Suppliers and packagers for FLOMAX

FLOMAX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi	FLOMAX	tamsulosin hydrochloride	CAPSULE;ORAL	020579	NDA	RedPharm Drug, Inc.	67296-1803-3	30 CAPSULE in 1 BOTTLE (67296-1803-3)	2019-04-16

Suppliers for the Pharmaceutical Drug: FLOMAX

Last updated: August 7, 2025

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Introduction

Flomax (tamsulosin hydrochloride) is a widely prescribed medication primarily used to treat benign prostatic hyperplasia (BPH). Approved by the FDA in 1997, Flomax functions as an alpha-1 adrenergic receptor antagonist, relaxing muscles in the prostate and bladder neck to improve urinary flow. Given its significant market share and broad prescription base, understanding its suppliers—manufacturers, API producers, and formulation partners—is vital for stakeholders seeking to analyze supply chain stability, patent landscapes, and market competition. This article explores the landscape of Flomax suppliers, emphasizing key manufacturers, API (Active Pharmaceutical Ingredient) producers, and the dynamics influencing the supply chain.

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Manufacturers of Flomax

Baxter International Inc.

Baxter held a prominent role as the original developer and marketer of Flomax. As of the late 1990s and early 2000s, Baxter’s U.S. operations handled the manufacturing, commercialization, and distribution of Flomax. Over the years, Baxter’s pharmaceutical division, particularly within its U.S. subsidiary Baxalta (later merged into Baxter), maintained a robust manufacturing network dedicated to generic formulations and branded drugs.

Astellas Pharma

In 2005, Astellas Pharma acquired OSI Pharmaceuticals, the original patent holder of Flomax. Post-acquisition, Astellas became the primary supplier and patent owner of Flomax. Astellas continues to oversee the marketing and distribution of Flomax globally, especially in North America, Europe, and select markets.

Generic Manufacturers

Beyond originators, multiple generic pharmaceutical companies produce bioequivalent versions of Flomax, often under different brand names or as unbranded generics. These manufacturers may procure their API from various API producers and assemble the formulations in-house or via contract manufacturing organizations (CMOs). Notable generic producers include:

• Teva Pharmaceutical Industries Ltd.
• Mylan (now part of Viatris)
• Sun Pharmaceutical Industries Ltd.
• Zydus Cadila
• Lupin Limited

Their production volumes and market presence vary across regions, influenced by patent expiration dates and regulatory approvals.

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Key API Suppliers for Tamsulosin Hydrochloride

The supply chain for Flomax heavily depends on the availability and quality of the active pharmaceutical ingredient (API), tamsulosin hydrochloride. The API market is globalized, with key producers situated in Asia, Europe, and North America.

Asian API Producers

• China: The Chinese pharmaceutical industry is a dominant API supplier. Companies such as Hefei Jinda Pharmaceutical Co., Ltd., and Shandong Xinhua Pharmaceutical produce tamsulosin API for export markets. Chinese API manufacturers benefit from cost advantages but have faced scrutiny over compliance with international quality standards.

• India: India hosts several API manufacturers with rigorous regulatory standards, notably:

  • Sun Pharmaceutical Industries Ltd.: A major producer of the API, with strong regulatory compliance aligned with USFDA and European requirements.

  • Lupin Limited: Known for producing high-quality APIs with global export credentials.

  • Aarti Drugs and Granules India also produce tamsulosin API, catering to both bulk supply and proprietary formulations.

European and North American API Producers

• EU-based manufacturers like Recipharm and Evonik Industries supply APIs compliant with stringent European and U.S. standards.

• North American API producers tend to focus on high-quality, GMP-compliant manufacturing, such as Alcami and other regional suppliers, often serving as secondary or specialty API sources for downstream manufacturers.

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Contract Manufacturing and Licensing

Given market dynamics, a significant portion of Flomax formulations is produced through contract manufacturing organizations (CMOs). These entities specialize in formulation, packaging, and distribution. Leading pharma companies usually establish licensing or supply agreements with CMOs to secure flexible, high-quality manufacturing capabilities.

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Supply Chain Challenges and Trends

Patent Expirations and Generic Entry

Since the original patent on tamsulosin hydrochloride expired around 2008, the patent landscape has shifted dramatically. Numerous generic manufacturers have entered the market, increasing competition and supply chain complexity. This proliferation led to diversified sources of APIs and formulations globally.

Regulatory Oversight and Quality Standards

API suppliers face increasing regulatory scrutiny, especially from agencies like the USFDA, EMA, and PMDA. Non-compliance can disrupt the supply chain, affect pricing, and impact market availability.

Regional Manufacturing Concentrations

• Chinese and Indian APIs dominate global supply, affected by geopolitical and trade considerations.

• Recent emphasis on supply chain resilience has prompted manufacturers to diversify sourcing and increase inventories.

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Market Dynamics and Future Outlook

The supply landscape for Flomax is expected to evolve with patent status further clarified and potential biosimilar or new competitors emerging. API production in Asia remains pivotal, although regulatory pressures will influence quality standards and supply stability. Collaborations and licensing agreements between originators, generic firms, and API manufacturers will determine the future robustness of the Flomax supply chain.

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Key Takeaways

• Major originator: Astellas Pharma is the primary proprietary supplier of Flomax, with production and distribution rights primarily in developed markets.

• API market dominance: China and India are critical API sourcing hubs, providing tamsulosin hydrochloride at competitive costs but with evolving regulatory oversight.

• Generic proliferation: Numerous global generic manufacturers produce bioequivalent formulations, increasing supply diversity but also competition.

• Supply chain risks: Geopolitical factors, regulatory compliance, and quality standards influence supply stability.

• Future considerations: Strategic sourcing, diversification, and regulatory adherence will remain crucial for uninterrupted supply.

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FAQs

1. Who are the main API suppliers for tamsulosin hydrochloride used in Flomax?
The principal API suppliers operate mainly in China and India, including companies such as Hefei Jinda Pharmaceutical, Sun Pharmaceutical Industries, and Lupin Limited, all producing GMP-compliant tamsulosin hydrochloride for international markets.

2. Which companies manufacture generic versions of Flomax?
Global pharmaceutical firms, including Teva, Mylan (Viatris), Sun Pharmaceutical, Zydus Cadila, and Lupin, produce generic formulations that are bioequivalent to branded Flomax.

3. How does patent expiration affect Flomax supply?
Patents expired around 2008, leading to increased generic entry. This has diversified sources, lowered prices, and expanded global availability, though it has also introduced supply chain variability.

4. Are there regional differences in Flomax production?
Yes. Originator formulations are primarily produced by Astellas and licensed manufacturers. API production is concentrated in China and India, with European and North American firms focusing on regulation-compliant manufacturing.

5. What are future risks to Flomax supply?
Potential risks include regulatory non-compliance at API manufacturing sites, geopolitical tensions affecting trade, quality control issues, and shifts in patent or market exclusivity status.

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References

1. U.S. Food and Drug Administration (FDA). "Tamsulosin Hydrochloride." https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers.
2. Astellas Pharma. "Flomax (tamsulosin) Prescribing Information." 2022.
3. PharmSource Industry Reports. "Global API Market Trends," 2023.
4. Commercial Data on Generic Pharmaceutical Companies. IQVIA, 2022.
5. World Health Organization (WHO). "Prequalification of Medicines Programme," 2022.

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