Enterprise Botanical CRO & CDMO Ecosystem

China Biological Functions Manufacturers & Suppliers

Comprehensive Research, Analytical Method Development, Toxicological Validation, and Industrial-Scale Contract Manufacturing for Global Phytopharmaceutical & Nutraceutical Formulations.

Industry Strategic White Paper

Engineering Verifiable Biological Functions from Botanical Complexity

Bridging millennia of Traditional Chinese Medicine (TCM) empirical evidence with Western pharmacopeial compliance, quantitative metabolomics, and reproducible bioactivity.

Translational Phytochemistry

MedGence (Yineng Pharma) operates at the convergence of botanical taxonomy, separation technology, and molecular pharmacology. By transitioning classical TCM formulations into well-characterized botanical drug substances, we decipher complex biological functions into quantifiable chemical markers.

Evidence-Based Medicine

14+ Years of Rigorous R&D

With an active multidisciplinary cadre of over 300 research scientists, we have spearheaded modernized research on 83 classic TCM formulas, engineered 22 innovative natural medicines, achieved 56 hospital preparation registrations, and standardized near 400 single-herb extracts.

300+ Dedicated Scientists

Strict IP & Formulation Integrity

Operating exclusively under non-disclosure entrusted CDMO frameworks, client IP remains hermetically sealed. Proprietary extraction parameters, custom fractional ratios, and proprietary formulation recipes are never commercialized under internal house labels.

100% Client IP Protection
Global Sourcing Matrix

Addressing International Enterprise Sourcing Requirements

Global pharmaceutical corporations, dietary brand conglomerates, and functional beverage enterprises face escalating scrutiny over raw material consistency, supply continuity, and botanical authenticity.

Batch Heterogeneity Elimination

Botanicals harvested across disparate microclimates exhibit wide variations in secondary metabolite yields. Our comprehensive multi-origin seasonal potency evaluations remove volatility, guaranteeing batch-to-batch standardization.

Contaminant & Residue Rigor

Tier-1 markets demand rigorous compliance regarding heavy metals, polycyclic aromatic hydrocarbons (PAHs), ethylene oxide (EtO), and pesticide residues. Our protocols meet strict USP, EP, and JP statutory thresholds.

Full Preclinical Dossier Support

Securing market clearance requires more than pure chemistry; it requires defensible biological proof. We deliver comprehensive toxicological safety dossiers (LD50, Ames test, micronucleus) and validated in vitro / in vivo efficacy files.

Scalable CDMO Transition

Eliminating translational failure between bench-top discovery and multi-ton industrial campaigns. Our integrated pilot facilities and contract manufacturing lines guarantee flawless tech transfer without loss of biological yield.

Competitive Advantage

China Industrial Manufacturing & Supply Chain Dominance

Harnessing China’s unique geographic diversity, deeply clustered industrial supply chains, and advanced bioprocess engineering infrastructure.

Geographic Herb Authenticity (Geo-Authentic / Dao-Di)

China is home to the world’s most extensive natural habitat diversity for medicinal flora. Direct proximity to indigenous botanical cultivation hubs ensures our materials preserve their full spectrum of secondary bioactive components.

Integrated Extraction Technologies

Our collaborative industrial manufacturing centers house high-capacity continuous countercurrent extraction lines, supercritical CO2 equipment, macroporous resin adsorption columns, and low-temperature freeze-drying complexes.

Superior Capex & Timeline Efficiencies

Deploying specialized natural medicine CRO programs in China compresses discovery timelines by over 45% compared to Western clinical research firms, while substantially reducing initial clinical R&D expenditure.

Complete Service Portfolio

End-to-End CRO & CDMO Botanical Capabilities

Explore our 12 deeply integrated service modules, built to accompany projects from raw herb discovery through validated manufacturing and clinical certification.

01. Botanical Active Ingredient Screening

Plants contain alkaloids, polysaccharides, saponins, and flavonoids. Leveraging extensive phytochemistry databases and high-content screening, we identify molecules delivering targeted biological functions with optimal environmental sustainability.

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02. Potency Evaluation by Origin, Season & Plant Part

Bioactive density varies significantly across growing regions, micro-climates, and harvest periods. We quantify secondary metabolite yields across roots, stems, leaves, and flowers to establish competitive procurement blueprints.

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03. Analytical Method Establishment

Analytical rigor guarantees quality reliability. We formulate validated assay and qualitative identification standards utilizing HPTLC, HPLC-DAD, GC-MS, and multi-wavelength chromatographic fingerprinting for multi-herb formulas.

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04. Process Study for Active Ingredients

Industrial scale-up economics define global market viability. Our chemical engineers optimize raw-herb preparation, enzymatic digestion, solvent ratios, resin separation, and spray drying to maximize purity and economic yields.

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05. Process Study for Finished Products

Formulating sensitive botanical extracts into solid or liquid forms frequently leads to degradation or loss of bioavailability. We resolve crystallization, poor solubility, and hygroscopicity to maintain biological activity.

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06. Toxicity Studies (LD50, Acute, Chronic, Genotox)

Documented safety profiles are critical prerequisites for health authorities worldwide. We execute rigorous GLP-compliant acute oral toxicity, LD50, 90-day subchronic oral studies, and in vitro Ames bacterial reverse mutation tests.

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07. In Vitro Testing

Direct cellular and enzymatic models elucidate complex bioactivity mechanisms. We deploy high-throughput assays for metabolic enzyme inhibition, reactive oxygen species (ROS) neutralization, and anti-inflammatory cellular pathways.

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08. Animal Studies

Preclinical in vivo rodent models evaluate biological bioavailability, targeted tissue distribution, pharmacodynamics, and specific efficacy endpoints (glycemic regulation, lipid balancing, and neurocognitive protection).

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09. Clinical Studies (Phase I–IV)

Comprehensive human trials covering small-cohort dietary supplement efficacy substantiation through full GCP-compliant Phase I–IV clinical study protocols required for Botanical Investigational New Drug (IND/NDA) filings.

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10. Natural Formulation Research

Harnessing deep classic TCM systemic theory combined with modern pharmacological synergy. We design specialized natural formulations offering superior functional efficacy across immune support, metabolic balance, and skin integrity.

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11. Contract Manufacturing (OEM) for Active Ingredients

Commercialization backed by fully owned pilot facilities and inspected collaborative factories. Bioactive extracts are produced as customized concentrated liquids, crystalline extract powders, pastes, and volatile botanical oils.

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12. Contract Manufacturing (OEM/CDMO) for Finished Products

Turnkey finished dosage manufacturing operating under pharmaceutical-grade GMP environments. Formats include functional oral liquids, hard gelatin capsules, vegan softgels, direct-compression tablets, soluble powders, and micro-granules.

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Global Regulatory Alignment

Localized Support & International Compliance Assurance

Overcoming jurisdictional friction. Our regulatory science division aligns technical packages directly with health authority standards across all major target territories.

FDA (NDI / GRAS / cGMP 21 CFR 111)

Preparation of comprehensive New Dietary Ingredient (NDI) notifications and Generally Recognized as Safe (GRAS) affirmation dossiers. Batch documentation complies fully with FDA 21 CFR Part 111 dietary supplement standards.

EFSA & Novel Food Standards (EU)

Assistance in constructing European Food Safety Authority (EFSA) Novel Food dossiers, ensuring compliant residual solvent levels, absence of irradiation, and full alignment with EU Traditional Herbal Medicinal Products Directive (THMPD 2004/24/EC).

TGA (Australia) & NMPA (China) Filings

Providing Listed Medicine evidence dossiers for the Australian Therapeutic Goods Administration (TGA) as well as Blue Hat dietary filings and Hospital Preparation registrations for China's National Medical Products Administration (NMPA).

Empirical Track Record

Quantified Excellence in Botanical R&D

Fourteen years of sustained scientific achievement supporting premier medical institutions and multinational pharmaceutical corporations.

14+
Years Dedicated Botanical R&D
300+
Phytochemists & Medical Scientists
100+
Pharma Groups & Hospitals Served
100+
Innovative Custom Projects Completed
83
Classic TCM Formulas Modernized
22
Novel Natural Medicines Developed
56
Hospital Preparation Registrations
~400
Single-Herb Standards Established
Application Horizons

Commercial Application Verticals for Global Brands

Translating active botanical biological functions into distinct, highly bioavailable commercial delivery architectures.

Dietary Supplements & Nutraceuticals

Potency-standardized extracts with verified bioassays for metabolic health, cognitive clarity, immune resilience, and healthy aging. Designed for high shelf-stability and clear label claims.

Phytochemical Botanical Pharmaceuticals

Purified active fractions and standardized botanical drug substances engineered to satisfy stringent FDA Botanical Drug Guidance thresholds, supported by robust preclinical and clinical data packages.

Cosmeceuticals & Clean Beauty Actives

Water-soluble, clear-dissolution botanical bioactives delivering clinical dermatological performance: tyrosinase inhibition, dermal barrier repair, and advanced anti-pollution antioxidant defense.

Next-Gen Technology

Emerging Trends in Biological Functions & Botanical CDMO

The botanical functions sector is moving rapidly beyond crude macerations toward molecularly precise, bio-engineered phyto-therapeutics.

AI-Guided Phenotypic Screening

Integrating machine learning algorithms with high-resolution mass spectrometry (HRMS) to predict molecular targets, synergistic multi-compound interactions, and bio-affinity before initiating wet-lab synthesis.

Enzymatic Biotransformation

Harnessing enzymatic catalysis and microbial fermentation to convert bulky glycosylated ginsenosides, icariins, and astragalosides into highly bioavailable rare aglycones with improved bioavailability profiles.

Nano-Encapsulation & Liposomal Delivery

Overcoming the poor water solubility of complex polyphenols and terpenes via pharmaceutical-grade phospholipid nano-liposomes, solid lipid nanoparticles (SLNs), and microencapsulated beadlets.

Structured Engagement Model

End-to-End Workflow: From Herb Discovery to Commercial Batches

A transparent milestone-driven structure providing procurement and scientific teams with defined deliverables at each development phase.

01

Screen & Source

Identify target compounds delivering the intended biological function and select optimal geographic origins, seasons, and plant organs.

Deliverable: Target & Sourcing Report
02

Standardize & Analyze

Establish validated analytical methods via HPTLC, HPLC, and GC-MS alongside comprehensive raw material release monographs.

Deliverable: Validated Methods & Specs
03

Optimize the Process

Determine pretreatment parameters, solvent recovery ratios, column purification efficiencies, and optimal drying conditions.

Deliverable: Key Process Parameters
04

Prove Safety & Efficacy

Conduct in vitro high-content cellular assays, in vivo animal models, acute toxicity (LD50), chronic toxicity, and genotoxicity tests.

Deliverable: Preclinical Data Package
05

Clinical Validation

Execute human dietary pilot cohorts or full Phase I–IV clinical studies in compliance with Good Clinical Practice (GCP) guidelines.

Deliverable: Clinical Study Dossier
06

Manufacture & Supply

Seamless tech transfer to pilot and commercial cGMP OEM/CDMO production with confidential batch release and export documentation.

Deliverable: Commercial C-GMP Batches
Institutional Provenance

Trusted by 33+ Leading Pharmaceutical Groups & TCM Hospitals

Our collaborative research footprint powers China’s premier national pharmaceutical enterprises and tier-3 clinical university hospitals.

China Beijing Tongrentang Group Co., Ltd.China Beijing Tongrentang Group
China Resources Sanjiu Medical & PharmaceuticalChina Resources Sanjiu Medical
Sunflower Pharmaceutical Group Co., Ltd.Sunflower Pharmaceutical Group
Livzon Pharmaceutical Group Inc.Livzon Pharmaceutical Group
Dihon Pharmaceutical Group Co., Ltd.Dihon Pharmaceutical Group
Golden Throat Holdings Group Company LimitedGolden Throat Holdings Group
Yangtzi River Pharmaceutical GroupYangtzi River Pharmaceutical
Beihai Gofar Chuanshan Biological Co., Ltd.Beihai Gofar Chuanshan Biological
Humanwell Healthcare (Group) Co., Ltd.Humanwell Healthcare Group
SCIMYTH Pharmaceutical GroupSCIMYTH Pharmaceutical Group
Shandong Hanfang Pharmaceutical Co., Ltd.Shandong Hanfang Pharmaceutical
Luoxin Pharmaceutical Group Stock Co., Ltd.Luoxin Pharmaceutical Group
Guangdong Zhongsheng Pharmaceutical Co., Ltd.Guangdong Zhongsheng Pharma
Hunan Brilliance & Abundance Scientific Chinese Herbal MedicineBrilliance & Abundance Herbal
Apeloa Pharmaceutical Co., Ltd.Apeloa Pharmaceutical
Hunan Heng Chang Pharmaceutical Group Co., Ltd.Hunan Heng Chang Pharma
Baotou Traditional Chinese Medicine Co., Ltd.Baotou Traditional Chinese Medicine
Kamp Medicine Co., Ltd.Kamp Medicine Co., Ltd.
Guangxi Santo Pharmaceutical Co., Ltd.Guangxi Santo Pharmaceutical
Hunan Kangshou Pharmaceutical Co., Ltd.Hunan Kangshou Pharmaceutical
Jiangxi Juwang Pharmaceutical Industry Co., Ltd.Jiangxi Juwang Pharmaceutical
Beijing Tcmages Pharmaceutical Co., Ltd.Beijing Tcmages Pharmaceutical
Guizhou Ruihe Pharmaceutical Co., Ltd.Guizhou Ruihe Pharmaceutical
Anhui CR Jinchan Pharmaceutical Co., Ltd.Anhui CR Jinchan Pharmaceutical
Kangmei Pharmaceutical Co., Ltd.Kangmei Pharmaceutical Co.
Hunan Tianjicaotang Pharmaceutical Co., Ltd.Hunan Tianjicaotang Pharma
Jiangxi Kingstone Unite Pharmaceutical Co., Ltd.Jiangxi Kingstone Unite Pharma
Shuguang Hospital affiliated with Shanghai University of TCMShuguang Hospital, Shanghai TCM
Hunan Province Directly Affiliated TCM HospitalHunan Affiliated TCM Hospital
The First Hospital of Hunan University of Chinese Medicine1st Hospital of Hunan TCM Univ.
The Second Xiangya Hospital of Central South University2nd Xiangya Hospital, CSU
The Second Hospital of Hunan University of Chinese Medicine2nd Hospital of Hunan TCM Univ.
The Orthopedics of Traditional Chinese Medicine Zhuzhou CityThe Orthopedics of Traditional Chinese Medicine of Zhuzhou City
Technical FAQ

Frequently Addressed Scientific & Procurement Inquiries

Direct technical answers addressing regulatory oversight, intellectual property frameworks, analytical parameters, and batch scale-up.

What does a natural medicine CRO like MedGence do?
MedGence provides end-to-end research and development for plant-derived ingredients: active ingredient screening, potency evaluation by origin and season, analytical method establishment, process studies, toxicity, in vitro, animal and clinical studies, natural formulation research and contract manufacturing of active ingredients and finished products.
Can one partner take my botanical project from lab research to commercial supply?
Yes. Our own pilot plant and collaborative factories are directly managed by our technical team, so validated study results transfer smoothly into OEM/CDMO production without the knowledge gaps or loss of yield that occur when research and manufacturing are split between separate vendors.
Which analytical techniques are used to establish quality standards?
Depending on the product, methods include high-performance thin-layer chromatography (HPTLC) identification, high-performance liquid chromatography (HPLC-DAD/ELSD), gas chromatography (GC-FID/MS), and multi-peak chromatographic fingerprinting to confirm chemical identity, assay potency, and verify batch-to-batch consistency.
How is my formula and process know-how protected?
We work strictly on an entrusted contract research and manufacturing model under binding non-disclosure agreements (NDAs). Your product information, target indications, formulations, and proprietary process parameters remain your exclusive intellectual property and are never disclosed.
Which dosage forms can MedGence develop and manufacture?
Active ingredients can be supplied as concentrated liquids, spray-dried powders, pastes, and volatile essential oils. Finished product forms encompass oral functional liquids, hard gelatin and vegan capsules, softgels, tablets, soluble powders, and micro-granules.
Do you support clinical studies for new drug applications?
Yes. We coordinate small-group human efficacy trials for dietary supplements as well as comprehensive Phase I, II, III, and IV clinical studies designed to fulfill requirements for formal Botanical New Drug Applications (IND/NDA) across international health agencies.
How do you guarantee botanical identity and prevent adulteration?
We employ an orthogonal identification regime: botanical macroscopic inspection, microscopic tissue identification, DNA barcoding, HPTLC comparative finger-printing against authentic reference standards, and quantitative marker assay using HPLC to eliminate species confusion or deliberate adulteration.
What documentation accompanies commercial CDMO shipments for international customs clearance?
Every shipment is accompanied by a full Certificate of Analysis (CoA) reporting active marker assays, residual solvents, microbiological counts, heavy metals (ICP-MS), pesticide screens (GC-MS/MS), non-GMO declarations, allergen statements, TSE/BSE statements, and customs-ready phytosanitary certificates.

Initiate Your Custom Botanical Function Program

Whether you require targeted active molecule screening, chromatographic fingerprint establishment, in vivo toxicology files, or multi-ton commercial extract manufacturing under strict non-disclosure, our scientific team is ready to assist.