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Vardenafil Powder

1.Name:Vardenafil
2.Appearance:White to off-white crystalline powder
3.Specification:99%
4.CAS No.:224785-90-4
5.Molecular Formula:C23H32N6O4S
6.Molecular Weight:488.60
7.Certificates: FDA,Organic,Kosher, ISO, HALAL, FSSC, cGMP
8.Factory situation:Factories & Three production lines.cGMP standard workshop & two independent laboratories.
9.Storage method:Dry and cool place 10.Export Only
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  • Product Description

Vardenafil Powder: Comprehensive Guide to Quality Manufacturing and Global Supply

Vardenafil Powder represents a critical pharmaceutical ingredient in the global healthcare market, offering significant therapeutic value for pharmaceutical manufacturers worldwide.It is a pharmaceutical‑grade API designed for erectile dysfunction formulations. As a leading phosphodiesterase type 5 (PDE5) inhibitor, this active pharmaceutical ingredient (API) has gained considerable attention from pharmaceutical companies seeking reliable supply sources. Shaanxi Hongda Phytochemistry Co., Ltd. stands at the forefront of Vardenafil production, leveraging advanced manufacturing capabilities and stringent quality control measures to meet international pharmaceutical standards. 

 

Product Specification

Parameter
Specification
Appearance
White to off-white crystalline powder
Purity
≥99.0%
Melting Point
205-210°C
Loss on Drying
≤0.5%
Residual Solvents
Meets ICH guidelines
Particle Size
90% < 100 μm

 

Vardenafil Benefits

Vardenafil API Powder dilates the blood vessels in the penis, causing an erection, and is suitable for treating erectile dysfunction. Our product is a medication for treating erectile dysfunction, improving erectile dysfunction and enhancing male sexual performance.

 

Dosage and Administration of Vardenafil

The dosage of Vardenafil ranges from 5 to 20 mg per dose. The specific dosage should be taken under the supervision of a healthcare professional.

 

Certifications & Regulatory Compliance

Our manufacturing facility maintains comprehensive international certifications that ensure global regulatory acceptance:

  • cGMP Certification - Current Good Manufacturing Practice compliance
  • FDA Registration - United States regulatory approval
  • ISO9001 & ISO22000 - Quality management and food safety standards
  • FSSC22000 - Food Safety System Certification
  • HALAL & KOSHER - Religious compliance certifications
  • Organic Certification - Sustainable production verification

Third-party verification through SGS and Eurofins laboratories provides additional quality assurance and international credibility for your regulatory submissions.

Certifications

 

Production & Quality Control

Manufactured in 100,000-class purification workshops with:

  • Advanced Testing: HPLC, GC, and spectrophotometry
  • Third-Party Verification: Every batch validated by SGS/Eurofins
  • Stability Studies: ICH-compliant accelerated & long-term testing

Laboratory

Raw Material Traceability

We are in charge of our own supply chain since trained agronomists keep an eye on our own planting areas. This vertical integration keeps the quality the same from growing the plants to generating the final API.
You can see where your Vardenafil Powder originated from and how it was made with our blockchain-based tracking system, which lets you trace every batch. This openness will meet your needs for regulatory paperwork and quality assurance.

Factory

Customization & OEM/ODM Services

Tailor-made solutions for:

Formulations: Micronized powder, sterile-grade API

Packaging: 25kg drums, 1kg retail bags, nitrogen-flushed pouches

Documentation: DMF/ASMF filings, excipient compatibility reports

OEM Service

Our Packaging

Packaging


FAQ

Q. Is your Vardenafil FDA-approved?

A: Yes. We comply with 21 CFR Part 211 and provide DMF references for client submissions.

Q. What’s the lead time for 500kg orders?

A:7–14 days, with optional expedited production.

Q. Can you customize particle size?

A: Absolutely. Our nanomilling tech achieves D90 from 10µm to 150µm.

Q. How do you ensure shipment integrity?

A: We use vacuum-sealed, desiccant-lined containers with temperature tracking.

 

Contact & Quote Request

Ready to discuss your project? Email us at duke@hongdaherb.com for a free sample of Vardenafil Powder and a detailed quotation. Our team is happy to answer any technical questions and guide you through regulatory documentation.

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