Evidence-Based Global Life Science CDMO & CRO

OEM Health Care Manufacturer & Supplier: Evidence-Based Botanical Therapeutics

Empowering Global Nutraceutical, Pharmaceutical, and Cosmeceutical Brand Leaders with End-to-End Contract Research, Modernized Phytochemical Fingerprinting, Preclinical Validation, and Scalable cGMP Commercial Manufacturing.

Flagship R&D Pipeline Solutions

Primary CRO/CDMO Analytical & Manufacturing Services

Immediate procurement and contract research access to validated botanical extraction protocols, preclinical screening assays, and regulatory-approved production processes.

ODM Study and evaluation of the potency of the botanical active ingredients
Discovery & Assay
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
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ODM Clinic study Phase1 Phase 4 Manufacturer Suppliers
Clinical Trials
ODM Clinic study (Phase1 - Phase 4) Manufacturer, Suppliers
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China Screening of the active ingredients of plants Manufacturer
Phytochemistry
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
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China Establishment of analysis methods of active ingredients Supplier
Quality Control
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
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OEM Animal study Supplier Suppliers
In Vivo Toxicology
OEM Animal study Supplier, Suppliers
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OEM In Vitro Test Research Service Manufacturers Suppliers
Cellular Assays
OEM In Vitro Test /Research Service Manufacturers, Suppliers
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Botanical Active Ingredient High-Throughput Screening
Bioassay Profiling
Botanical Active Ingredient Target Screening & Phytochemical Characterization
Explore Specifications
Evaluation for Natural Materials and Botanical Potency
Agronomic QC
Comprehensive Evaluation for Natural Botanical Materials & Cultivar Optimization
Explore Specifications
Industry White Paper Insights

The Paradigm Shift in Global Health Care OEM/CDMO Manufacturing

The worldwide healthcare and preventative medicine sector is experiencing an unprecedented structural transition. Consumer demand for clean-label, bioavailable, and clinically supported therapeutic solutions has forced pharmaceutical and nutraceutical brands to move away from generic blending facilities toward integrated CRO-CDMO partnerships. Modern health enterprises require verified phytochemical integrity, absolute supply-chain transparency, and defensible clinical data to navigate international regulatory hurdles.

Stringent Regulatory Convergence

Global regulatory bodies—including the United States FDA (21 CFR Part 111 & Part 211), the European Medicines Agency (EMA), and China’s NMPA—are synchronizing identification standards. Modern buyers require botanical fingerprinting (HPTLC/HPLC) to guarantee zero adulteration and consistent pharmacological potency across all production batches.

Traceability Compliance Index: 99.8%

Clinical substantiation as a Baseline

Health claims in the modern functional food, dietary supplement, and phyto-drug sectors are obsolete without rigorous empirical backing. Enterprise procurers actively seek CDMOs capable of organizing controlled in vitro cellular mechanisms, GLP-compliant rodent animal models, and ethical human clinical trials (Phase I–IV) directly attached to manufactured lots.

Pharmacological Assay Depth: Cellular to Clinical

Supply Chain Resiliency & Upstream Control

Geopolitical turbulence and climate variability have exposed severe vulnerabilities in raw botanical procurement. MedGence solves this through geobotanical origin mapping, evaluating active chemical densities across micro-climates, soil compositions, and harvest calendars to stabilize production economics and guarantee commercial availability.

Multi-Region Sourcing Network: 400+ Monographed Herbs
Technical Excellence

12 Integrated R&D and Manufacturing Solutions

MedGence (Yineng Pharma) provides an uninterrupted continuum connecting molecular discovery to commercial cGMP production. Enterprise clients can engage our infrastructure as a turnkey end-to-end CDMO partner or commission individual analytical and regulatory work packages.

1. Botanical Active Screening

High-throughput identification of bioactive alkaloids, polyphenols, flavonoids, and polysaccharides targeting specific biological pathways (metabolic, immunological, cognitive, or anti-aging mechanisms).

2. Potency & Origin Evaluation

Systematic quantification of secondary metabolite variance across geographical origins, seasonal harvesting windows, and anatomical plant parts (root, leaf, rhizome, bark) to maximize yield efficiency.

3. Analytical Method Establishment

Validation of chromatographic fingerprinting standards using HPLC, HPTLC, GC-MS, and LC-MS/MS compliant with USP, EP, ChP, and JP pharmacopeias, establishing irrevocable purity baselines.

4. Active Extraction Process Study

Pilot-scale parameter optimization covering solvent systems, critical temperatures, column adsorption kinetics, ultrafiltration, and vacuum drying to prevent molecular degradation.

5. Finished Product Formulation

Engineering stable delivery matrices that resolve bioavailability limitations, hygroscopic moisture instability, active ingredient oxidation, and off-taste botanical profiles.

6. Toxicology & Safety Profiling

Comprehensive GLP-compliant toxicological screening: Acute LD50, sub-acute 90-day dietary toxicity, chronic toxicity, and Ames test genotoxicity profiling for regulatory submissions.

7. In Vitro Cellular Assays

Mechanistic bioassays using primary cell cultures to map anti-inflammatory cytokines, enzymatic inhibition (e.g., alpha-glucosidase), ROS radical neutralization, and cellular viability.

8. In Vivo Preclinical Studies

Animal disease model testing (rodent metabolic models, cognitive decline, hepatic protection) providing statistically validated preclinical dossiers to de-risk investment before human trials.

9. Clinical Studies (Phases I–IV)

End-to-end human trials execution: double-blind, randomized, placebo-controlled clinical protocols for functional dietary claim substantiation and NDA pharma regulatory filings.

10. TCM Classical Formulation Modernization

Translating ancient clinical wisdom into reproducible molecular mechanisms, backed by the successful modernization of 83 classic Chinese medicine multi-herb master formulas.

11. Active Ingredient OEM Supply

Bulk production of standardized plant extracts, high-purity single active isolates, purified volatile oils, concentrated liquids, and bio-fermented botanicals under strict IP quarantine.

12. Finished Dosage OEM / CDMO

High-speed commercial encapsulation, multi-layer tableting, softgel encapsulation, liquid shot sterile bottling, and moisture-barrier granule sachet packaging in ISO/GMP suites.

Proven Enterprise Metrics

Empirical Scale & R&D Footprint (14+ Years)

MedGence (Yineng Pharma) operates one of the Asia-Pacific region's most comprehensive botanical research institutes and CDMO manufacturing complexes. Our technical capabilities are validated by commercial contracts with Tier-1 pharmaceutical conglomerates and national medical research hospitals.

14+
Years Dedicated R&D
Continuous leadership in plant biochemistry, extraction technology, and botanical drug registration.
300+
Scientists & Technicians
Ph.D. phytochemists, clinical trial biostatisticians, formulation engineers, and regulatory QA directors.
100+
Pharma Groups & Hospitals
Entrusted OEM/CDMO partner to public hospital networks and global OTC supplement conglomerates.
100+
Patented Projects Completed
Proprietary active ingredient delivery mechanisms, novel solvent mixtures, and bioavailability enhancers.
83
Modernized TCM Formulas
Classic multi-herb prescriptions decoded into standardized chemical fingerprints and target markers.
22
Innovative Natural Drugs
Phytochemical entities taken from benchtop screening through Phase II/III human clinical endpoints.
56
Hospital Registrations
Official in-hospital pharmaceutical preparation approvals obtained for licensed clinical applications.
~400
Single-Herb Standards
Comprehensive identification, extraction SOPs, and stability data monographs established.
Commercial Dosage Architecture

Finished Dosage Formulations & Bulk Active Delivery

We solve macro-level supply chain complexity by offering versatile formulation modalities engineered for immediate shelf readiness, global customs clearance, and accelerated consumer adoption.

Solid Dose Delivery Systems

Precision hard-gelatin and HPMC vegetarian capsules, micro-tablets, enteric-coated bi-layer tablets, effervescent discs, and specialized moisture-resistant granules packaged in nitrogen-flushed blisters or recyclable bottles.

Capacity: 12,000,000 units / month

Bioavailable Liquids & Softgels

Micro-encapsulated oil softgels, liposomal suspensions, sublingual dropper tinctures, and sterile oral liquid health shots (10ml to 50ml ampoules/bottles) designed for rapid systemic absorption and pleasant palatability.

Capacity: 8,000,000 liquid units / month

Functional Powder Formulations

Instantized micro-fine soluble powders, instant botanical teas, meal replacement fortified blends, and vacuum freeze-dried botanical matrices packaged in stick packs, gusseted pouches, or bulk HDPE drums.

Capacity: 150 Metric Tons / month
Audit Readiness

Regulatory Compliance, Quality Assurance & IP Protection

International health brand expansion hinges upon bulletproof compliance dossiers. MedGence maintains an unyielding quality infrastructure certified against the world’s most stringent regulatory frameworks.

Multinational cGMP Certifications

Our collaborative and proprietary manufacturing cleanrooms strictly follow US FDA 21 CFR Part 111 (Dietary Supplements), 21 CFR Part 211 (cGMP for Pharmaceuticals), and European Good Manufacturing Practices (EU cGMP Annex 1).

Strict Non-Disclosure & IP Quarantine

Every commercial client benefits from segregated cleanroom runs, dedicated batch record numbers, and legally enforceable mutual NDA agreements. We do not manufacture competing proprietary house brands, preventing conflicts of interest.

Complete Regulatory Dossier Preparation

Full-spectrum documentation support for market authorization: Certificate of Analysis (CoA), Master Batch Records (MBR), Process Validation Protocols, Accelerated Stability Reports (ICH Q1A), and Non-GMO/Allergen/Heavy Metal testing suites.

Institutional Trust

Trusted by Leading Pharmaceutical Enterprises & Medical Universities

Over 14+ years, our scientific research leadership and CDMO production output have supported China's largest listed pharmaceutical conglomerates and accredited academic medical institutions.

China Beijing Tongrentang Group Tongrentang Group
China Resources Sanjiu CR Sanjiu
Sunflower Pharmaceutical Sunflower Pharma
Livzon Pharmaceutical Livzon Group
Dihon Pharmaceutical Dihon Pharma
Golden Throat Group Golden Throat
Yangtzi River Pharmaceutical Yangtzi River Pharma
Beihai Gofar Chuanshan Biological Beihai Gofar
Humanwell Healthcare Humanwell Group
SCIMYTH Pharmaceutical SCIMYTH Pharma
Shandong Hanfang Pharmaceutical Hanfang Pharma
Luoxin Pharmaceutical Luoxin Pharma
Guangdong Zhongsheng Zhongsheng Pharma
Hunan Brilliance Abundance Brilliance Herbal
Apeloa Pharmaceutical Apeloa Pharma
Hunan Heng Chang Pharmaceutical Heng Chang Pharma
Baotou Traditional Chinese Medicine Baotou TCM
Kamp Medicine Kamp Medicine
Future Technology Roadmap

Next-Generation Phytochemical AI & Green Extraction Engineering

To maintain information gain leadership for our enterprise clientele, MedGence invests heavily in emerging biopharmaceutical methodologies that redefine yield efficiency, environmental sustainability, and pharmacokinetic performance.

AI-Assisted Metabolomic Discovery

Integrating machine-learning chemometric software with high-resolution mass spectrometers to instantly match uncharacterized botanical fractions against vast therapeutic protein target databases, compressing initial hit discovery timelines by up to 65%.

Supercritical Fluid & Continuous Extraction

Replacing high-emission organic solvents with state-of-the-art Supercritical Carbon Dioxide (scCO2) and pressurized water extraction loops, yielding solvent-free botanical compounds that surpass European green chemistry regulations.

Nano-Self-Emulsifying Drug Delivery Systems (SNEDDS)

Overcoming the poor water-solubility of key botanical molecules (curcumin, resveratrol, berberine) via thermodynamic lipid formulation engineering, boosting in vivo intestinal bioavailability by 300% to 800%.

Client Intelligence

Frequently Asked Questions for Global Procurement Directors

Direct answers regarding commercial contracting, tech transfer timelines, regulatory documentation, minimum order quantities (MOQs), and intellectual property protection.

What specific functions does MedGence handle as a natural medicine CRO/CDMO?
MedGence provides comprehensive, end-to-end preclinical, clinical, and commercial manufacturing solutions for botanical entities. Our services span raw material botanical screening, active compound isolation, geographical and seasonal potency evaluation, analytical method establishment (HPLC, HPTLC, GC, fingerprinting), extraction process scale-up, GLP toxicology profiling (LD50, acute, sub-chronic, Ames tests), in vitro cellular mechanisms, in vivo animal models, full Phase I–IV clinical trials management, and finished dosage formulation manufacturing (liquids, capsules, tablets, softgels, granules).
Can one single partner transition my botanical asset from laboratory discovery into commercial supply?
Yes. Unlike fragmented research labs that lack production lines, or high-volume contract packagers that possess zero research capacity, MedGence operates its own pilot extraction facilities and directly manages collaborative cGMP factories. Study parameters validated at the benchtop transfer directly into commercial pilot runs without knowledge leakage, specification discrepancies, or technical transfer friction.
What analytical chromatographic techniques are utilized to establish batch identity and purity?
Our quality assurance laboratories utilize High-Performance Thin-Layer Chromatography (HPTLC) for unequivocal botanical authentication, High-Performance Liquid Chromatography (HPLC) coupled with UV/DAD or MS for active marker quantification, Gas Chromatography (GC) for volatile components and residual solvent clearance, and ICP-MS for heavy metal limits. Furthermore, we develop complete multi-peak chromatographic fingerprinting to verify batch-to-batch chemical equivalence.
How is our proprietary formula, processing know-how, and commercial trade secret preserved?
We operate strictly under an entrusted research and contract manufacturing paradigm governed by enforceable international Non-Disclosure Agreements (NDAs). Your specific formulations, process parameters, proprietary solvent recipes, and clinical files remain your sole property. Furthermore, MedGence does not market or distribute direct-to-consumer competing proprietary retail lines, ensuring complete alignment of interest.
Which finished product dosage forms can be scaled under MedGence CDMO operations?
For raw actives, we supply standardized dry powders, freeze-dried extracts, concentrated pastes, liquid extracts, and purified essential oils. For finished packaging, we offer hard-shell gelatin/vegetable capsules, liquid-fill softgels, single-layer and bi-layer compressed tablets, moisture-barrier effervescent tablets, single-dose liquid shot bottles, and nitrogen-purged micro-granule sachets.
Do you supervise human clinical trials for dietary supplement claim substantiation and NDA approvals?
Yes. MedGence routinely designs and manages small-scale human intervention trials to satisfy EFSA (EU) and FTC/FDA (USA) health structure-function claims. In addition, for pharmaceutical phyto-drug development, we coordinate formal Phase I pharmacokinetic/safety studies and multicenter Phase II/III/IV randomized controlled clinical trials in partnership with accredited university hospitals.
Ready-to-Deploy Contract Solutions

Explore Core Botanical R&D Work Packages

Access standard commercial protocols or request customized research quotes from our technical team. Each work package yields tangible analytical and physical deliverables.

ODM Study and evaluation of the potency of the botanical active ingredients
Discovery & Assay
ODM Study and evaluation of the potency of the botanical active ingredient(s) from different seasons and different origins. Manufacturer, Suppliers
Explore Specifications
ODM Clinic study Phase1 Phase 4 Manufacturer Suppliers
Clinical Trials
ODM Clinic study (Phase1 - Phase 4) Manufacturer, Suppliers
Explore Specifications
China Screening of the active ingredients of plants Manufacturer
Phytochemistry
China Screening of the active ingredient(s) of plants Manufacturer, Manufacturers
Explore Specifications
China Establishment of analysis methods of active ingredients Supplier
Quality Control
China Establishment of analysis methods of active ingredient(s) Supplier, Suppliers
Explore Specifications
OEM Animal study Supplier Suppliers
In Vivo Toxicology
OEM Animal study Supplier, Suppliers
Explore Specifications
OEM In Vitro Test Research Service Manufacturers Suppliers
Cellular Assays
OEM In Vitro Test /Research Service Manufacturers, Suppliers
Explore Specifications
Botanical Active Ingredient High-Throughput Screening
Bioassay Profiling
Botanical Active Ingredient Target Screening & Phytochemical Characterization
Explore Specifications
Evaluation for Natural Materials and Botanical Potency
Agronomic QC
Comprehensive Evaluation for Natural Botanical Materials & Cultivar Optimization
Explore Specifications
Enterprise Consultation

Initialize Your Custom Health Care CDMO Program

Collaborate directly with our principal phytochemists and regulatory affairs directors. Share your target biological claims, compound specifications, or commercial batch forecasts to receive a rigorous technical study scope within 48 hours.