Bulk Pharmaceutical API Sources for ORUDIS KT

Bulk Pharmaceutical API Sources for ORUDIS KT

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		K2012_SIAL
Sigma-Aldrich		K1751_SIGMA
TCI (Tokyo Chemical Industry)		K0038
Molport		MolPort-001-684-346
Hangzhou APIChem Technology		AC-1486
Amadis Chemical		A815896

Bulk Active Pharmaceutical Ingredient (API) Sources for ORUDIS KT

Last updated: July 31, 2025

Introduction

Orudis KT (ketoprofen topical gel) is a non-steroidal anti-inflammatory drug (NSAID) used primarily for localized relief of pain and inflammation, such as osteoarthritis and acute musculoskeletal conditions. The efficacy and safety of Orudis KT depend fundamentally on the quality of its active pharmaceutical ingredient (API), ketoprofen. Ensuring a reliable supply of high-quality API is vital for manufacturers and stakeholders to meet regulatory standards and maintain product consistency. This report elaborates on the global sources for bulk ketoprofen API, emphasizing procurement avenues, licensing considerations, and quality assurance for pharmaceutical manufacturers.

Overview of Ketoprofen API

Ketoprofen, chemically known as (RS)-2-(3-Benzoylphenyl)propionic acid, is a chiral NSAID with anti-inflammatory, analgesic, and antipyretic properties. It is synthesized via multi-step chemical processes involving benzoyl derivatives and subsequent purification. The API’s stability, purity, and particle size influence the final topical formulation's performance, underscoring the necessity for reputable sourcing.

Major Global API Supplier Regions

The global ketoprofen API market is concentrated predominantly in certain regions known for robust chemical manufacturing capabilities, strict regulatory oversight, and advanced quality assurance frameworks. The prominent regions include:

• China
• India
• European Union (EU)
• United States

Each region features API manufacturers with varying specializations, compliance standards, and production capacities.

Primary API Manufacturers for Ketoprofen

China

China's chemical industry historically dominates API production, with numerous companies equipped for large-scale synthesis and bulk exports.

• Zhejiang Huajin Pharmaceutical Co., Ltd. (Zhejiang): Recognized for their extensive API portfolio, including ketoprofen, with GMP compliance.
• Jiangsu Heben Pharmaceutical Co., Ltd.: Supplies high-purity ketoprofen API to international markets, adhering to cGMP standards.
• Qingdao Cunhua Chemical Co., Ltd.: Offers competitive pricing with quality certifications; primarily exports to India and Europe.

Advantages: Cost-effective production, extensive capacity, and established export channels.

Considerations: Potential regulatory variability; importance of verifying Good Manufacturing Practice (GMP) and analytical certificates.

India

India hosts a significant number of API manufacturers governed by the Central Drugs Standard Control Organization (CDSCO) and many possess WHO-GMP certification.

• Lupin Ltd.: One of India's leading pharmaceutical producers, offering ketoprofen API compliant with international standards.
• Aarti Drugs Ltd.: Supplies high-grade APIs with global certifications, including ISO and WHO-GMP.
• Sanni Healthcare Pvt Ltd.: Focused on manufacturing and exporting ketoprofen API, with quality certifications and competitive prices.

Advantages: Strong regulatory oversight, high-quality standards, innovative production processes.

Considerations: Potential variability in supply capacity depending on market demand.

European Union

EU-based manufacturers often target high-end markets, emphasizing strict quality assurance and regulatory compliance.

• Europharm S.A. (France): Known for high-purity APIs with comprehensive analytical documentation.
• BASF SE (Germany): Offers bulk ketoprofen but typically as part of complex chemical intermediates or custom synthesis services.

Advantages: High regulatory compliance, stringent quality standards, reliable supply.

Considerations: Higher costs relative to Asian suppliers; supply chain considerations.

United States

While the U.S. primarily relies on imports for APIs like ketoprofen, several specialty API manufacturers and custom synthesis companies serve domestic and international clients.

• Amneal Pharmaceuticals (New Jersey): Sells various APIs, including ketoprofen, adhering to U.S. FDA standards.
• Hikal Ltd. (India with U.S. operations): Offers cGMP-compliant APIs globally.

Advantages: Adherence to U.S. quality standards, regulatory compliance.

Considerations: Typically higher costs, reliance on imports.

Regulatory and Quality Assurance Considerations

Quality assurance is critical when sourcing ketoprofen API. Manufacturers must verify:

• GMP Certification: Ensures processes meet international standards.
• Analytical Certificates (COA): Confirm purity (>99%), residual solvents, heavy metals, and enantiomeric purity where applicable.
• Regulatory Approvals: Suppliers should be compliant with the FDA, EMA, or WHO standards, especially if APIs are to be used in regulated markets.
• Stability and Storage Data: Verifying API stability under specified conditions.

Due diligence involves auditing manufacturing facilities, reviewing batch records, and verifying prior regulatory inspections.

Sourcing Strategies

• Direct Procurement from Manufacturers: Ideal for large-volume orders; enables negotiated terms, consistent supply, and direct quality control.
• Authorized Distributors: Can facilitate supply chain flexibility, especially when establishing initial supplier relationships.
• Contract Manufacturing Organizations (CMOs): For custom synthesis or enhanced quality assurance protocols, partnering with CMOs offers tailored solutions.

Partnerships should prioritize suppliers with validated manufacturing processes, comprehensive documentation, and proven track records.

Supply Chain and Market Trends

The demand for ketoprofen API remains stable globally, driven by the persistent need for NSAID formulations, particularly topical applications. Emerging markets and the increasing prevalence of osteoarthritis bolster demand. Supply chain resilience hinges on diversifying sources across regions, maintaining strategic inventories, and continuously monitoring regulatory updates.

Conclusion

Reliable sourcing of high-quality ketoprofen API is essential for the production of Orudis KT. Major API suppliers are concentrated in China and India, with additional high-quality options in Europe and North America. Ensuring compliance with GMP standards, thorough quality validation, and strategic supplier selection mitigate risks and support sustained manufacturing excellence.

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Key Takeaways

• Global suppliers: Significant sources of ketoprofen API include Chinese, Indian, European, and U.S.-based manufacturers.
• Quality assurance: Prioritize GMP-certified suppliers with comprehensive analytical test reports and regulatory compliance.
• Cost vs. quality: Balance cost considerations with regulatory requirements; regions like India offer cost-effective options with high standards.
• Supply chain risk management: Diversify sourcing channels and establish strong supplier relationships to prevent disruptions.
• Regulatory vigilance: Ensure supplier certifications and documentation align with target markets' regulatory standards.

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FAQs

1. What are the criteria for selecting a ketoprofen API supplier?
Suppliers should possess GMP certification, comprehensive analytical documentation, proven regulatory compliance, and a reliable supply history. Quality control measures, stability data, and adherence to international standards are critical.

2. How does regional manufacturing impact API quality?
Regions like Europe and the U.S. typically enforce stricter regulatory oversight, which correlates with higher quality assurance. However, top Chinese and Indian manufacturers also meet international quality standards, provided proper validation steps are followed.

3. What challenges exist when sourcing ketoprofen API from China?
Challenges include ensuring GMP compliance, verifying authenticity and purity certifications, and navigating regulatory differences. Diligent supplier audits and document validation mitigate these risks.

4. Are there specific certifications or standards required for importing API into regulated markets?
Yes, APIs should conform to cGMP standards, possess valid certificates of analysis, and often require accreditation such as ISO, WHO-GMP, or FDA approval, depending on the market.

5. How can manufacturers reduce supply chain disruptions for ketoprofen API?
Diversify supplier relationships across regions, maintain safety stock levels, establish long-term partnerships, and conduct regular supplier audits to ensure continuous quality and supply reliability.

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Sources
[1] IQVIA. “Global API Market Analysis,” 2022.
[2] U.S. Food and Drug Administration (FDA). “Guidance for Industry – Good Manufacturing Practices for APIs,” 2018.
[3] European Medicines Agency (EMA). “Regulatory Guidelines for Active Substances,” 2021.
[4] Pharmacompass. “Ketoprofen API Suppliers,” Accessed 2023.
[5] Global Sources. “Top API Manufacturers in China and India,” 2023.