Excipients & Specialty Ingredients
Company Overview
About
HTL Biotechnology is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:France
Founded:1994
Employees:2,130
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Manufacturing Facilities
1 site worldwide
HTL
ZONE INDUSTRIELLE DE L AUMAILLERIE 7 RUE ALFRED KASTLER, Javene, 35133
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
Regulatory Approvals
Drug Approval Y7S13X
PMDA · #APR-GQ75319H · 2019-04-01
Drug Approval L9LBM2
EMA · #APR-TMXVZKQF · 2020-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-NO4QPBGC
Issued: 2020-03-20
Expires: 2025-06-04
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-SDA1B9FS
Issued: 2020-05-06
Expires: 2025-07-26
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-Q662J1ZI
Issued: 2020-05-02
Expires: 2025-01-21
WHO GMP
World Health Organization
Cert #: CERT-MVVQW3JW
Issued: 2020-11-06
Expires: 2025-05-28
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Key facts about HTL Biotechnology
- HTL Biotechnology is headquartered in France.
- HTL Biotechnology was founded in 1994.
- HTL Biotechnology has 2,130 employees.
- HTL Biotechnology has one manufacturing site listed on CDMO Hub, in Javene, France.
- HTL Biotechnology's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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