Litchlab, a Contract Development and Manufacturing Organization (CDMO) specializing in advanced drug delivery technologies, today announces the strategic expansion of its clinical Active Pharmaceutical Ingredient (API) services. The enhanced offering includes comprehensive support from process development and scale-up to GMP manufacturing and regulatory submissions, with a strong emphasis on green chemistry, continuous manufacturing, and global compliance.
As the biopharmaceutical industry increasingly seeks agile and compliant partners to accelerate clinical development, Litchlab responds with a vertically integrated API platform that bridges innovation, scalability, and regulatory expertise. According to industry reports, the global CDMO market for APIs is projected to exceed $140 billion by 2030, driven by growing clinical pipelines, rising outsourcing trends, and stricter regulatory expectations.
✔ Advanced Process Development
Route scouting and synthetic optimization for novel and known compounds
Application of QbD (Quality by Design) principles for robust, scalable processes
Integration of green chemistry approaches to minimize environmental impact
✔ GMP Manufacturing Infrastructure
Multi-purpose GMP suites for small to mid-scale API production (gram to kilogram)
Flexible batch and continuous flow systems (CFS) for high-purity, low-impurity synthesis
Expertise in highly potent APIs (HPAPIs) with containment up to OEB 5
✔ Regulatory & Compliance Services
IND/IMPD/CMC documentation support for FDA, EMA, NMPA
Full analytical method development, validation, and ICH stability studies
Audit-ready GMP facility with ISO certifications
✔ Technology-Driven Differentiation
Use of flow chemistry for cleaner synthesis and better scalability
Support for chiral chemistry, photo-redox catalysis, and biocatalytic transformations
Solid-state characterization including polymorph, salt, and co-crystal screening
With increasing attention to API sustainability and supply chain resilience, Litchlab’s platform integrates:
Green solvent selection and waste reduction protocols
Energy-efficient continuous flow systems
Local and global supply chain traceability
Litchlab’s clinical API services support small molecules, peptides, and nucleotide-based APIs across:
Oncology
CNS disorders
Infectious diseases
Rare and metabolic disorders
“At Litchlab, we recognize the critical role that high-quality API development plays in early clinical success,” said Dr. Li yu, Senior Director of API Services. “Our mission is to deliver chemistry that not only works but scales responsibly, enabling our clients to accelerate from lab to clinic with confidence.”
📞 Partner with Litchlab to bring your API program to life — efficiently and compliantly.
🔗 Learn more: www.litchlab.com
📧 Contact: sales@litchlab.com
