BioDuro (BioDuro-Sundia)
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
BioDuro (BioDuro-Sundia) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:2017
Employees:2,075
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Regulatory Approvals
Drug Approval CR6VU6
FDA · #APR-LCJSZJFP · 2021-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-Z6JETZOT
Issued: 2020-02-22
Expires: 2025-01-24
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-33IAK0GV
Issued: 2020-02-03
Expires: 2025-08-13
Health Canada GMP
Health Canada
Cert #: CERT-3RRNK787
Issued: 2020-05-26
Expires: 2025-07-02
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Key facts about BioDuro (BioDuro-Sundia)
- BioDuro (BioDuro-Sundia) is headquartered in the United States.
- BioDuro (BioDuro-Sundia) was founded in 2017.
- BioDuro (BioDuro-Sundia) has 2,075 employees.
- BioDuro (BioDuro-Sundia)'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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