Drug Product
Analytical & Bioanalytical Services
Chemistry, Manufacturing and Controls
Company Overview
About
Simtra BioPharma Solutions is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1998
Employees:1,434
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
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Regulatory Approvals
Drug Approval WM3ZO8
Health Canada · #APR-O4N8VB4G · 2019-09-01
Drug Approval A9ERTV
EMA · #APR-7NE7S8HN · 2021-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-AE299JYJ
Issued: 2020-04-10
Expires: 2025-10-21
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-O8BR9HER
Issued: 2020-09-06
Expires: 2025-07-17
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-4VDOY5S4
Issued: 2020-11-04
Expires: 2025-09-03
Health Canada GMP
Health Canada
Cert #: CERT-3KHKUBWM
Issued: 2020-01-12
Expires: 2025-02-24
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Key facts about Simtra BioPharma Solutions
- Simtra BioPharma Solutions is headquartered in Germany.
- Simtra BioPharma Solutions was founded in 1998.
- Simtra BioPharma Solutions has 1,434 employees.
- Simtra BioPharma Solutions's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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