ODM Natural Formulations Manufacturers & Suppliers

MedGence (Yineng Pharma) operates across the full discovery-to-commercialization continuum. We perform high-throughput botanical active screening, chemometric source and seasonal potency evaluations, develop and validate chromatographic analytical methods (HPLC, HPTLC, GC-MS), execute comprehensive toxicology (GLP-compliant acute and chronic safety assays), run in vitro target screening and in vivo animal disease models, coordinate Phase I to Phase IV GCP clinical trials, and run cGMP-compliant OEM/CDMO production lines supplying bulk actives and finished commercial dosage forms.

Botanical consistency is secured through multi-dimensional chromatographic fingerprinting. Rather than standardizing to a single active biomarker, we profile the full matrix distribution of secondary metabolites, locking in similarity thresholds above 0.95 relative to certified reference monographs. By mapping raw material provenance across distinct geo-climatic production zones in China and maintaining multi-harvest blending protocols, we eliminate standard deviation across commercial production campaigns.

Our finished-dosage manufacturing plants produce: oral liquid ampoules/solutions, two-piece hard gelatin and vegetable HPMC capsules, rotary-die softgels (both animal-based and vegan carrageenan shells), enteric-coated and chewable tablets, spray-dried dispersible powders, and vacuum-granulated effervescents. Actives can also be delivered in intermediate bulk forms, such as high-viscosity paste extracts, supercritical fluid volatile oils, and standardized crystal powders.

Every entrusted R&D and custom manufacturing program is executed under a rigorous, legally enforceable Non-Disclosure Agreement (NDA). All intellectual property generated throughout formulation optimization, including extraction parameters, column chromatography fractions, solvent ratios, and pharmacological dossier outcomes, is exclusively assigned to the client. MedGence maintains air-gapped data architecture to ensure project parameters remain completely confidential.

Yes. Our preclinical packages, analytical method validations (ICH Q2(R1)), stability study protocols (ICH Q1A(R2)), and GCP clinical trial structures are intentionally architected to satisfy US FDA Botanical Drug Development Guidelines and EMA Herbal Medicinal Product monographs. We have successfully developed 22 innovative natural medicines and contributed documentation leading to 56 official hospital preparation authorizations.

Engagements typically initiate with an introductory technical consultation and Mutual NDA execution. The client provides target therapeutic claims, preferred botanical actives, dosage vehicle requirements, and destination market regulatory expectations. Our scientific leadership delivers a multi-phase Proposal Scope encompassing target screening, analytical establishment, pilot extraction, preclinical validation, and production milestones, with discrete stage-gate review checkpoints for transparent project oversight.