Precision botanical active ingredient synthesis, chromatography validation, and end-to-end pharmaceutical-grade quality assurance systems.
ISO/IEC 17025 compliant analytical protocols and biological evaluation systems ready for OEM commercial deployment.
In the globalized botanical, nutraceutical, and pharmaceutical markets, brand liability begins and ends with phytochemical reproducibility. MedGence (Yineng Pharma) operates as a dedicated Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) based in Changsha, China. We replace agricultural variability with strict molecular standardization, transforming empirical Traditional Chinese Medicine (TCM) insights into validated chromatographic datasets defensible before the US FDA, EMA, and NMPA.
Over 14 years of intensive R&D, serving 100+ tier-one pharmaceutical groups, completing 83 modernized classic TCM formula monographs, developing 22 new botanical entities, and registering 56 hospital preparations.
Proprietary analytical spectra from hundreds of thousands of research batches across China's geo-authentic herbal zones (Daodi) ensure instant reference mapping against adulteration, pesticides, and heavy metals.
Strict entrusted contract research execution guarantees that extraction parameters, solvent fractions, chromatography run sheets, and master formulas remain 100% proprietary assets belonging entirely to the client.
Empowering multinational procurement teams with verifiable analytical precision and industrial scale.
Overseas nutraceutical, cosmeceutical, and pharmaceutical brands face escalating regulatory pressure. Here is how our engineering bridges the risk gap.
Raw botanical extracts often exhibit 30%–60% variation in target markers between harvest batches. We deploy chromatographic fingerprinting (HPLC-DAD/ELSD) to establish rigid botanical reference standards, locking purity and assay ratios permanently.
Global customs reject shipments over trace ethylene oxide, aflatoxins, polycyclic aromatic hydrocarbons (PAHs), and unauthorized synthetic fortifiers. Our GC-MS/MS and LC-MS/MS testing screens out 500+ agrochemical and industrial contaminants prior to dispatch.
Purchasing raw ingredients without documentation delays NDA or FDA NDI submissions. We supply full technical filing dossiers containing validation reports, stability profiles, solvent clearance, and ICH-compliant toxicological portfolios.
Harnessing direct access to prime botanical origins with global regulatory translation frameworks.
Our direct ties to China’s authentic regional agricultural zones (Daodi) allow complete oversight from seed selection and soil composition analysis to optimized seasonal harvest windows, guaranteeing high biomarker accumulation.
From bench-scale rotary evaporation to industrial countercurrent continuous extraction, resin column chromatography, and cleanroom spray drying, our manufacturing infrastructure accelerates technology transfers from days to hours.
We customize documentation for diverse market entry: USP/NSF compliance for North America, EFSA novel foods registration dossiers for the European Union, and TGA requirements for Australia, smoothing regional cross-border customs.
The botanical extraction and OEM control market is shifting from bulk crude commodities toward single-compound precision and bio-synthetic synergy.
Market demand has moved away from ambiguous extract ratios (e.g. 10:1) to molecular concentrations: standardized ginsenosides, quantified curcuminoids, isolated polyphenols, and high-purity alkaloids with certified clinical outcomes.
Global brands are phasing out harsh chemical solvents. Supercritical CO2, pressurized hot-water extraction (PHWE), and enzymatic digestion now dominate research budgets, ensuring non-toxic profiles and pristine organoleptic properties.
By integrating molecular docking, virtual affinity assays, and high-throughput chromatographic confirmation, discovery pipelines for target biological receptors (e.g., AMPK, GLP-1 agonists, GABA) are shortened from years to quarters.
Every engagement phase terminates with tangible experimental deliverables, empowering your regulatory and QC committees.
Evaluation of plant origins, seasonal biomarker concentrations, and plant organ distribution to isolate raw sources with optimal chemical density.
Establishing qualitative and quantitative identification methods via HPTLC, HPLC, UPLC, GC-MS, and chromatographic fingerprinting.
Refinement of raw preparation, fluid solvent extraction, macroporous resin column purification, membrane separation, and spray crystallization.
Screening across in vitro cellular arrays, animal metabolic modeling, acute oral toxicity (LD50), sub-chronic evaluations, and Ames genotoxicity.
Designing and monitoring human safety trials for dietary supplements as well as formal GCP Phase I–IV clinical designs for investigational new drugs (INDs).
Executing pilot batch scale-up to high-capacity commercial tonnage production, packaged under strict non-disclosure across multiple dosage formats.
Engineered physical properties customized for superior bioavailability, dissolution stability, and packaging elegance.
Free-flowing, non-hygroscopic powders optimized for high-speed two-piece capsule filling, direct-compression tableting, softgel suspensions, and instant effervescent drink formulations.
Decolorized, odorless botanical actives designed for clear serum matrices, stable lipid-water cosmetic emulsions, anti-inflammatory topical gels, and transdermal patches.
Highly purified active pharmaceutical fractions (≥98% single isomer/marker) engineered for parenteral liquid vials, controlled-release micro-pellets, and pharmaceutical oral syrups.
MedGence's quality control systems underpin R&D and manufacturing programs for premier health institutions.
Tongrentang Group
CR Sanjiu
Sunflower Pharma
Livzon Pharma
Dihon Pharma
Golden Throat
Yangtzi River Pharma
Beihai Gofar
Humanwell Health
SCIMYTH Pharma
Shandong Hanfang
Luoxin Pharma
Zhongsheng Pharma
Brilliance Herbal
Apeloa Pharma
Heng Chang Pharma
Baotou TCM
Kamp Medicine
Guangxi Santo
Kangshou Pharma
Juwang Pharma
Tcmages Pharma
Ruihe Pharma
CR Jinchan
Kangmei Pharma
Tianjicaotang
Kingstone Unite
Shuguang Hospital
Hunan Direct TCM
1st Hospital of Hunan TCM
2nd Xiangya Hospital
2nd Hospital of Hunan TCM
Direct insights addressing compliance, analytical methods, IP protection, and trial execution.
Select your intended research module or contract manufacturing scope for direct scientific consultation.
Submit your product parameters, targeted biological markers, preferred dosage forms, or target export regions. Our lead scientists will scope a comprehensive protocol and validated study framework.