Explore our core turnkey research, screening, testing, and pilot-to-scale ODM modules engineered to validate, standardize, and scale therapeutic phytochemical active substances.
Transitioning from unstandardized crude botanical powders toward mathematically modeled, clinically validated phytochemical supramolecular matrices.
The global natural products formulation and botanical drug CDMO sector has expanded beyond $140 billion globally, driven by strict regulatory demands for reproducible therapeutics. Modern pharmaceutical sponsors and tier-one supplement conglomerates no longer accept traditional crude extracts with unknown chemical profiles. The market mandates defined bioavailability kinetics, non-thermal preservation of labile secondary metabolites, and certified absence of environmental impurities like heavy metals, aflatoxins, and ethylene oxide residuals.
Over 70% of highly promising botanical compounds—such as curcuminoids, silymarin flavonolignans, quercetin, and ginsenosides—suffer from Biopharmaceutics Classification System (BCS) Class II or IV limitations (low aqueous solubility and compromised intestinal membrane permeability). Modern contract formulation requires specialized molecular delivery systems, including Self-Nanoemulsifying Drug Delivery Systems (SNEDDS), phospholipid phytosomes, and cyclodextrin supramolecular encapsulation, to achieve measurable therapeutic outcomes.
Brand owners navigating multinational supply pipelines face stringent divergence between US FDA Botanical Drug Guidance, European Medicines Agency (EMA) HMPC monographs, and the Chinese Pharmacopoeia (ChP). An advanced ODM partner must deliver full Chemistry, Manufacturing, and Controls (CMC) dossiers, verifiable chromatographic fingerprints, and stability data under ICH Q1A(R2) conditions to ensure frictionless cross-border customs registration and retail validation.
MedGence (Yineng Pharma) provides an uninterrupted contract research and manufacturing pipeline spanning over 14 years of scientific mastery across 300+ dedicated pharmaceutical researchers.
Systematic screening of complex plant matrices using high-resolution UHPLC-QTOF-MS to isolate and pinpoint targeted alkaloids, glycosides, and triterpenoid saponins matching your chosen therapeutic endpoints.
Evaluation of raw botanical materials across diverse microclimates, harvesting periods, and botanical anatomy to locate cultivars with peak marker density, guaranteeing cost-controlled commercial scaling.
Development and validation of robust HPTLC, HPLC, and GC chromatographic fingerprinting methods compliant with ICH Q2(R1) guidelines to ensure absolute qualitative and quantitative reproducibility.
Optimization of critical process parameters (CPPs)—such as solid-to-liquid ratios, solvent polarity, temperature cascades, and macroporous resin adsorption—to maximize yields while preventing compound pyrolysis.
Eliminating organoleptic bitterness, stabilizing moisture-sensitive hygroscopic botanical fractions, and developing specialized enteric coats or sustained-release matrices that maintain dissolution kinetics.
Preclinical GLP toxicology studies including acute median lethal dose (LD50), 90-day repeated-dose subchronic toxicity, bacterial reverse mutation (Ames test), and mammalian micronucleus genotoxicity assays.
Target engagement screening using primary human and rodent cell cultures, elucidating enzymatic pathways (e.g., AMPK activation, NF-κB inhibition, COX-2 down-regulation) before investing in live animal models.
Preclinical validation across disease models (metabolic syndrome, neuroprotection, hepatic inflammation, osteoarthritis) designed to generate peer-reviewable efficacy data packages for regulatory submissions.
GCP-compliant human clinical trials: exploratory pilot trials for dietary supplement health claim substantiation, as well as formal Phase I pharmacokinetics to Phase III multicenter pivotal registration trials for botanical NDAs.
Modern medical reimagining of classical polyherbal formulations (e.g., Traditional Chinese Medicine formulas). We isolate synergistic mechanisms, weed out toxic herb-herb interactions, and formulate streamlined, highly concentrated extracts.
Confidential pilot and commercial batch synthesis supplying active botanical substances as spray-dried standardized powders, vacuum concentrated extracts, lipophilic oleoresins, and purified isolates.
End-to-end commercial cGMP production across oral liquids, two-piece hard gelatin and vegetarian HPMC capsules, softgel encapsulation, bi-layer tablets, and effervescent or directly dispersible granules.
Our ODM formulation matrix transforms chemical complexity into verified product solutions customized for distinct regulatory jurisdictions.
Designed for market leaders pursuing clinically proven structure-function claims. We engineer standardized herbal extracts for metabolic balance (AMPK/GLP-1 pathways), adaptogenic cognitive nootropics (bacopasides and withanolides), and cardiovascular longevity formulas. Our dosage systems utilize microencapsulation to prevent oxidative degradation and shield gastrointestinal transit.
Providing full CRO support for biotech sponsors filing botanical Investigational New Drugs (IND) under US FDA 21 CFR Part 312 or EMA Herbal Medicinal Product pathways. We supply documented botanical raw material authentication, multi-batch chromatographic fingerprint concordance, batch consistency studies, and GCP Phase I–III human pivotal trial data.
Transdermal botanical active substances engineered for medical-grade skincare and dermatological treatments. Our formulations utilize submicron liposomes and solid lipid nanoparticles (SLN) to deliver high concentrations of polyphenols, centella asiaticosides, and resveratrol through the stratum corneum barrier without triggering epidermal sensitization.
How MedGence integrates artificial intelligence, green extraction thermodynamics, and supramolecular chemistry to lead the future of natural medicine development.
Deploying quantitative structure-activity relationship (QSAR) and molecular docking algorithms to predict botanical polypharmacology, identifying synergisms across multi-herb formulations before physical wet-lab synthesis.
Replacing toxic organic solvents with Natural Deep Eutectic Solvents (NADES) and Supercritical Fluid CO2 (SFE-CO2) extraction to isolate unstable lipophilic and hydrophilic phytochemicals with zero toxic residue.
Industrialization of self-emulsifying phospholipid conjugates and mesoporous silica nanoparticles that elevate the oral bioavailability of poorly absorbed polyphenols and terpenes by up to 1,200%.
Implementation of Process Analytical Technology (PAT) coupled with continuous simulated moving bed (SMB) chromatography, allowing real-time batch correction and uniform active compound concentration.
Conventional natural contract manufacturing suffers from high variance and poor auditability. Here is how our enterprise engineering resolves these risks.
Industrial Pain: Variations in rainfall, soil chemistry, and harvest times cause dramatic fluctuations in active compound levels (e.g., ginsenoside levels fluctuating by >300%), causing unpredictable consumer results and failed regulatory assay tests.
MedGence Engineering Solution: We implement chromatographic fingerprinting alongside multi-marker normalization. By blending raw botanicals guided by chemometric algorithms, every finished lot meets exact HPLC/HPTLC reference peaks within ±3% tolerance.
Industrial Pain: High-temperature concentration and standard spray-drying frequently thermal-degrade delicate flavonoids and essential terpenes, yielding darkened powders with foul odors and reduced therapeutic potency.
MedGence Engineering Solution: We utilize low-temperature vacuum belt drying and membrane counter-osmosis concentration under inert nitrogen purging, preserving thermally delicate molecular bonds and safeguarding complete organoleptic profiles.
Industrial Pain: Agricultural pesticides, cadmium, lead, and polycyclic aromatic hydrocarbons (PAHs) frequently contaminate wild-harvested herbs, causing border seizures and costly product recalls.
MedGence Engineering Solution: We operate strictly mapped Good Agricultural and Collection Practice (GACP) contracted farms. Every incoming lot undergoes ICP-MS heavy metal analysis and GC-MS/MS 400+ pesticide multi-residue screening prior to processing.
Industrial Pain: Traditional contract suppliers frequently white-label proprietary client blends to competitors, eroding market defensibility and brand valuation.
MedGence Engineering Solution: We work under strict, legally binding CRO/CDMO confidentiality agreements. Proprietary formulation recipes and process parameters are isolated in compartmentalized cleanrooms, safeguarding your long-term IP assets.
A proven track record serving premier pharmaceutical manufacturers, clinical research hospitals, and global life-science enterprises.
Our collaborative research, analytical testing, and CDMO supply chain power leading organizations across the health and life sciences sector.
Beijing Tongrentang Group
CR Sanjiu Pharmaceutical
Sunflower Pharmaceutical
Livzon Pharmaceutical
Dihon Pharmaceutical
Golden Throat Holdings
Yangtzi River Pharma
Beihai Gofar Chuanshan
Humanwell Healthcare
SCIMYTH Pharmaceutical
Shandong Hanfang Pharma
Luoxin Pharmaceutical
Guangdong Zhongsheng
Hunan Brilliance Herbal
Apeloa Pharmaceutical
Hunan Heng Chang Pharma
Baotou TCM Co.
Kamp Medicine
Guangxi Santo Pharma
Hunan Kangshou Pharma
Jiangxi Juwang Pharma
Beijing Tcmages Pharma
Guizhou Ruihe Pharma
Anhui CR Jinchan Pharma
Kangmei Pharmaceutical
Hunan Tianjicaotang
Jiangxi Kingstone Unite
Shuguang Hospital, Shanghai
Hunan Province TCM Hospital
First Hospital of Hunan TCM
Second Xiangya Hospital
Second Hospital of Hunan TCM
Orthopedics TCM ZhuzhouSelect your formulation pathway, preclinical protocol, or active ingredient manufacturing package to initialize technical transfer.
In-depth responses for procurement leaders, formulation scientists, and regulatory officers evaluating our ODM natural product capabilities.
Connect with MedGence (Yineng Pharma) senior scientific directors to review target claims, evaluate botanical marker feasibility, and receive a customized CRO/CDMO technical proposal.