Bulk Pharmaceutical API Sources for OXAPROZIN

Bulk Pharmaceutical API Sources for OXAPROZIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		O9637_SIGMA
Molport		MolPort-000-146-829
AKos Consulting & Solutions		AKOS000206807
Oakwood Products		066202

Bulk Active Pharmaceutical Ingredient (API) Sources for: OXAPROZIN

Last updated: July 29, 2025

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Introduction

Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) widely used to reduce pain, swelling, and joint stiffness associated with osteoarthritis and rheumatoid arthritis. Its chemical name is 4-(3-Benzoylpropionamido)phenylacetic acid. The manufacturing of Oxaprozin hinges on sourcing high-quality active pharmaceutical ingredients (APIs), which significantly influence drug efficacy, safety, regulatory compliance, and supply chain stability.

This report explores the current landscape of bulk API sources for Oxaprozin, analyzing key manufacturers, geographic distribution, supply chain considerations, and future trends.

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Understanding Oxaprozin’s API Chemistry and Synthesis

The synthesis of Oxaprozin involves multistep organic reactions, primarily centered on constructing the phenylacetic acid core with specific substitutions, notably the benzoyl group and the amide linkage. The primary precursor typically involves para-aminophenylacetic acid derivatives, with further benzoylation to introduce the benzoyl substituent.

Manufacturers often employ established synthetic routes, adhering to Good Manufacturing Practices (GMP), using high-grade reagents, and implementing rigorous purification techniques—including recrystallization, chromatographic separations, and solvent extraction—to ensure API purity surpassing 99%.

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Major API Manufacturers for Oxaprozin

1. Established API Producers in China

China remains a dominant force in bulk API supply for NSAIDs, including Oxaprozin. Key players include:

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  A leading manufacturer, with robust capacity for NSAID APIs, adhering to international GMP standards. The company supplies both domestic and foreign markets, maintaining consistent quality and competitive pricing.

• Hubei Biocause Pharmaceutical Co., Ltd.
  Specializes in synthesizing NSAIDs, including Oxaprozin, with integrated R&D capabilities to optimize synthesis routes and reduce costs.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  A significant supplier with exports to North America and Europe, emphasizing quality assurance and regulatory compliance.

These companies often leverage their large-scale synthesis facilities, raw material sourcing networks, and comprehensive quality management systems aligned with ISO standards.

2. Indian API Manufacturers

India's pharmaceutical sector has gained recognition for high-quality APIs and cost competitiveness:

• Torrent Pharmaceuticals
  Operates GMP-compliant facilities producing NSAIDs, including Oxaprozin, with focus on continuous process improvement and regulatory standards.

• Aurobindo Pharma
  Offers a diverse API portfolio, including Oxaprozin, emphasizing scalable production and strict quality control protocols.

• Unichem Laboratories
  An established manufacturer providing reliable bulk Axaprozine API to international markets, conforming to cGMP and international regulatory standards.

These Indian firms prioritize pharmaceutical excellence, aided by advanced synthesis technologies and strategic raw material procurement.

3. European API Suppliers

European manufacturers tend to focus on high-purity, regulatory-compliant APIs, often serving clients with stringent quality requirements:

• BASF
  The German industrial giant supplies pharmaceutical-grade NSAIDs and often sources intermediates for Oxaprozin synthesis, although direct API manufacturing may be limited.

• Evonik Industries
  Provides high-quality intermediates and custom synthesis services supporting Oxaprozin production, especially for clients requiring tailored formulations.

European constituents typically invest heavily in sustainable manufacturing, regulatory audits, and long-term supply partnerships.

4. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource API production to CMOs:

• Deepak Nitrite Ltd. (India)
• Hikal Ltd. (India)
• AMRI (AMRI Global) (USA)

CMOs often possess tailored synthesis capabilities, customizable batch sizes, and streamlined quality processes, making them attractive sources for bulk Oxaprozin API.

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Market Dynamics and Supply Chain Considerations

Supply Chain Diversification

Reliance on Chinese and Indian suppliers remains prevalent due to cost advantages. However, recent geopolitical shifts, export restrictions, and global pandemics highlight the importance of diversification. Manufacturers and marketers increasingly seek diversified sources to mitigate supply risks.

Regulatory Standards and Compatibility

APIs must comply with stringent regulations, notably the US FDA, EMA, PMDA, and other regional agencies. Suppliers demonstrating thorough documentation, validated manufacturing processes, and quality certifications (ISO, cGMP) are preferred.

Quality Assurance and Certification

Reputable API sources provide comprehensive certificates of analysis (CoA), stability data, and batch-to-batch consistency documentation. For global markets, APIs must meet pharmacopoeial standards—USP, EP, or JP.

Cost and Lead Times

Cost competitiveness influences procurement choices. Indian and Chinese sources typically offer competitive pricing but require rigorous validation checks. Lead times vary with production capacity and demand shifts, underscoring the need for strategic inventory planning.

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Future Trends and Innovations

• Sustainable Manufacturing: Emphasis on greener synthesis routes, reducing solvent waste, and energy consumption. Suppliers investing in environmentally friendly processes will gain market favor.

• Advanced Synthesis Technologies: Employing flow chemistry and biocatalysis to improve yield, reduce impurities, and streamline manufacturing.

• Regulatory Harmonization: Growing global regulatory alignment enables easier market access, but also demands higher compliance standards from API suppliers, impacting sourcing strategies.

• Supply Chain Resilience: Increasing adoption of dual sourcing, regional manufacturing bases, and inventory buffering to withstand global disruptions.

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Key Takeaways

• Diverse Geographic Sourcing: Major API sources for Oxaprozin include China, India, and Europe, each with unique strengths in cost, quality, and regulatory compliance.

• Quality and Certification Priority: Reliable APIs stem from suppliers adhering to cGMP standards, with robust quality certification processes, crucial for global regulatory acceptance.

• Supply Chain Resilience: Diversification and long-term partnerships are vital for minimizing supply disruptions amid geopolitical and logistical challenges.

• Sustainable & Innovative Manufacturing: Emerging trends favor suppliers adopting environmentally friendly processes and advanced synthesis technologies.

• Regulatory Alignment: Staying aligned with evolving global standards ensures Uninterrupted access to markets and maintains competitive advantage.

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FAQs

1. Which countries dominate the bulk API supply for Oxaprozin?
China and India lead in manufacturing due to cost advantages and manufacturing scale, complemented by European suppliers emphasizing high-quality standards.

2. How important are GMP certifications for API sourcing?
Extremely. GMP compliance ensures consistent quality, regulatory acceptance, and patient safety, making it a non-negotiable criterion for reputable API sources.

3. What are the key considerations when selecting an API supplier for Oxaprozin?
Quality certifications, manufacturing capacity, regulatory compliance, supply reliability, cost, and environmental standards are paramount.

4. Are there emerging alternatives to traditional bulk API sources?
Yes. Advances in green synthesis, biotechnological methods, and regional manufacturing hubs aim to diversify sourcing and reduce reliance on high-volume suppliers.

5. How can manufacturers mitigate supply chain risks for Oxaprozin APIs?
By establishing multiple supplier relationships, maintaining strategic inventories, and engaging in long-term partnerships with certified manufacturers.

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References

1. United States Pharmacopeia (USP). "NSAID APIs standards." USP, 2022.
2. European Pharmacopoeia. "Quality standards for NSAIDs." EP, 2021.
3. Pharmaceutical Technology. "Global NSAID API Market Overview." 2022.
4. Market Research Future. "API Market for NSAIDs," 2023.
5. Official EU Medicines Agency (EMA). "Guidelines on API manufacturing." EMA, 2022.

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This comprehensive overview equips pharmaceutical entrepreneurs, procurement managers, and regulatory professionals with critical insights into Oxaprozin API sourcing strategies, highlighting current market dynamics, quality imperatives, and future trends essential for informed decision-making.