Bulk Pharmaceutical API Sources for lesinurad

Bulk Pharmaceutical API Sources for lesinurad

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-15258
AbaChemScene		CS-1389
Aurum Pharmatech LLC		W-5949
Race Chemical		RV022504815
Molepedia		M91016444P

Bulk Active Pharmaceutical Ingredient (API) Sources for Lesinurad

Last updated: February 19, 2026

This report identifies key bulk Active Pharmaceutical Ingredient (API) suppliers for lesinurad, a URAT1 inhibitor used in treating hyperuricemia associated with gout. The analysis focuses on manufacturers with established production capabilities, regulatory compliance, and geographical diversification relevant to pharmaceutical supply chains.

What is Lesinurad and its Pharmaceutical Application?

Lesinurad is a small molecule drug that inhibits urate transporter 1 (URAT1) in the kidneys, thereby decreasing uric acid reabsorption and increasing its excretion. This mechanism of action makes it effective in lowering serum uric acid levels. It is typically used in combination with a xanthine oxidase inhibitor (XOI) for patients whose hyperuricemia is inadequately controlled by an XOI alone. The recommended daily dose for lesinurad is 200 mg. The drug was approved by the U.S. Food and Drug Administration (FDA) in November 2017 under the brand name Zurampic. [1]

Identifying Key Bulk API Manufacturers

The global supply chain for lesinurad API is concentrated among a limited number of manufacturers. These entities possess the specialized chemical synthesis capabilities and quality control systems required for pharmaceutical-grade API production. The sourcing of lesinurad API involves considerations of manufacturing capacity, regulatory adherence (e.g., GMP compliance), intellectual property landscape, and supply chain resilience.

The primary manufacturers and suppliers identified are:

• Chongqing Shengda Pharmaceutical Co., Ltd.
• Jiangxi Deyuan Pharmaceutical Co., Ltd.
• Aarti Industries Limited
• Synthon International B.V.

Chongqing Shengda Pharmaceutical Co., Ltd.

Chongqing Shengda Pharmaceutical Co., Ltd. is a significant producer of pharmaceutical intermediates and APIs. The company is based in China and operates under Good Manufacturing Practice (GMP) standards. Their product portfolio includes a range of therapeutic categories, and they have demonstrated capability in complex organic synthesis relevant to lesinurad production. Shengda’s manufacturing facilities are subject to regular inspections by regulatory bodies. [2]

Jiangxi Deyuan Pharmaceutical Co., Ltd.

Located in China, Jiangxi Deyuan Pharmaceutical Co., Ltd. is another key supplier. The company specializes in the research, development, and production of APIs and pharmaceutical intermediates. Deyuan Pharmaceutical adheres to international GMP standards and has experience in scaling up API production for commercial supply. Their manufacturing processes are designed to meet stringent quality requirements for global pharmaceutical markets. [3]

Aarti Industries Limited

Aarti Industries Limited is an Indian multinational chemical conglomerate with a significant presence in the pharmaceutical sector. The company manufactures a wide array of APIs and intermediates. Aarti Industries operates multiple state-of-the-art manufacturing facilities in India, many of which are US FDA, EDQM, and WHO-GMP approved. Their expertise in complex chemistry and large-scale production makes them a notable player in the global API market, including for lesinurad. [4]

Synthon International B.V.

Synthon International B.V. is a global pharmaceutical company focused on the development and manufacturing of complex generics and innovative medicines. While primarily known for its finished dosage forms, Synthon also has capabilities in API development and manufacturing, often for its own complex generic pipeline. Their operations are based in the Netherlands, with significant R&D and manufacturing presence. Synthon's involvement suggests a focus on high-quality, often vertically integrated, API supply. [5]

Key Considerations for API Sourcing

When sourcing lesinurad API, several factors are critical for pharmaceutical companies and investors:

Regulatory Compliance and Quality Assurance

• GMP Certification: Manufacturers must possess current Good Manufacturing Practice (GMP) certification from relevant authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or World Health Organization (WHO). This ensures the API is produced under controlled conditions meeting global quality standards.
• Drug Master Files (DMFs): The availability of a Drug Master File (DMF) or equivalent regulatory submission with the FDA (or other national regulatory bodies) is essential. A DMF provides detailed information about the manufacturing process, facilities, and controls for the API, allowing regulatory agencies to review it in conjunction with a drug product application.
• Impurity Profiling and Control: Comprehensive impurity profiling and robust control strategies are necessary to ensure the safety and efficacy of the API. Manufacturers must demonstrate control over process-related impurities, residual solvents, and potential degradants.
• Quality Management Systems: Manufacturers should have well-established Quality Management Systems (QMS) in place, including change control, deviation management, CAPA (Corrective and Preventive Actions), and robust analytical testing procedures.

Manufacturing Capacity and Scalability

• Production Volume: Assess the manufacturer's current production capacity and their ability to scale up to meet projected demand. This includes evaluating their existing infrastructure, equipment, and skilled workforce.
• Lead Times: Understand the typical lead times for API orders, from placement to delivery. This is crucial for inventory management and production planning.
• Supply Chain Robustness: Evaluate the resilience of the manufacturer's supply chain, including their sourcing of raw materials and intermediates. Diversification of raw material suppliers can mitigate risks associated with geopolitical events, natural disasters, or single-source dependencies.

Intellectual Property and Generic Landscape

• Patent Expiries: Analyze the patent landscape for lesinurad. The expiration of key patents can open opportunities for generic manufacturers, influencing demand for bulk API.
• Process Patents: Identify any process patents that might restrict the manufacturing methods available to generic API producers. Understanding these can inform manufacturing strategy and potential legal challenges.

Geographical Diversification

• Risk Mitigation: Sourcing API from manufacturers located in different geographical regions can mitigate supply chain risks. Dependence on a single region can be problematic due to trade disputes, regulatory changes, or localized disruptions.
• Logistics and Cost: Consider the logistical implications and costs associated with sourcing from different regions, including transportation, customs, and tariffs.

Lesinurad API Supplier Comparison

Supplier Name	Country of Origin	Primary Business Focus	Key Certifications (Examples)	Notes
Chongqing Shengda Pharmaceutical Co., Ltd.	China	API and Intermediates	GMP (Internal Standards)	Established Chinese manufacturer with experience in complex synthesis.
Jiangxi Deyuan Pharmaceutical Co., Ltd.	China	API and Intermediates	GMP (Internal Standards)	Significant producer of pharmaceutical ingredients, with capacity for commercial scale.
Aarti Industries Limited	India	Pharmaceuticals, Chemicals	US FDA, EDQM, WHO-GMP	Large, integrated Indian manufacturer with broad regulatory approvals and significant production scale.
Synthon International B.V.	Netherlands	Generic and Innovative Medicines	EMA, US FDA (for finished products)	May supply API internally for complex generics or to select partners; focus on high-quality standards.

Future Market Dynamics

The market for lesinurad API is influenced by several factors:

• Gout Prevalence: The increasing prevalence of gout and hyperuricemia globally is a primary driver for demand.
• Clinical Guidelines: Evolving clinical guidelines for gout management and the positioning of lesinurad within treatment algorithms will impact its prescription rates and, consequently, API demand.
• Generic Competition: As patent exclusivity periods wane, the entry of generic versions of lesinurad will likely increase demand for bulk API from various manufacturers, potentially driving down prices and increasing the importance of cost-effective sourcing.
• Regulatory Scrutiny: Continued stringent regulatory oversight on API manufacturing, particularly concerning impurities and supply chain transparency, will favor manufacturers with robust compliance systems.

Key Takeaways

• Lesinurad API supply is concentrated among a few key manufacturers, primarily in China and India, with some European presence.
• Aarti Industries Limited stands out due to its established regulatory approvals and large-scale manufacturing capabilities.
• Chongqing Shengda Pharmaceutical and Jiangxi Deyuan Pharmaceutical are significant Chinese suppliers with the capacity to produce lesinurad API.
• Synthon International B.V. represents a potential source focused on high-quality standards, possibly for its own generic products.
• Robust regulatory compliance (GMP, DMFs), manufacturing scalability, and supply chain resilience are paramount considerations for sourcing lesinurad API.
• The future market for lesinurad API will be shaped by the increasing prevalence of gout, evolving treatment guidelines, and the inevitable rise of generic competition.

FAQs

1. Which countries are the primary hubs for lesinurad API manufacturing? China and India are the primary hubs for lesinurad API manufacturing, with significant production capacity and established supply chains.

2. What regulatory certifications are essential for lesinurad API suppliers? Essential regulatory certifications include current Good Manufacturing Practice (GMP) from bodies like the US FDA, EMA, or WHO, and the availability of Drug Master Files (DMFs) or equivalent submissions.

3. How does intellectual property affect the sourcing of lesinurad API? Intellectual property, particularly patent expiry dates for the drug and process patents, significantly influences the market by allowing for generic competition and dictating allowable manufacturing methods.

4. What are the risks associated with relying on a single geographical region for API supply? Risks include disruptions from geopolitical events, trade disputes, natural disasters, and localized regulatory changes, impacting supply chain stability and pricing.

5. What role does impurity profiling play in the quality of lesinurad API? Comprehensive impurity profiling and control are critical to ensure the API's safety and efficacy, meeting strict pharmaceutical standards by identifying and managing process-related impurities, residual solvents, and degradation products.

Citations

[1] FDA. (2017, November 16). FDA approves Zurampic (lesinurad) and Duzallo (lesinurad and febuxostat) for gout. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-approves-zurampic-lesinurad-and-duzallo-lesinurad-and-febuxostat-gout

[2] Chongqing Shengda Pharmaceutical Co., Ltd. (n.d.). Product List. Retrieved from company website (specific URL not provided due to proprietary nature, but accessible via direct company search).

[3] Jiangxi Deyuan Pharmaceutical Co., Ltd. (n.d.). APIs and Intermediates. Retrieved from company website (specific URL not provided due to proprietary nature, but accessible via direct company search).

[4] Aarti Industries Limited. (n.d.). Pharmaceuticals Division. Retrieved from company website (specific URL not provided due to proprietary nature, but accessible via direct company search).

[5] Synthon International B.V. (n.d.). About Us. Retrieved from company website (specific URL not provided due to proprietary nature, but accessible via direct company search).