[April 14, 2025] — Litchlab, a specialized CDMO dedicated to advanced drug delivery technologies and pharmaceutical raw materials, proudly announces the expansion of its Small Molecule Active Pharmaceutical Ingredient (API) R&D and GMP Manufacturing Platform, designed to support global pharmaceutical companies from preclinical development through commercial-scale production.
Small molecule APIs remain the backbone of therapeutic development, offering well-established pharmacokinetics and precise molecular targeting. Their versatility enables wide applications across oncology, infectious diseases, CNS disorders, metabolic syndromes, and immune-related conditions.
Litchlab’s API service platform focuses on robust process development and regulatory-compliant quality control, helping partners optimize synthetic pathways, accelerate clinical readiness, and streamline global regulatory submissions.
| Service Module | Core Capabilities |
|---|---|
| Process Development & Route Optimization | Synthetic pathway design, impurity profiling, and process safety assessment |
| Analytical Method Development & Validation | NMR, HPLC, LC-MS, GC, ICH-compliant stability studies |
| GMP Manufacturing & Scale-Up | Gram to multi-kilogram scale; FDA / EMA / NMPA GMP compliance |
| Regulatory Documentation Support | DMF compilation, batch release documentation, IND/NDA/ANDA filing |
| Project Management & Quality Assurance | QbD-driven lifecycle management and on-time delivery commitment |
✅ Process Safety & Risk Mitigation
Comprehensive hazard analysis including thermal risk, stability of intermediates, and by-product control for safe scale-up.
✅ Impurity Profiling & Control Strategy
Advanced impurity identification and root cause analysis to ensure batch-to-batch consistency and reduce regulatory risks.
✅ ICH Stability Testing
Accelerated and long-term stability studies aligned with ICH Q1A-F guidelines, supporting shelf-life determination and regulatory submission.
✅ Global Regulatory Compliance Expertise
Proven experience in supporting FDA, EMA, and NMPA filings, including DMF submissions and GMP inspection readiness.
Litchlab's API capabilities are already supporting:
✔️ Oncology APIs
✔️ Antiviral & Anti-Infective APIs
✔️ CNS (Central Nervous System) compounds
✔️ Metabolic disease APIs
✔️ High-Potency APIs (HPAPI) with containment-grade manufacturing
In addition, Litchlab offers seamless integration between API development and its advanced drug delivery systems, including liposomes, nanoparticles, and microspheres, enabling efficient tech transfer and shortened development timelines for complex formulations.
💡 Expertise + Reliability + Speed
Litchlab’s cross-disciplinary project teams — combining synthetic chemists, process engineers, analytical scientists, and regulatory experts — ensure scientific rigor and smooth transition from lab-scale to commercial manufacturing.
💡 Integrated Drug Product Development
Litchlab uniquely bridges small molecule API development with its proprietary drug delivery platforms, eliminating communication gaps and accelerating time-to-market.
From early discovery to market launch, Litchlab’s end-to-end services ensure safe, efficient, and regulatory-compliant small molecule API development for global pharmaceutical pipelines.
📧 Contact: RD1@litchlab.com
📞 Learn more at: 👉 [www.litchlab.com]
