WuXi STA
Integrated small molecule CRDMO services designed to accelerate drug development from preclinical to commercial.
Scalable Processes, Purpose-Drive Pace
Bringing a new therapy to market is a complex journey. We seamlessly integrate every stage of development, simplifying your molecule’s path to market, efficiently and safely.
Early-Stage Drug Substance Development
The foundation of successful small molecule drug development is an optimized chemical synthesis process.
Work with WuXi STA:
🔹 Route Scouting & Process Development – Identify the most efficient, scalable, and cost-effective synthetic pathway for your API.
🔹Lead Optimization & Preclinical Supply – Rapidly synthesize lead compounds and intermediates ensuring early-stage feasibility.
🔹 Custom Synthesis & Scale-Up – Develop robust, high-yield synthetic processes for clinical and commercial production.
API Development and Manufacturing
From Pilot-Scale to Commercial Supply partner with WuXi STA and seamless scale-up to GMP API production while ensuring consistent quality.
🔹 Flexible Manufacturing Capacity – From gram-scale to metric tons.
🔹 Advanced Technologies – Continuous flow chemistry, high-potency API (HPAPI) handling, and complex chemical synthesis capabilities.
🔹 Regulatory Compliance & Tech Transfer – cGMP manufacturing with global regulatory approvals (FDA, EMA, NMPA, etc.), ensuring seamless tech transfer.
Drug Product Development & Manufacturing
Formulation Expertise for Optimized Drug Delivery
Ensure optimal stability, and bioavailability with speed and consistency —
🔹 Oral Solid Dosage Forms – Tablets, capsules, and granules with specialized solubility enhancement and modified-release formulations.
🔹 Injectable Formulations – Sterile fill-finish, lyophilization, and pre-filled syringes for small molecules requiring parenteral administration.
🔹 Technology Transfer & Scale-Up – Seamless tech transfer from R&D to commercial manufacturing
Analytical & Regulatory Support
Assure compliance and help to expedite approvals in a complex global environment.
🔹 Analytical Method Development & Validation – Ensuring drug substance and drug product meet all required quality specifications.
🔹 Stability Studies & Quality Control – ICH-compliant stability testing, impurity profiling, and batch release testing.
🔹 Regulatory Filing Support – Assistance with IND, NDA, and BLA submissions for global markets, accelerating approvals.
Commercial Manufacturing & Lifecycle Management
Reliable, Large-Scale Production for Global Supply
🔹 Dedicated Commercial-Scale Facilities – Supporting high-volume API and drug product manufacturing with supply chain resilience.
🔹 Post-Approval Optimization – Continuous process improvement to enhance efficiency and reduce costs.
🔹 Lifecycle Management & CMC Support – Ensuring long-term regulatory compliance and global supply continuity.
Small molecules, Big Plans – Let our team help accelerate your molecule’s path to patients
Discover how our team customizes solutions that drive your success.
Featured Article
WuXi AppTec’s Changzhou and Taixing API Sites Successfully Pass FDA Inspections
Shanghai, China – April 1, 2025 — WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, today announced that its Active Pharmaceutical Ingredient (API) manufacturing sites at Changzhou and Taixing in Jiangsu province of China,
Webinar
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Work With Us:
📌 Collaborative, Agile, and Customized to Your Needs.
From early discovery to full-scale production — whether you’re seeking a partner for hit identification, process optimization, or full CRDMO services, we have the expertise, technology, and supply chain to support you
Quality & Compliance Assurance
We operate at the highest regulatory standards, ensuring your molecules meet global quality, safety, and compliance requirements throughout your product’s lifecycle.
Cost Optimization
Our strategic sourcing, process efficiency, and vertical integration reduce costs while ensuring high-quality outputs, helping you maximize value without compromising innovation.
Embracing Digital Transformation
We leverage Data driven analytics, real-time tracking, and digital procurement solutions to optimize processes, enhance visibility, and drive smarter decision-making.
