Vardenafil API powder

Product Overview

 

Vardenafil API powder is a selective phosphodiesterase type 5 (PDE5) inhibitor API widely used in the pharmaceutical industry for the formulation of erectile dysfunction (ED) medications. As a high-value active pharmaceutical ingredient, Vardenafil requires strict manufacturing control, validated production processes, and consistent impurity management to ensure compliance with international pharmaceutical standards.

 

We are a GMP-certified Vardenafil API manufacturer and global supplier, specializing in the production and export of pharmaceutical-grade Vardenafil Hydrochloride powder. Our manufacturing system is designed to support long-term bulk supply for pharmaceutical companies, generic drug manufacturers, and regulated market distributors.

 

Unlike trading companies, we operate as a direct API manufacturer, ensuring stable quality, traceable production batches, and competitive factory pricing for global partners.

 

Vardenafil API Technical Specifications

 

We provide consistent, well-characterized vardenafil hydrochloride API with complete documentation support for regulatory and industrial use.

 

Item	Specification
Product Name	Vardenafil
CAS Number	224785-91-5
Molecular Formula	C23H33ClN6O4S
Chemical Form	Vardenafil Hydrochloride
Appearance	White to off-white crystalline powder
Assay	≥99.0% (HPLC)
Grade	Pharmaceutical Grade / GMP API
Impurities	Controlled according to ICH guidelines
Packaging	1kg, 5kg, 10kg, 25kg (customizable)
Documentation	COA, MSDS, TDS available

 

All batches undergo strict quality testing before release, including HPLC assay, impurity profiling, residual solvent analysis, and stability evaluation.

 

GMP Manufacturing & Quality Assurance

 

Quality consistency is critical in pharmaceutical API supply chains. Our Vardenafil API is manufactured in a GMP-compliant facility equipped with controlled production systems and validated processes.

 

Our quality assurance system includes:

 

•GMP-aligned manufacturing environment

 

•Batch-controlled production with full traceability

 

•In-process quality control (IPQC) at each stage

 

•Final release testing before shipment

 

•Impurity profiling aligned with ICH Q3A/Q3B guidelines

 

•Stability monitoring under controlled conditions

 

Each batch of Vardenafil Hydrochloride is released only after passing internal quality review, ensuring consistent performance in downstream formulation processes.

 

We also provide full regulatory documentation support, including COA per batch, MSDS, and technical data sheets to support customer regulatory filings and internal quality audits.

 

Manufacturing Capability & Supply Reliability

 

As a long-term Vardenafil manufacturer and exporter, we maintain stable production capacity to support continuous bulk supply.

 

Our production system is designed for:

 

•Long-term contract manufacturing

 

•Multi-batch consistency for large-volume buyers

 

•Flexible scaling from trial orders to commercial supply

 

•Export-oriented packaging and logistics coordination

 

We support pharmaceutical companies requiring reliable API sourcing for:

 

•Generic drug production

 

•Formulation development

 

•Contract manufacturing projects (CMO/CDMO supply chains)

 

Our supply chain is optimized for international markets, including Europe, Asia, Latin America, and emerging regulated regions.

 

Vardenafil Hydrochloride API Applications

 

Vardenafil API is primarily used in the pharmaceutical industry for the development of PDE5 inhibitor-based medications.

 

Key applications include:

 

•Erectile dysfunction (ED) pharmaceutical formulations

 

•Generic drug manufacturing programs

 

•Pharmaceutical R&D and clinical formulation studies

 

•Combination therapy development involving PDE5 inhibitors

 

•Regulatory-approved tablet and oral dosage forms

 

Our Vardenafil Hydrochloride API is supplied strictly for industrial pharmaceutical use only and is not intended for direct human consumption.

 

Documentation Support & Regulatory Readiness

 

Global API buyers require more than just product supply—they require regulatory confidence and documentation completeness.

 

We provide a full documentation package to support regulatory submissions and internal compliance systems:

 

•Certificate of Analysis (COA) for each batch

 

•Material Safety Data Sheet (MSDS)

 

•Technical Data Sheet (TDS)

 

•Manufacturing process overview (upon request)

 

•Stability data summary (project-based availability)

 

For customers operating in regulated markets, we can also provide additional technical and compliance support depending on project requirements.

 

Vardenafil API Forms & Packaging Options

 

We supply Vardenafil Hydrochloride in multiple packaging configurations to support different supply chain needs:

 

•1kg aluminum foil bags (lab and pilot scale)

 

•5kg / 10kg intermediate bulk packaging

 

•25kg fiber drums for commercial shipment

 

•Custom labeling for distributors and contract partners

 

Packaging is designed to maintain product stability, moisture protection, and safe international transport compliance.

 

MOQ is flexible depending on project stage, with trial orders available for qualification purposes.

 

Why Choose CHEN LANG BIO TECH as Your Vardenafil API Manufacturer

 

Selecting a reliable Vardenafil API manufacturer and supplier is not only about pricing—it is about long-term supply stability, process capability, regulatory compliance, and scalable manufacturing support.

 

CHEN LANG BIO TECH is a China-based pharmaceutical company specializing in the R&D, manufacturing, and global supply of active pharmaceutical ingredients (APIs) and advanced pharmaceutical intermediates. Established in 2007, we have built a fully integrated production system supporting both commercial API supply and CDMO (Contract Development and Manufacturing Organization) services.

 

Integrated API Manufacturing & CDMO Capability

 

Beyond standard API supply, we provide custom manufacturing and CDMO services for a wide range of pharmaceutical intermediates and APIs.

 

Our product portfolio includes established APIs such as:

 

•Febuxostat

 

•Rosuvastatin Calcium

 

•Lenvatinib Mesylate

 

•Sunitinib Malate

 

•Sorafenib Tosylate

 

•Erlotinib Hydrochloride

 

This diversified product background reflects our capability to manage complex synthetic routes and multi-step pharmaceutical processes, including both generic APIs and high-value oncology intermediates.

 

Industrial-Scale Production Infrastructure

 

Our manufacturing base consists of two production workshops with a total area of approximately 6,400 m², designed according to modern pharmaceutical engineering standards.

 

The facility includes:

 

•5 independent production lines

 

•Dedicated Grade D clean zones for each line

 

•69 reaction vessels (50L–3000L scale)

 

•27 centrifuges (LB450–LB800 series)

 

•29 drying systems of various configurations

 

•13 blending and milling units for particle size control

 

This infrastructure enables flexible scaling from laboratory development to commercial-scale production, supporting both pilot projects and long-term API supply programs.

 

Advanced Process Control & Engineering Systems

 

To ensure process safety, reproducibility, and batch consistency, all reactor systems are integrated with advanced control technologies, including:

 

•TCU (Temperature Control Unit) automated thermal regulation systems

 

•DCS (Distributed Control System) for centralized process monitoring

 

•SIS (Safety Instrumented System) for process risk control

 

•Multi-layer interlock safety mechanisms

 

These systems allow precise control of reaction conditions, ensuring stable performance across complex chemical transformations.

 

Strong Chemical Process Capability

 

Our engineering team is experienced in a broad range of pharmaceutical chemical reactions, including both conventional and highly demanding processes such as:

 

· Metal-catalyzed coupling reactions

· Amide bond formation and condensation chemistry

· Heterogeneous hydrogenation systems

· Asymmetric hydrogenation and transfer hydrogenation

· Acid- and base-catalyzed reactions (including Lewis acid chemistry)

 

We are also capable of handling high-risk and specialized chemical processes, including:

 

•Hydrogenation reactions

 

•Nitration and sulfonation

 

•Oxidation and chlorination

 

•Fluorination chemistry

 

•Polymerization processes

 

•Diazotization and azo chemistry

 

•Peroxide and peroxy compound reactions

 

•Alkylation and amination reactions

 

•Phosgene and phosgenation-related chemistry

 

This wide technical capability enables us to support complex API development pathways and difficult synthetic routes required in modern pharmaceutical manufacturing.

 

Quality, Compliance & Global Supply Standards

 

All production activities are conducted under a structured pharmaceutical quality management system aligned with GMP principles.

 

We maintain strict control over:

 

•Raw material qualification

 

•In-process quality control (IPQC)

 

•Final product release testing

 

•Batch traceability and documentation integrity

 

Each shipment of Vardenafil API is supported with full documentation including COA, MSDS, and technical specifications to meet global regulatory expectations.

 

Long-Term Manufacturing Partnership Approach

 

We do not operate as a spot-market supplier. Instead, we focus on building long-term API manufacturing partnerships with pharmaceutical companies, distributors, and formulation developers.

 

Our collaboration model supports:

 

•Early-stage process development (R&D support)

 

•Pilot-scale validation

 

•Commercial-scale API production

 

•Continuous supply agreements

 

•CDMO project-based cooperation

 

This allows customers to scale efficiently from development to commercialization with a stable manufacturing partner.

 

9. Pricing, MOQ & Commercial Supply Terms

Vardenafil API is supplied in accordance with project-based commercial terms, reflecting differences in specification requirements, order volume, and destination market regulatory expectations.

For standard pharmaceutical-grade Vardenafil Hydrochloride, our typical pricing range is:

USD 1,164 – 1,300 per kilogram (subject to final specification and order conditions)

This pricing structure is intended for qualified buyers engaged in formulation development, generic manufacturing, or regulated pharmaceutical distribution.

 

Minimum Order Quantity (MOQ)

The standard minimum order quantity is:

100 g (for evaluation or laboratory qualification purposes)

For commercial-scale procurement, we support scalable supply from pilot quantities to multi-kilogram and industrial bulk orders under long-term cooperation agreements.

 

Commercial Supply Terms

We provide flexible supply arrangements based on customer requirements, including:

•Trial orders for qualification and stability evaluation

•Bulk supply contracts for continuous production programs

•Long-term pricing agreements for recurring annual demand

•Documentation-supported shipments (COA, MSDS, technical dossier)

All commercial terms are defined following technical confirmation of specification, intended use, and destination regulatory requirements.

 

Quotation Policy

Due to variations in regulatory expectations across different markets (EU, CIS, Asia, and LATAM), final pricing is confirmed upon inquiry.

To receive an accurate quotation, customers are advised to provide:

•Required quantity (trial or bulk scale)

•Specification and grade requirements

•Destination country

•Intended regulatory pathway (if applicable)

Our commercial team typically responds within 24 hours with a formal quotation and technical documentation package.

Frequently Asked Questions (FAQ)


Q1: What is Vardenafil API used for?

Vardenafil API is a pharmaceutical active ingredient belonging to the PDE5 inhibitor class. It is used in the manufacturing of finished dosage forms within regulated pharmaceutical production environments.

 

Q2: Are you a Vardenafil manufacturer or trading company?

CHEN LANG BIO TECH is a direct GMP-certified API manufacturer, established in 2007. We operate production facilities for active pharmaceutical ingredients and advanced intermediates, and also provide CDMO services for selected projects.

 

Q3: What is your MOQ for Vardenafil API powder?

Our standard minimum order quantity (MOQ) is 100g, mainly for laboratory evaluation, qualification, or R&D purposes. Bulk commercial supply is available for larger-scale production requirements.

 

Q4: What is the price of Vardenafil API?

The reference price range is:

USD 1,164 – 1,300 per kilogram

Final pricing depends on order volume, specification requirements, and destination market conditions. Formal quotation is provided upon inquiry.

 

Q5: Can you provide COA and regulatory documentation?

Yes. Each batch of Vardenafil API is supplied with a Certificate of Analysis (COA). Additional documentation such as MSDS and technical data sheets (TDS) is also available upon request.

 

Q6: Do you support GMP and regulated market supply?

Yes. Our production system is aligned with GMP principles, and our quality management process supports supply to regulated and semi-regulated markets, including Europe and CIS regions.

 

Q7: Do you offer bulk supply and long-term contracts?

Yes. We support both bulk supply orders and long-term API supply agreements, including stable production scheduling for recurring demand and contract manufacturing projects.

 

Q8: What packaging options are available?

We provide flexible packaging options including:

•100g laboratory packs

•1kg standard packaging

•5kg / 10kg intermediate packaging

•25kg industrial fiber drums

Custom packaging and labeling are available for distributors.

 

Q9: How fast can I receive a quotation?

We typically respond within 24 hours after receiving complete inquiry details, including required quantity, destination, and specification requirements.

 

Q10: How can I contact you for Vardenafil API supply?

You can contact our team directly for quotation and technical discussion:

•Email: admin@chenlangbio.com

•WhatsApp: +86-17782478823

•Tel: +86-17782478823

We support global API sourcing inquiries and provide full technical and commercial assistance.

 

Contact for Vardenafil API Supply & Quotation

For professional inquiries regarding vardenafil API powder (CAS 224785-90-4), including bulk supply, pricing, GMP documentation, or sample evaluation, please contact our team directly.

We support pharmaceutical manufacturers, distributors, and formulation developers with stable and traceable supply of Vardenafil Hydrochloride API under controlled quality systems.

All inquiries are handled on a project basis, with technical confirmation followed by formal quotation and documentation package.

 

📩 Contact Information

CHEN LANG BIO TECH

📧 Email: admin@chenlangbio.com

📞 Tel: +86-17782478823

💬 WhatsApp: +86-17782478823

🌐 Website: https://www.chenlangbio.com/