Phase 01 · Discovery
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
Explore Service Spec
Pioneering scientific precision in natural medicine R&D. We deliver turnkey contract research (CRO) and custom CDMO production—transforming complex botanical bioactives into reproducible, globally compliant ingredients.
End-to-end active pharmaceutical, nutraceutical, and clinical validation programs engineered to satisfy international pharmacopeia standards.
Modern nutraceutical and pharmaceutical enterprises require deterministic purity, supply chain provenance, and empirical bioequivalence over anecdotal herbal claims.
Global authorities (US FDA FSMA, EU EFSA Novel Foods, and TGA) now mandate comprehensive chromatographic fingerprint profiles, rigorous contaminant ceilings (pesticides, polycyclic aromatic hydrocarbons, heavy metals), and full traceability to harvest origin.
The transition from generic herbal powders to IP-protected, standardized extracts requires validated mechanism-of-action studies. Brands require in vitro pathway identification, animal pharmacokinetic data, and human clinical trial endpoints.
Procurement directors face pricing volatility and climate risks. China’s centralized agro-botanical supply networks provide critical mass, combining authentic regional cultivation (Dao Di) with energy-efficient supercritical extraction infrastructures.
Harnessing complete vertical integration: From localized agro-botanical harvesting belts to multi-ton continuous manufacturing complexes.
Direct integration with certified agricultural cooperatives across China's geo-authentic botanical zones ensures high-potency raw herbs. Sourcing is optimized across seasons, altitudes, and harvest times to maximize target compound density.
Equipped with continuous countercurrent extraction, membrane separation, simulated moving beds (SMB), and spray freeze drying, bridging 100g benchtop trials to 500-ton industrial commercial campaigns seamlessly.
Operating under strict contractual CRO protocols. Formulas, extraction yields, custom chromatographic methods, and synthetic steps remain 100% segregated and protected under legally binding international CDMO agreements.
Every phase delivers clear, documented milestone criteria to reduce investment risk and accelerate go-to-market execution.
Systematic phytochemical evaluation across geographic origins, growth cycles, and harvesting conditions to identify peak biomarker concentrations.
Deliverable: Phytochemical Profiling DossierEstablishment of HPLC, GC-MS, LC-MS/MS, and HPTLC fingerprint assays compliant with ICH Q2(R1) guidelines for repeatable quantification.
Deliverable: Transferable Analytical SOPsOptimization of critical process parameters (CPPs)—solvent ratios, temperature, residence times, resin elution—to maximize active yields while reducing impurities.
Deliverable: Pilot Batch Manufacturing RecordExecution of in vitro cell assays, GLP-compliant acute (LD50), sub-chronic, Ames bacterial reverse mutation, and chromosomal aberration testing.
Deliverable: Preclinical Safety Data PackageStatistically powered, IRB-reviewed clinical programs for structure-function health claims or Investigational New Drug (IND) regulatory filings.
Deliverable: GCP Clinical Study ReportFull-scale commercial synthesis and cleanroom packaging: spray-dried powders, purified crystals, concentrated liquids, softgels, and multi-layer tablets.
Deliverable: Commercial cGMP SupplyTransparent comparison of traditional herbal extracts versus MedGence validated evidence-based botanical ingredients.
| Quality Attribute | Conventional Herbal Commodity | MedGence ODM Standardized Active | Testing & Assay Methodology |
|---|---|---|---|
| Biomarker Assay | Crude Extract Ratio (e.g., 10:1 unverified) | Standardized Target Potency (e.g., ≥98% Pure) | HPLC-DAD / GC-FID Quantitative Assay |
| Species Authentication | Macroscopic inspection only | DNA Barcoding & HPTLC Chromatographic Fingerprint | PCR Sequencing / High-Performance TLC |
| Heavy Metal Limits | Unmonitored / Variable levels | Pb ≤ 0.5ppm, As ≤ 0.5ppm, Cd ≤ 0.2ppm, Hg ≤ 0.1ppm | ICP-MS (Inductively Coupled Plasma Mass Spec) |
| Residual Solvents | Industrial alcohol residue risks | Strict Compliance with USP <467> / EP Class 3 | Headspace Gas Chromatography (HS-GC-MS) |
| Stability & Degradation | Not established; open shelf degradation | 24–36 Month Real-Time & Accelerated Stability Studies | ICH Q1A(R2) Controlled Climatic Chambers |
Engineered to integrate into final customer dosage matrices across major regulated consumer and clinical verticals.
Microencapsulated, free-flowing, directly compressible botanical powders tailored for gummies, effervescent tablets, chewables, and clear beverage solutions without turbidity or precipitation.
High-purity isolates (>99%) prepared under cGMP cleanroom controls for prescription phytomedicines, hospital preparations, and targeted therapeutics for cardiovascular and metabolic indications.
Water-soluble, non-staining, and low-odor plant fractions designed for anti-aging serums, skin barrier repair emulsions, and clean-beauty topical formulas supported by in vitro skin permeation data.
Demonstrated collaborative track record supporting multinational pharmaceutical groups, listed nutraceutical brands, and university medical centers.
Tongrentang Group
CR Sanjiu Medical
Sunflower Pharma
Livzon Pharma Group
Dihon Pharma
Golden Throat Group
Yangtzi River Pharma
Humanwell Healthcare
Transparent answers for QA directors, technical procurement managers, and R&D innovators.
Select your target research phase or standardized botanical active ingredient program to initialize quotation and feasibility scoping.