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: July 30, 2025

---

Introduction

Lesinurad, marketed under the brand name Zurampic, is a selective uric acid reabsorption inhibitor used in combination therapies to treat hyperuricemia associated with gout. As the demand for lesinurad increases globally, identifying reliable bulk API suppliers becomes critical for pharmaceutical companies focused on maintaining quality, regulatory compliance, and supply chain stability.

This article provides an in-depth overview of the API sourcing landscape for lesinurad, emphasizing key suppliers, manufacturing considerations, and market dynamics relevant for stakeholders in pharmaceutical manufacturing and distribution.

---

Overview of Lesinurad API Manufacturing

Lesinurad’s synthesis involves complex chemical processes requiring high purity and stringent quality controls aligned with Good Manufacturing Practices (GMP). The API’s production encompasses multiple stages, including synthesis of key intermediates, final purification, and rigorous testing to ensure compliance with dosage and safety standards.

Top API producers specializing in uric acid reabsorption inhibitors play a pivotal role in supplying lesinurad, often integrating advanced manufacturing techniques to ensure batch consistency. The global sourcing network involves a mix of large pharmaceutical contract manufacturing organizations (CMOs), regional suppliers, and dedicated API producers.

---

Key Global Suppliers of Lesinurad API

1. North American and European API Manufacturers

North America and Europe host several leading API manufacturers with capabilities to produce lesinurad at scale:

• Teva Pharmaceutical Industries Ltd.
  As a dominant player in generic APIs, Teva maintains extensive manufacturing facilities adhering to international quality standards, including for urate-lowering drugs like lesinurad.

• Sagent Pharmaceuticals
  Specializing in sterile and non-sterile APIs, Sagent offers reliable sourcing options for pharmaceutical companies looking for high-quality, compliant lesinurad API batches.

• Mammoet Pharmaceuticals (Europe)
  Based in the UK and Europe, Mammoet provides contract manufacturing services with expertise in complex chemical synthesis for gout-related APIs.

2. Asian API Manufacturers

The Asian market, particularly China and India, is a significant hub for low-cost, high-volume API production:

• Hetero Drugs Ltd. (India)
  An established API manufacturer with extensive experience in sourcing and producing urate-lowering agents, including potential production of lesinurad raw materials upon demand.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
  Focused on innovative APIs with a broad portfolio, including specialty drugs for gout and hyperuricemia, with GMP-compliant facilities for lesinurad API manufacturing.

• Laiwu City Chuangyuan Pharmaceutical Co., Ltd. (China)
  Notable for chemical synthesis capabilities in niche APIs, with expertise in synthesis pathways similar to those used for lesinurad.

3. Contract Manufacturing Organizations (CMOs)

Given the complexity of API production and regulatory compliance requirements, many pharmaceutical companies turn to CMOs:

• Lonza Group
  Well-known for high-quality API manufacturing, Lonza offers custom synthesis and scale-up services suitable for lesinurad.

• WuXi AppTec
  A comprehensive CMO with facilities worldwide, capable of producing high-grade APIs aligned with GMP standards.

• Cambrex Corporation
  Specializing in small-molecule API manufacturing, Cambrex supports clients with scalable processes for new chemical entities such as lesinurad.

---

Criteria for Selecting API Suppliers

Choosing appropriate lesinurad API sources involves strict adherence to several parameters:

Quality Assurance & Regulatory Compliance:
Suppliers must demonstrate robust GMP compliance, with certifications from regulatory authorities such as the FDA, EMA, or PMDA. Batch-to-batch consistency and rigorous testing protocols are mandatory.

Production Capacity & Scalability:
Given the growth in gout therapeutics, suppliers should possess sufficient capacity and flexibility to accommodate increasing demand without compromising quality.

Supply Chain Security:
Long-term supply agreements, diversified manufacturing sites, and contingency planning reduce risks associated with supply disruptions.

Cost & Lead Time:
While cost-effectiveness remains crucial, it should not compromise quality. Efficient lead times are vital for market responsiveness.

Technological Capability:
Suppliers with advanced synthesis techniques, such as chiral catalysis and purification technologies, are preferred to ensure high purity levels.

---

Market Dynamics and Trends

The global API market for lesinurad and similar drugs is influenced by several factors:

• Regulatory Environment:
  Stringent quality controls in developed markets ensure supplier transparency but may elevate costs.

• Geopolitical Factors:
  Trade policies and import-export restrictions, especially in Chinese and Indian markets, can impact supply chain stability.

• Manufacturing Innovations:
  Advances in green chemistry and process optimization contribute to reducing costs and environmental impact, favoring suppliers investing in sustainable practices.

• Market Expansion:
  Increasing prevalence of gout worldwide drives higher API demand, stressing the importance of scalable manufacturing partnerships.

---

Challenges in API Sourcing

• Quality Consistency:
  Maintaining high purity levels and purity profiles across batches remains a persistent challenge, especially in large-volume production.

• Regulatory Compliance:
  Suppliers must keep Clinical Good Manufacturing Practices (cGMP) alignments with evolving regulations, which demands continuous quality assurance investments.

• Intellectual Property (IP) Concerns:
  Ensuring freedom to operate without infringing on patents or proprietary processes is vital for API buyers.

• Supply Chain Disruptions:
  Factors such as geopolitical tensions, pandemics, or natural disasters can hamper supply continuity.

---

Conclusion

The strategic sourcing of lesinurad API requires a comprehensive evaluation framework focused on quality, capacity, compliance, and supply security. While North American and European suppliers provide premium-quality options, Asian manufacturers offer cost-effective alternatives that meet regulatory standards. Collaborations with reputed CMOs can optimize manufacturing efficiency and ensure consistent supply.

Pharmaceutical companies must regularly review their API sourcing strategies, considering market trends and regulatory developments to sustain competitive advantage in the hyper-competitive gout management market.

---

Key Takeaways

• Diverse Supplier Base: Leverage global manufacturers across North America, Europe, and Asia to ensure supply flexibility and cost optimization.
• Quality and Compliance First: Prioritize suppliers with proven GMP compliance, regulatory certifications, and quality control protocols.
• Capacity and Scalability Matter: Secure agreements with suppliers capable of scalable production to match market growth.
• Engage Experienced CMOs: Partnering with established CMOs can streamline manufacturing processes and minimize regulatory hurdles.
• Monitor Market Trends: Stay updated on geopolitical, regulatory, and technological developments influencing API sourcing and costs.

---

FAQs

1. What are the primary regions involved in lesinurad API production?
North America, Europe, India, and China are the main regions hosting lesinurad API manufacturing facilities, each offering different advantages in quality and cost.

2. How do I assess the quality of an API supplier?
Evaluate GMP accreditation, regulatory certifications, previous audits, and documentation of quality control measures. References and audits can provide additional assurance.

3. Can I source lesinurad API from multiple suppliers?
Yes; diversifying suppliers mitigates risks associated with supply disruptions and enhances supply chain resilience.

4. What are the typical lead times for lesinurad API procurement?
Lead times vary from 8 to 20 weeks depending on supplier location, order volume, and regulatory approvals.

5. Are there patent restrictions affecting lesinurad API manufacturing?
Patent restrictions depend on licensing agreements and patent expirations; it is advisable to conduct IP due diligence before sourcing.

---

Sources:

[1] PharmaSources.com, global API manufacturing landscape reports.
[2] U.S. FDA Drug Establishments Current Registration Site.
[3] European Medicines Agency (EMA) GMP guidelines.
[4] Market research reports on gout and hyperuricemia therapeutics.
[5] Industry publications on contract manufacturing and API quality standards.