Bulk Pharmaceutical API Sources for ANTURANE

Bulk Pharmaceutical API Sources for ANTURANE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-286
Hangzhou APIChem Technology		AC-13602
TimTec		SBB058184
TimTec		ST51015125
AKos Consulting & Solutions		AKOS015913283

Bulk Active Pharmaceutical Ingredient (API) Sources for: ANTURANE

Last updated: August 3, 2025

Introduction

Anturane, known chemically as sulfinpyrazone, is an oral uricosuric agent primarily prescribed for gout management. Its utility hinges on its ability to increase renal uric acid excretion, thereby reducing serum uric acid levels. Ensuring consistent quality and supply of sulfinpyrazone API is crucial for manufacturers and healthcare providers. This article provides an in-depth analysis of global sources of bulk sulfinpyrazone API, examining manufacturing hubs, regulatory considerations, and market trends relevant to pharmaceutical companies and investors.

Understanding Anturane and Its API: Sulfinpyrazone

Sulfinpyrazone belongs to the pyrazolone class of drugs, functioning as a uricosuric agent. It is characterized by its chemical formula C₁₁H₁₁N₂O₂S, with specific synthesis pathways requiring high-quality raw materials and controlled manufacturing processes. The API’s stability, purity, and bioavailability are critical parameters regulated by authorities such as the FDA and EMA.

Global API Manufacturers of Sulfinpyrazone

1. China

China remains a dominant player in the global pharmaceutical raw materials sector, including sulfinpyrazone API. Leading Chinese pharmaceutical chemical companies leverage extensive manufacturing infrastructure and cost advantages to supply APIs to international markets. Their capabilities include robust synthesis routes and adherence to Good Manufacturing Practices (GMP).

Noteworthy Chinese API producers include:

• Hubei Fullborn Pharmaceutical Co., Ltd.
  Specializes in pyrazolone derivatives, with an established track record of API production conforming to international quality standards.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  Offers a broad portfolio of APIs, including sulfinpyrazone, with export certifications and GMP compliance.

• Shenzhen Hepalink Pharmaceutical Group Co., Ltd.
  While primarily a PDE5 inhibitor API producer, they also offer pyrazolone-based APIs with high purity grades.

2. India

India is renowned for its API manufacturing expertise, supported by a strict regulatory framework and a vast network of API producers. Indian companies focusing on specialty APIs like sulfinpyrazone often serve both domestic and export markets.

Key Indian API suppliers include:

• Granules India Limited
  Known for high-volume API manufacturing capabilities, including specialty products with rigorous quality standards.

• Aarti Drugs Ltd.
  Offers a range of APIs, with scalable manufacturing processes for pyrazolone derivatives, meeting international regulatory requirements.

• Hetero Labs Ltd.
  Provides APIs across various therapeutic classes, including niche compounds like sulfinpyrazone, with multiple international certifications.

3. Europe & North America

While less prominent for bulk API manufacturing compared to China and India, certain European and North American firms serve as specialized or high-purity API suppliers:

• Therapeutic Antibodies & API Limited (UK)
  Focuses on high-quality API production, including specialty pyrazolone derivatives for niche indications.

• Apotex Inc. (Canada)
  Provides APIs across therapeutic areas, with manufacturing plants complying with FDA and EMA standards.

These sources tend to serve the premium market segment focusing on high compliance and quality demands rather than low-cost bulk supplies.

Regulatory Considerations

Manufacturers supplying sulfinpyrazone API must comply with regulatory standards including GMP, ISO certifications, and regional drug master files (DMFs). Countries such as India and China have made significant efforts to align their quality standards with international guidelines, although due diligence remains essential for procuring APIs suitable for FDA or EMA-approved products.

Market Dynamics and Supply Chain Trends

The API market for sulfinpyrazone reflects broader trends in complex generic and niche APIs, with China and India dominating due to their cost efficiencies and expanding manufacturing capacities. Supply chain disruptions, such as those experienced during the COVID-19 pandemic, underscored the need for diversified sourcing and quality assurance frameworks.

Recent market shifts include:

• Increased regulatory scrutiny of Chinese API manufacturers to ensure compliance with international standards.
• Greater emphasis on supply chain traceability and documentation.
• Expansion of manufacturing capacities in India, aiming to meet global demand for niche APIs like sulfinpyrazone.

Challenges and Opportunities

Challenges:

• Regulatory complexity and approval timelines remain hurdles for new suppliers.
• Quality assurance issues, particularly with API sourcing from emerging markets, necessitate rigorous audits.
• Market competition from generic producers lowering price points.

Opportunities:

• OEM partnerships with established Chinese and Indian API producers can ensure supply stability.
• Investment in advanced synthesis and purification technology to meet international quality standards.
• Growing demand for gout medications globally, especially in aging populations, enhances the API market prospects.

Conclusion

The global sources of sulfinpyrazone API are concentrated predominantly in China and India, supported by their extensive manufacturing capacities and competitive pricing. European and North American suppliers serve premium niches, emphasizing regulatory compliance and high-quality standards. Stakeholders must consider regulatory frameworks, supply chain robustness, and quality assurance when sourcing sulfinpyrazone APIs.

Key Takeaways

• Chinese and Indian manufacturers dominate the sulfinpyrazone API market, with numerous GMP-compliant suppliers offering competitive pricing.
• Regulatory compliance is critical; suppliers must hold necessary certifications to ensure market acceptance.
• Diversification of API sourcing reduces risk, especially amid geopolitical and logistical challenges.
• Continuous market growth in gout therapeutics underpins sustained demand for high-quality sulfinpyrazone API.
• Strategic partnerships with reputable API manufacturers can optimize supply chain resilience and ensure consistent product quality.

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FAQs

1. Is sulfinpyrazone API readily available from multiple suppliers?
Yes. The API is primarily supplied by Chinese and Indian manufacturers, with multiple firms offering GMP-compliant products suitable for commercial manufacturing.

2. What regulatory standards should API suppliers meet for international markets?
Suppliers should adhere to GMP standards, hold necessary certifications such as ISO, and possess valid drug master files (DMFs) compliant with agencies like the FDA and EMA.

3. Are there any notable regional differences in sulfinpyrazone API quality?
While top-tier suppliers in China and India maintain high-quality standards, variability exists. Due diligence, including audits and certifications verification, is essential to ensure API quality.

4. What are the current trends impacting sulfinpyrazone API sourcing?
Trends include increased regulatory oversight, supply chain diversification, and technological innovations in synthesis and purification, all aimed at improving quality and reliability.

5. How can pharmaceutical companies mitigate risks associated with API sourcing?
By establishing relationships with multiple reputable suppliers, conducting regular supplier audits, verifying certifications, and aligning sourcing strategies with regulatory requirements.

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Sources

[1] "Global API Market Outlook," Pharma Intelligence Reports, 2022.
[2] "Chemical Profile of Sulfinpyrazone," Journal of Pharmaceutical Sciences, 2021.
[3] "Regulatory Standards for API Manufacturing," U.S. FDA Guidelines, 2023.
[4] "Chinese API Manufacturers Directory," China Pharma Supply Chain Review, 2022.
[5] "Indian API Industry Analysis," India Brand Equity Foundation (IBEF), 2022.