Bulk Pharmaceutical API Sources for UROXATRAL

Bulk Pharmaceutical API Sources for UROXATRAL

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-1116
Molport		MolPort-006-391-851
Amadis Chemical		A840121
BioChemPartner		BCPP000417
BioChemPartner		BCP9000271

UROXATRAL (Alfuzosin Hydrochloride) API Sourcing Analysis

Last updated: February 19, 2026

This analysis details the current landscape of bulk Active Pharmaceutical Ingredient (API) sourcing for Uroxatral (alfuzosin hydrochloride), a selective alpha-1 adrenergic receptor antagonist used to treat benign prostatic hyperplasia (BPH). The report identifies key manufacturers, regulatory considerations, and market dynamics impacting API procurement.

What is the Chemical Composition and Mechanism of Action for Alfuzosin Hydrochloride?

Alfuzosin hydrochloride is chemically known as N-[3-[(4-Amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]-tetrahydro-2-furancarboxamide monohydrochloride. Its molecular formula is C19H24N4O4•HCl.

Alfuzosin hydrochloride acts by selectively blocking alpha-1 adrenergic receptors, primarily in the smooth muscle of the prostate gland and bladder neck. This blockade leads to smooth muscle relaxation, reducing urethral obstruction and improving urine flow in patients with BPH. It exhibits greater selectivity for alpha-1 receptors in the lower urinary tract compared to alpha-1 receptors in the cardiovascular system, resulting in a lower incidence of orthostatic hypotension.

Who are the Primary Manufacturers of Alfuzosin Hydrochloride API?

The manufacturing of alfuzosin hydrochloride API is concentrated among a limited number of global suppliers, primarily located in Asia. These manufacturers must adhere to stringent Good Manufacturing Practices (GMP) and meet pharmacopeial standards (e.g., USP, EP).

• Purity/Quality Standards: Manufacturers must ensure alfuzosin hydrochloride API meets specified purity levels, with strict limits on impurities and residual solvents. Typical purity requirements exceed 99.0%.
• Regulatory Filings: API manufacturers commonly file Drug Master Files (DMFs) with regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These filings provide detailed information about the manufacturing process, controls, and specifications.

Key suppliers include:

• Zhejiang NHU Co., Ltd.
  • Located in Zhejiang, China.
  • Holds DMF filings for alfuzosin hydrochloride with various regulatory bodies.
  • Operates under ISO 9001 and GMP certifications.
• Alchem International Pvt. Ltd.
  • Based in India.
  • Known for its pharmaceutical ingredient manufacturing capabilities.
  • Has a presence in regulated markets.
• Divi's Laboratories Limited
  • An Indian API manufacturer with significant global reach.
  • Supplies a broad portfolio of APIs, including those for genitourinary conditions.
  • Subject to regular inspections by international regulatory authorities.
• Lianyungang Pharma-chem Inc.
  • A Chinese API producer with GMP-compliant facilities.
  • Focuses on the development and manufacturing of generic APIs.
• Sanbe Pharma Co., Ltd.
  • Another Chinese manufacturer with a portfolio of APIs.
  • Emphasizes quality control and regulatory compliance.

What are the Regulatory Requirements for Importing Alfuzosin Hydrochloride API?

Importation of alfuzosin hydrochloride API into major pharmaceutical markets is governed by strict regulatory frameworks to ensure drug safety and efficacy.

• FDA Requirements (United States):

  • DMF Submission: The API manufacturer must have an active DMF on file with the FDA. The finished drug product manufacturer references this DMF in their Abbreviated New Drug Application (ANDA) or New Drug Application (NDA).
  • GMP Compliance: Manufacturing facilities must comply with U.S. FDA's Current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211. Facilities are subject to inspection by FDA investigators.
  • Import Alerts: Products from facilities subject to import alerts may be detained without physical examination.
  • Certificate of Analysis (CoA): Each batch of imported API must be accompanied by a CoA detailing its testing results against established specifications.

• EMA Requirements (European Union):

  • CEP/COS (Certificate of Suitability to the monographs of the European Pharmacopoeia): A CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) serves as a declaration that the API complies with the relevant European Pharmacopoeia monograph. This simplifies the regulatory process for Marketing Authorisation Applications (MAA).
  • GMP Compliance: Manufacturing sites must be GMP-certified by a competent authority of an EU Member State or a country with Mutual Recognition Agreements (MRAs).
  • Written Confirmation: For APIs imported from countries without MRAs with the EU, a "Written Confirmation" from the exporting country's competent authority, certifying GMP compliance, is required.
  • Inspection: EMA and national competent authorities conduct GMP inspections.

• Other Regulated Markets: Similar requirements exist in Japan (PMDA), Canada (Health Canada), Australia (TGA), and other jurisdictions, often involving DMFs or equivalent filings and GMP compliance.

What is the Market Landscape and Pricing for Alfuzosin Hydrochloride API?

The market for alfuzosin hydrochloride API is driven by the demand for generic Uroxatral products. The price of the API is influenced by several factors:

• Manufacturing Costs: Raw material availability, labor costs in the manufacturing region, energy prices, and economies of scale impact production costs.
• Regulatory Compliance Burden: The cost associated with maintaining GMP certification, conducting validation studies, and preparing/updating regulatory filings contributes to the overall API price.
• Supply Chain Stability: Geopolitical factors, transportation costs, and the reliability of key raw material suppliers can affect pricing.
• Competition: The presence of multiple qualified API manufacturers generally leads to competitive pricing. However, if a critical supplier faces production issues or regulatory challenges, prices can increase.

Estimated Pricing Range (as of Q4 2023/Q1 2024): The price of alfuzosin hydrochloride API can range significantly based on quantity, supplier, quality certifications, and contractual terms. For bulk purchases (multi-kilogram to metric ton quantities), prices are typically in the $50 to $150 per kilogram range.

• Factors influencing price within this range:
  • Volume: Larger orders command lower per-unit pricing.
  • Purity and Specifications: Meeting pharmacopeial standards (USP, EP) and specific customer impurity profiles will affect cost.
  • Regulatory Support: Suppliers with robust and up-to-date DMFs or CEPs may command a premium.
  • Lead Time: Rush orders or suppliers with shorter lead times may have higher pricing.
  • Supplier Location and Logistics: Shipping costs and import duties vary by region.

What are the Challenges and Risks in Alfuzosin Hydrochloride API Sourcing?

Sourcing alfuzosin hydrochloride API presents several potential challenges and risks for pharmaceutical companies.

• Quality Control and Assurance:
  • Impurity Profiling: Ensuring consistent control over known and unknown impurities, including genotoxic impurities, is critical.
  • Batch-to-Batch Consistency: Variations in manufacturing processes can lead to inconsistencies in API quality.
  • Analytical Method Validation: Ensuring that analytical methods used by the API manufacturer are properly validated and meet regulatory expectations.
• Supply Chain Disruptions:
  • Geopolitical Instability: Political events in manufacturing regions can disrupt production and export.
  • Natural Disasters: Environmental events can impact manufacturing facilities and logistics.
  • Raw Material Shortages: Dependencies on specific precursor chemicals or reagents can create vulnerabilities.
  • Logistical Issues: Shipping delays, port congestion, and customs hold-ups can impact timely delivery.
• Regulatory Compliance:
  • Facility Audits: Unfavorable outcomes during regulatory inspections (FDA, EMA, etc.) of API manufacturing sites can lead to import bans or product recalls.
  • Changes in Regulations: Evolving regulatory expectations regarding impurity control, analytical testing, or environmental impact can necessitate process changes and revalidation.
  • DMF/CEP Updates: Manufacturers must keep their regulatory filings current, which requires ongoing investment and oversight.
• Intellectual Property:
  • While the primary patents for alfuzosin hydrochloride have expired, manufacturers must ensure they do not infringe on any remaining process patents or formulation patents.
• Supplier Viability:
  • Financial stability of API manufacturers is crucial to ensure long-term supply reliability.
  • Dependence on a single supplier can be risky; developing relationships with multiple qualified vendors is recommended.

What are the Future Trends in Alfuzosin Hydrochloride API Sourcing?

Several trends are likely to shape the future of alfuzosin hydrochloride API sourcing.

• Increased Scrutiny on Supply Chain Transparency: Regulatory bodies and pharmaceutical companies are demanding greater transparency regarding the origin of raw materials and intermediates used in API manufacturing.
• Reshoring and Nearshoring Initiatives: Geopolitical tensions and concerns about supply chain resilience may drive some companies to explore manufacturing or sourcing options closer to their finished product manufacturing sites, although cost remains a significant factor.
• Focus on Sustainable Manufacturing: Growing pressure to reduce the environmental footprint of chemical manufacturing may lead to the adoption of greener chemistry principles and more efficient production processes, potentially impacting API costs and availability.
• Advancements in Analytical Technologies: Improved analytical techniques will enable more precise identification and quantification of impurities, leading to stricter quality control measures and potentially more complex manufacturing processes.
• Consolidation in the API Manufacturing Sector: Mergers and acquisitions within the API manufacturing industry could lead to fewer, larger players, potentially impacting competitive pricing and supply diversity.

Key Takeaways

• Alfuzosin hydrochloride API sourcing is dominated by manufacturers in China and India, requiring rigorous adherence to GMP and pharmacopeial standards.
• Regulatory compliance, particularly through DMF filings and facility inspections by agencies like the FDA and EMA, is paramount for market access.
• API pricing is sensitive to volume, quality, regulatory support, and supply chain stability, with current bulk pricing estimated between $50-$150/kg.
• Key risks include quality control failures, supply chain disruptions, and regulatory non-compliance.
• Future trends point towards increased supply chain transparency, potential nearshoring, and a greater emphasis on sustainable manufacturing practices.

Frequently Asked Questions

1. What is the typical shelf life of alfuzosin hydrochloride API?

The typical shelf life for alfuzosin hydrochloride API, when stored under recommended conditions (e.g., protected from light and moisture), is generally 2 to 5 years. Manufacturers provide specific storage conditions and retest dates on their Certificates of Analysis.

2. Are there specific impurity limits for alfuzosin hydrochloride API mandated by pharmacopeias?

Yes, major pharmacopeias such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP) set specific limits for known impurities, unknown impurities, and residual solvents in alfuzosin hydrochloride API. Manufacturers must comply with these monograph requirements.

3. How can pharmaceutical companies mitigate the risk of API supply interruption?

Companies can mitigate supply interruption risks by qualifying multiple API suppliers, maintaining strategic inventory levels, conducting thorough due diligence on supplier financial stability and regulatory history, and establishing robust supply chain monitoring processes.

4. Does the manufacturing location of alfuzosin hydrochloride API significantly impact its quality?

While quality is ultimately determined by adherence to GMP and pharmacopeial standards, the manufacturing location can influence factors like the availability of skilled labor, the cost of raw materials, and the specific regulatory oversight environment. However, for established suppliers in China and India, rigorous quality systems ensure compliance with international standards.

5. What is the role of the API manufacturer in the filing of a generic drug application?

The API manufacturer plays a critical role by providing a Drug Master File (DMF) or equivalent regulatory submission detailing their manufacturing process, controls, and specifications. The generic drug applicant references this DMF in their ANDA or MAA, allowing regulatory agencies to review the API's quality independently.

---

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Drug Master Files. Retrieved from www.fda.gov

[2] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). Certificate of Suitability to the monographs of the European Pharmacopoeia. Retrieved from www.edqm.eu

[3] United States Pharmacopeia. (n.d.). General Notices and Chapter Information. Retrieved from www.usp.org

[4] European Pharmacopoeia. (n.d.). General Chapters and Monographs. Retrieved from www.edqm.eu/en/european-pharmacopoeia-ph-eur