Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Fortex Nutraceuticals Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Bulgaria
Founded:1992
Employees:2,836
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval EAORN6
EMA · #APR-RGIZBYO8 · 2021-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-VYDDAT6M
Issued: 2020-09-09
Expires: 2025-06-24
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-22DPM4IC
Issued: 2020-09-27
Expires: 2025-07-16
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-LSVVPDZ3
Issued: 2020-09-25
Expires: 2025-04-14
WHO GMP
World Health Organization
Cert #: CERT-YUJ6RSQC
Issued: 2020-02-05
Expires: 2025-07-21
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Key facts about Fortex Nutraceuticals Ltd.
- Fortex Nutraceuticals Ltd. is headquartered in Bulgaria.
- Fortex Nutraceuticals Ltd. was founded in 1992.
- Fortex Nutraceuticals Ltd. has 2,836 employees.
- Fortex Nutraceuticals Ltd.'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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