Introduction: Your Strategic Partner in API Production and CDMO Services
If you are seeking a reliable partner for API production, API services, and CDMO services, Lianhe Aigen offers you a fully integrated solution backed by decades of technical expertise and regulatory experience. As a professional API production company, we understand the challenges you face in developing, scaling, and commercializing your active pharmaceutical ingredients under strict timelines and compliance requirements.
At Lianhe Aigen, we position ourselves not just as a manufacturer, but as your strategic collaborator in the complex pharmaceutical supply chain. Whether you represent a global pharmaceutical enterprise or a fast-growing biotech company, you can rely on our agile project management, robust quality systems, and flexible production capabilities to support every stage of your molecule’s journey—from early development to commercial launch.
With a strong foundation in process chemistry and scale-up manufacturing, our API services are designed to shorten your development timelines, reduce technical risks, and ensure regulatory compliance. By partnering with Lianhe Aigen, you gain access to a complete portfolio of CDMO services that deliver both scientific and operational excellence across a wide range of therapeutic categories and molecule types.
Comprehensive API Production Capabilities
Your API project requires a production partner that combines deep chemistry know-how with operational flexibility. Lianhe Aigen delivers on both fronts. As your dedicated API production company, we provide fully integrated manufacturing solutions across our GMP-compliant facilities in China, supporting early-phase, late-phase, and commercial API production.
Our core expertise includes complex multi-step synthesis, fluorination, nitration, chiral synthesis, hydrogenation, enzymatic reactions, and high-pressure chemistry. You gain access to both small-scale and commercial-scale assets, including kilo labs, pilot plants, and multi-purpose production lines with capacities ranging from 100L to 10,000L. This enables seamless scale-up while maintaining process control and batch consistency.
Your molecules are handled with strict attention to regulatory compliance, including adherence to global GMP standards (ICH Q7, FDA, EMA). Our teams work closely with your technical experts to ensure your API is manufactured with precision, quality, and traceability, whether you're preparing for a Phase I IND filing or launching at commercial scale.
Customized API Services for Your Project Lifecycle
Every API project has unique technical challenges and regulatory milestones. At Lianhe Aigen, our API services are tailored to support your molecule from early-stage route scouting to regulatory filing. Whether you require route selection, impurity profiling, crystallization development, or analytical method validation, we provide expert support at each phase.
You benefit from a fully integrated project team that manages process research, optimization, scale-up, and validation activities. Our development centers are equipped with state-of-the-art instrumentation and staffed by experienced chemists who understand the nuances of drug substance development across a wide range of therapeutic areas.
We provide complete documentation packages aligned with regulatory expectations, including DMF preparation, CMC writing, and QbD-based risk assessment. With flexible engagement models, you can access our API services either as a standalone solution or as part of an end-to-end CDMO services partnership.
Integrated CDMO Services Tailored to Your Needs
If your goal is to streamline development timelines and reduce complexity, our integrated CDMO services offer you a one-stop solution. From route design and process scale-up to registration and commercial manufacturing, we align our operations with your objectives at every stage.
Our CDMO business model supports FFS (Fee-for-Service), FTE (Full-Time Equivalent), and strategic partnerships, depending on your needs. You can rely on us to manage multiple stages of your program within a single organization, reducing handoffs, mitigating risk, and enhancing data continuity.
Over the past two decades, we have supported dozens of global pharma and biotech companies in bringing their NCEs and specialty APIs to market. By choosing Lianhe Aigen for CDMO services, you gain a partner who is committed to operational transparency, scientific rigor, and on-time delivery.
Regulatory Compliance and Quality Assurance
Regulatory compliance is non-negotiable when selecting a partner for API production and CDMO services. At Lianhe Aigen, our quality systems are designed to meet the highest international standards. Our manufacturing sites are routinely inspected by US FDA, EMA, NMPA, and other global authorities.
Our Quality Management System (QMS) covers the full lifecycle of product development and manufacturing. You benefit from robust systems for deviation control, change management, analytical testing, raw material traceability, and documentation. We enforce strict standards for data integrity, electronic batch records, and compliance with ICH, USP, and Ph. Eur. requirements.
We are also deeply committed to environmental safety and occupational health (EHS). Our production practices align with global EHS guidelines, ensuring your project is handled responsibly throughout development and manufacturing.
Technology Platforms and Manufacturing Facilities
Your success depends on infrastructure that is scalable, flexible, and technology-enabled. At Lianhe Aigen, we operate multiple GMP-certified facilities across Zhejiang, Jiangsu, and other strategic locations, giving you access to redundant capacity, risk diversification, and logistical efficiency.
Our advanced technology platforms include flow chemistry, high-potency compound handling, cryogenic capabilities, and multi-step continuous processes. You can leverage these platforms to develop and produce complex molecules with improved safety, yield, and reproducibility.
We continuously invest in digital transformation and intelligent manufacturing systems. With real-time monitoring, automated control, and integrated MES systems, your product is manufactured with precision and reliability from lab to launch.
Partnership and Project Confidentiality
At Lianhe Aigen, we understand the importance of trust, confidentiality, and IP protection in CDMO partnerships. When you work with us, your project is protected under strict non-disclosure agreements, and your proprietary technologies remain fully secure throughout all phases of collaboration.
You can choose from various engagement models, including long-term strategic alliances, milestone-driven contracts, or flexible ad hoc service scopes. Our project governance structure ensures timely communication, clear deliverables, and full accountability.
We have earned the trust of many global pharma clients who return to us for multi-program engagements. Their continued partnerships are a testament to the value, reliability, and scientific excellence we bring to each collaboration.
Why Global Pharma and Biotech Companies Trust Lianhe Aigen
Choosing the right API production company is critical to your development success. At Lianhe Aigen, we provide the scientific capability, regulatory knowledge, operational scale, and customer-centric flexibility you need to accelerate your program and reduce risk.
Our end-to-end API services and CDMO services are designed to integrate seamlessly with your internal team, helping you stay focused on innovation while we handle the complexities of manufacturing and compliance.
If you’re ready to move your program forward with a trusted partner, we invite you to contact Lianhe Aigen today. Discover how our platform can support your molecule from discovery to market—with confidence, quality, and speed.
Synthetic Chemistry