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 of extracts and finished dosage forms.

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), gas chromatography (GC) and chromatographic fingerprinting.

How is my formula and process know-how protected?

We work on an entrusted contract research and manufacturing model under non-disclosure, so your product information, formulas and process parameters are not disclosed and your competitive advantage is preserved.

Which dosage forms can MedGence develop and manufacture?

Active ingredients can be supplied as concentrated liquids, powders, pastes and volatile oils. Finished products include oral liquids, capsules, softgels, tablets, soluble powders and granules.

Do you support clinical studies for new drug applications?

Yes. We arrange small-group human trials for dietary supplements as well as Phase I, II, III and IV clinical studies to help clients obtain the data required for a new drug application (NDA).

ODM Processing Methods Manufacturer & Suppliers

Validated CRO & CDMO Services

Precision ODM Research & Pilot Scale Methods

Direct contract capabilities for natural product discovery, qualitative analytics, and clinical dossier compilation.

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

Industrial Status Quo

The Global Shift in Botanical ODM Processing Methods

Addressing the paradigm shift from basic aqueous-solvent extractions to multi-tiered phytonutrient fractionation and bio-guided isolation.

In the global pharmaceutical, nutraceutical, and dermocosmetic manufacturing landscape, natural medicines and standardized botanical extracts are facing rigorous quality scrutiny. Regulatory bodies including the US FDA (21 CFR Part 111 & Botanical Drug Guidance), EFSA, and the European Pharmacopoeia (Ph. Eur.) require absolute batch-to-batch chemical conformity and deep toxicological profiles. Traditional open-loop solvent evaporation and crude maceration fail to satisfy modern chromatographic fingerprint criteria. As a consequence, international brand owners are increasingly outsourcing to specialized Original Design Manufacturers (ODM) equipped with both exploratory CRO benchtop capabilities and scalable CDMO infrastructure.

Fractionated Extraction & Chromatography

Transitioning from unstandardized crude tinctures to supercritical CO₂, macroporous adsorption resin matrices, and continuous countercurrent extractions to isolate targeted saponins, polyphenols, or alkaloids.

Zero Solvent Residue Purity

Metabolite Fingerprinting

Comprehensive high-performance thin-layer chromatography (HPTLC), HPLC-DAD, and GC-MS profiling ensuring distinct marker compound retention while screening out pesticides and heavy metals.

Validated Batch Traceability

Phase-Gated Safety Validation

Integrated GLP-aligned LD50 determination, subchronic 90-day animal testing, and Ames genotoxicity screening performed early in process design to prevent late-stage product regulatory rejections.

Risk-Free Market Entry

Supply Chain Competitiveness

Why Tier-1 Chinese Manufacturing Hubs Lead ODM Methods

Capitalizing on integrated agro-industrial clusters, massive domestic empirical libraries, and cutting-edge continuous processing plants.

14+

Years Dedicated Natural R&D

300+

In-House Scientists & Engineers

400+

Monographed Herb Standards

83

Modernized Classic TCM Formulations

Upstream Agricultural Integration

Direct geographic access to authentic regional botanicals (Daodi herbs). By mapping active metabolite accumulation across seasonal cycles and local climates, raw feedstock costs decrease up to 34% while optimizing yield.

Continuous Automated Production

MedGence's facility in Changsha, Hunan, utilizes computerized SCADA extraction skids, multi-effect falling film evaporators, and spray drying systems running round-the-clock, driving high process repeatabilities.

Turnkey IP & Regulatory Clearance

Entrusted contractual exclusivity ensures client formulas, parameter matrices, and chemical fingerprints remain protected while generating full CTD-formatted dossiers suitable for FDA NDI or NMPA filings.

Customized Engineering

End-Market Processing Methods & Dosage Formats

Bridging pharmacological discovery with physical stability, consumer organoleptics, and pharmaceutical bio-accessibility.

Nutraceuticals & Dietary Supplements

Process method: High-yield water/ethanol fractionation followed by microencapsulation. Designed for high shelf-life, masking bitter plant polyphenols, and rapid gastric disintegration.

Directly compressible spray-dried granules
Zero-degradation liquid filled softgels
Instant cold-water dispersible drink powders

Phytochemical Investigational Drugs

Process method: Preparative high-performance column chromatography, membrane nanofiltration, and crystallization producing target monomers at >98% chromatographic purity.

Phase I–IV clinical batch manufacturing
Validated ICH stability data testing
Pharmacokinetic (PK) & bioavailability modeling

Dermocosmetic Active Actives

Process method: Low-temperature ultrasonic extraction and enzyme-assisted digestion to capture fragile flavonoids and polyphenols without thermal oxidation or discoloration.

Clarified high-transparency hydrosols
Oil-soluble liposomal carriers for skin penetration
In vitro anti-inflammatory/melanin inhibition assays

Future Projections

Emerging Trends & Global Procurement Imperatives

A strategic analysis for Chief Procurement Officers (CPOs) and Head of Formulations navigating sustainable sourcing and tightening border controls.

DNA Barcoding Verification

Supply chain adulteration has forced multinational buyers to demand phylogenetic DNA identification alongside chemical assays to definitively weed out counterfeit herb varietals.

Green Chemistry Solvents

Global consumer demand is phasing out chlorinated compounds. ODM processing methods must prioritize clean technologies like subcritical water extraction and bio-ethanol recycling.

End-to-End CDMO Consolidation

Procurement teams are reducing vendor fragmentation by partnering with singular entities capable of handling agronomic extraction through to blister-packed finished capsules.

Transparent Auditability

Traceability back to individual cultivation fields, complete with soil pesticide residual tests, heavy metal screens, and validated batch assay records, has become non-negotiable.

Enterprise Alliances

Trusted by 100+ Leading Pharmaceutical Manufacturers

Our extraction standards and analytical protocols serve tier-1 healthcare conglomerates and state clinical centers.

Tongrentang Group

CR Sanjiu

Sunflower Pharma

Livzon Pharma

Yangtzi River Pharma

Humanwell Healthcare

Apeloa Pharma

Shuguang Hospital

Technical FAQs

Frequently Asked Questions on Botanical ODM Processing

Essential guidance covering intellectual property, scaling thresholds, regulatory dossiers, and analytical methods.

What does a complete natural medicine CRO/CDMO ODM engagement entail?

Our end-to-end framework bridges lab discovery and bulk commercial supply. We conduct exploratory active ingredient screening, potency quantification by botanical harvest origin and season, development of HPLC/GC analytical validation methods, manufacturing optimization (extraction, fractionation, spray-drying), safety toxicological profiles (LD50, genotoxicity), in vitro and animal assays, full Phase I–IV clinical investigations, and cGMP finished product manufacturing.

How are proprietary formulas and technical extraction parameters protected?

All research, optimization runs, and scale-up routines are conducted under strict non-disclosure contracts (NDA). We operate exclusively on an entrusted research model where our clients retain full intellectual property ownership. Your proprietary ratios, solvent mixes, isolation steps, and chromatographic fingerprints are never commercialized or shared with third parties.

Which analytical instrumentation is utilized for method validation and release testing?

Our QC testing facilities deploy high-performance thin-layer chromatography (HPTLC) for fingerprinting species identity, high-performance liquid chromatography (HPLC with DAD, ELSD, and MS detectors) for active compound quantification, and gas chromatography (GC) for volatile components, residual solvents, and pesticide analysis. Every release certificate confirms batch conformity to pharmacopeial monographs.

Can MedGence scale from initial micro-assays directly into multi-ton production?

Yes. Through our Changsha pilot plant and directly managed large-scale cooperative facilities, process parameters established at bench scale (100g to 5kg) are mapped through pilot reactors (50L to 500L) before moving to multi-ton automated extraction skids. This unified technical oversight eliminates batch transfer failure rates and unexpected yield losses.

What finished dosage forms and delivery options are available for global export?

We supply both intermediate active ingredients (standardized extract powders, concentrated liquids, purified fractions, and volatile essential oils) and fully formulated, commercially packaged finished products. Our dosage lines include two-piece hard gelatin or vegetarian capsules, liquid-filled softgels, functional oral liquids, directly compressible tablets, soluble botanical drink granules, and sachet-filled micro-powders.

Do you supply clinical documentation for international drug regulatory submissions?

Yes. We design and monitor human dietary supplement safety and efficacy trials as well as structured Phase I, II, III, and IV clinical programs. We provide complete biostatistical evaluations, institutional ethics committee reviews, and CTD-standard technical documentation necessary to support New Drug Applications (NDA) or novel ingredient registrations worldwide.

Procurement Catalog