Vardenafil API Powder: Premium Quality for Pharmaceutical Excellence
Guangzhou Jianbei Biotechnology Co., Ltd. is a leading manufacturer and supplier of Vardenafil API Powder. Our commitment to quality, advanced R&D, and customer-centric approach sets us apart in the pharmaceutical industry. We offer high-purity product that meets stringent quality standards, ensuring reliability for your pharmaceutical formulations.
Product Introduction
The product is a potent phosphodiesterase type 5 (PDE5) inhibitor used in the treatment of erectile dysfunction. Our premium-grade product is synthesized using state-of-the-art technology, guaranteeing exceptional purity and consistent quality. This fine, white to off-white crystalline powder is ideal for pharmaceutical manufacturers seeking a reliable source for their ED medication formulations.
Specifications
Parameter | Specification |
---|---|
Appearance | White to off-white crystalline powder |
Purity | ≥ 99.0% |
Solubility | Sparingly soluble in water, freely soluble in ethanol |
Melting Point | 200-204°C |
Heavy Metals | ≤ 10 ppm |
Residual Solvents | Meets ICH guidelines |
Uses and Applications
The product is primarily used in the pharmaceutical industry for the production of oral medications treating erectile dysfunction. It's also being explored for potential applications in:
- Pulmonary arterial hypertension treatment
- Benign prostatic hyperplasia management
- Enhancing exercise capacity in certain cardiovascular conditions
Our high-quality Vardenafil API Powder is suitable for various formulations, including tablets, oral dispersible films, and other innovative drug delivery systems.
Dosage and Usage
The recommended starting dose for most patients is 10 mg taken orally approximately 60 minutes before sexual activity. Based on efficacy and tolerability, the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dosing frequency is once per day.
Quality Standards and Certifications
At Guangzhou Jianbei Biotechnology Co., Ltd., we adhere to the highest quality standards:
- GMP-certified manufacturing facilities
- ISO 9001:2015 certified quality management system
- Compliance with ICH guidelines and pharmacopeia standards (USP, EP, JP)
- Full traceability and comprehensive documentation (COA, DMF)
- Regular quality audits and stability testing
Packaging
We offer flexible packaging options to meet your specific requirements:
- Standard: 1kg aluminum foil bags
- Custom: Various sizes available upon request
- Tamper-evident seals and appropriate labeling
- Temperature-controlled shipping to maintain product integrity
Why Choose Us
Guangzhou Jianbei Biotechnology Co., Ltd. stands out as your preferred product supplier:
- Consistent high quality and purity (≥99.0%)
- Competitive pricing and flexible order quantities
- Robust supply chain with quick turnaround times
- Comprehensive technical and regulatory support
- Customization capabilities for specific formulation needs
- Strong R&D team for continuous product improvement
FAQ
Q1: What is the shelf life of your product?
A1: Our product has a shelf life of 3 years when stored properly in its original packaging at controlled room temperature.
Q2: Do you provide stability data for your product?
A2: Yes, we offer comprehensive stability data, including long-term and accelerated studies, to support your regulatory filings.
Q3: Can you supply small quantities for R&D purposes?
A3: Absolutely. We offer flexible quantities to support your research and development needs, from gram-scale to bulk orders.
Q4: What documentation do you provide with each order?
A4: Each order comes with a Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and other relevant documentation as required.
Q5: Are you able to manufacture product to custom specifications?
A5: Yes, our experienced R&D team can work with you to develop custom specifications that meet your specific requirements.
Q6: What are your shipping terms for international orders?
A6: We offer various shipping options including EXW, FOB, and CIF. We'll work with you to determine the best shipping method for your needs.
Contact Us
For inquiries about our Vardenafil API Powder or to request a quote, please contact us at h33727868@gmail.com. Our team is ready to assist you with any questions and provide the support you need.