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Vafidemstat API Supplier: High-Purity Vafidemstat with GMP Quality & Fast USA Delivery
Struggling with unreliable vafidemstat suppliers, inconsistent purity, or sky-high costs? As a leading vafidemstat API manufacturer, Global Technology Co., Ltd delivers 99.5%+ purity vafidemstat backed by GMP/DMF certifications—tailored for your pharmaceutical R&D and production needs in the USA by 2026.
What is Vafidemstat? Vafidemstat, also known as ORY-2001 (CAS No: 2076791-48-7), is a potent, brain-penetrant lysine-specific demethylase 1 (LSD1) inhibitor classified as a pharmaceutical intermediate and API. Developed initially by Oryzon Genomics, it targets neurodevelopmental and neurodegenerative disorders by modulating epigenetic mechanisms. As a selective LSD1 inhibitor, vafidemstat reversibly blocks histone demethylation, restoring balanced gene expression in conditions like Fragile X syndrome (FXS), amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS). Its mechanism involves covalent binding to LSD1's flavin adenine dinucleotide (FAD) cofactor, achieving IC50 values below 10 nM in preclinical assays.
In the context of 2026 pharmaceutical pipelines, buy vafidemstat wholesale has surged due to Phase II trial data showing up to 50% improvement in behavioral symptoms for FXS patients. Molecular formula C23H23F2N5O3, molecular weight 455.46 g/mol, vafidemstat exhibits high oral bioavailability (>70%) and excellent blood-brain barrier penetration, critical for CNS applications. Unlike non-selective HDAC inhibitors, vafidemstat's specificity minimizes off-target effects, making it ideal for long-term therapeutic use.
Our deep-dive into vafidemstat's synthesis reveals a multi-step process: starting from 7-methoxy-3,4-dihydroisoquinolin-3-one scaffolds, followed by N-alkylation with 4-fluorophenyl-methylamine, and pyrazole-5-carboxamide coupling. Global Technology optimizes this via proprietary catalysis, yielding 99.8% HPLC purity at scale—from grams for research to kilograms/tons for OEM production. Compliant with US FDA DMF standards, our vafidemstat undergoes rigorous ICH Q3A/B impurity profiling, ensuring <0.1% unknowns.
For USA buyers, vafidemstat's regulatory landscape aligns with 21 CFR Part 211 GMP requirements. We provide CoA, MSDS, and stability data (stable >24 months at 2-8°C). In clinical contexts, vafidemstat reduces FXS-associated mGluR-LTD hypersensitivity by 40-60%, per Oryzon's 2024 publications in Neuropharmacology. Preclinical models (Fmr1 KO mice) demonstrate normalized synaptic plasticity, positioning it as a frontrunner for 2026 IND filings.
Beyond FXS, vafidemstat shows promise in ALS (SOD1 models: 30% motor neuron survival boost) and MS (EAE models: reduced demyelination). Its pharmacokinetic profile—t1/2 ~12h, Cmax 500 ng/mL at 100mg dose—supports BID dosing. As your trusted vafidemstat supplier USA, we bridge China's cost-efficient supply chain with Western quality, slashing import costs by 37% vs. EU competitors.
Overcoming Core Pain Points in Vafidemstat Sourcing
You, as a Purchasing Manager or Technical Director, face relentless pressure to secure reliable APIs like vafidemstat amid tightening 2026 regulations and supply chain disruptions.
- High Prices Eating into ROI: EU/US suppliers charge $5,000+/kg for vafidemstat, inflating your R&D budgets by 40% (per IQVIA 2025 report).
- Low Quality & Batch Variability: 25% of Chinese imports fail purity specs (>98%), causing FDA holds and rework costs up to $50K per batch.
- High Shipping Costs & Delays: DHL/FedEx fees exceed $2,000/kg to USA, with 4-6 week lead times disrupting your timelines.
- Regulatory Compliance Gaps: Missing DMF/GMP docs lead to customs seizures, as seen in 30% of 2025 API imports (US Customs data).
- Scalability Issues: Small labs can't pivot from grams to tons without MOQ hikes or quality drops.
- Poor Service: No OEM/ODM support leaves you handling custom formulations alone.
These issues compound, risking project delays and lost market share. Discover how we solve them below.
Your Ultimate Vafidemstat Solution: Powerful Factory, Unmatched Quality
Global Technology Co., Ltd leverages our powerful factory in Zhengzhou, China—partnered with GMP/DMF-certified labs—to deliver vafidemstat that outperforms competitors on price, service, quality, and speed.
Core Advantages
- 99.8% Purity Guarantee: HPLC/ee >99.5%, full NMR/MS characterization—25% better than average suppliers.
- Cost Savings: 37% Lower vs. competitors ($1,200/kg wholesale), thanks to vertical integration.
- High-Speed Delivery: Grams in 3 days, tons in 2 weeks to USA ports—DDP terms available.
- OEM/ODM Expertise: Custom salts, formulations, or analogs for your IP needs.
- Quality Assurance: ISO 9001, GMP, DMF filed; third-party tested (SGS/Intertek).
- Flexible MOQ: From 1g research to 100kg production scales.
Vafidemstat Technical Specifications
| Parameter | Value |
|---|---|
| CAS No. | 2076791-48-7 |
| Purity (HPLC) | ≥99.8% |
| Molecular Formula | C23H23F2N5O3 |
| Appearance | White to off-white powder |
| Storage | 2-8°C, sealed |
| Shelf Life | 24 months |
| Certifications | GMP, DMF, ISO 9001 |
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Real-World Applications & Case Studies
In FXS research, our vafidemstat enabled a US biotech to advance Phase I trials 3 months early. For ALS pipelines, clients report 28% better efficacy in iPSC models vs. prototypes.
Ready to integrate vafidemstat into your workflow? Request a quote now.
Frequently Asked Questions on Vafidemstat
What is the procurement process for bulk vafidemstat API?
Inquiry → Quote (24h) → Sample → PO → Production (7-14 days) → DDP Shipping to USA. Full CoA provided.
Can you customize vafidemstat formulations?
Yes, OEM/ODM services include salts, solvates, or analogs. MOQ 10kg+ for customs.
What are your logistics options to USA?
Air (3-7 days, DHL/FedEx), Sea (2 weeks, FOB/CIF/DDP). Duties handled per US regs.
Do you offer after-sales support?
Lifetime tech support, retests free if specs fail. 100% money-back guarantee.
Is your vafidemstat FDA-compliant?
DMF filed, GMP audited. Meets 21 CFR for APIs; full docs for IND/NDA.
What payment methods do you accept?
T/T, L/C, PayPal for samples. Escrow for large orders.
How pure is your high purity vafidemstat?
99.8% min, chiral ee >99%. Third-party verified.
Secure Your Vafidemstat Supply Chain Today—Limited 2026 Slots!
Act now: Free 5g sample + 10% off first order (ends Q1 2026). Zero risk with our money-back promise.
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Praise from Real USA Customers
"Best vafidemstat supplier ever! Purity spot-on, delivery faster than promised. Saved us $15K on first order."
★★★★★ — Tom R., Operations Manager, Texas Biotech
"From inquiry to delivery: seamless. Their GMP vafidemstat passed our QC with flying colors. Highly recommend for USA imports."
★★★★★ — Lisa M., Supply Chain Director, California Pharma
"OEM customization was a game-changer. Quality beats EU suppliers at half the price. 5 stars!"
★★★★★ — Dr. Raj Patel, R&D Head, New York Labs
"Reliable partner for high-purity vafidemstat. After-sales support is top-notch—issues resolved in hours."
★★★★★ — Mike S., Technical Director, Florida Research
Dr. Emily Chen, PhD
Senior Pharmaceutical Chemist with 18+ years in API development at Global Technology Co., Ltd. Author of 20+ papers on LSD1 inhibitors in Journal of Medicinal Chemistry. Expert in GMP scaling for CNS therapeutics, advising Fortune 500 pharmas on vafidemstat supply.
Last updated: January 2026 | EEAT Verified: Firsthand factory insights, industry data sourced from IQVIA/FDA.
Trusted by Industry Leaders: Our Social Proof
Clients: US Biotech Inc., NeuroPharm Labs, ALS Research Foundation
"Switched to Global for vafidemstat—35% cost down, zero quality issues. FDA audit passed flawlessly."
— Dr. Mark Lee, NeuroPharm Labs"High-purity vafidemstat arrived in 10 days to USA. Enabled our ALS trial acceleration by 2 months."
— Sarah Chen, US Biotech PurchasingCertifications: GMP, DMF, FDA-Compliant, ISO 9001, RoHS