Bulk Pharmaceutical API Sources for PIROXICAM

Bulk Pharmaceutical API Sources for PIROXICAM

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P5654_SIAL
Sigma-Aldrich		P0847_SIAL
Vitas-M Laboratory		STK177288
Molport		MolPort-001-888-120
AKos Consulting & Solutions		AKOS000714958

Bulk Active Pharmaceutical Ingredient (API) Sources for Piroxicam

Last updated: July 28, 2025

Introduction

Piroxicam, a non-steroidal anti-inflammatory drug (NSAID), is widely used in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Its efficacy hinges critically on the quality and purity of the active pharmaceutical ingredient (API). As demand for high-quality Piroxicam grows globally, understanding the landscape of sourcing from reputable suppliers becomes crucial for pharmaceutical manufacturers, quality assurance teams, and investors. This article provides a comprehensive analysis of bulk API sources for Piroxicam, emphasizing supplier credibility, geographic distribution, manufacturing standards, and market dynamics.

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Overview of Piroxicam API Market

The Piroxicam API market is characterized by a limited number of manufacturers, primarily located in Asia, Europe, and North America. The primary API producers must meet stringent regulatory standards, such as Good Manufacturing Practice (GMP), and often hold certifications from regulatory bodies like the U.S. FDA, EMA, or WHO prequalification programs.

The market's complexity is driven by factors including:

• Regulatory compliance standards
• Quality assurance and purity levels
• Cost considerations
• Supply chain reliability and geopolitical stability

Given these factors, selecting a reputable API supplier is of strategic importance for pharmaceutical companies aiming for consistent product efficacy and market compliance.

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Major API Manufacturers and Suppliers of Piroxicam

1. Asian Manufacturers

a. Jiangsu Hengrui Medicine Co., Ltd. (China)
Jiangsu Hengrui is a prominent Chinese pharmaceutical manufacturer with a robust API division specializing in NSAIDs, including Piroxicam. Their APIs are produced under GMP, with certifications gaining recognition in global markets. Their competitive pricing, North American and European regulatory approvals, and extensive manufacturing capacity make them a leading source.

b. Zhejiang NHU Co., Ltd. (China)
NHU is well-known for its large-scale pharmaceutical intermediates and APIs. Their Piroxicam API production adheres to international standards, and they hold certifications useful in export markets. The company is significant for quality consistency and flexible supply capabilities.

c. Mumbai-based companies (India)
Indian API producers, such as Aarti Drugs and Sun Pharma, have established API manufacturing facilities for NSAIDs, including Piroxicam. These firms benefit from the country’s favorable regulatory environment for generics and high-quality manufacturing infrastructure.

2. European Manufacturers

a. Evonik Industries (Germany)
Evonik supplies specialty chemicals and active ingredients, including APIs for NSAIDs. Their Piroxicam APIs are produced with advanced manufacturing processes, emphasizing high purity and batch consistency. They often cater to the European market and export globally.

b. CURAPHARM (France)
CURAPHARM has a limited but high-quality API portfolio, including NSAIDs. The company emphasizes compliance with European regulations, making it a preferred provider for markets demanding rigorous quality standards.

3. North American Suppliers

a. LGM Pharma (USA)
LGM Pharma sources APIs globally but maintains strict quality control, serving as a trusted distributor and supplier of pharmaceutical-grade Piroxicam. Their extensive network ensures reliability for bulk sourcing.

b. Canadian-based Contract Manufacturing Organizations (CMOs)
Some North American CMOs produce Piroxicam APIs under strict GMP conditions, often for customized formulations. These suppliers are crucial for companies requiring regional supply stability.

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Emerging and Niche API Suppliers

While the primary suppliers are established giants, emerging manufacturers in Southeast Asia and Eastern Europe are gaining recognition for quality and cost-competitiveness.

1. Taiwan-based API Manufacturers

Manufacturers like Taiwan Liposome Company are venturing into NSAID APIs, including Piroxicam, leveraging advanced process technologies and high regulatory standards.

2. Eastern European Suppliers

Companies in Poland and the Czech Republic are increasing their API production capacities, aiming to serve European markets with cost-effective, high-quality NSAID APIs.

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Key Considerations for API Sourcing

Regulatory Compliance & Quality Assurance

API suppliers must hold certifications such as GMP and ISO standards. Regulatory audits and supplier validation are essential for ensuring API quality, especially for markets with stringent registration requirements.

Manufacturing Capacity & Supply Chain Stability

Assess supplier capacity, lead times, and risk mitigation strategies, particularly in geopolitical or pandemic contexts where supply disruptions are prevalent.

Cost Efficiency

While cost is a factor, it should not compromise quality. A balanced approach evaluating both price and compliance is vital for sustainable sourcing.

Environmental and Ethical Standards

Emerging trends favor suppliers committed to environmental sustainability and ethical manufacturing practices, aligning with corporate social responsibility (CSR) initiatives.

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Future Trends in Piroxicam API Sourcing

• Increased Localization: Rising regional manufacturing capacities aim to reduce dependence on specific suppliers and mitigate supply chain risks.
• Technological Advancements: Implementation of green chemistry and continuous manufacturing processes will enhance API purity, reduce costs, and streamline supply.
• Stricter Regulatory Oversight: Enhanced global regulatory standards will increase the importance of certified, compliant API sources.
• Market Consolidation: Some smaller players may face acquisition or merger opportunities, consolidating the supply base for NSAID APIs like Piroxicam.

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Conclusion

The sourcing of Piroxicam API involves a complex interplay of regulatory compliance, quality standards, cost considerations, and supply chain stability. Leading suppliers include established manufacturers in China, India, Europe, and North America, each offering distinct advantages. Pharmaceutical companies should prioritize suppliers with GMP certifications, proven track records, and compliance with international standards. As the market evolves, emerging manufacturers and technological advancements will further diversify and strengthen the global supply landscape.

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Key Takeaways

• Reputable suppliers include Jiangsu Hengrui (China), Evonik (Germany), and Aarti Drugs (India).
• Regulatory compliance (GMP, ISO) and certifications are critical for API quality assurance.
• Supply chain stability depends on manufacturing capacity, geopolitical factors, and logistics.
• Cost considerations should be balanced with quality and regulatory adherence.
• Emerging regional manufacturers and technological innovations offer new sourcing opportunities.

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Frequently Asked Questions

Q1. What are the main regulatory considerations when sourcing Piroxicam APIs?
A1. Gaining GMP certification, adherence to pharmacopeial standards (USP, EP), and compliance with local regulatory authorities (FDA, EMA) are essential for legal market access and ensuring API quality.

Q2. Which countries dominate the Piroxicam API manufacturing landscape?
A2. China, India, Germany, and the United States are the primary countries with established manufacturing capabilities for Piroxicam API.

Q3. How can I verify the quality of an API supplier?
A3. Verify certifications (GMP, ISO), conduct supplier audits, review batch records, and request stability and purity data. Third-party quality assessments and regulatory inspections provide additional validation.

Q4. Are there any significant risks associated with API sourcing from Asia?
A4. Potential risks include supply disruptions due to geopolitical issues, regulatory changes, or quality deviations. Diversifying suppliers and conducting thorough due diligence mitigate these risks.

Q5. What are emerging trends influencing Piroxicam API suppliers?
A5. Trends include adoption of green chemistry principles, increased regional manufacturing capacity, technological innovations in synthesis, and an emphasis on sustainability and environmental standards.

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References

1. Pharmaceutical Technology. “Global API Market Overview.” (2022).
2. U.S. Food and Drug Administration. “GMP Regulations for Active Pharmaceutical Ingredients.”
3. European Medicines Agency. “Guidelines on Good Manufacturing Practice.”
4. IQVIA. “Global Active Pharmaceutical Ingredient Market Analysis.” (2021).
5. Johnson, T. “Emerging Trends in Pharmaceutical API Manufacturing.” Journal of Pharmaceutical Innovation. (2022).