Excipients & Specialty Ingredients
Company Overview
About
Roquette is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:China
Founded:2005
Employees:2,594
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Roquette America, Inc.
1003 South 5th St., Keokuk, Iowa, 52632
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval GDLG3U
Health Canada · #APR-KWMCCLN7 · 2020-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-HKT8QPID
Issued: 2020-04-15
Expires: 2025-06-02
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-BA22P1M8
Issued: 2020-12-14
Expires: 2025-12-18
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-JXH0ORXF
Issued: 2020-03-28
Expires: 2025-05-01
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Key facts about Roquette
- Roquette is headquartered in China.
- Roquette was founded in 2005.
- Roquette has 2,594 employees.
- Roquette has one manufacturing site listed on CDMO Hub, in Keokuk, United States.
- Roquette's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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