Fluid Bed Processing
- Forced Degradation Studies
- Formulation Development
- Generics
- High Throughput Screening
- Hot Melt Extrusion
- In Vitro Testing
- IND/NDA Submissions
- Inhalables
- Labelling
- Lead Optimization
- Library Synthesis
- Liquids
- Lot Release Testing
- Medicinal
- Metabolic Analysis
- Mixing & Blending
- Mixing and Granulating Equipment
- Non Sterile Dosage
- Nonclinical Research
- Nutraceuticals
- Oral Drug Delivery
- OTC
- Packaging
- Particle Size Analysis
- Pharmacodynamics
- Pharmacokinetics
- Pharmacology
- Photostability
- Physical Testing
- Pilot-Scale Filling
- Powders
- Preclinical Study Design
- Preclinical Testing
- Preformulation
- Process Development
- Process Validation Studies
- Project Management
- Quality QA/QC
- Raw Materials
- Raw Materials Analysis
- Regulatory Services
- Research & Development
- Scale-Up
- Shipping
- Size Reduction
- Solid Dosage
- Solutions & Suspensions
- Spray Drying
- Statistical Analysis
- Storage
- Supply Chain & Logistics
- Sustained Release
- Sustained Release Delivery Systems
- Tablet Coating
- Tablets
- Target Profiling
- Technology Transfer
- Testing
- Thermogravimetric Analysis
- Validation
- Warehousing
- X-Ray Powder Diffraction
Contact Information
Website
Phone
Email
Twitter (X)
Address
9601 Jeronimo Road
Zip/Post Code
92618
Facility Locations
United States, China
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