Suppliers and packagers for CARDURA XL

CARDURA XL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269	NDA	Viatris Specialty LLC	58151-078-93	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-078-93)	2024-04-23
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269	NDA	Viatris Specialty LLC	58151-079-93	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-079-93)	2024-01-04

Suppliers for the Pharmaceutical Drug: CARDURA XL

Last updated: August 1, 2025

Introduction

Cardura XL (doxazosin mesylate) is a prescription medication primarily used to treat hypertension and benign prostatic hyperplasia (BPH). As a long-acting alpha-1 adrenergic blocker, Cardura XL offers extended release benefits that improve patient compliance and therapeutic outcomes. Understanding the global supplier landscape for Cardura XL is critical for pharmaceutical companies, healthcare providers, and supply chain strategists aiming to ensure consistent drug availability, competitive procurement, and risk mitigation.

This article details the primary suppliers of Cardura XL, explores their manufacturing footprints, discusses regulatory considerations, and examines market dynamics influencing supply stability.

Manufacturers and Key Suppliers of Cardura XL

1. Boehringer Ingelheim

Boehringer Ingelheim, a German pharmaceutical giant, is the originator of Cardura XL. The company developed doxazosin mesylate, including its controlled-release formulation, over two decades ago. As the patent holder, Boehringer Ingelheim initially controlled the global supply chain, holding exclusive rights for a significant period.

Following patent expiration in various jurisdictions, Boehringer Ingelheim has transitioned from sole manufacturing to licensing arrangements and partnerships that expand the drug's availability from authorized generic producers. Its manufacturing facilities in Germany and the United States ensure high-quality standards compliant with global regulatory requirements.

2. Authorized Generics and Licensed Manufacturers

Post-patent expiration, multiple pharmaceutical companies have entered the market as authorized generic (AG) manufacturers or through licensing agreements with Boehringer Ingelheim. These include:

• Teva Pharmaceuticals
  As one of the world’s largest generic drug producers, Teva has obtained rights to manufacture and distribute generic versions of Cardura XL. Its facilities across the United States and Europe adhere to Good Manufacturing Practice (GMP) standards, ensuring large-scale, reliable supply.

• Mylan (now part of Viatris)
  Viatris, formed through the merger of Mylan and Pfizer's Upjohn unit, also produces generic doxazosin mesylate. With a vast global footprint—comprising manufacturing plants in the U.S., Europe, and Asia—Viatris plays a significant role in meeting demand.

• Alkem Laboratories
  An Indian pharmaceutical company, Alkem manufactures doxazosin in various formulations, including controlled-release formulations similar to Cardura XL. Its global export network contributes to supply across Asia, Africa, and the Middle East.

• Sun Pharmaceutical Industries
  Another major Indian supplier, Sun Pharma, produces generic doxazosin under several brand names and as an unbranded generic. Their manufacturing units Super Speciality Plants in India are certified for GMP.

3. Emerging and Regional Suppliers

In emerging markets, local pharmaceutical companies often produce generic versions of Cardura XL, sometimes under different brand names or as unbranded generics. These include:

• Dr. Reddy’s Laboratories (India)
  Develops and supplies doxazosin formulations, catering primarily to the Indian and Latin American markets.

• Aurobindo Pharma
  Offers generic doxazosin with regional distribution strategies, supported by its manufacturing facilities in India and the U.S.

• Zydus Cadila
  Produces doxazosin formulations for regional markets, with certifications enabling export to regulatory bodies such as the FDA, EMA, and others.

Regulatory Landscape and Its Impact on Suppliers

Patent Expiry and Market Entry

The original patent for Cardura XL expired in many key jurisdictions after 2012, catalyzing the entry of multiple generic manufacturers. Regulatory approval via agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and DSIR (India’s Department of Scientific & Industrial Research) plays a critical role in establishing legitimate supply channels.

Quality Standards and Certification

Suppliers must comply with GMP and other regulatory standards to access global markets. Deep regulatory vetting influences which manufacturers can produce and distribute Cardura XL, affecting supply stability and pricing. Facilities with WHO prequalification or appropriate regional certifications tend to be preferred, especially in emerging markets.

Supply Chain Disruptions

Global events such as pandemics, geopolitical tensions, and raw material shortages can disrupt supply chains. For example, recent COVID-19 disruptions have affected manufacturing at various facilities, prompting healthcare providers to diversify suppliers and build inventory buffers.

Market Dynamics and Supply Trends

Global Demand and Market Size

The global market for alpha-1 blockers, including doxazosin, is estimated to grow steadily, driven by aging populations and increasing prevalence of hypertension and BPH. According to IQVIA data, the regional demand primarily resides in North America, Europe, and Asia.

Price Competition and Market Shares

Price competition among generic suppliers has intensified, pressuring profit margins but also incentivizing supply expansion. Major players like Teva, Viatris, and Sun Pharma hold significant market shares, often competing on price, quality, and supply reliability.

Strategic Supply Chain Considerations

Pharmaceutical firms often adopt dual sourcing or multiple supplier strategies to mitigate risks. Regional suppliers are increasingly vital to ensure supply security tailored to local regulations and market conditions.

Supply Chain Challenges and Opportunities

Challenges

• Regulatory Delays: Approval bottlenecks can delay generic entry or expansion.
• Raw Material Scarcity: Shortages in active pharmaceutical ingredients (APIs) impact production timelines.
• Quality Variability: Maintaining high GMP standards across multiple facilities influences supply consistency.
• Market Volatility: Fluctuating demand and pricing pressures can affect long-term supplier investments.

Opportunities

• Manufacturing Scale Expansion: Larger facilities and automation improve capacity and resilience.
• Regional Manufacturing Hubs: Developing localized production in emerging markets reduces dependency on imports.
• Strategic Partnerships: Collaborations with Contract Manufacturing Organizations (CMOs) bolster supply flexibility.

Conclusion

The supply landscape for Cardura XL is characterized by a blend of original manufacturer Boehringer Ingelheim and numerous generic producers spanning North America, Europe, and Asia. The expiration of patents provided opportunity for multiple regional and global competitors to enter the market.

Ensuring stable supply requires strategic oversight, particularly given industry-specific regulatory complexities, raw material challenges, and geopolitical influences. Companies investing in diversified supplier networks, robust quality assurance, and regional manufacturing capabilities position themselves strongly to meet rising global demand and mitigate supply risks.

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Key Takeaways

• Primary manufacturers include Boehringer Ingelheim as the original patent holder, with major generics producers like Teva, Viatris, Sun Pharma, and Alkem Labs serving global markets.
• Post-patent expiration sparked an increase in regional and generic suppliers, expanding access but also intensifying competition.
• Regulatory adherence remains critical for supplier credibility, with GMP compliance and certifications ensuring market access and supply quality.
• Supply stability depends on diversified sourcing, resilient manufacturing infrastructure, and proactive management of raw material sourcing.
• Emerging markets are increasingly self-sufficient in manufacturing doxazosin, reducing reliance on Western suppliers and fostering local pharmaceutical growth.

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FAQs

1. Who were the original manufacturers of Cardura XL?
   Boehringer Ingelheim developed and originally marketed Cardura XL, maintaining patent rights until patent expiry in various markets around 2012.

2. Which companies currently supply generic versions of doxazosin mesylate?
   Major global suppliers include Teva Pharmaceuticals, Viatris (formerly Mylan), Sun Pharmaceutical Industries, Alkem Laboratories, and several regional producers such as Dr. Reddy’s and Zydus Cadila.

3. How does patent expiration influence supplier availability?
   Patent expiration allows multiple generic manufacturers to produce doxazosin, broadening supply sources, increasing competition, and often leading to reduced prices and improved access.

4. What regulatory considerations affect Cardura XL supply chains?
   Manufacturers must comply with GMP standards set by agencies like the FDA and EMA, with certifications influencing their ability to export and supply globally.

5. What are the main risks to Cardura XL supply stability?
   Risks include raw material shortages, regulatory delays, geopolitical tensions, manufacturing disruptions, and quality compliance issues. Diversification and regional manufacturing are key mitigation strategies.

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Sources:
[1] IQVIA Reports on Global Pharmaceutical Markets (2022)
[2] FDA Drug Approvals and Certificate Databases
[3] Boehringer Ingelheim Corporate Website
[4] European Medicines Agency (EMA) Regulatory Data
[5] Indian Pharmaceutical Industry Reports (2022)