Benuvia Operations, LLC
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Benuvia Operations, LLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:United States
Founded:2009
Employees:3,049
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Benuvia Operations, LLC
3950 N Mays St, Round Rock, Texas, 78665
Site Capabilities
6 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
REPACK
Regulatory Approvals
Drug Approval 5XUZMZ
PMDA · #APR-A2AFIVZZ · 2021-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-7EYWRY3L
Issued: 2020-06-13
Expires: 2025-02-06
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-SUGOFP7Q
Issued: 2020-01-28
Expires: 2025-04-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-GXWLBLVV
Issued: 2020-02-05
Expires: 2025-07-28
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-ONALPHL9
Issued: 2020-09-25
Expires: 2025-02-02
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Key facts about Benuvia Operations, LLC
- Benuvia Operations, LLC is headquartered in the United States.
- Benuvia Operations, LLC was founded in 2009.
- Benuvia Operations, LLC has 3,049 employees.
- Benuvia Operations, LLC has one manufacturing site listed on CDMO Hub, in Round Rock, United States.
- Benuvia Operations, LLC's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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