Drug Product
Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
Actylis is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Canada
Founded:1990
Employees:3,008
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
A & C American Chemicals Ltd
3010 rue de Baene, Saint Laurent, Quebec H, 4S 1L2
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
LABEL
PACK
REPACK
Regulatory Approvals
Drug Approval 0D50QY
FDA · #APR-718JE3MZ · 2021-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-LJTOAQ36
Issued: 2020-08-22
Expires: 2025-11-26
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-IJLEL0PB
Issued: 2020-07-05
Expires: 2025-04-13
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-GVSPUR57
Issued: 2020-03-28
Expires: 2025-06-22
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-UX0P8AHF
Issued: 2020-10-12
Expires: 2025-01-23
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Key facts about Actylis
- Actylis is headquartered in Canada.
- Actylis was founded in 1990.
- Actylis has 3,008 employees.
- Actylis has one manufacturing site listed on CDMO Hub, in Saint Laurent, Canada.
- Actylis's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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