Introduction: Lianhe Aigen as a Small Molecule API Manufacturer

If you are seeking a reliable small molecule API manufacturer to support your pharmaceutical development pipeline, Lianhe Aigen offers a fully integrated platform that meets your requirements from early-stage development to commercial supply. As a professional provider of small molecule API manufacture services, we serve global pharma and biotech companies with customized, scalable, and compliant API production solutions.

With decades of expertise in process chemistry, analytical development, and regulatory compliance, we understand the complexities you face in advancing small molecule therapeutics. You can rely on our experienced teams, state-of-the-art manufacturing infrastructure, and robust quality systems to ensure that your APIs are delivered on time, at the right scale, and to global GMP standards.

Whether you require kilogram-scale materials for preclinical development or ton-scale GMP batches for market launch, our capabilities in small molecule API manufacture ensure flexibility and quality across all stages of development.

Small Molecule API Manufacture Services from Development to Commercial Scale

At Lianhe Aigen, our small molecule API manufacture services are structured to support your entire drug development cycle. From initial route design and process optimization to scale-up, validation, and commercial production, we offer a single-source solution that adapts to your technical and regulatory needs.

You can engage with us at any stage—whether your molecule is in discovery, IND-enabling studies, Phase I–III clinical trials, or ready for commercialization. Our flexible infrastructure includes kilo labs, pilot plants, and multi-purpose GMP manufacturing lines, allowing seamless scale-up and rapid response to evolving project requirements.

Our dedicated project teams ensure close coordination with your scientists, ensuring technical transparency, milestone tracking, and alignment with your regulatory timelines. This end-to-end support structure enables you to reduce tech transfer risks, optimize manufacturing costs, and accelerate market entry.

Custom Process Development for Small Molecule APIs

Your small molecule project may involve complex synthetic challenges, impurity control requirements, or specific polymorph and crystallization considerations. Lianhe Aigen offers custom process development services that address these challenges with scientific rigor and regulatory foresight.

Our chemists and engineers specialize in route scouting, process intensification, impurity profiling, crystallization development, and analytical method validation. We apply QbD principles and risk-based approaches to build scalable, robust, and economically viable processes tailored to your compound’s characteristics.

You will benefit from our experience across multiple chemical platforms, including hydrogenation, halogenation, asymmetric synthesis, Grignard, nitration, fluorination, enzymatic reactions, and high-potency handling. Every process we deliver is designed to minimize environmental impact, ensure reproducibility, and facilitate regulatory approval.

GMP Manufacturing Facilities and Global Compliance

Our small molecule API manufacturing infrastructure spans several GMP-certified production sites across China, designed to meet the requirements of global regulatory agencies including the US FDA, EMA, NMPA, and PMDA. With over 500 m³ of reactor capacity and modular multi-product lines, we ensure efficient and risk-controlled production at every scale.

Our facilities include high-containment areas for HPAPIs, cryogenic systems, cleanrooms, solvent recovery units, and full automation for process control. Each site operates under an integrated Quality Management System (QMS), ensuring consistent execution, documentation, and release of your small molecule APIs.

You can count on our regulatory affairs team to support DMF filings, CMC documentation, and regulatory inspections worldwide. We prioritize audit readiness, data integrity, and transparency to help you navigate complex global compliance requirements.

Flexible CDMO Services to Accelerate Your Pipeline

As part of our broader service offering, Lianhe Aigen provides end-to-end CDMO services that integrate seamlessly with our API manufacturing platform. You can consolidate your development and manufacturing activities with one trusted partner—reducing handovers, enhancing efficiency, and accelerating your project timelines.

Our CDMO offering spans FTE-based collaboration, fee-for-service contracts, and long-term partnerships, allowing you to tailor engagement models to your internal resource strategy. You retain full control over your IP and data, while we provide responsive and technically sound solutions across early and late development.

From synthetic route optimization to scale-up, regulatory support, and post-approval supply, our CDMO services are built around your molecule’s lifecycle needs. You gain flexibility, speed, and cost control—delivered with scientific discipline and operational excellence.

Quality, EHS, and Regulatory Assurance

Your small molecule API project depends on the assurance of quality, safety, and compliance. Our integrated quality systems cover every aspect of development and manufacturing, from raw material sourcing to final product release. You can rely on our full traceability, rigorous documentation, and validated methods for complete confidence.

We follow international EHS standards and implement best practices for occupational health, waste management, and energy efficiency. Our commitment to responsible manufacturing supports your ESG goals and ensures regulatory alignment in every major market.

Through regular internal audits, continuous training, and digital quality tracking, we maintain inspection readiness and global compliance across all projects. You benefit from reliable quality outputs and reduced regulatory risk.

Integrated Supply Chain & Technology Transfer Capabilities

We understand that supply continuity and tech transfer efficiency are critical to your program’s success. Our integrated supply chain services include raw material qualification, vendor management, safety stock planning, and global logistics coordination.

You also benefit from our proven technology transfer protocols, which enable rapid handover between development and manufacturing teams. Our technology transfer specialists ensure alignment in process understanding, documentation, validation strategy, and quality requirements.

With multi-site capabilities and standardized practices, we offer reliable transfer options across our own facilities or to your chosen partners—supporting global launch, tech redundancy, or market expansion.

Why Pharmaceutical and Biotech Companies Choose Lianhe Aigen

Global pharma and biotech clients choose Lianhe Aigen for our technical expertise, regulatory experience, and operational flexibility. As a trusted small molecule API manufacturer, we bring transparency, responsiveness, and scientific strength to every collaboration.

Our strong track record in delivering development and commercial-scale projects—combined with robust infrastructure and deep customer focus—positions us as a long-term partner you can rely on. You gain reduced development timelines, improved cost efficiency, and global compliance assurance.

If you're looking for a CDMO partner who understands your business goals and delivers on your expectations, Lianhe Aigen is ready to support your success.

Start Your Project with a Trusted Small Molecule API Manufacturer

We invite you to connect with our business development and technical teams to explore how our small molecule API manufacture services and CDMO services can support your next development or commercial program. Contact us to learn more about our capabilities, request a proposal, or arrange a technical discussion.