Sepax Bioscience / Sepax Technologies, Inc.
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Excipients & Specialty Ingredients
Analytical & Bioanalytical Services
Manufacturing & Lab Equipment
Company Overview
About
Sepax Bioscience / Sepax Technologies, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:1993
Employees:1,688
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval RK7JN2
Health Canada · #APR-FINGV1C1 · 2022-04-01
Drug Approval 61RNFV
EMA · #APR-E70PF2IV · 2021-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-9LQD8JAC
Issued: 2020-01-27
Expires: 2025-10-02
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-RN5TSNB5
Issued: 2020-12-02
Expires: 2025-09-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-G8LHKVUI
Issued: 2020-08-26
Expires: 2025-04-11
Health Canada GMP
Health Canada
Cert #: CERT-7L8I7KI7
Issued: 2020-06-11
Expires: 2025-08-11
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Key facts about Sepax Bioscience / Sepax Technologies, Inc.
- Sepax Bioscience / Sepax Technologies, Inc. is headquartered in the United States.
- Sepax Bioscience / Sepax Technologies, Inc. was founded in 1993.
- Sepax Bioscience / Sepax Technologies, Inc. has 1,688 employees.
- Sepax Bioscience / Sepax Technologies, Inc.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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