Introduction
Vardenafil Hydrochloride (HCl) powder is a pharmaceutical-grade raw material primarily used in the treatment of erectile dysfunction (ED). As a potent PDE5 inhibitor, Vardenafil works by enhancing blood flow to the corpus cavernosum, improving erection quality and duration.
Since the expiry of original patents (Levitra®, Staxyn®), the global market for generic Vardenafil API has grown rapidly. Today, buyers can source Vardenafil powder from China, India, and regulated markets at competitive prices, provided they ensure purity, compliance, and documentation.
This guide is written for:
- Pharma manufacturers scaling generic ED formulations
- Bulk distributors sourcing APIs for global resale
- Compounding pharmacies customizing ED treatments
- Research labs investigating PDE5 inhibitors
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What is Vardenafil Hydrochloride Powder?
- Chemical Name: Vardenafil Hydrochloride
- Molecular Formula: C23H32N6O4S·HCl
- Molecular Weight: ~579.1 g/mol (HCl salt)
- CAS Number: 224785-90-4
- Appearance: White to pale yellow crystalline powder
- Solubility: Freely soluble in methanol, ethanol; sparingly soluble in water
- Stability: Stable when stored at 2–8°C, protected from moisture & light
Pharmacology
- Vardenafil is a phosphodiesterase type 5 (PDE5) inhibitor, similar to Sildenafil (Viagra) and Tadalafil (Cialis).
- It prevents PDE5 from breaking down cGMP, a molecule responsible for smooth muscle relaxation and blood flow.
- Clinical trials show Vardenafil provides a faster onset and higher selectivity for PDE5 compared to Sildenafil, making it a preferred option in some treatment settings.
Approved Indications
- Erectile Dysfunction (ED): Standard dose 5–20 mg per use.
- Research/Off-label: Investigated for pulmonary arterial hypertension (PAH) and potential vascular applications.
👉 For USP specifications, see How to Check Vardenafil Powder Quality: USP Standards & COA.
Pharmaceutical & Research Applications
- Erectile Dysfunction (ED)
- Primary approved use.
- Comparable to Sildenafil, with shorter half-life (~4–5 hours) but higher PDE5 selectivity.
- Pulmonary Arterial Hypertension (PAH)
- PDE5 inhibitors improve pulmonary vascular relaxation.
- Vardenafil is less studied than Sildenafil but remains an active area of research.
- Comparative Studies
- Used in pharmacological research comparing PDE5 inhibitors.
- Helps map selectivity profiles (PDE5 vs PDE6, relevant for visual side effects).
- Formulation Development
- Research into orally disintegrating tablets (ODTs) and fast-dissolving films.
- Compounding pharmacies use powder to create customized ED formulations.
👉 For practical sourcing details, see Vardenafil Research Powder Applications.
Forms of Vardenafil Supply
Vardenafil is available in several forms across the global supply chain:
- Vardenafil Hydrochloride Powder (API form)
- Supplied in bulk powder (25 kg fiber drums) with foil inner bags.
- Used by pharmaceutical manufacturers for tablet and capsule production.
- Requires COA, GMP certificate, and DMF/CEP filings (if targeting FDA/EMA markets).
- USP/EP-Grade Powder
- Meets pharmacopeial standards (USP, EP, JP).
- Mandated for regulated markets where compliance is critical.
- Research-Grade Powder (RUO)
- Packaged in 100 g – 1 kg lots, labeled For Research Use Only.
- Primarily used by labs and CROs for formulation and PK/PD studies.
- Finished Tablets (Levitra, Staxyn, generics)
- 5–20 mg doses, widely prescribed for ED.
- Not sold in raw API form; distributed through pharma channels.
👉 For a direct comparison, see Vardenafil Powder vs Tablets: What Buyers Should Know.
Global Market Overview (2025)
The global erectile dysfunction (ED) treatment market is projected to exceed $4.5 billion USD by 2030, driven by aging populations, lifestyle-related health issues, and increased acceptance of sexual health treatments.
Vardenafil Market Position:
- Vardenafil (Levitra®) entered the market after Sildenafil (Viagra®).
- Its faster onset and higher PDE5 selectivity gave it niche adoption.
- After patent expiries, Vardenafil API became widely available as a generic bulk powder.
Regional Insights:
- China: World’s largest exporter of Vardenafil API, offering competitive bulk pricing.
- India: Focused on GMP-certified API production for FDA/EMA markets.
- US/EU: Mostly limited to finished drugs; API imports used for research and compounding.
- Middle East & Latin America: Growing markets with high demand for generic PDE5 inhibitors.
Growth Drivers:
- Rising ED prevalence: Estimates suggest 1 in 3 men over 40 experiences some form of ED.
- Expanding access to generic PDE5 inhibitors.
- Demand for alternative dosage forms (films, ODTs).
👉 For supplier-specific insights, see Top Vardenafil Powder Manufacturers & Suppliers 2025.
Quality Standards & Testing
When purchasing Vardenafil HCl powder, strict quality control is essential to ensure safety, efficacy, and regulatory compliance.
Documents to Request:
- COA (Certificate of Analysis): Confirms batch purity and assay.
- MSDS: Safety and handling guidelines.
- GMP Certificate: Confirms manufacturing standards.
- DMF/CEP filings: Required for FDA/EMA import clearance.
Testing Methods:
- HPLC (High Performance Liquid Chromatography): Purity ≥99%.
- Residual Solvents: Must comply with ICH Q3C standards.
- Heavy Metals: ≤10 ppm.
- USP Compliance: Ensures identity, potency, and stability align with pharmacopeia.
⚠️ Buyer Tip: Beware of suppliers quoting below $300/kg bulk — often counterfeit or diluted material.
👉 For verification procedures, see How to Check Vardenafil Powder Quality: USP Standards & COA.
Pricing Benchmarks & Trends (2025)
Global Vardenafil Powder Price Ranges:
| Region | Small Lot (1–5 kg) | Bulk Lot (25+ kg) | Annual Contract (500+ kg) | Notes |
|---|---|---|---|---|
| China | $650–$900/kg | $350–$500/kg | $280–$350/kg | Lowest cost, flexible MOQ |
| India | $700–$950/kg | $400–$600/kg | $350–$450/kg | Strong compliance, DMF/CEP |
| US/EU | $1000–$1500/kg | $800–$1100/kg | $650–$850/kg | Most expensive, small-lot supply only |
Factors Affecting Price:
- MOQ: 25 kg drums are standard; smaller orders priced higher.
- Purity Level: USP/EP-compliant APIs cost 5–10% more.
- Documentation: DMF/CEP adds $2–5/kg.
- Shipping: Air freight +$20–30/kg; sea freight cheaper but slower.
👉 For long-term contracts, see Wholesale & Bulk Vardenafil Supply Guide.
Supplier Landscape
1. China Factories
- Strengths: Lowest cost globally, wide production base, flexible MOQs (5–25 kg).
- Weaknesses: Inconsistent quality across suppliers; risk of counterfeit.
- Buyer Tip: Always request COA + GMP certificate + MSDS, and validate with independent HPLC testing.
2. Indian API Manufacturers
- Strengths: WHO-GMP and FDA-inspected facilities; often provide DMF/CEP filings.
- Weaknesses: Higher prices and larger MOQs (25+ kg).
- Best For: Buyers in regulated markets (US, EU) who require documentation for import approval.
3. US/EU Distributors
- Role: Primarily resell Chinese or Indian API in small-lot (1–5 kg) packages.
- Strengths: Faster delivery, regulatory oversight, suitable for labs and compounding pharmacies.
- Weaknesses: Highest cost, not scalable for bulk production.
👉 For a comparison of vetted factories, see Top Vardenafil Powder Manufacturers & Suppliers 2025.
MSDS & Safety Guidelines
Every shipment of Vardenafil Hydrochloride powder should include a Material Safety Data Sheet (MSDS). This ensures safe handling and smooth customs clearance.
Hazard Classification:
- Mild irritant (eye/skin/respiratory).
- Harmful if ingested in uncontrolled/raw form.
- Not classified as carcinogenic.
Safe Handling:
- PPE: Gloves, lab coat, protective goggles, dust mask.
- Work under fume hood or well-ventilated area.
- Avoid creating dust; use calibrated scoops for weighing.
Storage:
- Store at 2–8°C in sealed foil bags inside fiber drums.
- Keep away from heat, light, and humidity.
- Shelf life: 24–36 months under proper conditions.
Transport:
- HS Code: 29339990 (heterocyclic compounds with nitrogen).
- UN classification: Not a dangerous good, but regulated as API.
Buyer’s Checklist
Before finalizing a Vardenafil powder order, buyers should confirm:
- Essential Documents
- COA (with batch number and HPLC purity ≥99%)
- GMP Certificate
- MSDS
- DMF/CEP filings (for US/EU imports)
- Quality Testing
- Conduct third-party HPLC, NMR, and residual solvent analysis.
- Check particle size distribution if micronized API is required.
- Negotiation Tips
- Start with a 1–5 kg pilot lot before scaling.
- Secure discounts at 25+ kg bulk orders.
- Lock in annual contracts (500+ kg) for stable pricing and guaranteed supply.
- Red Flags
- Quotes below $280/kg bulk (often counterfeit).
- Suppliers refusing to provide COA/GMP docs.
- Poor packaging (non-sealed foil bags).
Conclusion & Next Steps
Vardenafil Hydrochloride powder remains one of the most in-demand PDE5 inhibitor APIs in 2025, with strong market potential for generic ED formulations, research applications, and custom compounding.
Key takeaways:
- China offers the lowest price, India the strongest compliance, US/EU the fastest small-lot supply.
- Prices range $300–$500/kg bulk in Asia, and $800–$1200/kg in Western markets.
- Always demand COA, MSDS, GMP certificate, DMF/CEP for regulated markets.
- Start small, test quality independently, and scale via long-term contracts.
📌 Next Steps:
- Trial orders
- Scale supply
- Vet vendors
- Compliance
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By combining cost efficiency, compliance, and rigorous quality assurance, buyers can secure a safe, stable, and profitable Vardenafil supply chain in 2025 and beyond.