Description
Dalton Pharma Services, a subsidiary of Seikagaku Corporation Japan, is a FDA Registered & Health Canada licenced North American CDMO. At Dalton Pharma Services, we pride ourselves as an integrated
drug discovery, quality orientated company providing pharmaceutical development and manufacturing services. Our core competencies include formulation development, cGMP manufacturing of API, sterile/non-sterile liquid and powder filling.
Type of Drugs Manufactured:
Small Molecule;Medical Devices
CDMO Services :
Drug Substance Manufacturing (API);Drug Product Formulation (FDF);Aseptic Fill Finish;Research & Development;Clinical Trials materials and logistics;Analytical Development
No. of Manufacturing Facilities:
1
High Potent Products capabilities:
OEB 3
Facilities Locations:
North America
Regulatory Approvals for facilities:
FDA (United States);GMP;Health Canada
Manufacturing Technologies:
Liquids;Solids;Sterile Vials
Current Capacity:
Synthesis (API):
Batch size: up to 100 L, 1-5kg
Compound Class: Cat 1-3, Cat 3+ (up to 100 g batch)
Process: 1-5 steps, various temperatures.
Reaction Type: oxidation, reduction, transition, elimination, addition, acid, heat…all for small molecules
Liquid Fill
up to 10,000 units/run
Vial size: 2-20 mL
Powder Fill:
up to 1,100 units (sterile);up to 2,500 (non-sterile)
Capabilities
- Accelerated Stability Studies
- Analytical Services
- Animal Health
- Antibody-Drug Conjugates
- APIs (Active Pharmaceutical Ingredients)
- Asceptic Fill-Finish
- Assay Development
- Biologics
- Capsule
- cGMP Synthesis
- Chemical Analysis
- Chemistry (CMC)
- Chiral Separations
- Clinical Dose
- Clinical Packaging
- Clinical Trial Materials
- Clinical Trials
- Combinatorial
- Containment
- Contract Development
- Contract Development and Manufacturing (CDMO)
- Contract Research (CRO)
- Controlled Release
- Controlled Substances
- Custom Manufacturing
- Custom Synthesis
- Dosage Form Development
- Dose Form
- Drug Development
- Ethical
- Excipients
- Filling
- Filtration
- Forced Degradation Studies
- Formulation Development
- Generics
- ICH
- Injectables
- Large Volume
- Lipids/Phospholipids
- Liquids
- Lyophilization
- Mass Spectrometry
- Medicinal
- Microbiological Testing
- Non Sterile Dosage
- Nonclinical Research
- OTC
- Packaging
- Parenterals
- Parenterals Development
- Photostability
- Physical Testing
- Pilot-Scale Filling
- Powders
- Preclinical Testing
- Preformulation
- Process Characterization
- Process Development
- Process Validation Studies
- Protein and Peptide
- Purification
- Quality QA/QC
- Raw Materials
- Raw Materials Analysis
- Regulatory Services
- Research & Development
- Scale-Up
- Solid Dosage
- Solutions & Suspensions
- Stability Studies
- Sterile
- Sterile Filling
- Sustained Release
- Syringe
- Tablets
- Vaccines
- Validation
- Vials
- Wet Chemical Analysis
Contact Information
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