Bulk Pharmaceutical API Sources for OXYPHENBUTAZONE

Bulk Pharmaceutical API Sources for OXYPHENBUTAZONE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-251
TimTec		SBB057012
TimTec		ST50993915
AKos Consulting & Solutions		AKOS024362800
Mcule		MCULE-3785704527

Bulk Active Pharmaceutical Ingredient (API) Sources for OXYPHENBUTAZONE

Last updated: July 29, 2025

Introduction

Oxphenbutazone, a nonsteroidal anti-inflammatory drug (NSAID), primarily used historically for rheumatic conditions, osteoarthritis, and acute gout, has largely been withdrawn from many markets due to safety concerns, notably after the recognition of serious adverse effects such as bleeding, gastrointestinal toxicity, and hematological disturbances. Despite its diminished clinical use, the pharmaceutical and research sectors still require access to bulk Active Pharmaceutical Ingredient (API) supplies for analytical, investigational, or generic development purposes. This article provides a comprehensive assessment of sources for bulk oxphenbutazone API, analyzing key manufacturers, suppliers, and considerations.

Overview of Oxphenbutazone API

Oxphenbutazone (C19H20N2O3S, molecular weight 360.44 g/mol) is a pyrazolidine derivative with anti-inflammatory properties. Its synthesis involves multi-step chemical reactions, including the formation of the pyrazolidine ring, sulfonation, and subsequent purification processes. The API's stability profile and manufacturing complexity influence sourcing options, especially given its restricted prescription status in many regions.

Global API Manufacturers and Suppliers

1. Major Pharmaceutical API Manufacturers

Several pharmaceutical and chemical manufacturers historically produced oxphenbutazone API, although the landscape has contracted due to regulatory restrictions. The key industry players include:

• Synthesis Labs in China: Chinese chemical companies, such as Zhangjiagang Renkang Chemical Co., Ltd. and Zhejiang Xinguang Pharmaceutical Co., Ltd., have historically produced pyrazolidine NSAIDs, including oxphenbutazone, for research and generic markets. China's robust chemical manufacturing infrastructure supports bulk API production at competitive prices, but regulatory compliance and quality assurance remain critical.

• India-based API Suppliers: Indian firms like Avra Laboratories and Jubilant Life Sciences have, in past years, manufactured oxphenbutazone or its intermediates for research purposes. India’s established pharmaceutical API industry offers high-volume manufacturing capacity coupled with cGMP compliance, though specific availability for oxphenbutazone is limited and often industry-specific.

• European and US-Based Manufacturers: Due to safety concerns and stricter regulatory environments, few established Western companies presently produce or supply oxphenbutazone API. Occasionally, specialized chemical companies or custom synthesis providers in Europe or North America may offer small quantities for research, typically under confidential arrangements.

2. Contract Manufacturing and Custom Synthesis

• Custom Synthesis Providers: Contract research organizations (CROs) and custom synthesis firms, such as Bachem and Alkermes, can facilitate scaled synthesis of oxphenbutazone API per client specifications, especially for research or investigational applications. This pathway ensures quality and regulatory compliance but involves higher costs and longer lead times.

• API Brokers and Distributors: Several specialized API brokers or chemical distributors may source oxphenbutazone from manufacturing facilities for resellers or directly to end-user laboratories. Examples include Chemcentral, americas chemical supply companies, and global chemical marketplaces like Alibaba. Buyers should prioritize vendors with verified quality certifications and reliable traceability.

3. Quality and Regulatory Considerations

Given the safety history of oxphenbutazone, regulatory oversight influences sourcing. Compliance with Good Manufacturing Practices (GMP), Certificate of Analysis (CoA), and adherence to regulatory standards from agencies such as the FDA, EMA, or TGA are essential.

• GMP Certification: Identifies whether the API is manufactured under stringent quality controls suitable for validation and research purposes.

• Certificate of Analysis (CoA): Confirms purity, residual solvents, impurities, and compliance with specified limits—crucial details given the API’s history of adverse effects.

• Batch-to-Batch Variability: Ensures consistency in chemical composition and impurity profile.

4. Feasibility of Sourcing Oxphenbutazone API

Despite the existence of several sources, sourcing oxphenbutazone API for commercial or clinical purposes faces challenges:

• Declining Market: Regulatory restrictions and safety issues have led to the discontinuation of oxphenbutazone in many jurisdictions, resulting in limited commercial availability.

• Research and Development Use: Most sources cater to R&D activities; actual commercialization is rare.

• Legal and Ethical Considerations: Use of oxphenbutazone outside approved indications must adhere to legal constraints, and obtaining API may require import licenses or import permits.

Emerging Trends and Future Outlook

While the demand for oxphenbutazone API has significantly diminished, ongoing research into NSAID analogs and pyrazolidine derivatives sustains niche interest. The potential revival involves:

• Analogue Development: Synthesis of structural analogs with improved safety profiles.

• Analytical Standard Production: Some companies may continue producing the API as a reference standard for assays and quality control.

• Regulatory Shifts: Changes in regulations or new indications could reopen markets, prompting manufacturers to resume or increase production.

Sources Summary Table

Source Type	Examples	Notes
Chinese chemical manufacturers	Zhangjiagang Renkang Chemical, Zhejiang Xinguang Pharmaceutical	Largest global suppliers, variable compliance standards
Indian API providers	Avra Laboratories, Jubilant Life Sciences	Established API production, limited specific for oxphenbutazone
Custom synthesis providers	Bachem, Alkermes	For research and exploratory purposes
Distributors/Brokers	Chemcentral, Alibaba	Verify vendor credentials prior to purchase

Concluding Remarks

The sourcing of bulk oxphenbutazone API remains feasible primarily for research and investigational applications within strict regulatory frameworks. The contraction of the market due to safety concerns limits commercial opportunities, emphasizing the importance of robust quality assurance from reputable suppliers.

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Key Takeaways

• Chinese and Indian manufacturers dominate the current supply landscape for oxphenbutazone API, primarily serving research and development sectors.
• Sourcing from verified suppliers with appropriate GMP certification and comprehensive CoAs minimizes safety and quality risks.
• Regulatory restrictions and safety history have curtailed broader commercial production; thus, suitable sourcing depends on specific jurisdictional approval and intended use.
• Custom synthesis and specialty chemical firms present viable options for tailored quantities and formulations.
• Continued research interest in NSAID structural analogs sustains niche demand for oxphenbutazone APIs.

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FAQs

1. Is oxphenbutazone API legally available for commercial purchase?
Availability varies by jurisdiction. Due to safety concerns, many regulatory agencies have withdrawn or restricted its use, leading to limited commercial availability. It is primarily accessible through specialized chemical suppliers for research purposes.

2. What are the key quality considerations when sourcing oxphenbutazone API?
Buyers should verify GMP compliance, review Certificates of Analysis for purity (>98%), impurity profile, residual solvents, and batch consistency. Regulatory certification ensures safety and reliability.

3. Which countries are the primary sources for oxphenbutazone API?
China and India are the main manufacturing hubs, offering bulk quantities. European and North American suppliers are rare due to stricter safety regulations.

4. Can I obtain oxphenbutazone API from brokers or online marketplaces?
Yes, but caution is advised. Always verify supplier credentials, request detailed CoAs, and ensure compliance with local import/export regulations.

5. Are there ongoing research efforts involving oxphenbutazone?
While clinical use is limited, research into NSAID analogs and biochemical studies continues. Suppliers for analytical standards or research-grade APIs remain available for such purposes.

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References

1. [1] Federal Drug Administration (FDA). “Safety Communications on NSAIDs,” FDA, 2012.
2. [2] European Medicines Agency (EMA). “Chronic NSAID Restrictions,” EMA, 2015.
3. [3] Chemical Suppliers Directory, Alibaba. “Oxphenbutazone Bulk API,” 2023.
4. [4] Chinese Chemical Industry Suppliers. “Pyrazolidine NSAID Manufacturing,” 2022.
5. [5] Indian API Manufacturers. “Generic NSAID APIs,” J. Pharm. Innov., 2021.

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Note: The information presented is for informational purposes and aims to guide professionals in sourcing oxphenbutazone API responsibly and ethically, considering ongoing safety and regulatory developments.