Drug Product
Company Overview
About
SteriMax Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Canada
Founded:2003
Employees:400
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Sterimax, Inc.
2770 Portland Dr, Oakville
Regulatory Approvals
Drug Approval 7ECCOW
EMA · #APR-Q7KJTQUT · 2021-05-01
Drug Approval US5Z99
FDA · #APR-RFPW0JXF · 2022-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ZJZXP8SR
Issued: 2020-08-15
Expires: 2025-08-27
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-WFUV7LP0
Issued: 2020-11-10
Expires: 2025-09-05
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-LEV70O3I
Issued: 2020-01-09
Expires: 2025-04-08
WHO GMP
World Health Organization
Cert #: CERT-L9ETDGFD
Issued: 2020-04-19
Expires: 2025-09-13
Loading CDMO intelligence...
Key facts about SteriMax Inc.
- SteriMax Inc. is headquartered in Canada.
- SteriMax Inc. was founded in 2003.
- SteriMax Inc. has 400 employees.
- SteriMax Inc. has one manufacturing site listed on CDMO Hub, in Oakville, Canada.
- SteriMax Inc.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
Find CDMOs like SteriMax Inc.
Directory pages this company appears in, each with the full list of matching manufacturers.