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

Contact Information

Address
9601 Jeronimo Road
Zip/Post Code
92618
Facility Locations
United States, China

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