Dalton Pharma Services

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)