Fluvoxamine Maleate

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Fluvoxamine Maleate

Struggling with unreliable fluvoxamine maleate suppliers? Get premium-grade API direct from our FDA-DMF filed factory – reduce costs by 30% and ensure compliance for your OCD pharmaceutical production. As a pharmaceutical purchasing manager or




Buy Fluvoxamine Maleate API – GMP Certified, 99%+ Purity, Fast Delivery to USA

Struggling with unreliable fluvoxamine maleate suppliers? Get premium-grade API direct from our FDA-DMF filed factory – reduce costs by 30% and ensure compliance for your OCD pharmaceutical production.

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Introduction to Fluvoxamine Maleate: The Essential SSRI API for OCD Treatment

As a pharmaceutical purchasing manager or technical director in the USA, you're likely sourcing high-quality APIs for selective serotonin reuptake inhibitors (SSRIs). Fluvoxamine maleate, with CAS number 61718-82-9, stands out as a cornerstone active pharmaceutical ingredient (API) primarily used in the formulation of medications for obsessive-compulsive disorder (OCD). This maleate salt form of fluvoxamine enhances solubility and bioavailability, making it ideal for oral tablet production.

Discovered in the 1980s by Solvay Pharmaceuticals, fluvoxamine maleate functions by selectively inhibiting the reuptake of serotonin in the brain, thereby increasing serotonin levels and alleviating symptoms of OCD, social anxiety disorder, and even some depression cases. Its chemical formula, C15H21F3N2O2 • C4H4O4, has a molecular weight of 434.4 g/mol, and it's typically supplied as a white to off-white crystalline powder with high purity levels exceeding 99%.

In the global market projected to reach $XX billion by 2026 for SSRI APIs (source: Grand View Research, 2025 forecast), demand for fluvoxamine maleate is surging due to rising OCD diagnoses—over 2.2% of US adults affected per CDC data. Pharma manufacturers prefer this API for its established efficacy, backed by FDA approvals for brands like Luvox. However, supply chain disruptions post-2020 have led to shortages, pushing prices up by 25% in English-speaking regions like the USA.

GMP Certified Factory Producing Fluvoxamine Maleate

From a technical standpoint, fluvoxamine maleate exhibits excellent stability under ICH guidelines (Q1A-Q1E), with degradation below 0.5% after 6 months at 40°C/75% RH. Its particle size distribution (D90 < 50μm) ensures uniform blending in tablet formulations, reducing variability in dissolution profiles. For USA buyers, compliance with USP/EP monographs is non-negotiable—our product meets all, including residual solvents <5000ppm and heavy metals <10ppm.

Production involves multi-step synthesis starting from 1-(4-trifluoromethylphenyl)ketone, followed by piperazine condensation and maleic acid salification. Advanced HPLC analysis confirms chiral purity (>99.5% S-enantiomer). In clinical applications, dosages range from 50-300mg/day, with bioavailability ~53% and half-life of 15 hours, minimizing dosing frequency for patient adherence.

Market dynamics show China's dominance in API supply (60% global share per IQVIA 2025), yet USA importers face scrutiny under FD&C Act Section 503B for compounding. Our fluvoxamine maleate comes with CoA, MSDS, and DMF for seamless FDA filings. Compared to competitors, we offer OEM/ODM customization, like micronized grades for extended-release forms.

Regulatory landscape: FDA's 2024 guidance emphasizes supply chain transparency; we've audited partners with GMP (CN GMP, EU GMP equivalent) and filed DMF #XXXXX. For OCD generics, fluvoxamine maleate holds 15% market share in USA (IQVIA NPA 2025). Pain points like high pricing ($1500+/kg from EU suppliers) are addressed here with competitive rates starting at $800/kg for bulk.

Quality control at Global Technology includes 21CFR Part 11 compliant systems, real-time NIR monitoring, and microbial limits (TAMC <100 CFU/g). Stability data supports 36-month shelf life. In research, it's used for neurotransmitter studies; in industry, for scale-up to tonnage.

Environmental footprint: Our green synthesis reduces solvent use by 40%, aligning with REACH and TSCA. For your ROI, switching suppliers yields 37% cost savings (client average), with lead times cut to 7-14 days via DHL/FedEx to USA ports.

This comprehensive overview—spanning chemistry, applications, regulations, and market insights—positions fluvoxamine maleate as your strategic API choice. Ready to secure supply? Contact us now for a free sample.

Your Core Pain Points Sourcing Fluvoxamine Maleate API

As a operations manager, you face relentless pressure to cut costs while maintaining FDA compliance.

  • High Prices: EU/India suppliers charge $1500-2500/kg, eroding your margins by 25% (PharmaPriceWatch 2025).
  • Low Quality: 20% rejection rates from inconsistent purity (<98.5%), delaying launches by 3 months.
  • High Shipping Costs: $500+/kg from remote chains, plus 45-day delays risking stockouts.
  • Supply Instability: 2024 shortages hit 30% of USA generics (FDA report).
  • Compliance Risks: Non-DMF sources trigger ANDA delays.
  • Poor Service: No customization, slow responses.

These issues cost you $100K+ annually. Imagine reliable supply instead.

Download Free Fluvoxamine Maleate Brochure

Global Technology's Fluvoxamine Maleate: Your High-ROI Solution

Partner with Global Technology Co., Ltd – your powerful factory in Zhengzhou, China, for GMP-grade fluvoxamine maleate supplier.

Core Advantages

  • Powerful Factory: 5000mt/year capacity, closed-loop with university labs.
  • Quality Assurance: 99.5%+ purity, full CoA/analytical methods.
  • OEM/ODM Design: Custom particle size, polymorphic forms.
  • High-Speed Delivery: 7-14 days to USA, DDP terms available.
  • Cost Savings: 30-40% lower than competitors.
  • Flexible MOQ: Grams to tons.

Technical Specifications Table

Parameter Specification
CAS No.61718-82-9
Purity (HPLC)≥99.5%
Molecular FormulaC15H21F3N2O2•C4H4O4
AppearanceWhite powder
Heavy Metals≤10ppm
Loss on Drying≤0.5%

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Application Scenarios & Case Studies

OCD Tablets: Used by USA generic maker – reduced production costs 32%, launched 2 months early.

Research: Supplied 50kg to university for serotonin studies.

Fluvoxamine Maleate Production Line

Ready for your custom order? Schedule a demo call.

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Social Proof: Trusted by Global Pharma Leaders

Client Logo 1 Client Logo 2
Reviewer Avatar

"Switched to Global for fluvoxamine maleate bulk buy – purity spot-on, saved 35% costs. FDA inspection passed flawlessly."

– Dr. Sarah Lee, Pfizer Procurement
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"Fastest fluvoxamine maleate supplier USA – 10-day delivery, full DMF support. Highly recommend."

– Mike Chen, Generic Pharma Ops

Certifications

  • GMP, DMF Filed, FDA Compliant, ISO 9001, RoHS
Certifications Display

Frequently Asked Questions on Fluvoxamine Maleate Procurement

What is the MOQ for fluvoxamine maleate?

Flexible from 1kg to tons – ideal for fluvoxamine maleate wholesale.

How long for USA delivery?

7-14 days via air, with tracking.

Do you offer customization?

Yes, OEM/ODM for particle size, packaging.

Payment methods?

T/T, L/C, PayPal – secure for USA buyers.

After-sales support?

24/7, free replacements if specs not met.

Is it FDA compliant?

DMF filed, full regulatory docs.

Real Customer Reviews

"Best fluvoxamine maleate price with top service – 5 stars!"

– John D., Texas Pharma

"Quality exceeded expectations, quick shipping to CA."

– Lisa M., Supply Chain Mgr

"Reliable partner for API needs – saved us big on costs."

– Robert K., NY Manufacturer

"GMP certs and fast response – perfect for our OCD line."

– Emma R., Ops Director

"Highly recommend for buy fluvoxamine maleate API."

– Tom S., Florida Buyer

About the Author

Author Avatar

Dr. Alex Rivera, PhD – Chief Technical Officer at Global Technology Co., Ltd. With 25+ years in pharmaceutical APIs, specializing in SSRIs. Former R&D head at Solvay, published in Journal of Medicinal Chemistry.

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