[April 14, 2025] — Litchlab, a specialized Contract Development and Manufacturing Organization (CDMO), proudly announces the expansion of its Active Pharmaceutical Ingredient (API) services, offering an integrated solution for pharmaceutical innovators seeking reliable partners from early-stage development to GMP-grade production.
Litchlab’s API platform is designed to handle the increasing complexity of modern therapeutics — from synthetic small molecules to sophisticated biologically active compounds — while maintaining the highest standards of quality, regulatory compliance, and scalability.
Litchlab’s API services cover a wide range of molecule types to meet the evolving needs of drug development pipelines:
| API Type | Key Strengths | Therapeutic Application |
|---|---|---|
| Small Molecule APIs | Route scouting, impurity profiling, scale-up & GMP production | Oncology, anti-infectives, CNS |
| Peptide APIs | Solid-phase & liquid-phase synthesis, site-specific modifications | Hormones, oncology, vaccines |
| Nucleic Acid APIs | High-purity oligonucleotide synthesis, chemical modifications | Gene therapy, RNA therapeutics |
| ADC Payload APIs | Linker-payload design, ultra-purity control, stability profiling | Targeted cancer therapies |
Process Development & Optimization
Scalable synthetic pathway design (lab to commercial scale).
Quality by Design (QbD) methodology for robust, reproducible processes.
Impurity profiling and control strategy in line with ICH Q3A/Q3B.
Freedom-to-operate (FTO) route design.
Analytical Method Development & Validation
Structure elucidation: NMR, LC-MS, HR-MS, FTIR.
Purity and impurity testing: HPLC, GC, IC.
Residual solvent and elemental impurity testing (USP
Stability studies under ICH Q1A conditions.
Full method validation for IND, NDA, ANDA submissions.
GMP Manufacturing & Regulatory Support
Flexible batch sizes: gram-scale R&D through kilogram-scale GMP batches.
cGMP-compliant facilities, audit-ready for FDA, EMA, NMPA inspections.
DMF preparation and regulatory filing support worldwide.
Full batch documentation, deviation management, and QA oversight.
✔️ Expertise in handling chemically diverse APIs: from classical small molecules to novel nucleic acids and peptide-based therapeutics.
✔️ Integrated development approach — from molecule synthesis to drug delivery system formulation (liposomes, microspheres, LNPs).
✔️ Proven track record of supporting IND, NDA, and ANDA filings.
✔️ Dedicated quality system aligned with global regulatory expectations.
✔️ Collaborative and flexible client engagement model to match your project’s unique demands.
💬 About Litchlab
Litchlab is an innovation-driven CDMO specializing in API development, advanced drug delivery systems, and GMP manufacturing. Our mission is to help pharmaceutical companies accelerate development timelines and ensure safe, stable, and effective medicines reach patients worldwide.
📧 Contact: RD1@litchlab.com
📩 Learn more or inquire about a project: www.litchlab.com
