CDMO Services

Scope of Services

Scope of Services

CDMO Services

Business Field

Small molecule chemical APIs mRNA materials

Research & Development

Design, screen and optimize synthesis route, patent challenges, comprehensive quality studies


Clinical sample preparation, lab scale-up, pilot and process validation, commercial supplying


Provides regulatory affairs services in China, the United States, Europe and Japan

Technical Capability

Technical Capability

Production Lines

18 regular production lines, 6 independent lines for high potency and cytotoxic APIs DCS-SIS system, with dangerous reaction capabilities including hydrogenation, oxidation, chlorination, sulfonation, diazotization and alkylation
Capability of high pressure, high temperature, cryogenic reaction conditions Pressure range: 0~8MPa, temperature range: -100 ℃~250℃

Quality System

cGMP site inspection and approval by NMPA and USFDA;
Customer audits from Europe, USA and Japan.

Technology Platform

Asymmetric synthesis
Transition metal catalysis
Enzyme catalysis
Micro-channel continuous reaction

CDMO Services

Project Experience

Experienced in patent challenging on crystalline form & synthesis process
Experienced in synthetic route development and scale-up & quality research

International Registration

Experienced regulatory affairs team;
Obtained 3 CEPs, 3 JDMFs, and 5 US DMF/VMFs

Testing Instruments

HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc.

Cooperative Partner

Cooperative Partner

  • Coblopasvir Hydrochloride: NCE for Kawin. Qingmu is responsible for optimizing the process and quality research, clinical lots, pilot and process scale up, process validation, GMP inspection. The projects has been approved by NMPA in 2020 and under commercial supplying now.
  • One project is being registered in Europe.
  • One project for Japanese customer is under Phase II clinical trial.
  • Tens of generic drug projects are under validation or registration stage.