From oncology breakthroughs to orphan drug development we deliver fully custom APIs — with speed, precision, and regulatory clarity

    We don’t just make molecules. We engineer scalable, regulatory-grade solutions from lab to launch.

    FDA, EMA, NMPA, and ICH-compliant synthesis and documentation packages.

    Oncology, CNS, hormonal, and rare disease APIs are our specialty.

    Proprietary eco-efficient reactions — including single-step biosynthesis, solvent recovery, and energy-efficient systems.

    In-house QC and impurity profiling using NMR, MS, IR, HPLC, LC-MS, and stability testing.

    Agile pilot batches, process optimization, and transfer to full CDMO scale-up when needed.

    What We ​Offer

    🧱 Route Design & Feasibility Studies

    • Synthetic pathway development for new or difficult compounds
    • Literature and IP mapping (FTO analysis optional)
    • Cost modeling and scalability evaluation

    🧪 Small-Scale Synthesis (mg–100g)

    • Ideal for method development, bioassays, or early-stage R&D
    • Includes full analytical profile: NMR, HPLC, MS, IR, CoA
    • Quick delivery from our Singapore or India labs

    🧪 Pilot Batch Production (100g–2kg)

    • Process validation under GLP/GMP-ready conditions
    • Supports preclinical and early formulation development
    • Includes DMF support (if required)

    🧪 Scale-Up to Commercial Quantities

    • Transfer to CDMO/CDx manufacturing at Chemigran Tuas facility or validated partner network
    • Full tech transfer support, analytical method transfer, and process optimization
    • Optional: ESG tracking and GRI-based sustainability reporting

    Regulatory & Documentation ​Excellence

    We understand regulatory. Every API we synthesize comes with full documentation support:

    Certificate of Analysis

    “From research support to submission-ready data — we synthesize APIs with the end in mind.”

    Batch Records

    “From research support to submission-ready data — we synthesize APIs with the end in mind.”

    ICH Q3A/B Impurity Profile

    “From research support to submission-ready data — we synthesize APIs with the end in mind.”

    GMP Compliance Audit Trail

    “From research support to submission-ready data — we synthesize APIs with the end in mind.”

    DMF (Open & Closed Part)

    “From research support to submission-ready data — we synthesize APIs with the end in mind.”

    CTD Section Support

    “From research support to submission-ready data — we synthesize APIs with the end in mind.”

    Case Studies: ​From Bench to Scale

    ✅ Oncology API for European PartnerOncology API for European Partner

     

    API: Anthracycline analog

    Result: 40x reduction in process waste via biosynthesis

    Delivered: 3 kg GMP-batch under exclusive contract (Fresenius Kabi)

    ✅ Rare Disease Compound for Orphan Drug Filing

     

    API: Custom intermediate for enzyme therapy

    Timeline: 8 weeks from inquiry to validated pilot batch

    Delivered: CoA, MS, and batch-specific ICH impurity report

    Ready to Start a Synthesis Project?

    Whether you’re sourcing a rare oncology intermediate or scaling a complex impurity — Chemigran is your reliable, sustainable synthesis partner.

    Contact Us

    © 2023 Created with Royal Elementor Addons