Evidence-Based Botanical CDMO & CRO

OEM Traditional Chinese Medicine Formulas Supplier & Suppliers

Decoupling botanical complexity through high-resolution analytical chromatography, standardized extraction matrices, and cGMP-certified industrial scale.

Industrial R&D Core Capabilities

Standardized Botanical & Preclinical Contract Formulations

Direct supply of verified TCM extract precursors, active ingredient isolations, and comprehensive pharmacokinetics study suites for global developers.

OEM Animal study Supplier, Suppliers

OEM Animal study Supplier, Suppliers

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China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers

China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers

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OEM In Vitro Test /Research Service Manufacturers, Suppliers

OEM In Vitro Test /Research Service Manufacturers, Suppliers

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China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers

China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers

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ODM Clinic study (Phase1 - Phase 4) Manufacturer, Suppliers

ODM Clinic study (Phase1 - Phase 4) Manufacturer, Suppliers

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ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins

ODM Potency Study: Seasonal & Origin Botanical Actives

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Active Ingredients Screening Manufacturer Supplier

Phytochemical Active Ingredient High-Throughput Screening

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Botanical Origin & Potency Evaluation Service

Evaluation for Natural Materials & DaoDi Authenticity

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Global Industry Whitepaper

Modernizing Traditional Chinese Medicine: The Global Market Landscape

Navigating the transition from empirical herbal concoctions to standardized, molecular-profiled phytopharmaceuticals.

The Paradigm Shift in Botanical Drug Development

The global demand for Traditional Chinese Medicine (TCM) formulas and botanical therapeutics is witnessing unprecedented expansion across North America, the European Union, and the Asia-Pacific region. Historically constrained by batch-to-batch inconsistency, non-standardized multi-herb synergy, and opaque pesticide/heavy metal screening, modern enterprise buyers now mandate rigorous scientific substantiation.

International regulatory frameworks—including the US FDA Botanical Drug Guidance and the European Medicines Agency (EMA) Committee on Herbal Medicinal Products (HMPC)—require total fingerprint profiling, multi-target pharmacodynamics, and verified reproducibility. As an OEM Traditional Chinese Medicine formulas supplier, MedGence solves these bottlenecks by merging traditional "Jun-Chen-Zuo-Shi" pharmaceutical logic with advanced HPLC-MS/MS, GC-MS, and high-performance thin-layer chromatography (HPTLC).

  • Multi-Target Synergy Validation: Decoding multi-herb interactions via metabolomics and network pharmacology.
  • Contaminant-Free Clean Standards: Fully compliant with USP <561>, Ph. Eur. 2.8.13 for pesticide residues, aflatoxins, and elemental impurities.
  • Strict IP Protection Protocols: High-security entrusted CDMO protocols ensuring customer formulas remain exclusive proprietary assets.
Industrial Benchmark

Chinese Supply Chain & Manufacturing Efficiency Advantage

Operating out of Changsha, Hunan—the historic cradle of Chinese botanical medicine—MedGence commands unmediated access to authentic "DaoDi" medicinal herb origins across Southwestern and Central China. This geographic proximity delivers critical efficiency benefits:

1. Sourcing Compression: Direct wild-crafted and GAP-cultivated raw herb procurement eliminates multiple intermediary layers, compressing raw material cycle times by over 45% compared to Western contract repackagers.

2. Pilot-to-Commercial Integration: With our state-of-the-art continuous countercurrent extraction lines and closed-loop ultra-low-temperature concentration, scale-up hurdles from 5kg bench testing to 20-ton commercial batches are resolved in weeks rather than quarters.

3. Comprehensive Formulation Matrix: Full-spectrum custom synthesis available in spray-dried powders, microporous osmotic pump tablets, fluid extracts, standardized softgels, and bio-enhanced water-dispersible granules.

Active Ingredient Screening

Screening bioactive secondary metabolites (alkaloids, saponins, polyphenols, polysaccharides) across tens of thousands of herbal phenotypes to secure target-directed bioactivity.

Chromatographic Fingerprinting

Establishing comprehensive HPLC/GC-MS reference markers ensuring batch consistency, accurate peak identification, and chemical stability over extended shelf lives.

Phase I–IV Clinical & Toxicity Studies

Robust GLP animal models, genotoxicity assays, acute LD50 determination, and hospital clinical trials to validate functional claims and prepare registration dossiers.

Empirical Validation

Enterprise Scale & Research Track Record

Quantifiable infrastructure supporting leading multinational pharmaceutical groups, TCM hospitals, and functional health enterprises.

14+
Years Dedicated to Natural Medicine CRO/CDMO
300+
In-House Research Scientists & Analytical Chemists
83
Classic TCM Formula Modernization Programs Completed
~400
Single-Herb Quality Standards & Process Monographs
Strategic Implementation

Global B2B Procurement Demand & Formulation Applications

Targeted manufacturing frameworks tailored to divergent regulatory environments and consumer consumption habits worldwide.

North American Dietary Supplements

Meeting the dietary supplement market’s shift toward adaptogenic stress formulas, immune modulators (Astragalus, Reishi), and metabolic support complexes. Formulated specifically to comply with 21 CFR Part 111 cGMP standards and ready for structure/function claim notifications.

European Phytotherapeutic Drugs (THMPD)

Engineered for Traditional Herbal Medicinal Products Directive compliance. We provide complete dossier support including historical use documentation, botanical DNA barcoding, chromatographic comparability batches, and stability data under ICH Q1A guidelines.

Cosmeceutical & Derma-Actives

Clean-label bioactive TCM fractions optimized for transdermal delivery. Targeting anti-inflammatory, barrier repair, and melanogenesis-inhibiting pathways with in vitro 3D skin model testing and cellular antioxidant efficacy documentation.

Enterprise Alliances

Trusted by Tier-1 Pharmaceutical Groups & TCM Hospitals

Our validated methodologies support national research bodies, certified clinical institutions, and public healthcare manufacturers.

China Beijing Tongrentang GroupTongrentang Group
China Resources SanjiuCR Sanjiu
Sunflower Pharmaceutical GroupSunflower Pharma
Livzon Pharmaceutical GroupLivzon Group
Dihon Pharmaceutical GroupDihon Pharma
Golden Throat Holdings GroupGolden Throat
Yangtzi River Pharmaceutical GroupYangtzi River
Beihai Gofar Chuanshan BiologicalBeihai Gofar
Humanwell Healthcare GroupHumanwell
SCIMYTH Pharmaceutical GroupSCIMYTH Group
Shandong Hanfang PharmaceuticalHanfang Pharma
Luoxin Pharmaceutical GroupLuoxin Group
Guangdong Zhongsheng PharmaceuticalZhongsheng Pharma
Hunan Brilliance & AbundanceHunan Brilliance
Apeloa PharmaceuticalApeloa Pharma
Hunan Heng Chang PharmaceuticalHeng Chang Pharma
Baotou Traditional Chinese MedicineBaotou TCM
Kamp Medicine Co., Ltd.Kamp Medicine
Guangxi Santo PharmaceuticalSanto Pharma
Hunan Kangshou PharmaceuticalKangshou Pharma
Jiangxi Juwang PharmaceuticalJuwang Pharma
Beijing Tcmages PharmaceuticalBeijing Tcmages
Guizhou Ruihe PharmaceuticalRuihe Pharma
Anhui CR Jinchan PharmaceuticalCR Jinchan
Kangmei PharmaceuticalKangmei Pharma
Hunan Tianjicaotang PharmaceuticalTianjicaotang
Jiangxi Kingstone Unite PharmaceuticalKingstone Unite
Shuguang Hospital Affiliated with Shanghai University of TCMShuguang Hospital
Hunan Province Directly Affiliated TCM HospitalHunan TCM Hosp.
First Hospital of Hunan University of Chinese MedicineHunan Univ. TCM
Second Xiangya Hospital of Central South UniversityXiangya 2nd Hosp.
Second Hospital of Hunan University of Chinese MedicineHunan 2nd TCM
Orthopedics of TCM Zhuzhou CityZhuzhou TCM Orth.
Technical Clarifications

Enterprise Buyer FAQ: Procurement, Quality & Compliance

In-depth responses covering extraction yield mechanics, chromatography validation, and regulatory filings.

What does an end-to-end natural medicine CRO/CDMO partner provide?
MedGence delivers complete horizontal integration across botanical drug and supplement life cycles: high-throughput active ingredient screening, DaoDi authenticity evaluation by geographical origin and harvest timing, analytical method development (HPTLC, HPLC-MS, GC), benchtop process optimization, non-GLP/GLP animal toxicology (LD50, Ames test), in vitro biological testing, hospital clinical studies, and cGMP-compliant OEM/ODM industrial manufacturing.
How do you guarantee batch consistency across variable herbal harvests?
We employ modern chromatographic fingerprinting (similarity evaluation threshold >0.95) coupled with multi-marker quantitative HPLC assays. By establishing strict baseline profiles and sourcing exclusively from authenticated GAP cultivation bases, we control upstream variables prior to extraction, compensating for climate fluctuations via proprietary fractional blending algorithms.
How does MedGence handle international regulatory documentation?
We provide full technical documentation dossiers compliant with FDA Botanical Drug guidance, Health Canada NHP requirements, and EU THMPD modules. This includes validated analytical methods, stability testing under ICH conditions (accelerated and long-term), Certificate of Analysis (CoA) demonstrating non-detectable residual solvents, pesticide sweeps across 400+ compounds, and absence of heavy metals/aflatoxins.
How are customer proprietary formulations and IP rights protected?
We work exclusively under comprehensive Non-Disclosure Agreements (NDAs) and formal CDMO contract research entrustment structures. All research results, optimized process parameters, yield ratios, and clinical findings generated during your project remain 100% your exclusive intellectual property. Production runs can be compartmentalized with blinded ingredients if required.
What dosage forms can be supplied at commercial scale?
Our facilities support concentrated fluid extracts, volatile botanical oils, vacuum belt dried and spray dried extract powders, microencapsulated formulations, standard two-piece hard gelatin or vegetable capsules, softgels, enteric-coated tablets, oral liquids in ampoules/dropper bottles, and high-solubility effervescent granules.
Can you support Phase I–IV human clinical studies for botanical applications?
Yes. Leveraging deep collaborative ties with top-tier university hospitals—including Shuguang Hospital affiliated with Shanghai University of TCM and Xiangya Hospital—we coordinate GCP-compliant clinical evaluation protocols, managing patient cohort recruitment, placebo-controlled double-blind trials, and statistical outcome analyses for IND and NDA submissions.
Commercial Service Portfolio

Enterprise Procurement Formulations & Study Suites

Scalable botanical CDMO services configured for rapid tech-transfer and international regulatory filings.

OEM Animal study Supplier, Suppliers

OEM Animal study Supplier, Suppliers

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China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers

China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers

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OEM In Vitro Test /Research Service Manufacturers, Suppliers

OEM In Vitro Test /Research Service Manufacturers, Suppliers

View Specification
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers

China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers

View Specification
ODM Clinic study (Phase1 - Phase 4) Manufacturer, Suppliers

ODM Clinic study (Phase1 - Phase 4) Manufacturer, Suppliers

View Specification
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins

ODM Potency Study: Seasonal & Origin Botanical Actives

View Specification
Analysis Method Establishing Service

HPTLC & HPLC Multi-Component Method Development

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Clinical Study Phase I to Phase IV

Human Clinical Trial Services: Phase I to Phase IV

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Initiate Your Custom TCM Formulation Project

Consult with our lead pharmacognosists and analytical chemists to review target monographs, extraction yields, batch specs, or trial design.

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