Explore our core scientific and analytical CRO/CDMO services tailored for global pharmaceutical manufacturers and bio-nutraceutical developers.
Overcoming the historical limitations of batch inconsistency, undefined metabolic kinetics, and unverified traditional medicine formulations through analytical modernization.
Traditional natural medicine struggles with natural chemical variance caused by geographic, climatic, and seasonal factors. Our macro solution applies multidimensional chromatographic fingerprinting and chemometric analysis to eliminate variability across extraction batches, providing standardized Active Pharmaceutical Ingredients (APIs).
Bridging traditional empirical therapeutic claims to rigorous pharmacological science. We utilize phenotypic cellular assays, target-directed microfluidic models, and GLP-compliant rodent studies to establish quantifiable pharmacokinetics (PK) and pharmacodynamics (PD) acceptable to Western regulatory agencies.
Solving the common "pilot-to-production gap" where laboratory extractions lose yields or stability on commercial lines. Our co-located pilot plants and commercial cGMP manufacturing facilities eliminate technical handover losses, accelerating lead times by over 40% for novel formulations.
MedGence (Yineng Pharma) converts botanical know-how into reproducible biochemical entities across an expansive enterprise footprint.
Years of Botanical R&D Specialization
Senior Phytochemists & Bio-Analysts
Classic TCM Formulas Modernized
Single-Herb Standards Established
Pharma & Hospital Clients Served
Innovative Natural Drugs Developed
Hospital Clinical Registrations Won
Proprietary Formula IP Protection
Harmonizing botanical drugs and dietary matrices to the stringent statutory frameworks of the FDA, EMA, TGA, and NMPA.
Guidance compliance under the FDA Botanical Drug Development Protocol. Complete analytical traceability, chemical characterization of multi-component fractions, and compliance with cGMP (21 CFR Part 111/211) including residual solvents, elemental impurities, and pesticide panels.
Support for Traditional Herbal Medicinal Products (THMPD) and Well-Established Use filings. Comprehensive bibliographic research, genotoxicity profiling, and validation according to European Pharmacopoeia (Ph. Eur.) monograph requirements.
Alignment with China's modern TCM Innovation Policy and Australia's Therapeutic Goods Administration (TGA) Listed/Registered Medicine pathways. Full batch-dossier compilation for hospital preparations and global therapeutic import approvals.
Custom ODM solutions designed for specialized vertical markets seeking differentiated product performance.
Application of concentrated polyphenol and berberine alkaloid complexes for insulin sensitivity, AMPK pathway activation, and postprandial glucose regulation. Validated through in vitro gut-microbiome and murine metabolic syndrome models.
Standardized saponins and terpene lactones focused on cerebral microcirculation, acetylcholine protection, and mitochondrial neuro-rescue. Engineered for specialized nootropic capsules, effervescent granules, and functional drink mixes.
Water-soluble and liposomal-encapsulated flavonoid botanical actives with proven suppression of inflammatory cytokines (TNF-α, IL-6). Backed by certified cell membrane irritation and skin permeability assays for clean-label clinical beauty.
Architecting the intersection of high-throughput phytomics, machine learning, and green bioprocess chemistry.
Utilizing high-performance machine learning models to cross-reference multi-target affinity landscapes against millions of botanical chemical structures, cutting lead discovery from years to weeks.
Implementing superheated water and subcritical CO2 technologies to eliminate petrochemical solvents, maximizing yield purity while lowering carbon footprints and operational costs.
Overcoming the poor oral bioavailability common to botanical compounds using self-emulsifying drug delivery systems (SEDDS) and lipid nanoparticle delivery vehicles.
Engineering microbial strains for rare ginsenosides and scarce phyto-metabolites, establishing unlimited commercial capacity without botanical resource depletion.
Technical and commercial answers addressing non-disclosure, technology transfer, and regulatory qualification.
We are a genuine Contract Research and Development Organization with over 300 research scientists, modern pilot facilities, and analytical laboratories equipped with HPLC, GC-MS, LC-MS/MS, and HPTLC instruments. We own empirical data across hundreds of thousands of research batches, delivering primary data packages, validated assay methods, and clinical dossiers rather than brokering re-packaged commodity powders.
All contract development operates under strict, legally enforceable bilateral NDAs governed by international legal protections. Custom process parameters, proprietary solvent formulations, and analytical standards remain the client’s exclusive intellectual property. We implement strict digital air-gapping and code-numbered sample tracking throughout all laboratory and manufacturing workflows.
Yes. We deliver complete chemistry, manufacturing, and controls (CMC) packages, comprehensive Certificate of Analyses (CoAs), 3-year accelerated/real-time ICH stability studies, GLP-compliant in vitro mutagenicity (Ames) assays, and oral LD50 animal toxicology documentation required for IND or New Dietary Ingredient (NDI) submissions.
Our contract manufacturing lines handle both intermediate active ingredients (extract powders, standardized pastes, concentrated liquids, volatile essential oils) and consumer-ready dosage forms (two-piece hard gelatin/HPMC capsules, softgels, micro-tablets, effervescent granules, sachets, and liquid oral vials). We handle flexible volumes from pilot batches of 50kg up to full commercial campaigns exceeding 100 metric tons annually.
Our validated phytochemical research supports leading pharmaceutical manufacturers, hospital preparation pharmacies, and biotech entities globally.
Tongrentang Group
CR Sanjiu Pharmaceutical
Sunflower Pharma
Livzon Pharma Group
Dihon Pharmaceutical
Golden Throat Group
Yangtzi River Pharma
Humanwell Healthcare
SCIMYTH Pharma
Luoxin Pharma Group
Apeloa Pharmaceutical
Kangmei Pharmaceutical
Complete regulatory dossiers, pre-formulation assays, and cGMP production packages available for immediate scale-up.
