Drug Product Manufacturing

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    2Y-Chem, Ltd.
  • Add: No.10, Lane 1000, Zhangheng Road, China (Shanghai) Pilot Free Trade Zone
  • Tel: 86-21-51320090
  • Email: info@2ychem.com
  • Web: www.2ychem.com

    2Y-Biopharma, Ltd.
  • Add: Jiangfeng Road, High-Technology Industrial Development Zone, Qidong, Nantong, Jiangsu, China
  • Tel: 86-0513-83266672-8001

Jiangsu Qidong GMP Manufacturing Site

Drug Product cGMP Manufacturing
Total area: ~140,000 square meters
Oral solid dosages: 4 independent manufacturing facilities; ~1 billion units per year
Semi-solid topical dosages: 3 independent manufacturing facilities; ~50 million tubes per year
Including hormone topical preparations.
Solid dispersions: small and large scale solid dispersion preparation lines
Formulation CMO: tablets, granules, hard capsules, powders, tablets [including anti-tumor drugs (contract manufacturing)]
Including anti-tumor drugs (OEB3/4) production facility.



cGMP Manufacturing for Drug Products

Pilot-scale Production and Registration Batch Manufacturing
Production of Clinical Trial Samples
Development and Production of Placebo
Commercial Production Entrusted by MAH (Marketing Authorization Holder)
Repackaging, Blinding, and Labeling of Clinical Samples
Transfer and Validation of Analytical Methods
Stability Studies

All services are supported by a dedicated technical and project management team.



Specialties

Micronization, Solid Dispersions, and Micro pellets
Spray Drying, Hot-melt Extrusion, and Freeze-drying Processes
Topical Semi-solid Formulations
Facilities for Ordinary Oral and Targeted Anti-tumor Solid Formulations



Drug manufacturing license:

Tablets, hard capsules, granules, powder, cream, ointment and gel, tablets [including anti-tumor drugs  (contract manufacturing)].