Evidence-Based Botanical Engineering

ODM Traditional Chinese Medicine Manufacturers & Supplier

Pioneering CDMO & CRO botanical active ingredient development, from phytochemical fingerprinting and multi-target screening to global GMP-compliant production.

Proprietary Pipeline & Services

Precision CRO Services & Actives Formulation

Direct access to validated extraction assays, clinical trial protocols, and high-potency standardized botanical extracts.

OEM Animal study Supplier

OEM Animal Study Supplier, Preclinical In Vivo Screening

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ODM Study and evaluation of the potency of the botanical active ingredients

ODM Potency Evaluation of Botanical Actives by Origin & Season

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OEM In Vitro Test Research Service

OEM In Vitro Test & Cellular Assay Research Service

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Screening of the active ingredients of plants

Screening of Botanical Active Ingredients from Flora

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Establishment of analysis methods of active ingredients

HPLC/GC Method Establishment for Target Marker Isolation

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ODM Clinic study Phase1-Phase 4

ODM Clinical Trial Protocols (Phase I to IV Clinical Trials)

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Botanical Active Screening Protocol

Phytochemical Metabolite Mapping & Extraction Process

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Origin Verification System

Geo-Authentic TCM Potency & Fingerprint Assay Verification

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Global Industrial Horizon

Macro Trends: Modern TCM Commercialization Across Continents

Bridging empirical wisdom and molecular biology to service pharmaceuticals, functional foods, and clinical nutraceutical sectors worldwide.

North America: Clean-Label Phytotherapy

Accelerating demand under DSHEA mandates for standardized botanical derivatives. Brands require rigorous pesticide screens (USP <561>) and chromatographic identity confirmation to eliminate adulteration risks in high-growth cognitive and metabolic health sectors.

European Union: Strict THMPD Compliance

Europe’s Traditional Herbal Medicinal Products Directive requires exhaustive safety toxicology (EMA guidelines) and traceable botanical history. Our modern analytical packages support clients through simplified drug registrations and monograph submissions.

Asia-Pacific: Kampo & Integrative Formulations

The convergence of Japanese Kampo methodologies, South Korean functional cosmetics, and Southeast Asian botanical wellness demands ultra-high batch consistency, water-soluble microgranules, and bio-enhanced single-herb concentrates.

Next-Gen Phytochemicals

Technology Roadmap: The Future of Botanical Extraction & Synthesis

Harnessing artificial intelligence, network pharmacology, and green chemistry to unlock the polychemical power of traditional pharmacopeias.

AI Network Pharmacology

Computational screening maps TCM multi-target synergies onto human receptor pathways, predicting bioavailability and eliminating clinical liabilities before benchwork commences.

Supercritical Fluid Separation

CO₂ extraction paired with molecular distillation achieves selective active compound isolation without thermal degradation or harsh petrochemical solvent residue.

Liposomal Nano-encapsulation

Overcoming botanical solubility and gut permeability challenges by encapsulating hydrophobic actives (e.g., Curcuminoids, Ginsenosides) into bio-identical lipid carriers.

High-Density Bioprofiling

Coupling LC-MS/MS with high-performance thin-layer chromatography (HPTLC) fingerprints to identify both chemical constituents and geographic origins across 400+ herb varieties.

Infrastructure & Scalability

China Factory Supply Chain: Resilience, Scale & Cost Precision

How direct integration with agricultural cooperatives and high-throughput extraction hubs guarantees stable supply security against global climate volatility.

14+
Years Dedicated Natural Medicine R&D
300+
In-House Scientists & Lab Specialists
83
Classic TCM Formula Modernizations
~400
Herb Quality Monographs Established

GAP Origin Traceability

Raw herbs are collected under Good Agricultural Practices (GAP) directly from China's geo-authentic botanical heartlands (Daodi). Sourcing coordinates and seasonal harvest windows are systematically locked to prevent active constituent degradation.

High-Capacity Pilot-to-Tonnage

From 50-liter dynamic extraction reactors in pilot laboratories up to multi-ton continuous counter-current extractors, our managed facility ecosystem absorbs sharp market demand spikes with zero disruption.

Dual-Chain Risk Hedging

Integrated inventory warehousing buffering 6-month buffer stocks of strategic raw ingredients buffers global customers from extreme weather shocks, geopolitical friction, and sea-freight volatility.

End-to-End Delivery

Formulation Engineering & Commercial Application Scenarios

Bridging traditional decoction paradigms into modern user-friendly forms compliant with international consumption habits.

Nutraceuticals & Preventive Blends

Adaptogenic, immunity, and sleep formulations developed as micro-granules, effervescent tablets, and vegan capsules. Active components are standardized to precise marker chemicals (e.g., Astragaloside IV, Baicalin) for label claims.

Clinical Hospital Formulations

Direct translation of empirical hospital preparations (with 56 clinical hospital preparation approvals engineered) into reproducible, stable clinical-trial drugs and standardized pre-mixed extract solutions.

Functional Cosmeceuticals

Micro-filtered, decolorized, and deodorized herbal extracts optimized for transdermal penetration, designed specifically for topical anti-inflammatory, anti-aging, and skin-barrier reinforcement products.

Global Regulatory & Dossier Support System

Our regulatory affairs division produces comprehensive documentation tailored to buyer territories: Certificate of Analysis (CoA), full 3-batch validation protocols, pesticide multiresidue screenings (compliant with USP/EP), heavy metal limits by ICP-MS, residual solvent analysis (ICH Q3C), non-irradiated certifications, and stability study dossiers (accelerated and long-term testing under Zone IVb conditions).

Industry Recognition

Endorsed by Top Tier Pharmaceutical Groups & TCM Hospitals

Over a decade of trusted scientific partnerships across China's largest healthcare enterprises and premier university clinical institutions.

Beijing Tongrentang GroupTongrentang Group
China Resources Sanjiu MedicalCR Sanjiu
Sunflower Pharmaceutical GroupSunflower Pharma
Livzon Pharmaceutical GroupLivzon Pharma
Dihon Pharmaceutical GroupDihon Pharma
Golden Throat HoldingsGolden Throat
Yangtzi River PharmaceuticalYangtzi River Pharma
Beihai Gofar Chuanshan BiologicalBeihai Gofar
Humanwell HealthcareHumanwell Health
SCIMYTH PharmaceuticalSCIMYTH Pharma
Shandong Hanfang PharmaceuticalShandong Hanfang
Luoxin Pharmaceutical GroupLuoxin Pharma
Guangdong Zhongsheng PharmaceuticalZhongsheng Pharma
Apeloa PharmaceuticalApeloa Pharma
Hunan Heng Chang PharmaceuticalHeng Chang Pharma
Baotou Traditional Chinese MedicineBaotou TCM
Shuguang Hospital affiliated with Shanghai University of TCMShuguang Hospital
Second Xiangya Hospital of Central South UniversityXiangya Hospital
Technical & Procurement FAQ

Frequently Asked Questions on Botanical ODM & CRO

Definitive answers covering regulatory validation, IP safety, batch reproducibility, and scale transfer.

What specific capabilities differentiate MedGence from generic extract processors?
Unlike generic botanical mills, MedGence operates as a dual-engine CRO & CDMO. We possess independent phytochemical research centers with LC-MS, HPLC, GC, and HPTLC capability, cell culturing suites for in vitro bio-screening, licensed vivariums for preclinical toxicity studies, and dedicated pilot plants to translate raw medicinal herbs into patent-defensible botanical drug or supplement candidates.
How do you ensure batch-to-batch consistency despite natural variations in raw herbs?
We utilize chromatographic fingerprint analysis to establish multi-marker chemical profiles. By controlling our supply chain via geo-authentic (Daodi) farm co-ops, locking harvest seasons, and standardizing extraction parameters (temperature, solvent-to-material ratio, pressure, filtration pore-size), we deliver ingredients that meet strict statistical tolerance bounds batch after batch.
How is our proprietary formula and manufacturing know-how legally secured?
Every custom synthesis and formulation project is protected under enforceable Non-Disclosure and IP Transfer agreements. Customer projects are partitioned in segregated cleanroom suites with zero cross-contamination and strictly governed server permissions. All generated IP, analytical protocols, and manufacturing rights belong solely to the client.
What analytical testing methods are provided with each commercial shipment?
Each batch comes accompanied by an extensive Certificate of Analysis (CoA) containing assays by HPLC/GC, HPTLC visual identification fingerprint chromatograms, heavy metals analysis via ICP-MS (Lead, Arsenic, Cadmium, Mercury), USP <561> multi-residue pesticide screens, micro-biological bioburdens, and residual solvent clearances.
Can you assist with Human Clinical Trials and New Drug Applications (NDA)?
Yes. We manage clinical trials ranging from pilot human consumer evaluations to validate claims for dietary supplements, up to full GCP-compliant Phase I, II, III, and IV clinical studies for hospital preparation conversions and botanical pharmaceutical filings with the NMPA, FDA, or EMA.
What custom delivery forms are supported by your contract manufacturing division?
Our production lines support botanical active raw compounds (purified crystalline forms, standardized liquid concentrates, spray-dried micro-powders, paste extracts, and volatile aromatic oils) as well as finished dosage forms including two-piece hard gelatin/HPMC capsules, softgels, micro-tablets, oral liquid suspensions, and moisture-resistant soluble granules.
Manufacturing Catalog

Commercial Scale ODM Offerings & Technical Services

In-stock and made-to-order botanical contract supply pipelines ready for formulation integration.

Animal Studies for Botanicals

Standardized Preclinical Animal Studies for Botanical Actives

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Herbal Potency Screening

Comprehensive Seasonal Active Constituent Potency Audits

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In Vitro Cellular Assays

Cell-Based Molecular Bioassay & Pathway Profiling

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Screening Plant Actives

High-Throughput Bioactive Compound Isolation & Screening

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Analytical Method Establishment

Analytical Monograph Development (HPLC / HPTLC / GC)

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Clinical Trials

Full-Spectrum Clinical Development Phase I–IV Turnkey Services

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Botanical Active Process Study

Industrial Scale-Up & Crystallization Process Optimization

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Finished CDMO Dosage Products

Custom CDMO Finished Oral Forms: Softgels & Microgranules

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