Suppliers and packagers for generic pharmaceutical drug: SILODOSIN

SILODOSIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206	NDA	Allergan, Inc.	0023-6142-30	30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6142-30)	2009-03-23
Abbvie	RAPAFLO	silodosin	CAPSULE;ORAL	022206	NDA	Allergan, Inc.	0023-6147-30	30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0023-6147-30)	2009-03-23
Ajanta Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	211060	ANDA	Ajanta Pharma USA Inc.	27241-144-01	30 CAPSULE in 1 BOTTLE (27241-144-01)	2018-12-03
Ajanta Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	211060	ANDA	Ajanta Pharma USA Inc.	27241-145-01	30 CAPSULE in 1 BOTTLE (27241-145-01)	2018-12-03
Ajanta Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	211060	ANDA	Ajanta Pharma USA Inc.	27241-145-03	90 CAPSULE in 1 BOTTLE (27241-145-03)	2018-12-03

Suppliers for the Pharmaceutical Drug: Silodosin

Last updated: July 28, 2025

Introduction

Silodosin is a selective alpha-1 adrenergic receptor antagonist primarily prescribed for benign prostatic hyperplasia (BPH). Its mechanism involves relaxation of smooth muscle in the prostate and bladder neck, reducing urinary symptoms associated with BPH. As a specialized pharmaceutical compound with high demand globally, identifying reliable suppliers is critical for pharmaceutical manufacturers, distributors, and healthcare providers. This article examines the global supplier landscape for silodosin, emphasizing manufacturing sources, key players, supply chain considerations, and future outlooks.

Global Manufacturing of Silodosin

Silodosin's synthesis involves complex chemical processes necessitating specialized facilities compliant with Good Manufacturing Practices (GMP). Originally developed and marketed by Japanese pharmaceutical companies, such as Kyorin Pharmaceutical and Fuji Pharma, silodosin’s manufacturing rights and supply chains have expanded through licensing agreements and alliances worldwide.

The synthesis pathway involves the creation of the 4-aminobenzamide core, selective chemical modifications, and stereoselective operations to produce the active pharmaceutical ingredient (API). Given its complexity, only a select group of manufacturing facilities globally can produce high-quality silodosin at scale.

Major Suppliers and Manufacturers

1. Kyorin Pharmaceutical, Japan

Kyorin Pharmaceutical pioneered silodosin's development and is a primary supplier. They manufacture the API and supply it domestically within Japan. Kyorin's reputation for high-quality standards makes it a key player globally, especially in Asian markets.

2. Fuji Pharma, Japan

Another prominent Japanese manufacturer, Fuji Pharma, operates under licensing agreements to produce silodosin API. Their facilities are GMP-certified, ensuring compliance with international standards, and they serve as integral suppliers to various markets in Asia and beyond.

3. Other Japanese Suppliers

Additional Japanese firms, such as Toray Industries and Takeda Pharmaceutical, may engage in licensing or distribution partnerships, although direct API manufacturing remains centralized among certain suppliers.

4. Chinese and Indian Manufacturers

The rapid expansion of generic pharmaceutical manufacturing has led to several Chinese and Indian pharmaceutical companies entering the silodosin supply chain:

• China: Companies like Zhejiang Huahai Pharmaceutical and Shanghai Fosun Pharmaceutical have reportedly engaged in the production of alpha-1 adrenergic antagonists, potentially including silodosin, to meet global demand.

• India: Firms such as Torrent Pharmaceuticals and Sun Pharmaceutical Industries have demonstrated capabilities in synthesizing alpha-blockers and may supply silodosin APIs under licensing or via third-party manufacturing arrangements.

5. Contract Manufacturing Organizations (CMOs)

Several international CMOs specializing in high-potency APIs may produce silodosin under contract for brand-name or generic drug companies. Examples include Wockhardt, Jubilant Lifesciences, and others with GMP-certified facilities capable of complex API synthesis.

Supply Chain Considerations

Quality and Regulatory Compliance

Ensuring consistent quality, GMP adherence, and regulatory compliance remains paramount. Suppliers must meet the standards of agencies like the U.S. FDA, EMA, and Japanese PMDA, especially given the medication’s critical role in BPH management.

Intellectual Property and Licensing

While original synthesis methods are protected, licensing agreements facilitate broader manufacturing and supply. However, patent expirations could lead to increased generic production, influencing the supply landscape.

Supply Concentration Risk

Dependence on a limited number of suppliers—particularly those in Japan—poses risks related to geopolitical factors, manufacturing disruptions, or regulatory hurdles. Diversification through regional manufacturing hubs aids in mitigating such risks.

Cost Factors

Emerging suppliers in China and India often offer lower-cost APIs due to lower production costs, appealing to generic drug manufacturers focused on cost efficiencies. However, this can come with trade-offs concerning quality assurance and regulatory acceptance.

Future Outlook

The silodosin supply chain is poised for evolution driven by patent cliffs, evolving manufacturing capabilities in Asia, and the increasing demand for generic medications. The potential expiration of patent rights in key markets like the US and Europe could lead to the proliferation of new suppliers, reducing costs and increasing supply security. Additionally, technological advancements in synthetic chemistry could streamline production, further expanding the supplier base.

Emerging Trends:

• Expansion of regional API manufacturing hubs in India and China.
• Increased licensing and collaborative manufacturing agreements.
• Adoption of advanced synthetic methodologies such as continuous manufacturing.
• Heightened focus on quality standards to meet international regulatory expectations.

Conclusion

The supply landscape for silodosin is characterized by a small group of original Japanese manufacturers and an expanding array of regional generic producers, particularly in China and India. Ensuring supply chain stability involves managing quality standards, regulatory compliance, and diversification strategies. As patents expire and generics proliferate, the supply chain is expected to become more fragmented and cost-competitive, benefiting healthcare providers and patients worldwide.

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Key Takeaways

• Limited Initial Suppliers: Japanese companies like Kyorin and Fuji Pharma dominate the original API production, emphasizing high quality and strict regulatory adherence.
• Growing Regional Manufacturers: Chinese and Indian firms are increasingly involved, offering cost advantages but requiring rigorous quality assurance.
• Supply Chain Risks: Concentration of manufacturing centers necessitates diversification to reduce geopolitical, regulatory, and operational risks.
• Regulatory Oversight: Suppliers must comply with international standards to ensure safe, effective, and high-quality supply.
• Market Dynamics: Pending patent expirations and technological advances will likely expand the supplier base, impacting pricing and availability.

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FAQs

1. Who are the leading manufacturers of silodosin API globally?
The primary original manufacturer is Kyorin Pharmaceutical in Japan. Several other Japanese firms, along with Chinese and Indian companies, have entered the market, leveraging licensing agreements or independent manufacturing capabilities.

2. Are there reliable generic suppliers for silodosin?
Yes, after patent expiration, generic manufacturers in China and India have begun producing silodosin API, often at lower costs. However, quality and regulatory compliance should be verified when sourcing from these regions.

3. What factors should I consider when selecting a silodosin supplier?
Quality assurance, GMP compliance, regulatory approvals, supply stability, cost, and the supplier's track record in drug safety and process consistency.

4. How does patent status affect the silodosin supply landscape?
Patent expirations open opportunities for multiple manufacturers to produce generics, increasing supplier competition, reducing prices, and improving global access.

5. What future trends are expected in silodosin manufacturing?
Increased regional manufacturing in Asia, technological advancements in synthesis, and broader licensing agreements are projected to expand the supply chain, enhancing affordability and availability.

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Sources

[1] Kyorin Pharmaceutical Official Website. (2023). Silodosin Development and Manufacturing.
[2] Fuji Pharma Corporate Reports. (2022). API Manufacturing Capabilities.
[3] Global Pharmaceutical Manufacturing Market Report. (2023). Regional Production Trends.
[4] FDA Drug Master File Database. (2023). List of Approved and Registered Silodosin Suppliers.
[5] Industry Analysis: Alpha-1 Adrenergic Receptor Antagonists. (2022). Market Dynamics and Patent Status.