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
  • Fax: 86-0513-83266672-8005

GMP Drug Product Manufacturing Facilities:

Formulation CMO: Tablets, hard capsules, granules, powders, cream, ointment and gel;

Including anti-tumor drugs (OEB3/4) production facility.

GMP facilities ~13000 square meters


  • 7 independent Class D manufacturing areas
  • Oral solid dosages:
    • 4 areas, annual capacity: ~1 billion units
  • Semisolid topical dosages:
    • 2 area, annual capacity: ~ 40 million tubes
  • Solid dispersion: 1 area
  • GMP Warehouses of various storage conditions including cold storage.


  • Passed 2 joint State and Provincial NMPA on-site PAI and GMP inspections supporting NDA by MAH (Dec. 2021 and May 2022)
  • Passed >75 customer GMP audits (2019~2022), including Chinese, US and EU customers.
  • Passed 2 EU 3rd party QP remote GMP audit for clinical sample manufacturing. (Mar. 2021 and Oct. 2022)


cGMP Manufacturing Services for Drug Products:

Formulation scale up and registration batch production

Clinical sample preparations

Commercial drug product manufacturing for MAH

Analysis method transfer and validation

Micronization, pellets and solid dispersions

Spray drying; fluidized bed; lyophilization; hot-melt extrusion

Stability Study

Characteristics of semi-solid preparations for external use

General oral and targeted anti-tumor solid preparation facilities


Dosage forms: tablets, hard capsules, granules, powders, cream, ointment and gel