FDA-approved CDMO Partner – Regulatory-Compliant, Risk-Controlled, and Scalable Drug Substance Services

As a Manufacturer & Solution Provider, Lianhe Aigen offers integrated Drug Substance CDMO services with FDA-approved facilities, supporting global pharmaceutical companies from preclinical development to commercial API production.

Why FDA-approved CDMO Partner Matters

Choosing an FDA-approved CDMO Partner ensures that your drug development projects are executed under strict regulatory compliance, robust quality systems, and risk-controlled manufacturing processes.

Lianhe Aigen provides comprehensive Drug Substance CDMO services, covering:

• Preclinical API supply for early-stage drug candidates

• Clinical-stage API manufacturing for IND-enabling studies

• Commercial-scale API production for global markets

As a trusted Manufacturer & Solution Provider, we support seamless integration from R&D to commercial manufacturing, enabling regulatory-ready, high-quality, and scalable API supply.

Our FDA-approved CDMO Capabilities

Lianhe Aigen’s FDA-approved CDMO Partner services include:

• Preclinical API supply: supporting early-stage drug discovery under FDA inspection standards

• Clinical-stage API manufacturing: scalable and reproducible processes for clinical development

• Commercial-scale API production: reliable supply with full regulatory compliance

• Process development & optimization: reproducible, risk-controlled manufacturing for complex molecules

• Integrated CRDMO platform: seamless handover from RSM to Drug Substance to commercial API supply

Quality & Regulatory Compliance

Quality and compliance are at the core of our FDA-approved CDMO Partner service:

• Fully compliant with GxP regulations and ICH Q7 guidelines

• Facilities successfully inspected by FDA, EMA, PMDA, TGA, KFDA, NMPA

• Complete traceability of raw materials and intermediates

• Robust change control and deviation management

• Support for customer audits and regulatory filings

Our quality system ensures every batch is risk-controlled, consistent, and ready for regulatory submission.

Typical Project Scenarios

We deliver high-quality API manufacturing across project needs:

• Preclinical-stage API supply for small molecule candidates

• Clinical-stage drug substance manufacturing for IND-enabling studies

• Commercial-scale API production for regulatory-approved APIs

• Technology transfer and process scale-up for reproducible commercial manufacturing

Why Partner with Lianhe Aigen

As a Manufacturer & Solution Provider, we combine:

• End-to-end CRDMO capabilities covering RSM, Drug Substance, and commercial API stages

• Proven record with FDA and other international regulatory inspections

• Long-term, risk-controlled API supply for global pharmaceutical clients

• Experienced team in process development, quality assurance, and regulatory compliance

Partnering with Lianhe Aigen ensures your FDA-approved CDMO supply chain is robust, compliant, and capable of supporting critical projects from preclinical to commercial stages.

Accelerate your projects with a trusted FDA-approved CDMO Partner delivering preclinical to commercial API manufacturing.