Company Overview
Founded in 2022, BiochemAPI is a leading Contract Development and Manufacturing Organization (CDMO) specializing in bio/chemical synthesis, process development, and API production for innovative drugs. Our highly experienced team, composed of industry veterans from WuXi AppTec, Covance, and other top-tier CROs/CDMOs, represents one of China's earliest groups to pioneer nucleic acid drug process development and CMC research.
With over a decade of expertise in pharmaceutical development, we possess unparalleled experience in project execution, regulatory compliance, and product registration. Our state-of-the-art facilities and dedicated scientists work collaboratively to deliver exceptional quality and value to our global clients.
Core Competencies
End-to-End CDMO Services
From discovery to commercialization, we provide custom synthesis, process optimization, analytical development, scale-up, and GMP manufacturing of high-purity APIs (including oligonucleotides, peptides, and small molecules).
Industry-Leading Oligonucleotide CDMO Platform
Equipped with cutting-edge facilities and a mature workflow system, we support efficient, cost-effective production of nucleic acid therapeutics with exceptional purity and yield.
Proven Regulatory Expertise
Our team has successfully assisted clients in IND/NDA filings across China, the US, and Europe, ensuring accelerated timelines and reduced development risks through comprehensive regulatory guidance.
Strategic Global Partnerships
We collaborate closely with pharmaceutical and biotech companies worldwide, delivering high-quality, scalable, and compliant API solutions tailored to each client's specific needs.
Our Team
BiochemAPI's leadership and scientific teams comprise industry veterans with extensive experience from leading global pharmaceutical companies and CROs/CDMOs. Our experts, many with PhDs in relevant fields, bring specialized knowledge in oligonucleotide synthesis, peptide chemistry, analytical development, and regulatory affairs. This blend of expertise enables us to tackle complex challenges and deliver innovative solutions.
Our Mission
By combining scientific excellence, operational efficiency, and regulatory acumen, BiochemAPI is committed to shortening R&D cycles, lowering trial costs, and accelerating drug commercialization. Our vision is to enable faster, safer, and more accessible therapies through best-in-class CDMO services.
Partner with BiochemAPI – Where Innovation Meets Reliability.
Key Highlights
Team Background
Our team includes WuXi AppTec and Covance alumni who were among the early pioneers in nucleic acid drug CMC development in China, bringing unmatched experience to every project.
Technical Edge
Our oligonucleotide CDMO leadership and GMP-compliant API production capabilities set us apart with advanced manufacturing processes and analytical technologies.
Regulatory Strength
We've successfully supported numerous IND/NDA submissions in major markets, leveraging our deep understanding of global regulatory requirements.
Global Focus
As a trusted partner for international clients, we maintain rigorous quality standards and transparent communication throughout each collaboration.