Suppliers and packagers for uroxatral

uroxatral

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Advanz Pharma	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287	NDA	Advanz Pharma (US) Corp.	59212-200-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)	2013-06-03
Advanz Pharma	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287	NDA	Advanz Pharma (US) Corp.	59212-200-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)	2013-06-03

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: UROXATRAL

Introduction
Uroxatral, known generically as alfuzosin hydrochloride, is a prescription medication primarily used for the treatment of benign prostatic hyperplasia (BPH). Manufactured by Astellas Pharma, Uroxatral functions as an alpha-1 adrenergic receptor antagonist, facilitating the relaxation of smooth muscle tissue in the prostate and bladder neck. The demand for Uroxatral has driven a complex global supply chain involving multiple key suppliers for its active pharmaceutical ingredients (API), excipients, and finished dosage forms. This report comprehensively assesses the primary suppliers involved in the Uroxatral manufacturing process, highlighting their roles, geographic distribution, and market influence.

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1. Suppliers of Active Pharmaceutical Ingredient (API): Alfuzosin

The core component of Uroxatral is alfuzosin hydrochloride, the API synthesized by specialized chemical and pharmaceutical manufacturers. The quality, purity, and compliance of the API are pivotal to the drug's safety and efficacy, making the supplier selection critical.

Key API Suppliers

A. China-Based Chemical Manufacturers
China remains a dominant player in the production of pharmaceutical APIs due to its extensive chemical manufacturing industry. Several Chinese firms are involved in the synthesis of alfuzosin API, often supplying both branded and generic drug manufacturers internationally. These companies typically process bulk alfuzosin base, which is then transformed into the hydrochloride salt during formulation. Examples include Ningbo Inno Pharmchem Co., Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd.

B. Indian API Manufacturers
India hosts a robust pharmaceutical manufacturing sector, with companies like Natco Pharma, Jubilant Lifesciences, and Hetero Labs producing alfuzosin API. Indian firms often supply APIs to both domestic generic producers and multinational companies, leveraging cost advantages and regulatory compliance capabilities that meet global standards (e.g., US FDA, EUGMP).

C. European and US API Suppliers
Although smaller in scale, European and US-based manufacturers such as Teva Pharmaceuticals and Alcami Corporation produce high-purity alfuzosin APIs. These suppliers typically serve premium markets requiring stringent quality assurance and regulatory compliance.

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2. Excipient Suppliers

Uroxatral formulations comprise excipients that enhance stability, bioavailability, and patient compliance. Key excipients include microcrystalline cellulose, lactose monohydrate, and magnesium stearate. Major excipient suppliers include…

• FMC Corporation
• Meggle AG
• DuPont Nutrition & Health

These suppliers provide pharmaceutical-grade excipients conforming to pharmacopeial standards (USP, EP), supporting consistent manufacturing quality.

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3. Contract Manufacturers (CMOs) and Finished Dosage Production

While Astellas Pharma oversees the core formulation and branding, several Contract Manufacturing Organizations (CMOs) globally produce Uroxatral’s finished tablets. These companies typically handle large-scale tablet compression, coating, and packaging. Notable CMO players include:

• Recipharm (Sweden)
• STADA Arzneimittel AG (Germany)
• Wockhardt Ltd. (India)

These manufacturers often source API from various suppliers and adhere to strict regulatory standards to ensure batch-to-batch consistency.

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4. Regulatory and Supply Chain Dynamics

The supply chain for Uroxatral's API and formulations is affected by geopolitical factors, regulatory standards, and manufacturing capacities. China and India dominate API supply, attributed to their cost efficiencies and production scale. However, recent regulatory shifts, such as the US FDA stringent inspections, influence supplier viability.

Supply Chain Challenges include:

• Quality assurance and compliance: High standards necessitate rigorous audits of suppliers.
• Raw material price fluctuations: Impact sourcing costs for API and excipients.
• Geopolitical tensions: Affect cross-border trade and regulatory approvals.

Astellas Pharma maintains strategic relationships with key suppliers, employing dual sourcing strategies to mitigate risks.

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5. Future Outlook and Industry Trends

The pharmaceutical industry increasingly emphasizes supply chain transparency and resilience. For Uroxatral, this implies deeper engagement with diversified API suppliers, investment in local manufacturing, and adoption of digital supply chain solutions.

Emerging trends include:

• Enhanced supply chain monitoring: Use of blockchain for traceability.
• Regulatory alignment: Ensuring suppliers meet evolving global standards.
• Sustainable sourcing: Emphasis on environmentally friendly manufacturing practices.

By 2025, strategic supplier diversification and technological integration are expected to become standard practices among pharmaceutical manufacturers producing Uroxatral.

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Key Takeaways

• Major API suppliers for Uroxatral are predominantly based in China, India, and select European regions, emphasizing cost-effectiveness and high regulatory standards.
• Ensuring API quality involves stringent supplier qualification, with a focus on compliance with global pharmacopeial standards.
• Excipient suppliers play a critical role in ensuring formulation stability and bioavailability, with trusted global names dominating the market.
• Contract manufacturing organizations handle the large-scale production and packaging, often sourced from multiple API suppliers to ensure supply chain resilience.
• Supply chain risks are actively managed through diversification, regulatory compliance, and technological advances in traceability.

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FAQs

Q1: Who are the primary API suppliers for Uroxatral globally?
A1: Major API suppliers include Chinese companies like Ningbo Inno Pharmchem; Indian firms such as Natco Pharma and Jubilant Life Sciences; and select European and US manufacturers like Teva and Alcami, all adhering to stringent quality standards.

Q2: How does supply chain regulation impact Uroxatral production?
A2: Regulatory standards, particularly from the US FDA and EMA, require suppliers to maintain high quality assurance practices. Non-compliance can lead to supply delays, increased costs, or product recalls.

Q3: Are there concerns regarding API sourcing from specific regions?
A3: Yes, geopolitical tensions and regulatory scrutiny have prompted companies to diversify API sources, reducing dependence on China and India to mitigate supply disruptions.

Q4: What role do excipient suppliers play in the Uroxatral supply chain?
A4: They supply pharmaceutical-grade excipients that ensure formulation stability, bioavailability, and manufacturability, with essential suppliers like FMC Corporation dominating the market.

Q5: What future trends could influence suppliers for Uroxatrals?
A5: Increased focus on supply chain transparency, regulatory alignment, digital monitoring, and sustainability will shape sourcing strategies and supplier relationships.

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References

[1] Astellas Pharma. Uroxatral Product Details.
[2] US FDA. Pharmaceutical Good Manufacturing Practices.
[3] IMS Health. Global API Market Reports.
[4] Pharmevo. API Supplier Directory.
[5] European Medicines Agency. Supply Chain Standards.