Evidence-Based CDMO & CRO Infrastructure

OEM Highest Quality Manufacturers & Suppliers

Precision Botanical CDMO & CRO Engineering: Bridging Classical Ethnobotanical Legacy and Rigorous Pharmacological Validation for Global Pharmaceutical, Nutraceutical, and Personal Care Leaders.

Featured Capabilities

Flagship Clinical, Extraction & Preclinical Solutions

Directly access verified CDMO and analytical processes engineered to address the world’s most stringent pharmacokinetic and regulatory standards.

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

ODM Clinic Study (Phase 1 - Phase 4)

Human pharmacokinetic trials and clinical efficacy validation compliant with ICH GCP standards.

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

Screening of Botanical Active Ingredients

Phytochemical compound isolation, fraction analysis, and density enrichment screening.

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China Establishment of analysis methods of active ingredients Supplier, Suppliers

Analysis Method Establishment

Custom HPLC, GC-MS, and HPTLC chromatographic fingerprint development for release testing.

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ODM Study and evaluation of the potency of the botanical active ingredients from different seasons and different origins

Botanical Potency & Origin Evaluation

Spatiotemporal quantification of bioactive molecules across seasons, geographies, and chemotypes.

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OEM In Vitro Test Research Service Manufacturers, Suppliers

OEM In Vitro Test & Research Service

High-throughput molecular cellular assays, enzymatic receptor binding, and pathway screening.

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OEM Animal study Supplier, Suppliers

OEM In Vivo Animal Studies

In vivo pharmacodynamics, dose escalation curves, biodistribution, and toxicology profiling.

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Botanical Active Ingredient Extraction & Isolation OEM

OEM Botanical Actives Synthesis

Commercial isolation of pure alkaloids, polyphenols, saponins, and polysaccharides at scale.

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Finished Botanical Dosage Form CDMO Manufacturing

Finished Dosage Form CDMO

End-to-end processing of softgels, compressed tablets, oral tinctures, and micro-granules.

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Procurement Intelligence

Highest Quality Definition: The Global Corporate Procurement Shift

In the modern botanical and natural pharmaceutical industry, procuring "Highest Quality" has evolved from simple raw material verification into complex supply chain orchestration, multi-target chromatography, and international regulatory readiness.

Chromatographic Fingerprinting

Moving beyond single-marker UV spectroscopy. Enterprise procurement requires holistic HPLC, GC-MS, and HPTLC spectrum mapping to prove that the botanical composition is free of synthetic adulterants and batch variations.

Traceability & Heavy Metal Limits

Rigorous adherence to USP <561> pesticide limits, USP <2232> elemental contaminants (Lead, Arsenic, Cadmium, Mercury), and zero-tolerance microbial burdens (salmonella, aflatoxins) across wildcraft and farmed supply chains.

Evidence-Based Dossier Preparation

Leading brands require more than Certificates of Analysis; they demand validated toxicology portfolios, stability testing under ICH conditions (zone IVb), and scientific dossier generation ready for immediate FDA NDIN or EFSA filings.

"Modern natural medicine procurement no longer accepts fragmented supply chains where discovery labs are isolated from mass extractors. Highest quality OEM manufacturing requires closed-loop intellectual integrity, translating high-potency harvest cycles directly into calibrated clinical outcomes."
Integrated Value Chain

12 Core R&D and Manufacturing Divisions

MedGence (Yineng Pharma) operates as a single-source CRO & CDMO powerhouse based in Changsha, China, consolidating 14+ years of specialized TCM formulation and modern molecular medicine.

01. Discovery Phase

Botanical Active Ingredient Screening

Systematic screening across alkaloids, polysaccharides, flavonoids, and terpenes using multi-target bioassays to identify active fractions yielding optimal therapeutic density and ecological scalability.

02. Sourcing Science

Potency Evaluation by Region & Season

Quantifying variations in phytochemistry driven by altitude, microclimate, harvest timing, and anatomical plant parts (rhizome vs. aerial) to lock in raw supply channels of superior baseline potency.

03. Analytical Chemistry

Method Establishment & Validation

Formulation of proprietary HPTLC, HPLC, GC, and chromatographic fingerprint standards to deliver uncompromising batch-to-batch consistency and forensic adulteration prevention.

04. Scale-up Engineering

Process Study for Active Ingredients

Systematic optimization of countercurrent extraction, resin chromatography, nanofiltration, and lyophilization to maximize active recovery while lowering environmental footprint.

05. Galenic Science

Process Study for Finished Formulations

Overcoming formulation bottlenecks including volatile degradation, low aqueous solubility, and organoleptic bitterness to retain bio-potency across long-term shelf storage.

06. Preclinical Safety

Toxicity Studies (LD50 & Genotoxicity)

Execution of acute toxicity (LD50), 90-day sub-chronic toxicological regimes, Ames testing, and in vitro micronucleus genotoxicity testing fulfilling international safety thresholds.

07. In Vitro Screening

High-Throughput Cell Assays

Mechanistic validation spanning enzyme inhibition (e.g., alpha-glucosidase, COX-2), antioxidant radical scavenging, and cellular inflammatory cytokine suppression (TNF-α, IL-6).

08. In Vivo Validation

Targeted Animal Disease Models

Establishing efficacy curves in validated animal models of metabolic disorder, hepatoprotection, cognitive decline, and immune response to deliver reliable preclinical proofs.

09. Human Clinicals

Phase I–IV Clinical Trial Governance

Managing GCP-certified human trials from pilot exploratory evaluations for nutraceutical claim substantiation up to complete Phase I–IV clinical data for NDA registrations.

10. Formulation Design

Classic TCM & Modernized Formulas

Harmonizing ancient classical formulas with molecular synergy, backed by a clinical track record of modernizing 83 classic Traditional Chinese Medicine preparations.

11. Upstream CDMO

OEM Active Ingredients Supply

Supplying enterprise quantities of customized botanical pure extracts, vacuum-dried crystals, concentrated liquids, and standardized volatile oils under full IP isolation.

12. Downstream CDMO

OEM/CDMO Finished Dosage Delivery

cGMP commercial manufacture of capsules, softgels, functional oral liquids, micro-tablets, and water-dispersible granules ready for multi-national consumer markets.

Empirical Capacity

Proven Scale in Global Natural Medicine Engineering

Our institutional capacity rests upon measurable achievements supporting China’s premier state-owned pharmaceutical conglomerates and research institutions.

14+
Years of Dedicated R&D
300+
Senior Scientists & Chemists
100+
Pharma Enterprises Served
83
Classic TCM Formulas Modernized
22
Innovative Natural Medicines Built
56
Hospital Preparation Approvals
~400
Single-Herb Monograph Standards
100+
Innovative Clinical Projects
Strategic Roadmap

The Future of Botanical CDMO: 2025–2030 Roadmap

Navigating from empirical natural extraction to precision biotechnology, artificial intelligence multi-omics, and green carbon-neutral manufacturing.

01

AI-Driven Phytochemical Docking

Employing machine learning models to analyze thousands of secondary plant metabolites against targeted human cell receptor maps, reducing discovery timelines from years to months.

02

Supercritical & Green Extraction

Replacing volatile organic petroleum solvents with Supercritical Fluid Carbon Dioxide (scCO2) and subcritical water extraction systems to guarantee zero chemical solvent residues.

03

Liposomal & Nano-Encapsulation

Deploying advanced lipid bilayer encapsulation and targeted cyclodextrin complexation to dramatically boost the bioavailability of notoriously insoluble polyphenols and curcuminoids.

04

Continuous Synthetic Biology Bridging

Developing cellular enzymatic biotransformation pathways for rare and endangered botanical compounds, eliminating pressure on wild biomass while retaining chemical bio-equivalence.

Global Regulatory Integrity

Worldwide Compliance, IP Firewalls & Localized Support

Mitigating cross-border operational risk with dedicated project managers, internationally compliant data pipelines, and impenetrable non-disclosure environments.

Regional Dossier Customization

Direct preparation of technical paperwork matching US FDA 21 CFR Part 111/211, European Union EFSA novel food validation, Health Canada NPN dossiers, and Chinese NMPA standards.

Absolute Trade Secret Protection

Operating under strict bilingual Non-Disclosure Agreements (NDA) and segmented clean-room production schedules ensuring that proprietary client formulations and process logic remain isolated.

Direct Scientist-to-Scientist Liaison

Every overseas partner is assigned a specialized English-fluent technical lead, bridging real-time communication for analytical method transfer, protocol changes, and rapid pilot scheduling.

Proven Industry Trust

Trusted by Leading Pharmaceutical Groups & Academic Hospitals

Our validated analytical standards and manufacturing solutions power the supply chains of China's most historic pharmaceutical icons and premier medical research hospitals.

China Beijing Tongrentang GroupTongrentang Group
China Resources Sanjiu Medical & PharmaceuticalCR Sanjiu
Sunflower Pharmaceutical GroupSunflower Pharma
Livzon Pharmaceutical Group Inc.Livzon Pharma
Dihon Pharmaceutical GroupDihon Pharma
Golden Throat Holdings GroupGolden Throat
Yangtzi River Pharmaceutical GroupYangtzi River Pharma
Beihai Gofar Chuanshan BiologicalGofar Chuanshan
Humanwell Healthcare GroupHumanwell Healthcare
SCIMYTH Pharmaceutical GroupSCIMYTH Pharma
Shandong Hanfang PharmaceuticalHanfang Pharma
Luoxin Pharmaceutical GroupLuoxin Pharma
Guangdong Zhongsheng PharmaceuticalZhongsheng Pharma
Hunan Brilliance & Abundance ScientificBrilliance & Abundance
Apeloa PharmaceuticalApeloa Pharma
Hunan Heng Chang Pharmaceutical GroupHeng Chang Pharma
Baotou Traditional Chinese MedicineBaotou TCM
Kamp MedicineKamp Medicine
Guangxi Santo PharmaceuticalGuangxi Santo
Hunan Kangshou PharmaceuticalKangshou Pharma
Jiangxi Juwang Pharmaceutical IndustryJuwang Pharma
Beijing Tcmages PharmaceuticalTcmages Pharma
Guizhou Ruihe PharmaceuticalRuihe Pharma
Anhui CR Jinchan PharmaceuticalCR Jinchan
Kangmei PharmaceuticalKangmei Pharma
Hunan Tianjicaotang PharmaceuticalTianjicaotang Pharma
Jiangxi Kingstone Unite PharmaceuticalKingstone Unite
Shuguang Hospital, Shanghai University of TCMShuguang Hospital
Hunan Province Directly Affiliated TCM HospitalHunan Affiliated TCM
First Hospital of Hunan University of Chinese Medicine1st Hosp Hunan TCM
Second Xiangya Hospital of Central South University2nd Xiangya Hosp
Second Hospital of Hunan University of Chinese Medicine2nd Hosp Hunan TCM
Orthopedics of TCM Zhuzhou CityZhuzhou TCM Ortho
Procurement & Scientific Q&A

Frequently Asked Questions by Enterprise Buyers

Clear answers to regulatory, technical, and operational inquiries for global brands evaluating an integrated botanical contract manufacturer.

What specific scope does a specialized natural medicine CRO like MedGence provide?
We provide true end-to-end research and development for plant-derived ingredients and complex botanical combinations. This spans initial botanical active ingredient screening, spatiotemporal potency evaluation by geographic origin and harvest season, full analytical method establishment (HPLC, GC, HPTLC), extraction and refinement process studies, comprehensive toxicology (LD50, Ames, chronic safety), cell-based in vitro testing, pre-clinical animal studies, structured human clinical studies (Phase I through Phase IV), natural formulation development, and scalable contract manufacturing (CDMO/OEM) of pure active ingredients and finished formulations.
Can a single partner seamlessly transfer my botanical project from lab research to commercial supply?
Yes. Our internal pilot plant and collaborative industrial manufacturing bases are directly operated and managed by our scientific team. This guarantees that parameters validated during laboratory studies transfer cleanly into commercial OEM/CDMO production lines, eliminating the formulation failures, batch degradation, and knowledge gaps that routinely arise when research labs hand off recipes to unaffiliated manufacturing vendors.
Which analytical techniques are deployed to establish release standards?
Depending on target chemical classes, we build validated release protocols utilizing High-Performance Thin-Layer Chromatography (HPTLC) for holistic botanical identity verification, High-Performance Liquid Chromatography (HPLC) coupled with DAD/ELSD for precise quantitative assaying, Gas Chromatography (GC-MS) for volatile terpenes and residual solvent screens, and comprehensive chromatographic fingerprint profiling to eliminate adulteration and establish absolute batch consistency across years of harvesting.
How are proprietary formulas, client IP, and process know-how protected?
We operate exclusively under an entrusted contract research and manufacturing model safeguarded by legally enforceable international non-disclosure agreements. Your product specifications, proprietary ratios, molecular extraction parameters, and client trade secrets are strictly sequestered within compartmentalized access systems, ensuring that your commercial advantage remains completely confidential.
Which physical formats and finished dosage forms can MedGence produce?
For intermediate active ingredients, we supply standardized concentrated liquids, vacuum-purified extract powders, botanical pastes, and pure volatile essential oils. For commercial consumer applications, we manufacture finished dosage forms including hard-shell capsules, softgel capsules, two-piece liquid-filled capsules, micro-tablets, effervescent powders, soluble granules, and sterile functional oral liquids.
Do you execute clinical studies compliant with international New Drug Applications (NDA)?
Yes. We execute small-cohort randomized controlled human clinical trials to generate statistically significant substantiation for dietary supplement efficacy claims, as well as comprehensive Phase I, Phase II, Phase III, and Phase IV clinical trials managed in accordance with ICH GCP guidelines to support new botanical drug applications (NDA) and medical registrations globally.
Contract Manufacturing Catalogue

Standardized Industrial Active Ingredients & CDMO Services

Procure bulk botanical extracts or commission turnkey finished dosage developments engineered under full pharmacopeial compliance.

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

Clinical Study Services (Phase 1–4)

Institutional Review Board (IRB) monitored human trials for medical claims validation.

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

Screening Active Plant Ingredients

High-resolution fractionation and identification of previously uncharacterized phytomolecules.

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China Establishment of analysis methods of active ingredients Supplier, Suppliers

Establishing Analysis Methods

Custom QC assay validation conforming directly to USP, EP, and ChP statutory guidelines.

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ODM Study and evaluation of the potency of the botanical active ingredients from different seasons and different origins

Seasonal & Origin Potency Study

Optimizing supply chain yield curves by analyzing seasonal harvest kinetics.

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OEM In Vitro Test Research Service Manufacturers, Suppliers

In Vitro Bioactivity Testing

Cell viability, receptor-binding assays, and anti-inflammatory cellular pathways.

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OEM Animal study Supplier, Suppliers

Animal Pharmacology Studies

Rodent pharmacokinetic modeling, oral bioavailability assessments, and safety endpoints.

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Phytochemical CDMO Pilot Plant Synthesis

Bulk Active Compound Supply

Industrial supply of crystallized pure bio-actives and high-titer natural standardized powders.

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Commercial Finished Product Packaging and Formulation CDMO

Turnkey Commercial OEM Production

Full encapsulation, tableting, blister-packaging, and bottled finished formulation execution.

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