OEM Phytomedicine Development Manufacturers & Suppliers

MedGence provides an unbroken translational bridge between early botanical screening and commercial-scale cGMP manufacturing. Unlike academic institutes that end at analytical assay reports, or raw-extract trading companies lacking pharmacological capability, our 300+ scientists handle the whole lifecycle: bio-guided fraction screening, analytical method validation (HPLC/HPTLC/GC-MS), in vitro and animal toxicological safety packages, human Phase I–IV clinical designs, and industrial-scale manufacturing of standardized extracts and finished solid/liquid dosage forms.

We employ a three-tier standardization strategy: First, we evaluate raw materials across multiple geographic origins and seasons to define the peak chemical harvest window. Second, we establish multi-wavelength chromatographic fingerprinting to set minimum threshold ratios for both primary active markers and supporting synergistic constituents. Third, our pilot extraction processes utilize standardized blending and resin-fractionation parameters to normalize active concentrations within a tight ±5% tolerance across commercial production runs.

All analytical methods are validated in strict compliance with ICH Q2(R1) guidelines for specificity, linearity, range, precision (repeatability and intermediate precision), accuracy, and robustness. We routinely engineer High-Performance Thin-Layer Chromatography (HPTLC) for qualitative identification, High-Performance Liquid Chromatography with Photodiode Array/Evaporative Light Scattering/Mass Spectrometry (HPLC-PDA/ELSD/MS) for quantitative assays, Gas Chromatography (GC-FID/MS) for volatile oils and residual solvents, and ICP-MS for heavy metal determinations under USP <232>/<233>.

We operate exclusively on an entrusted, fee-for-service contract research and contract manufacturing model. Prior to receiving client project briefs, comprehensive bilateral Non-Disclosure Agreements (NDAs) are executed under governing laws chosen by the client. All project data, chromatography methods, intermediate fractions, and production batch parameters remain 100% client property. We do not market competing branded products in client jurisdictions, preventing commercial conflicts of interest.

For raw active ingredients, we supply spray-dried powders, vacuum belt-dried fine granules, concentrated aqueous/ethanolic extracts, purified resin-adsorbed pastes, and CO2 supercritical fluid volatile oils. For finished pharmaceutical and nutraceutical consumer goods, our CDMO facilities produce two-piece hard gelatin and vegetable (HPMC) capsules, liquid softgels, film-coated and sublingual tablets, effervescent granules, functional oral liquids, and aseptic ampoules.

Yes. We have designed and supervised modern clinical evaluations for 83 classic TCM formulas and 22 novel natural drug candidates. We arrange small-group double-blind, randomized, placebo-controlled human efficacy trials for dietary supplements as well as formal Phase I (pharmacokinetics and safety), Phase II (dose-ranging), Phase III (multi-center confirmatory), and Phase IV (post-market surveillance) trials adhering strictly to International Council for Harmonisation Good Clinical Practice (ICH GCP) standards.

Our preclinical toxicology suite includes Median Lethal Dose (LD50) assays, acute oral toxicity screening, 28-day and 90-day sub-chronic repeated-dose toxicity studies in rodents, skin and ocular irritation/sensitization testing (critical for cosmetic botanicals), and standard genotoxicity batteries (Ames test, in vitro chromosomal aberration, and mammalian erythrocyte micronucleus assays) following OECD guidelines.