Introduction: Your Trusted Partner for Contract API Manufacturing

If you are searching for a dependable partner for contract API manufacturing and CDMO services, Lianhe Aigen delivers comprehensive solutions tailored to your specific development and commercial needs. We support global pharmaceutical and biotechnology companies across every stage of the API lifecycle—from process development to commercial production.

With a strong foundation in synthetic chemistry, process scale-up, and regulatory compliance, we offer contract manufacturing solutions that meet your quality, speed, and cost requirements. You can count on our technical teams and GMP-compliant infrastructure to ensure your APIs are produced safely, efficiently, and to global standards.

Whether you are advancing a clinical candidate or launching a commercial product, our contract API manufacturing capabilities provide the flexibility and responsiveness your program demands.

End-to-End Contract API Manufacturing Services

Lianhe Aigen’s contract API manufacturing services are designed to support your project from early-phase development through to commercial supply. Our manufacturing model integrates process development, scale-up, validation, and GMP production, allowing you to streamline your operations and reduce risk.

You gain access to kilo labs, pilot plants, and multi-purpose commercial production lines equipped with capacities ranging from grams to multi-ton scale. Our infrastructure supports complex chemistries, including hydrogenation, halogenation, nitration, and cryogenic reactions, as well as high-potency compound handling.

Each project is supported by a cross-functional team that collaborates with your scientists and regulatory teams to ensure seamless execution, robust documentation, and inspection readiness. Our integrated project management model ensures full traceability, milestone control, and transparent reporting.

Integrated CDMO Services Tailored to Your Needs

Beyond manufacturing, Lianhe Aigen provides comprehensive CDMO services that align with your program goals. Whether you need support with route scouting, impurity profiling, analytical method validation, or regulatory documentation, we offer a complete platform that simplifies your supply chain.

Our CDMO services span early development, clinical supply, commercial manufacturing, and post-approval lifecycle management. You can engage us through flexible business models including fee-for-service (FFS), full-time equivalent (FTE), or long-term strategic collaboration. We support both innovator and generic drug pipelines across a broad range of therapeutic areas.

With our CDMO team managing development and manufacturing within a single organization, you benefit from faster tech transfer, reduced communication gaps, and more efficient program delivery.

Facilities and Quality Systems for Global Compliance

Our contract API manufacturing is conducted in GMP-certified facilities inspected by the US FDA, EMA, NMPA, and other global agencies. With over 500 m³ of reactor capacity and multiple production lines, we support flexible batch sizes and fast scale-up.

Our sites are equipped with advanced automation, cleanroom systems, solvent recovery units, and high-containment capabilities for potent APIs. Each facility operates under a robust Quality Management System (QMS) that ensures consistency, traceability, and regulatory alignment.

Our experienced QA and regulatory affairs teams work closely with your compliance teams to support inspections, DMF submissions, and global registrations. You receive full documentation packages and technical files in line with current regulatory expectations.

Technology Transfer and Project Management

Lianhe Aigen supports efficient technology transfer across your project lifecycle. Our structured protocols include technical data review, knowledge capture, process risk assessments, and validation planning. We ensure that process understanding is fully translated from your lab to our manufacturing sites.

You will work with a dedicated project manager who coordinates cross-functional communication, milestone tracking, and performance reporting. We maintain centralized project dashboards to ensure visibility and alignment at every stage.

With a proven track record of managing tech transfers for both clinical and commercial programs, you can trust our teams to reduce startup delays, mitigate scale-up risks, and maintain production continuity.

Why Choose Lianhe Aigen for Contract API Manufacturing

Choosing the right partner for contract API manufacturing is critical to the success of your pharmaceutical program. At Lianhe Aigen, we bring scientific depth, operational reliability, and regulatory expertise to every engagement.

You benefit from flexible scale, advanced technology platforms, and a collaborative approach that prioritizes your program’s success. Our consistent delivery and long-term client relationships reflect our commitment to quality, transparency, and customer satisfaction.

Whether you are seeking a CDMO for early development or need a commercial-scale partner, Lianhe Aigen provides the capabilities and responsiveness to support your goals.

Start Your Project with a Proven Contract API Manufacturer

If you are ready to advance your program with an experienced CDMO partner, Lianhe Aigen is here to support you. Our contract API manufacturing services and CDMO services provide a complete framework for accelerating development, reducing risk, and meeting global compliance requirements.

Contact our technical or business development team to learn how we can help bring your molecule from lab to market with confidence and precision.