GMP-Certified API Manufacturing You Can Trust

When you partner with an API GMP certified factory, your organization depends on consistent quality, global regulatory compliance, and secure API supply. Lianhe Aigen is an established API GMP certified manufacturer with multiple production sites that comply with international cGMP standards. Our manufacturing network supports your project from clinical development to commercial scale.

With certifications from authorities including the US FDA, EMA, NMPA, and PMDA, we provide the compliance framework and audit readiness your business requires. Our full-service approach ensures transparency, validated quality systems, and reliable product delivery—whether your goal is IND-enabling studies or ongoing commercial supply.

Explore our API manufacturing and CDMO services.

Facilities Built for API GMP Certified Production

Lianhe Aigen’s production infrastructure includes several API GMP certified sites with over 500 m³ of reactor capacity. Our facilities are equipped for small molecule API production, high-potency APIs (HPAPIs), and specialized synthesis processes. Each site operates under a centralized quality management system, ensuring reproducibility and regulatory consistency across batches.

You will benefit from modern automation, high-containment environments, cleanroom areas, solvent recovery systems, and full traceability from raw materials to finished APIs. Our teams follow rigorous cleaning validation, change control, and deviation investigation protocols.

For each project, we ensure tech transfer, scale-up, and batch production are executed according to cGMP standards, helping you meet your quality goals and regulatory obligations.

Regulatory Compliance and Global Audit Support

Our status as an API GMP certified manufacturer is reinforced by successful inspections from global regulatory bodies. You gain access to fully documented APIs backed by Drug Master Files (DMFs), CMC support, and ICH-compliant data packages.

Whether your APIs are destined for the US, EU, Japan, China, or other regulated markets, we ensure compliance with relevant guidelines including ICH Q7, Q8, Q9, and Q10. Our regulatory affairs team works directly with your RA team to support audits, address queries, and manage regulatory correspondence.

Our facilities undergo regular internal and external audits, ensuring continuous improvement and alignment with evolving global standards.

Integrated Quality Systems for API GMP Certified Operations

Your project benefits from our mature Quality Management System (QMS) which is fully aligned with API GMP certified operations. This includes validated SOPs, change management, deviation tracking, OOS investigations, batch record review, and analytical method validation.

All raw materials, intermediates, and APIs are tested in on-site QC labs equipped with advanced instrumentation, including HPLC, GC, LC-MS, ICP-MS, and microbiological platforms. You can trust the data integrity and documentation we deliver.

By maintaining robust quality and EHS programs, we ensure safety, compliance, and continuity across all production campaigns.

Why Lianhe Aigen as Your API GMP Certified Factory

Choosing Lianhe Aigen as your API GMP certified factory means partnering with a reliable, transparent, and highly capable manufacturer. Pharmaceutical and biotech companies worldwide trust us for:

Fully audited GMP-certified facilities
Support for IND, NDA, ANDA, and post-approval supply
High-potency and complex API synthesis
Dedicated project and regulatory support
Consistent quality and supply chain reliability

We bring the experience, infrastructure, and integrity to ensure your product success through every phase of development and commercialization.

Take the Next Step – Connect with Our GMP Manufacturing Team

If your program requires a qualified API GMP certified partner, Lianhe Aigen is ready to help. Our team is available to discuss your project needs and demonstrate how we can support your clinical or commercial success.