Regulatory, Tech Transfer & Support Services
Company Overview
About
Kinaxis is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Canada
Founded:1991
Employees:1,824
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
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval R42DXQ
EMA · #APR-TD8H9243 · 2021-04-01
Drug Approval FCX8YS
Health Canada · #APR-31T220WH · 2018-10-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ZMLPN4XD
Issued: 2020-07-22
Expires: 2025-02-05
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GCHI23X7
Issued: 2020-02-16
Expires: 2025-04-13
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-3Y9OTYP7
Issued: 2020-01-05
Expires: 2025-07-26
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-GCXLQ746
Issued: 2020-07-25
Expires: 2025-11-27
Loading CDMO intelligence...
Key facts about Kinaxis
- Kinaxis is headquartered in Canada.
- Kinaxis was founded in 1991.
- Kinaxis has 1,824 employees.
- Kinaxis's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
Find CDMOs like Kinaxis
Directory pages this company appears in, each with the full list of matching manufacturers.