Suppliers and packagers for rapaflo

rapaflo

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

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: RAPAFLO

Introduction
RAPAFLO (silodosin) is a prescription medication primarily used to treat benign prostatic hyperplasia (BPH), a condition characterized by prostate gland enlargement that impacts urination. As a selectivity α1-adrenergic receptor antagonist, RAPAFLO facilitates smooth muscle relaxation in the prostate and bladder neck, improving urinary flow. Given its clinical importance, understanding the supply chain and the landscape of vendors supplying RAPAFLO is critical for pharmaceutical companies, distributors, healthcare providers, and policymakers.

This article explores the leading suppliers of RAPAFLO, examining manufacturing sources, supply chain dynamics, and market penetration. The goal is to provide industry stakeholders with actionable intelligence to optimize procurement, ensure drug accessibility, and understand licensing and distribution patterns.

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Overview of RAPAFLO Supply Chain
RAPAFLO is a branded product developed by Kissei Pharmaceutical Co., Ltd., a Japanese pharmaceutical company. The active pharmaceutical ingredient (API), silodosin, is produced either through in-house manufacturing or outsourced to specialized API producers globally. Once produced, RAPAFLO is marketed and distributed via licensing agreements, partnerships, or direct sales by Kissei or its authorized distributors.

The supply chain involves three primary stages:

1. API Production
2. Finished Dosage Form Manufacturing
3. Distribution and Sales

1. API Production
Major API manufacturing hubs for silodosin include countries with established pharmaceutical chemical industries, notably China, India, and Japan. Key producers operate under strict regulatory standards such as GMP (Good Manufacturing Practice).

2. Finished Dosage Manufacturing
Contract manufacturing organizations (CMOs) or Kissei’s own facilities handle formulation, coating, and packaging. Top CMOs in the segment often partner with globally recognized pharmaceutical companies.

3. Distribution and Market Penetration
Distribution channels involve licensed regional distributors, authorized pharmacies, and healthcare institutions. Licensing agreements often limit production rights to specific manufacturers, affecting the availability of generic alternatives.

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Key Suppliers and Manufacturers of Silodosin API

A. Kissei Pharmaceutical Co., Ltd.
As the originator, Kissei controls the research, development, and initial production of silodosin. The company's manufacturing facilities in Japan are highly compliant with international quality standards, ensuring consistent API quality. Kissei’s strategic licensing agreements facilitate the global distribution of RAPAFLO in key markets, including North America, Europe, and Asia.

B. Chinese API Manufacturers
China is a significant supplier of generic silodosin APIs. Several Chinese pharmaceutical companies possess the infrastructure, GMP certification, and capacity to produce high-quality APIs. Notable players include:

• Hangzhou MinSheng Pharmaceutical Co., Ltd.: Known for producing cardiovascular APIs, including α1-adrenergic receptor antagonists.
• Jiangxi Holin Pharmaceutical Co., Ltd.: A site with approvals for complex chemical synthesis, including silodosin equivalents.
• Shandong Xinhua Pharmaceutical Co., Ltd.: An API manufacturer with certifications supporting export to regulatory agencies.

C. Indian API Suppliers
India’s pharmaceutical industry is a global powerhouse in generic drug manufacturing, including APIs for BPH medications. Leading firms include:

• Sun Pharmaceutical Industries Ltd.: Known for robust API manufacturing capacity, possibly producing silodosin under license or as a generic alternative.
• Lupin Limited: Has extensive API synthesis capabilities, with potential supply of silodosin or structurally related molecules.
• Divi’s Laboratories: Specializes in complex chemical synthesis, possibly supporting silodosin production.

D. Contract Manufacturing Organizations (CMOs)
CMOs that produce silodosin API or finished doses for various pharmaceutical firms include:

• Guangzhou Baijiang Pharmaceutical Co., Ltd. (China): Certified for complex API synthesis, including α1-adrenergic receptor antagonists.
• Spectra Organic Chemicals (India): Provides custom synthesis services and high-volume API production for global clients.
• WuXi AppTec (China): An integrated CMO offering end-to-end manufacturing, including API synthesis and formulation of BPH drugs.

E. Licensed Generic Manufacturers
Once patent exclusivity is relinquished or licenses granted, several generic pharmaceutical firms enter the market, sourcing APIs from certified suppliers to produce silodosin generics. These include in both emerging markets and developed countries, expanding access and affordability.

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Market Trends in RAPAFLO Supply

Patent Expiry and Generic Entry
The patent for RAPAFLO was filed in several jurisdictions with expiry dates ranging from late 2010s to early 2020s. Generics are now available in many markets, with local manufacturers sourcing APIs from China and India, thereby increasing supply options.

Regulatory Dynamics
Stringent regulations, including WHO GMP standards and US FDA approvals, influence supplier selection. Suppliers with approved manufacturing sites tend to dominate the market, ensuring both quality and legal compliance status.

Supply Chain Risks
Dependence on API supply from China and India presents risks related to geopolitical tensions, trade restrictions, and quality variability. Recent supply chain disruptions, notably during the COVID-19 pandemic, prompted manufacturers to diversify sourcing strategies.

Emerging Markets and Local Production
Countries like Brazil and South Africa are developing regional API production capabilities to reduce dependency on imports, resulting in a more resilient supply chain for RAPAFLO.

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Key Considerations for Stakeholders

• Quality Assurance: Confirm API suppliers’ GMP compliance and certification status before procurement.
• Regulatory Approvals: Ensure suppliers’ API batches are supported by validated analytical testing and regulatory documentation.
• Supply Security: Engage multiple sources or suppliers to minimize risk associated with geopolitical or logistical disruptions.
• Cost Factors: Balance quality and regulatory compliance with pricing, particularly in markets where generic versions are prevalent.

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Key Takeaways

• Kissei Pharmaceutical remains the primary producer and licensor of RAPAFLO, controlling core supply lines.
• China and India are dominant in manufacturing silodosin APIs, driven by cost-effective production and large capacities.
• Diversifying suppliers and sourcing from GMP-certified manufacturers mitigate supply chain risks.
• Regulatory diligence is critical when onboarding API vendors to ensure compliance and quality for approved markets.
• The entry of generics has increased the complexity of supply chains, with more players sourcing APIs from multiple regions.

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FAQs

Q1: Which countries dominate the supply of silodosin API for RAPAFLO?
A1: China and India are the primary producers of silodosin API, offering cost-effective manufacturing while maintaining global export standards.

Q2: Are there any alternative suppliers besides Kissei for RAPAFLO?
A2: While Kissei remains the original developer, licensed generics and APIs from Chinese and Indian manufacturers serve as alternative sources, especially post-patent expiry.

Q3: How does API quality affect RAPAFLO supply?
A3: High-quality APIs meeting GMP standards are critical for ensuring drug efficacy, safety, and regulatory compliance, directly impacting market acceptance and reimbursement.

Q4: What risks are associated with API sourcing from China and India?
A4: Risks include geopolitical trade restrictions, regulatory non-compliance, quality variability, and supply chain disruptions. Diversification and quality assurance mitigate these issues.

Q5: How has the patent expiration affected the competitive landscape for RAPAFLO?
A5: Patent expiry facilitated the entry of generic manufacturers, expanding supply options, reducing prices, and increasing access through multiple sourcing channels.

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Conclusion
The supply chain for RAPAFLO hinges on a combination of licensed originator sources and a growing array of generic and API manufacturers predominantly located in China and India. While Kissei Pharmaceutical retains control over the original product, the post-patent landscape has catalyzed diversification in API sourcing, leading to greater market competition and supply resilience. Stakeholders must prioritize regulatory compliance, quality assurance, and supply diversification to ensure uninterrupted access to RAPAFLO. Understanding regional manufacturing capacities and geopolitical risks will be essential for strategic procurement and market expansion.

References

1. Kissei Pharmaceutical. RAPAFLO Product Information. (2022).
2. globaldata.com. Global API Market Analysis - Silodosin Segment. (2022).
3. U.S. FDA Drug Approvals and Labeling Data. (2021).
4. Chinese GMP-certified API manufacturers' certifications and directories.
5. Indian pharmaceutical API export reports.