The Complete 2025 Buyer’s Guide to Dapoxetine HCl Powder

内容目录


Introduction

Dapoxetine Hydrochloride (HCl) is a short-acting selective serotonin reuptake inhibitor (SSRI) developed specifically for the treatment of premature ejaculation (PE) in men. Unlike most SSRIs, which were first designed as antidepressants, Dapoxetine is unique in its rapid onset and short half-life, making it well-suited for on-demand use in sexual medicine.

For bulk buyers, pharmaceutical manufacturers, contract formulators, and research labs, sourcing Dapoxetine HCl powder is a strategic decision that requires balancing purity, compliance, documentation, and price competitiveness.

This 2025 Buyer’s Guide provides a comprehensive overview of Dapoxetine powder:

  • What it is and how it works
  • Pharmaceutical and research applications
  • Market trends, suppliers, and pricing
  • Safety, compliance, and MSDS guidance
  • How to choose reliable manufacturers in China, India, and beyond

👉 If you’re ready to explore sourcing options, start with our Buy Dapoxetine Powder Online Guide.


What is Dapoxetine Hydrochloride Powder?

  • Chemical Name: Dapoxetine Hydrochloride
  • Molecular Formula: C21H23NO·HCl
  • CAS Number: 129938-20-1
  • Molecular Weight: 341.9 g/mol (free base), ~372.9 g/mol (HCl salt)
  • Appearance: White to off-white crystalline powder
  • Solubility: Freely soluble in methanol, ethanol, sparingly soluble in water
  • Stability: Stable under dry, cool storage; sensitive to moisture

Mechanism of Action:
Dapoxetine is a short-acting SSRI. By inhibiting serotonin reuptake in the central nervous system, it prolongs ejaculatory latency and improves control over ejaculation. Unlike conventional SSRIs (fluoxetine, paroxetine, sertraline), Dapoxetine reaches peak plasma levels within 1–2 hours and clears in about 12–24 hours.

Approved Clinical Indication:

  • Premature Ejaculation (PE): In many countries (EU, parts of Asia, Middle East), Dapoxetine is approved as a first-line pharmacological treatment for PE.
  • Off-label/Research: Investigated for other conditions related to serotonin regulation, though not approved for depression or anxiety.

👉 For lab-focused buyers, see Research-Grade Dapoxetine Powder Applications.


Pharmaceutical & Research Applications

  1. Premature Ejaculation (PE):
    • Clinical trials show Dapoxetine can increase intravaginal ejaculatory latency time (IELT) by 2–3 fold compared to placebo.
    • Well tolerated at 30 mg and 60 mg doses.
  2. Compounding Pharmacies:
    • Some regions permit custom compounding of Dapoxetine HCl into capsules or suspension liquids.
    • Powder form is preferred for flexibility.
  3. Research Applications:
    • CNS serotonin pathway modulation
    • Short-acting SSRI models in animal studies
    • Combination trials with PDE5 inhibitors (e.g., Sildenafil)
  4. Future Investigations:
    • Potential use in sexual dysfunction subtypes
    • Synergistic therapy with ED medications

👉 For consumer vs raw material comparison, read Dapoxetine Powder vs Tablets: What Buyers Should Know.


Forms of Dapoxetine Supply

  • Dapoxetine HCl Powder (API form):
    • Supplied in 25 kg fiber drums with foil inner bags.
    • Used by manufacturers for tablet/capsule production.
    • Requires full COA, MSDS, GMP documentation.
  • Finished Tablets (30 mg, 60 mg):
    • Marketed under brand names like Priligy.
    • Not typically sold as raw material.
  • Research Lots:
    • 100 g – 1 kg analytical/research-grade powder.
    • Labeled “for research use only, not for human consumption.”

👉 For direct sourcing info, see China Dapoxetine HCl Powder Factories.


Global Market Overview (2025)

The global demand for Dapoxetine HCl powder is steadily growing as awareness of premature ejaculation (PE) treatment options increases. By 2025, analysts estimate the global PE treatment market to surpass $1.8 billion USD, with Dapoxetine occupying a major share in regions where it is approved.

Regional Trends:

  • China: The world’s largest production hub for generic Dapoxetine HCl. Offers cost-efficient bulk supply, though buyers must carefully vet GMP compliance.
  • India: Houses multiple API manufacturers with WHO-GMP and DMF filings, targeting regulated markets (US, EU).
  • Europe: Approved in several countries as Priligy. API imports mainly from India and China.
  • US: Dapoxetine is not FDA-approved for PE, limiting its use to research and compounding labs.
  • Middle East & Latin America: Growing adoption, with imports from Asia dominating supply.

Market Drivers:

  • Increasing awareness of PE treatment.
  • Demand for short-acting SSRIs over daily antidepressant regimens.
  • Expansion of generic API production in Asia.

👉 See related pricing breakdowns in Dapoxetine Powder Price Trends 2025.


Pricing Benchmarks & Market Trends

2025 Dapoxetine HCl Powder Price Ranges:

RegionSmall Lot (1–5 kg)Bulk Lot (25+ kg)Notes
China$600–$850/kg$300–$450/kgFlexible MOQ, fastest lead times
India$650–$900/kg$400–$550/kgStrong compliance, slower lead time
US/EU$1000–$1400/kg$800–$1100/kgHighest cost, but trusted for research-grade use

Key Factors Affecting Price:

  1. Order size (MOQ): Smaller orders have a higher per-kilo price.
  2. Purity: ≥99% HPLC grade is industry standard.
  3. Documentation: DMF/CEP filings raise costs but ensure FDA/EMA compliance.
  4. Shipping Method: Air freight adds $20–$30/kg vs sea freight.

👉 For wholesale buyers, see our Bulk & Wholesale Supply Guide.


Supplier Landscape

1. China Factories:

  • Located mainly in Zhejiang, Jiangsu, and Shandong.
  • Offer the lowest global costs.
  • Buyer risks: quality inconsistency, counterfeit product, incomplete documentation.
  • Essential to demand COA + GMP certificate + independent HPLC test reports.

2. Indian API Plants:

  • Based in Hyderabad and Gujarat.
  • Often provide DMF filings and WHO-GMP compliance.
  • Slightly higher costs than China, but easier import clearance in US/EU.

3. US & EU Distributors:

  • Often resell API sourced from Asia.
  • Small-lot (1–5 kg) supply for research labs and compounding pharmacies.
  • Most expensive option, but ensures faster delivery and regulatory oversight.

👉 Compare vetted vendors in our Top Dapoxetine Powder Manufacturers & Suppliers 2025.


MSDS & Safety Guidelines

As with all APIs, Dapoxetine HCl powder requires careful handling under lab and manufacturing conditions.

Hazard Classification:

  • May cause irritation to eyes, skin, and respiratory system.
  • Toxic if ingested in raw form.
  • Not classified as carcinogenic, but not intended for uncontrolled human use.

Safe Handling:

  • Use PPE: gloves, protective glasses, dust mask.
  • Handle in ventilated areas or fume hoods.
  • Avoid generating airborne dust.

Storage:

  • Store at 2–8°C in sealed foil bags within fiber drums.
  • Keep away from light and moisture.
  • Shelf life: 24–36 months under proper storage.

Transport:

  • HS Code: 29339990 (other heterocyclic compounds).
  • Shipped in 25 kg fiber drums with inner polyethylene bags.

👉 For a full export-ready MSDS template, see our Dapoxetine MSDS & Safety Guidelines.


Buyer’s Checklist

Before finalizing a contract with any Dapoxetine HCl supplier, ensure the following:

  1. Documents Required:
    • COA (Certificate of Analysis)
    • MSDS
    • GMP certificate
    • DMF/CEP filings (if targeting regulated markets)
  2. Testing:
    • Independent 3rd-party HPLC purity test
    • Residual solvent and heavy metal checks
    • Particle size distribution (if micronized API)
  3. Negotiation Tips:
    • Start with 1–5 kg trial order before scaling.
    • Request discounts on 25+ kg lots.
    • Lock in annual contracts (500+ kg) for stable pricing.
  4. Red Flags:
    • Quotes below $250/kg → almost always counterfeit.
    • Refusal to share COA/GMP docs → avoid.
    • Poor communication & incomplete export docs → customs delays.

Conclusion & Next Steps

Dapoxetine HCl powder is a specialized short-acting SSRI API with unique positioning in the global market as a treatment for premature ejaculation (PE). For buyers, the challenge is to source high-purity, GMP-compliant material at competitive prices, while navigating regional regulations.

Key takeaways:

  • China offers the lowest cost, India provides compliance strength, US/EU ensures oversight.
  • Prices range $250–$450/kg bulk in Asia, $600–$1200/kg in Western markets.
  • Always demand COA, GMP, MSDS, DMF/CEP when sourcing.
  • Test small trial lots before long-term contracts.

📌 Next Steps for Buyers:

By combining scientific knowledge, procurement best practices, and compliance awareness, buyers can secure a stable and profitable supply chain for Dapoxetine HCl powder in 2025 and beyond.

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