OEM CDMO Contract Development And Manufacturing Organization Manufacturers

MedGence (Yineng Pharma) operates as a full-spectrum Contract Research and Development Organization (CRO) and Contract Development and Manufacturing Organization (CDMO). We provide end-to-end research and production services for plant-derived active compounds: target active ingredient bio-screening, geographic/seasonal raw-material potency evaluations, analytical method establishment (HPLC, GC-MS, HPTLC), process engineering, acute/chronic toxicology, in vitro receptor studies, in vivo animal models, clinical validation (Phase I–IV), formulation chemistry, and multi-ton GMP commercial batch manufacturing.

Contracting analytical research and mass manufacturing to separate entities creates significant knowledge transfer friction. Formula yields frequently collapse during scale-up due to undocumented operational nuances. By managing both the laboratory screening phases and commercial factories under one coordinated technical leadership team, we guarantee that critical process parameters (CPPs) developed on benchtop columns transfer seamlessly into large-scale commercial extraction vessels without quality decay.

Depending on target chemical classes, we employ high-performance thin-layer chromatography (HPTLC) fingerprinting for botanical authentication, high-performance liquid chromatography (HPLC) equipped with DAD/ELSD detectors for quantitative assaying, gas chromatography (GC) for volatile components, and tandem mass spectrometry (LC-MS/MS, GC-MS/MS) for trace pesticide and contaminant screens. This produces a holistic chemical fingerprint that proves identity, purity, and active content consistency across every manufacturing lot.

We work under an entrusted research and manufacturing model governed by enforceable international non-disclosure agreements (NDAs). Proprietary active recipes, fractionation methods, and process conditions belong exclusively to our client. Plant production batches use compartmentalized production campaigns, ensuring full isolation of proprietary datasets and preventing cross-client formulation visibility.

For intermediate active raw materials, we supply standardized concentrated liquids, spray-dried extract powders, viscous pastes, crystallized active isolates, and purified volatile essential oils. For finished retail-ready dosage forms, we manufacture bottled oral liquids, two-piece hard gelatin or vegetarian capsules, softgels, enteric-coated tablets, instantly soluble functional beverage powders, and effervescent granules.

Yes. We execute small-cohort randomized human clinical studies for dietary supplements to validate marketing structure/function claims, as well as formal GCP-compliant Phase I, Phase II, Phase III, and Phase IV clinical evaluations required by regulatory authorities to support new botanical drug applications (NDAs) or hospital preparation registrations.