Accelerate your product development pipeline with our vertically integrated phytochemical screening, analytical validation, preclinical studies, and commercial cGMP manufacturing.
Why leading pharmaceutical, nutraceutical, and dermaceutical developers are replacing conventional generic extracts with scientifically enhanced, clinically substantiated phytocomplexes.
In the global nutraceutical and biopharmaceutical markets, the era of commoditized crude botanical extracts is coming to an end. Brand owners and pharmaceutical formulators face stringent regulatory scrutiny, skeptical consumers demanding measurable health outcomes, and intense competition from synthetic actives.
At MedGence (Yineng Pharma), our contract research and manufacturing organization (CRO & CDMO) is pioneering the Efficacy Enhancement Paradigm. We do not merely extract botanical biomass; we identify the exact phytochemical moieties responsible for biological outcomes, optimize their stoichiometric ratios, remove antagonistic or non-active companion substances, and apply targeted delivery modifications to maximize cellular uptake.
“Natural medicine achieves lasting global authority only when every health claim is backed by reproducible chemistry, validated chromatography, and controlled clinical studies. We transform empirical Traditional Chinese Medicine (TCM) insights into verifiable, patentable, and globally compliant formulations.”
Over 14+ years of dedicated laboratory and clinical operation in Changsha, Hunan, MedGence has delivered end-to-end R&D programs for more than 100 top-tier pharmaceutical manufacturers and tertiary medical centers. Our scientific repository includes the modernization of 83 classic TCM prescription formulas, the synthesis and formulation of 22 novel natural medicines, and the registration of 56 hospital preparation licenses.
Furthermore, our team has established rigorous analytical quality specifications and scale-up manufacturing parameters for nearly 400 single-herb active ingredient matrices. By harmonizing molecular pharmacology, continuous counter-current isolation, and GCP-grade clinical validation, we provide multinational enterprises with an unassailable technical edge.
Years Phytomedicine CRO/CDMO
Scientists & Senior Researchers
Pharma Groups & Hospitals Served
Herbal Monograph Specs Developed
Leveraging the world's most comprehensive botanical biodiversity, mature cultivation infrastructure, and industrial extraction scale to eliminate supply risks for global partners.
Phytochemical expression varies sharply across macro-climates. Through our multi-province agricultural testing network (Daodi herb sourcing), we systematically map active secondary metabolite densities across Guizhou, Sichuan, Hunan, and Jilin provinces, guaranteeing high starting potencies.
A two-week deviation in harvest timing can reduce target saponin or flavonoid concentrations by up to 45%. We evaluate seasonal chronological curves to determine the precise biological peak for raw biomass collection, maximizing industrial yield while mitigating raw material waste.
China houses over 70% of global botanical extraction infrastructure. Our pilot-scale research facilities link directly with automated, multi-ton continuous counter-current extractors, low-temperature column chromatographs, and spray-drying towers, delivering unrivaled cost efficiencies.
| Evaluation Parameter | Conventional Generic Extraction | MedGence ODM Efficacy-Enhanced CDMO | Commercial Value for Global Buyers |
|---|---|---|---|
| Botanical Sourcing | Open market brokers; non-standardized terroir | Daodi-certified GAP contracted farms with origin GPS mapping | Elimination of adulteration; traceable supply chain |
| Harvest Chronology | Aggregated mass harvesting based on labor schedules | Active compound kinetic curve peak harvesting | 20%–45% higher concentration of target active moieties |
| Chromatographic Standard | Single-marker non-specific UV-Vis or crude TLC | HPTLC fingerprinting + High-Resolution HPLC/GC-MS assays | Zero lot-to-lot therapeutic variability; bulletproof QC dossiers |
| Bioavailability Enhancement | None; standard crystalline powder or aqueous paste | Molecular complexation, liposomal encapsulation, solid dispersions | Lower required dosage per capsule; higher bio-efficacy |
| Safety Verification | Basic microbiological and heavy metal screening | Full toxicological battery: LD50, acute, chronic, genotoxicity (Ames) | Turnkey safety dossiers for FDA NDI, EU Novel Food, and TGA Listing |
Bridging Chinese phytochemical manufacturing excellence with the world's most stringent regulatory frameworks across North America, the European Union, Australasia, and the Middle East.
We provide full analytical dossiers for New Dietary Ingredient (NDI) notifications and Generally Recognized As Safe (GRAS) self-affirmations. Our extraction facilities operate in strict accordance with dietary supplement and pharmaceutical cGMP standards, backed by validated USP/AOAC dissolution and impurity testing.
From Herbal Medicinal Products Monographs (HMPC) to EFSA Novel Food Article 10 authorizations, our testing protocols address European Pharmacopoeia (Ph. Eur.) residual solvent limits, pyrrolizidine alkaloids (PAs), polycyclic aromatic hydrocarbons (PAHs), and ethylene oxide (ETO) absence verification.
We support Australian Therapeutic Goods Administration (TGA) Listed Medicine electronic dossiers, Health Canada Natural Health Product (NPN) licensing, and provide worldwide certified Halal (MUI/JAKIM compliant) and Kosher certifications for global multicultural distribution.
From target molecular discovery in fresh botanicals to high-volume commercial finished dosage form release, our multidisciplinary scientists manage each critical inflection point.
High-throughput isolation and bio-guided fraction analysis across alkaloids, polysaccharides, flavonoids, and terpenes to pinpoint the most effective target molecules.
Comparative quantification of secondary active metabolites across geographic climates and botanical parts (root, leaf, cortex, seed) to secure peak raw material potency.
Development and full ICH Q2(R1) validation of assay methodologies using HPTLC, HPLC-DAD, GC-MS, LC-MS/MS, and multi-wavelength chemical fingerprinting.
Optimization of multi-stage extraction, macroporous resin adsorption, ultrafiltration, and crystallization to achieve targeted active purity while minimizing solvent waste.
Overcoming hygroscopicity, poor flowability, degradation under gastric pH, and offensive botanical bitterness through advanced microencapsulation and taste-masking.
Comprehensive GLP-compliant toxicological documentation: acute oral LD50, sub-chronic 90-day repeat dose toxicity, Ames bacterial reverse mutation, and in vitro micronucleus assays.
Target-driven cellular bioassays (RAW264.7 anti-inflammation, Caco-2 intestinal transport, HepG2 lipid metabolism, cell viability MTT) for high-speed go/no-go milestone decisions.
Pharmacodynamic and pharmacokinetic (PK/PD) investigations in validated rodent models: glycemic control, anti-hyperlipidemia, neuro-protection, and joint cartilage regeneration.
GCP-compliant double-blind, randomized, placebo-controlled clinical trials (RCTs) for dietary supplement efficacy claims, as well as formal Phase I-IV trials supporting clinical NDAs.
Harnessing multi-component botanical synergy principles to design proprietary functional formulations where active ingredients amplify efficacy and suppress mutual toxicities.
Scalable production of standardized extracts in diverse physical forms: concentrated botanical elixirs, free-flowing spray-dried powders, viscous oleoresins, and super-purified volatile oils.
Turnkey contract manufacturing of finished dosage forms: softgels, vegetarian two-piece capsules, precision-coated tablets, oral functional liquid shots, and effervescent granules.
Identify highest-potency phytocompounds and map Daodi origins, seasonal windows, and botanical parts.
Deliverable: Sourcing & Compound Target DossierConstruct validated HPLC, HPTLC, GC-MS fingerprints, and raw botanical monograph specifications.
Deliverable: Method Validation Protocol (ICH Q2)Establish critical process parameters (CPPs) for extraction, chromatography, solvent recovery, and drying.
Deliverable: Pilot Batch Scale-up Master RecordConduct cellular in vitro mechanisms, animal PK/PD models, and acute/subchronic GLP safety studies.
Deliverable: Preclinical Safety & Bioactivity PackageExecute double-blind human clinical trials or hospital preparation trials for regulatory health claims.
Deliverable: GCP Final Clinical Study Report (CSR)Continuous cGMP production, full batch release analytical documentation, and IP protection under strict NDA.
Deliverable: Commercial Batches & Regulatory COAHow tier-1 pharmaceutical, nutraceutical, and beauty conglomerates evaluate botanical CDMO partners in the light of emerging technology shifts.
Industry trend: Integrating computational in-silico screening with traditional botanical chemistry. We deploy virtual molecular docking to predict multi-target interactions between botanical polyphenols and inflammatory or metabolic enzyme cascades before executing wet-lab synthesis.
Industry trend: Phasing out hazardous petrochemical solvents. MedGence leverages subcritical water extraction, supercritical CO2 fluid fractioning, and ceramic membrane nanofiltration to deliver 100% clean-label, solvent-free botanical active complexes.
Global procurement requirement: Tier-1 brand owners require absolute legal guarantees that proprietary botanical blends, extraction solvent ratios, and clinical findings are quarantined. MedGence operates on an entrusted CRO/CDMO model with ironclad IP security protocols.
Before issuing purchase orders for botanical extracts, enterprise procurement executives require the following 5 critical verifications, all of which MedGence supplies as standard:
Engineering botanical actives to match consumer sensory preferences, biological uptake windows, and packaging demands across four distinct global commercial sectors.
Standardized polyphenol, polysaccharide, and alkaloid complexes formulated for metabolic balance, cognitive focus, stress mitigation, and longevity support.
High-purity botanical active pharmaceutical ingredients (APIs) and standardized fractions backed by preclinical PK/PD and clinical trials for pharmaceutical registration.
Topical skin barrier actives, cellular senescence regulators, and tyrosinase inhibitors with documented cellular permeability and non-irritancy certification.
100% water-soluble, crystal-clear, heat-stable, and taste-neutralized botanical extracts engineered for functional ready-to-drink beverages and electrolyte drink powders.
Our contracted efficacy research and commercial production programs support over 100 distinguished pharmaceutical giants and medical research universities.
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Pharma
Dihon Pharma
Golden Throat Group
Yangtze River Pharma
Gofar Chuanshan Bio
Humanwell Healthcare
SCIMYTH Pharma
Hanfang Pharma
Luoxin Pharma
Zhongsheng Pharma
Brilliance & Abundance
Apeloa Pharma
Heng Chang Pharma
Baotou TCM
Kamp Medicine
Santo Pharma
Kangshou Pharma
Juwang Pharma
Beijing Tcmages
Ruihe Pharma
CR Jinchan Pharma
Kangmei Pharma
Tianjicaotang Pharma
Kingstone Unite
Shuguang Hospital TCM
Hunan Affiliated TCM Hosp
1st Hosp Hunan Univ CM
2nd Xiangya Hospital
2nd Hosp Hunan Univ CM
Zhuzhou Orthopedics TCMEssential answers addressing contract models, technology transfer, IP protection, testing methodologies, and clinical study execution.
Connect with our technical research directorate to initiate screening, method standardization, or full CDMO commercial manufacturing.
Send us your target health indication, reference botanical compound, or desired finished dosage form. Our team will draft a detailed experimental study protocol and project scope.
