Drug Product
Company Overview
About
Dalton Pharma Services is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Neurology
Quick Facts
HQ:Canada
Founded:2008
Employees:2,599
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Dalton Chemical Laboratories Inc
349 Wildcat Road, Toronto, Ontario M, 3J 2S3
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
PACK
STERILIZE
Regulatory Approvals
Drug Approval DC4R3X
FDA · #APR-J9YR5JCL · 2020-04-01
Drug Approval UBDA5X
Health Canada · #APR-HN1BIV7X · 2020-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-ZB23KH82
Issued: 2020-04-26
Expires: 2025-03-12
Health Canada GMP
Health Canada
Cert #: CERT-H99UROII
Issued: 2020-09-26
Expires: 2025-03-23
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-PL1H5O2L
Issued: 2020-02-07
Expires: 2025-06-15
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-99ESSHMD
Issued: 2020-05-16
Expires: 2025-01-16
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Key facts about Dalton Pharma Services
- Dalton Pharma Services is headquartered in Canada.
- Dalton Pharma Services was founded in 2008.
- Dalton Pharma Services has 2,599 employees.
- Dalton Pharma Services has one manufacturing site listed on CDMO Hub, in Toronto, Canada.
- Dalton Pharma Services's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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