Amarex Clinical Research, LLC
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Contract Research Organization
Regulatory, Tech Transfer & Support Services
Company Overview
About
Amarex Clinical Research, LLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2004
Employees:1,976
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Europe
Manufacturing Facilities
2 sites worldwide
Amarex Clinical Research, LLC
20201 Century Blvd Fl 4, Germantown, Maryland, 20874
Frontier Biotechnologies Inc. (Zhidao Road site)
8 Zhidao Road, Jiangning District, Nanjing, Jiangsu, 211122
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
Regulatory Approvals
Drug Approval DCXKLV
Health Canada · #APR-DJEX0RKU · 2022-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-JD62RDZK
Issued: 2020-03-17
Expires: 2025-04-09
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-OKT8KRCU
Issued: 2020-07-04
Expires: 2025-07-21
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-29N0TFFP
Issued: 2020-01-21
Expires: 2025-11-20
Health Canada GMP
Health Canada
Cert #: CERT-5313R77V
Issued: 2020-04-09
Expires: 2025-02-25
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Key facts about Amarex Clinical Research, LLC
- Amarex Clinical Research, LLC is headquartered in the United States.
- Amarex Clinical Research, LLC was founded in 2004.
- Amarex Clinical Research, LLC has 1,976 employees.
- Amarex Clinical Research, LLC has 2 manufacturing sites listed on CDMO Hub, in Germantown, United States and Nanjing, China.
- Amarex Clinical Research, LLC's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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