Synthetic Biology · High-Purity Manufacturer

High-Purity Active
Ingredients Manufacturer

From NMN to NAD⁺ — pharmaceutical-grade purity ≥99.5%, ICH compliant, shipped to 50+ countries.

≥99.5% Purity

Above industry average by 1%

ISO / ICH Certified

USP · EP dual pharmacopeia

12 Invention Patents

Core proprietary processes

50+ Countries

Global compliant delivery

Flagship Products

Industry-Leading Core Portfolio

Six flagship actives spanning NAD⁺ precursors, cognitive health, and phytoestrogen markets

Browse all 38 products
NMNFlagship

β-Nicotinamide Mononucleotide

≥99.5%

Purity

  • Enzymatic synthesis — zero Cl⁻ contamination
  • 300 MT/year · largest scale in the market
  • USP & EP dual pharmacopeia certified
300 MT/year
USP/EP
USPEPISO
NRCFlagship

Nicotinamide Riboside Chloride

≥98.0%

Purity

  • Recrystallization purification — ultra-low impurities
  • Heavy metals ≤1 ppm, stable white crystals
  • Consistent batch-to-batch analytical profile
50 MT/year
ISO
ISOISO9001
NRHMFlagship

Nicotinamide Riboside Hydrogen Malate

≥98.0%

Purity

  • Malate salt — superior hygroscopicity vs. chloride
  • Electrodialysis desalting · patent-protected process
  • Optimized for tablet & capsule formulation
50 MT/year
Patent
ISOISO9001
NAD⁺Flagship

β-Nicotinamide Adenine Dinucleotide

≥98.0%

Purity

  • Biosynthetic fermentation — avoids the cost of full chemical synthesis
  • ≥98.0% purity, HPLC-verified every batch
  • ISO / ISO9001 system, full heavy-metal & microbial screening
MOQ 1 kg
ISO
ISOISO9001
CDP-CholineFlagship

Cytidine Diphosphocholine (Citicoline)

≥99.8%

Purity

  • ≥99.8% ultra-high purity — rare in the industry
  • USP & EP dual pharmacopeia · 100 MT/year scale
  • Premier cognitive health & stroke recovery API
100 MT/year
USP/EP
USPEPISO
S-EquolFlagship

S-Equol (Fermentation-derived)

≥98.0%

Purity

  • 100% S-configuration — not a racemic mixture
  • Fermentation synthesis: 40% cost vs. chemical resolution
  • Recombinant E. coli · no animal-derived material
20 MT/year
ISO
ISO

Infrastructure

Facility & Technology

Pharmaceutical-grade infrastructure built for scale and compliance.

1,500 m²

Clean Production Area

50L – 8,000L

Flexible Fermentation Scale

12

Core Invention Patents

Clean Room Production Floor

Fermentation Production Center

1,500㎡

HPLC Quality Control

HPLC Quality Control

In-House QC Lab

Column Chromatography Purification

Column Chromatography Purification

Agilent HPLC System

Analytical Instrument Platform

Analytical Instrument Platform

Cold-Chain Storage

Pharmaceutical Filling Line

Pharmaceutical Filling Line

Packaging & Dispatch

Enzymatic & Fermentation Platform

Fixed-enzyme catalysis and multi-strain fermentation (Lactobacillus, Hyphomicrobium, recombinant E. coli). Full aqueous-phase system, near-zero organic solvent, ultra-low impurity profile.

Zero SolventUltra-Low ImpurityPharma Grade

Chemical Synthesis Platform

Multi-step organic synthesis including catalytic hydrogenation (2 MPa) and electrodialysis desalination, followed by precision recrystallization for ≥99% purity.

Cost-EfficientReproducibleScalable

Fermentation & Bioconversion Platform

Multi-strain precision fermentation (Lactobacillus, Hyphomicrobium, recombinant E. coli) and whole-cell bioconversion. Scalable 50 L – 8,000 L. Produces GABA, PQQ, S-Equol and other high-value metabolites with low downstream impurity burden.

LactobacillusHyphomicrobiumE. coli

Our Advantage

Why PathGene

12

Invention Patents

+1%

Above Industry Purity

93M+

Enzyme Sequences (AI Platform)

USP/EP

Dual Pharmacopeia

Pfizer-Trained Quality Engineering

Our founder brings direct quality engineering experience from Pfizer, applying the world's most stringent pharmaceutical QA methodologies to every production batch.

Purity 1% Above Industry Average

Third-party tested. Our NMN and NAD⁺ consistently test ≥99.5%, outperforming the industry standard of ~98.5% — a critical differentiator for regulated markets.

12 Core Invention Patents

Proprietary enzymatic synthesis routes protected by granted invention patents, ensuring stable supply and defensible technical moats.

Global Regulatory Compliance

Full documentation support: COA, MSDS, Spec Sheet, DMF filing assistance. Ready for FDA, EMA, and NMPA submissions.

Knowledge Center

Technical Insights

FAQ

Questions Before You Order

Can't find your answer? Our technical sales team is happy to help.

What is the minimum order quantity (MOQ)?

Most products start at 1–25 kg for trial orders. Volume discounts apply from 10 kg. MOQ varies by product — NMN and CDP-Choline trials start at 1 kg, while some specialty actives require 100 g. Contact us for the exact MOQ for your product of interest.

How quickly can I receive samples?

Free samples (10–50 g) are available for qualified B2B buyers. After business verification, samples are dispatched within 3–5 business days via DHL/FedEx. International delivery typically takes 3–7 days depending on destination.

Which pharmacopeia standards do your products meet?

NMN and CDP-Choline are dual-certified to both USP (U.S. Pharmacopeia) and EP (European Pharmacopoeia) — rare among Chinese manufacturers. Full analytical documentation (COA, MSDS, TDS) is provided with every shipment.

What is the typical lead time for bulk orders?

Standard lead time is 3–10 business days for in-stock items. For large custom batches (>50 kg), lead time is typically 2–4 weeks. We maintain safety stock for flagship products (NMN, CDP-Choline) to support urgent orders. Contact us for current inventory status.

Do you support custom packaging and private label (OEM)?

Yes. We offer OEM packaging in 1 kg, 5 kg, 10 kg, and 25 kg formats with custom labels. White-label arrangements and bulk-to-finished-ingredient supply are both available. Our team can assist with ingredient specification sheets tailored to your brand requirements.

Can you assist with import documentation and regulatory filings?

Yes. We provide full export documentation including Certificate of Origin, MSDS, phytosanitary certificates, and customs-ready invoices. We have experience supporting regulatory submissions in the EU, US, Japan, and Southeast Asia. Our team can provide technical dossiers upon request.

Speak to Our R&D Experts

Tell us your specification requirements. We'll respond within 24 hours.

PathGene Biotech Co., Ltd.

Contact Information

Address

Room 301, 3F, Building 1, No. 41 Zonghui Road, Nanjing Economic & Technological Development Zone, Nanjing, China

Fermentation production
QC laboratory