Bulk Pharmaceutical API Sources for CARDURA

Bulk Pharmaceutical API Sources for CARDURA

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		D9815_SIGMA
Molport		MolPort-003-983-427
Hangzhou APIChem Technology		AC-6848
Amadis Chemical		A839262
TCI (Tokyo Chemical Industry)		D4126
AKos Consulting & Solutions		AKOS015895371
CAPOT		2385

Bulk Active Pharmaceutical Ingredient (API) Sources for: CARDURA (Doxazosin Mesylate)

Last updated: July 30, 2025

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Introduction

Cardura, the brand name for doxazosin mesylate, is an alpha-1 adrenergic receptor blocker prescribed primarily for benign prostatic hyperplasia (BPH) and hypertension. As a critical component in pharmaceutical manufacturing, the availability of high-quality bulk active pharmaceutical ingredients (APIs) directly influences drug safety, efficacy, regulatory compliance, and supply chain stability. This report details the key sources of bulk API for Cardura, analyzing manufacturers, geographic distribution, regulatory status, and market dynamics.

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1. Overview of Doxazosin Mesylate API

Doxazosin mesylate is synthesized via multi-step chemical processes involving the preparation of doxazosin precursors and subsequent mesylation. The API's purity, stability, and bioavailability depend on rigorous manufacturing protocols and supply chain integrity. As a class of selective alpha-1 adrenergic antagonists, doxazosin's therapeutic profile necessitates high-quality sourcing of raw materials and intermediates.

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2. Leading API Manufacturers for Cardura

A. Global Producers

Multiple pharmaceutical chemical companies dominate the manufacturing of doxazosin mesylate API, with top contenders spanning North America, Europe, and Asia. These manufacturers have demonstrated compliance with international standards such as cGMP and ISO certifications, essential for global distribution.

B. Notable API Suppliers

• Zhejiang Tianyue Medical Co., Ltd. (China)
  A key Asian pharmaceutical API manufacturer with extensive production capacity for doxazosin mesylate. Zhejiang Tianyue emphasizes process optimization and quality assurance aligned with FDA and EMA standards.

• Shilpa Meditech Ltd. (India)
  An established Indian supplier with a broad portfolio in cardiovascular APIs, including doxazosin mesylate. The company maintains GMP compliance and supplies both bulk API and intermediates to global clients.

• Xian Minsheng Biotech Co., Ltd. (China)
  Specializes in producing cardiovascular drug APIs with a focus on high-purity specifications. Xian Minsheng exports to North American and European markets, supporting regulatory requirements.

• Alphapharm (Australia)
  A smaller but reputable API manufacturer known for high-quality production standards and consistent supply. Alphapharm aligns its manufacturing processes with international regulatory standards.

• Pfizer and Teva Pharmaceutical Industries (Contract Manufacturers)
  Some brand-name pharmaceutical entities outsource API production to specialized contract manufacturing organizations (CMOs), ensuring quality and supply chain flexibility.

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3. Geographic Distribution and Market Dynamics

A. Asia-Pacific Region

Asia remains the dominant source of doxazosin mesylate API, primarily due to cost efficiencies and manufacturing scale. Chinese and Indian manufacturers account for a significant share of global API output, driven by lower production costs, burgeoning pharmaceutical sectors, and export-oriented policies.

B. North America and Europe

These regions focus on high-quality API production with stringent regulatory standards. While fewer in number, manufacturers in North America and Europe often serve niche markets demanding the highest standard of compliance and traceability.

C. Supply Chain Considerations

Recent years have witnessed disruptions in API supply chains due to geopolitical tensions, regulatory tightenings, and pandemic-related bottlenecks. Companies sourcing doxazosin API must rigorously assess supplier regulatory credentials, capacity scalability, and contingency plans.

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4. Regulatory and Quality Assurance Aspects

Manufacturers must adhere to cGMP guidelines and obtain certifications from agencies such as the FDA, EMA, and WHO. Due to the critical therapeutic role of Cardura, regulatory bodies conduct regular audits, and APIs must meet pharmacopoeial standards for potency, purity, and stability.

Certifications like ISO 9001 and certifications of analytical methods (e.g., HPLC, GC) underpin supplier credibility. Additionally, Certificate of Suitability (CEPs) issued by the EDQM attest to APIs conforming to European pharmacopoeial standards, facilitating international trade.

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5. Market Trends and Future Outlook

A. Increasing Demand

The global prevalence of BPH and hypertension correlates with a steady increase in Cardura prescriptions, bolstering demand for high-quality doxazosin API. This trend incentivizes manufacturers to expand capacity and improve process efficiencies.

B. Supply Chain Diversification

Manufacturers and pharmaceutical companies seek to diversify their API supplier base to mitigate dependency risks. Partnerships with multiple suppliers across different regions reduce vulnerability to disruptions.

C. Regulatory Tightening and Quality Upgrades

Regulatory agencies continue to enforce stricter standards on API manufacturing, prompting suppliers to invest in advanced quality systems and technology. Traceability, data integrity, and raw material sourcing transparency are increasingly prioritized.

D. Contract Manufacturing and OEM Partnerships

Large pharmaceutical firms increasingly rely on Contract Manufacturing Organizations (CMOs) to meet bulk API demands, ensuring flexibility, scalability, and compliance.

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Conclusion

The supply landscape for doxazosin mesylate API pertinent to Cardura hinges on a select network of reputable manufacturers predominantly located in Asia-Pacific, complemented by high-regulatory-standard suppliers in North America and Europe. Strategic sourcing, rigorous quality assurance, and supply chain diversification are pivotal for pharmaceutical companies to secure stable, compliant API supply essential for maintaining Cardura's market continuity.

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Key Takeaways

• Diverse Supplier Base: Asian manufacturers dominate API supply, with certified producers in India and China providing reliable sources for Cardura API.
• Regulatory Compliance is Crucial: Suppliers must demonstrate adherence to cGMP, ISO, and pharmacopoeial standards for safe, high-quality API production.
• Supply Chain Risks & Mitigation: External disruptions highlight the importance of supplier diversification and contingency planning.
• Market Growth Drives Capacity Expansion: Rising global demand for BPH and hypertension therapies accelerates API manufacturing investments.
• Quality and Traceability: Increasing emphasis on transparency, documentation, and quality assurance standards in API manufacturing to meet global regulatory requirements.

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FAQs

Q1. What are the principal regions producing doxazosin mesylate API?
Primarily China and India, with localized high-standard producers in Europe and North America offering compliance-certified APIs.

Q2. How do regulatory standards impact API sourcing for Cardura?
Manufacturers must comply with cGMP, ISO, and pharmacopoeial standards; non-compliance can lead to regulatory rejection and supply interruptions.

Q3. What are common challenges in sourcing bulk API for Cardura?
Supply chain disruptions, regulatory compliance, raw material availability, and quality consistency.

Q4. Are there contract manufacturing organizations (CMOs) specializing in doxazosin API?
Yes, several CMOs globally offer API manufacturing services, providing scalability and quality assurance for pharmaceutical companies.

Q5. How is market demand influencing API production for Cardura?
Increased demand for BPH and hypertension medications drives manufacturers to expand production capacity and improve process efficiencies.

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References

1. U.S. Food and Drug Administration. (2022). API Regulatory Requirements. [Online] Available at: https://www.fda.gov/drugs/pharmaceutical-quality-resources/drug-supply-chain-security-act
2. European Directorate for the Quality of Medicines & HealthCare. (2021). Certificate of Suitability (CEP) for Doxazosin Mesylate.
3. Global Quality Standards in Pharmaceutical API Manufacturing. (2021). International Society for Pharmaceutical Engineering (ISPE).
4. Market Intelligence Reports on API Manufacturing. (2022). IQVIA, Global Market Insights, and other industry sources.

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This comprehensive analysis provides business professionals with actionable insights into the primary sources, regulatory milieu, and market dynamics underlying the supply of doxazosin mesylate API for Cardura.