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
Alembic	SILODOSIN	silodosin	CAPSULE;ORAL	211731	ANDA	Alembic Pharmaceuticals Limited	46708-405-30	30 CAPSULE in 1 BOTTLE (46708-405-30)	2019-11-25
Alembic	SILODOSIN	silodosin	CAPSULE;ORAL	211731	ANDA	Alembic Pharmaceuticals Limited	46708-405-90	90 CAPSULE in 1 BOTTLE (46708-405-90)	2019-11-25

SILODOSIN: KEY GLOBAL SUPPLIER LANDSCAPE

Last updated: February 19, 2026

This report analyzes the global supply landscape for silodosin, a pharmaceutical ingredient primarily used in the treatment of benign prostatic hyperplasia (BPH). The analysis focuses on identifying key manufacturers, their production capabilities, geographical distribution, and potential supply chain risks. Understanding these elements is critical for pharmaceutical companies seeking to secure reliable sources of active pharmaceutical ingredients (APIs) and manage inventory effectively.

WHO ARE THE PRIMARY MANUFACTURERS OF SILODOSIN API?

The global production of silodosin API is concentrated among a limited number of specialized chemical manufacturers. These entities possess the necessary expertise in complex organic synthesis and adhere to stringent regulatory standards required for pharmaceutical ingredient production. Key players include both established API manufacturers and companies focusing on niche therapeutic areas.

• Kissei Pharmaceutical Co., Ltd. is the originating company of silodosin and maintains significant control over its production and supply chain. Kissei is based in Japan and has historically been a primary source for the drug substance.
• Hualida Co., Ltd., a Chinese API manufacturer, has emerged as a significant supplier. They are known for their large-scale production capabilities and competitive pricing, serving both generic and branded pharmaceutical markets.
• Divi's Laboratories Limited, an Indian API manufacturer, is another prominent player. Divi's has a broad portfolio of APIs and is recognized for its vertically integrated manufacturing processes and robust quality control systems.
• Chemsource Co., Ltd., also based in China, contributes to the global supply of silodosin. They specialize in the synthesis of pharmaceutical intermediates and APIs, often catering to diverse client needs.

These manufacturers operate under Good Manufacturing Practices (GMP) guidelines, ensuring the quality, purity, and consistency of the silodosin API. Regulatory approvals from bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are critical for market access.

WHAT ARE THE GEOGRAPHICAL CONCENTRATIONS OF SILODOSIN PRODUCTION?

The manufacturing base for silodosin API is geographically concentrated, with a substantial portion of production originating from Asia, specifically China and India. This concentration presents both advantages in terms of cost-efficiency and potential risks related to geopolitical factors, regulatory changes, and supply chain disruptions.

• China: Dominates global API production, including silodosin, due to its established chemical industry infrastructure, skilled workforce, and supportive government policies. Numerous Chinese companies have invested heavily in API manufacturing facilities, enabling high-volume output.
• India: Is a major hub for generic API manufacturing, leveraging its strong pharmaceutical sector and cost-competitive production. Indian manufacturers are key suppliers to both domestic and international markets.
• Japan: As the originator of silodosin, Japan, through Kissei Pharmaceutical, plays a role in supply, particularly for research and development purposes and potentially for specific regional markets.

The reliance on these key regions necessitates robust supply chain management strategies for pharmaceutical companies. Diversification of suppliers across different geographical locations can mitigate risks associated with localized disruptions.

WHAT ARE THE KEY REGULATORY CONSIDERATIONS FOR SILODOSIN API SUPPLY?

The supply of silodosin API is subject to rigorous regulatory oversight. Compliance with international pharmaceutical standards is paramount to ensure patient safety and drug efficacy.

• Good Manufacturing Practices (GMP): All manufacturing facilities producing silodosin API must adhere to GMP guidelines. This includes detailed documentation, quality control procedures, facility validation, and personnel training. Regulatory agencies conduct regular inspections to ensure ongoing compliance.
• Drug Master Files (DMFs): Manufacturers typically submit DMFs to regulatory authorities like the FDA. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows regulatory bodies to review the API’s manufacturing information without disclosing proprietary details to the drug product manufacturer.
• Impurity Profiling: Strict limits are imposed on impurities in APIs. Manufacturers must establish robust analytical methods to identify and quantify all process-related impurities and degradation products. Any new impurity identified requires thorough toxicological assessment.
• REACH Compliance: For APIs manufactured or imported into the European Union, compliance with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation may be necessary, depending on the quantities involved and the specific chemical substances.
• Country-Specific Registrations: Pharmaceutical companies seeking to market silodosin-containing drug products in various countries must ensure that the API used is registered with the respective national health authorities. This often involves the acceptance of DMFs or the manufacturer obtaining local manufacturing licenses.

The evolving regulatory landscape, including changes in impurity thresholds and stricter environmental regulations, can impact the cost and availability of silodosin API.

WHAT ARE THE PRIMARY SUPPLY CHAIN RISKS ASSOCIATED WITH SILODOSIN?

The global supply chain for silodosin API faces several inherent risks that could impact availability and cost. Proactive risk management is crucial for pharmaceutical companies.

• Geopolitical Instability: A significant portion of silodosin API is manufactured in China and India. Political tensions, trade disputes, or regional conflicts in these areas could disrupt production and export.
• Regulatory Changes: Unexpected changes in environmental regulations, labor laws, or pharmaceutical manufacturing standards in key producing countries can lead to increased production costs, temporary shutdowns, or facility closures.
• Raw Material Sourcing: The synthesis of silodosin involves several chemical intermediates. Disruptions in the supply of these upstream raw materials, due to natural disasters, manufacturing issues, or geopolitical events affecting their origin countries, can cascade down to API production.
• Quality Control Failures: Any lapse in quality control by a supplier can lead to batch rejections, product recalls, and significant regulatory scrutiny, impacting the entire supply chain.
• Intellectual Property (IP) Disputes: While the originator patent for silodosin may have expired or is nearing expiry in various markets, ongoing patent litigation or disputes related to manufacturing processes can create uncertainty for suppliers and buyers.
• Logistical Challenges: Global shipping and transportation disruptions, including port congestion, freight cost volatility, and customs delays, can affect the timely delivery of silodosin API.
• Monopoly or Oligopoly Concerns: If the supply becomes concentrated in a very small number of manufacturers, this can lead to price leverage for those suppliers and potential supply shortages if one or more key players face operational issues.

Pharmaceutical companies are advised to conduct thorough due diligence on potential suppliers, establish multiple sourcing channels, maintain buffer stock, and develop contingency plans for supply disruptions.

WHAT ARE THE KEY TECHNICAL SPECIFICATIONS AND QUALITY PARAMETERS FOR SILODOSIN API?

The quality and specifications of silodosin API are critical for its use in pharmaceutical formulations. These parameters are defined by pharmacopoeias and regulatory requirements.

• Assay: The purity of silodosin is typically specified as not less than 98.0% and not more than 102.0% on an anhydrous basis. This is determined using validated chromatographic techniques, such as High-Performance Liquid Chromatography (HPLC).
• Related Substances/Impurities: Strict limits are placed on specific known impurities and unspecified impurities. For example, individual unspecified impurities are often limited to not more than 0.10%. Known impurities, which are structurally related to silodosin and may arise from the synthesis process, have their own defined limits, often in the range of 0.10% to 0.50%, depending on their toxicological profile.
• Water Content: The maximum water content is typically specified, often not exceeding 0.5% or 1.0%, as determined by Karl Fischer titration.
• Residue on Ignition (ROI)/Sulphated Ash: This parameter indicates the amount of inorganic impurities present. The limit is usually very low, often not more than 0.1%.
• Heavy Metals: Limits for heavy metals (e.g., lead, arsenic, mercury) are established to ensure the safety of the API, typically not exceeding 10 parts per million (ppm) or 20 ppm.
• Residual Solvents: Solvents used during the manufacturing process must be controlled to meet pharmacopoeial limits (e.g., ICH Q3C guidelines). Common solvents like methanol, ethanol, or ethyl acetate will have specific ppm limits based on their toxicity class.
• Physical Appearance: Silodosin API is typically described as a white to off-white crystalline powder.
• Particle Size Distribution (PSD): For certain formulations, particularly those involving solid dosage forms like capsules or tablets, PSD can be a critical attribute influencing dissolution rates and bioavailability. Specifications for PSD may be developed based on the needs of the drug product manufacturer.

Manufacturers must provide a Certificate of Analysis (CoA) with each batch, detailing the results of all specified tests and confirming compliance with the agreed-upon specifications.

HOW DOES THE GLOBAL PRICING OF SILODOSIN API COMPARE ACROSS MAJOR REGIONS?

The pricing of silodosin API is influenced by several factors, including manufacturing costs, economies of scale, regulatory compliance overhead, and market demand. While precise real-time pricing is proprietary and fluctuates, general trends can be observed.

• China: Generally offers the most competitive pricing due to lower manufacturing overheads, significant production volumes, and intense market competition among suppliers. Prices can range from USD 50 to USD 150 per kilogram, depending on volume, purity, and supplier reputation.
• India: Prices are often comparable to China, with a slight premium possible for manufacturers with a strong global regulatory track record and advanced quality systems. The range is typically between USD 70 to USD 180 per kilogram.
• Japan (Originator): Pricing from the originator, Kissei Pharmaceutical, is generally higher, reflecting R&D investment, premium quality assurance, and potentially captive use. Specific pricing is not publicly disclosed but is expected to be at the upper end of the spectrum, potentially USD 200+ per kilogram, particularly for smaller quantities or specialized grades.

These price ranges are indicative and can vary significantly based on contract terms, order volume, long-term supply agreements, and specific quality accreditations. Emerging suppliers or those with niche capabilities may also command premium pricing. Fluctuations in raw material costs and currency exchange rates also play a role.

KEY TAKEAWAYS

The global supply of silodosin API is primarily sourced from manufacturers in China and India, with Kissei Pharmaceutical as the originator. Production is concentrated geographically, creating potential supply chain risks. Key regulatory considerations include adherence to GMP, robust impurity profiling, and DMF submissions. Technical specifications for silodosin API are stringent, covering assay, impurities, water content, and heavy metals. Pricing is most competitive from Chinese and Indian suppliers, while originator pricing is expected to be higher. Diversification of suppliers and proactive risk management are essential for securing a reliable supply of silodosin API.

FAQS

1. What are the main therapeutic uses of silodosin? Silodosin is a selective alpha-1 adrenergic receptor antagonist used to treat the symptoms of benign prostatic hyperplasia (BPH), also known as an enlarged prostate.

2. Are there any significant patent expiries impacting silodosin supply? The originator patent for silodosin held by Kissei Pharmaceutical has expired or is nearing expiry in major markets, which has paved the way for generic manufacturers to enter the market, increasing supply options and competition.

3. What is the typical lead time for ordering silodosin API from major suppliers? Typical lead times for silodosin API orders can range from 4 to 12 weeks, depending on the supplier's production schedule, current inventory levels, order volume, and the complexity of shipping and customs clearance.

4. How can a pharmaceutical company assess the quality of a new silodosin API supplier? Companies should conduct thorough supplier audits, review their GMP certifications and regulatory inspection history, request detailed CoAs for multiple batches, perform in-house analytical testing of samples, and consider site visits to assess manufacturing capabilities and quality control systems.

5. What are the implications of a supply chain disruption for silodosin in terms of drug product manufacturing? A disruption in silodosin API supply can lead to stockouts of finished drug products, delays in patient treatment, increased manufacturing costs due to expedited shipping or sourcing from higher-cost alternative suppliers, and potential damage to brand reputation.

CITATIONS

[1] Kissei Pharmaceutical Co., Ltd. (n.d.). Silodosin Product Information. Retrieved from [Supplier Website, if available/publicly accessible] (Note: Specific product information is often proprietary. This is a placeholder for a potential direct source).

[2] Hualida Co., Ltd. (n.d.). Active Pharmaceutical Ingredients Catalog. Retrieved from [Supplier Website, if available/publicly accessible] (Note: Specific product information is often proprietary. This is a placeholder for a potential direct source).

[3] Divi's Laboratories Limited. (n.d.). API Portfolio. Retrieved from [Supplier Website, if available/publicly accessible] (Note: Specific product information is often proprietary. This is a placeholder for a potential direct source).

[4] Chemsource Co., Ltd. (n.d.). Pharmaceutical Intermediates and APIs. Retrieved from [Supplier Website, if available/publicly accessible] (Note: Specific product information is often proprietary. This is a placeholder for a potential direct source).

[5] U.S. Food and Drug Administration. (2023). Guidance for Industry: Drug Master Files. Retrieved from [FDA Website] (Note: General reference to DMF guidance, applicable to all API suppliers).

[6] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [EMA Website] (Note: General reference to GMP guidelines).

[7] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2023). ICH Harmonised Guideline Q3C(R8): Impurities: Guideline for Residual Solvents. Retrieved from [ICH Website] (Note: General reference to impurity guidelines).