CDMO Custom Development & Manufacturing Service

CHU Pharma delivers professional full-chain pharmaceutical CDMO custom development and commercial manufacturing services targeting global overseas pharmaceutical markets. Supported by self-owned well-equipped R&D laboratories, professional technical R&D teams and standardized GMP-compliant production bases, we boast independent full-spectrum implementation capabilities covering API process development, formulation research, analytical method development and validation, stability study, pilot scale-up and large-scale commercial mass production.

1. **Core R&D Services** We conduct process route optimization, formulation screening & development, establishment and validation of analytical testing methods, impurity profiling research, quality specification formulation, registration-grade full-set stability studies for APIs and finished dosage forms of innovative drugs and generic drugs. We accept customized assignments including overseas clients’ process improvement, technical problem solving, compilation of technical documents for regulatory submission. Our quality system complies with mainstream pharmacopoeia standards including EP, USP, BP and CP, assisting overseas customers in smooth drug registration across multiple countries and regions.

2. **Manufacturing Implementation** We perform pilot process verification, process performance qualification and commercial-scale production under strict international GMP quality management system with full traceability throughout production. Our flexible capacity satisfies overseas clients’ demands at all stages, including clinical trial sample manufacturing, small-batch trial production and large-volume commercial supply, solving key challenges of R&D industrialization, capacity layout and compliant production for global pharmaceutical partners in one stop.

3. **Service Highlights** With years of in-depth experience in overseas pharmaceutical markets and thorough understanding of local pharmaceutical regulatory requirements worldwide, our core competitiveness lies in independent R&D strength. Rather than simple contract manufacturing, we participate deeply in early-stage product R&D design to provide customized, integrated and compliant turnkey solutions combining pharmaceutical research and production for global partners. ---