Bulk Pharmaceutical API Sources for ORUDIS

Bulk Pharmaceutical API Sources for ORUDIS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		K2012_SIAL
NovoSeek		3825
Sigma-Aldrich		K1751_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for ORUDIS

Last updated: July 30, 2025

Introduction

Orudis (generic: ketoprofen) is a non-steroidal anti-inflammatory drug (NSAID) widely utilized for its analgesic, anti-inflammatory, and antipyretic properties. As a core component in pharmaceutical manufacturing, the procurement of high-quality bulk Active Pharmaceutical Ingredients (APIs) is pivotal to ensuring drug efficacy, safety, and regulatory compliance. This report delineates the global API sourcing landscape specific to ketoprofen, emphasizing quality standards, key suppliers, and strategic considerations for pharmaceutical companies.

Overview of Ketoprofen API

Ketoprofen was first introduced in the 1960s and remains in commercial use worldwide. Its mechanism involves inhibition of cyclooxygenase (COX) enzymes, notably COX-1 and COX-2, reducing prostaglandin synthesis [1]. The API’s specifications, including purity levels (typically ≥99%), stereochemistry, and residual solvent limits, conform to the requirements set by pharmacopeias such as USP/NF and EP.

Global API Manufacturing Landscape for Ketoprofen

Major API Production Regions

1. India

India is a leading API manufacturer, with numerous WHO-GMP-certified facilities producing ketoprofen. Major Indian API producers such as Divi’s Laboratories, Bidharma, and Aarti Drugs offer bulk APIs compliant with international standards [2]. Indian suppliers are valued for their cost competitiveness, flexible production capacities, and robust quality management systems.

2. China

Chinese pharmaceutical GMP-compliant manufacturers contribute significantly to the global API supply chain. Companies like Zhejiang Hisun Pharmaceuticals and Shanghai Pharma provide high-quality ketoprofen APIs. Chinese API suppliers are experiencing increased validation processes to meet stringent European and North American requirements, yet remain an essential source due to their large-scale manufacturing capabilities and competitive pricing [3].

3. European Union

European API producers, such as Recipharm and FAMAR, supply ketoprofen APIs with high purity and rigorous regulatory compliance. These suppliers often position themselves for markets demanding stringent quality assurances and stability data, especially for products intended for highly regulated regions.

4. United States

While the U.S. predominantly relies on imported APIs due to manufacturing complexities, certain API producers within the U.S. provide ketoprofen manufacturing capabilities aligned with FDA standards. However, the U.S. market for ketoprofen APIs is limited compared to bulk supplier offerings elsewhere.

Key Factors in API Source Selection

• Regulatory Certification: Suppliers with current WHO-GMP, USFDA, EMA, or equivalent certifications are preferred for compliance with international regulations.
• Quality Standards: Certificates of analysis (CoA), stability data, residual solvent profiles, and endotoxin levels influence supplier selection.
• Supply Reliability: Consistency in supply, ability to scale production, and lead times are critical.
• Cost-effectiveness: Geographical location, production volume, and quality certifications influence pricing strategies.

Leading API Suppliers for Ketoprofen (ORUDIS)

Supplier	Region	Certifications	Notes
Divi’s Laboratories	India	WHO-GMP, ISO 9001	Large-scale producer, extensive domestic and international distribution channels.
Bidharma	India	WHO-GMP	Known for high-purity APIs, flexible batch sizes.
Aarti Drugs	India	WHO-GMP	Competitive pricing, reliable quality.
Zhejiang Hisun Pharmaceuticals	China	GMP	Emphasizes compliance, large manufacturing capacity.
Shanghai Pharma	China	GMP	Focuses on high-quality APIs for global markets.
Recipharm	Europe	EMA, GMP	Focused on high-quality, regulated markets with robust supply chain management.

Quality and Regulatory Compliance

Ensuring API quality involves adherence to rigorous standards. Suppliers must provide comprehensive documentation, including CoA, GMP certificates, and stability data. For ORUDIS manufacturing, the API must meet the specifications outlined in pharmacopeias, with typical impurities and residual solvents within limits.

Regulatory authorities like the USFDA and EMA conduct inspections and audits to verify compliance standards, influencing market acceptance. Suppliers with validated manufacturing processes and consistent batch quality support seamless regulatory approval for final drug products.

Strategic Considerations for Sourcing API for ORUDIS

• Vertical Integration: Engaging with suppliers possessing in-house synthesis and quality assurance capabilities reduces supply chain variability.
• Long-term Contracts: Establishing agreements with reputable suppliers ensures stable supply and cost predictability.
• Quality Management: Conduct periodic audits, qualification visits, and batch testing to validate supplier compliance.
• Supply Chain Risk Mitigation: Diversify sources across geographic regions; implement safety stocks to buffer against disruptions.

Emerging Trends in API Sourcing

• Regulatory Stringency: Increasing compliance standards motivate suppliers to upgrade manufacturing processes, enhancing overall API quality.
• Sustainability Initiatives: Focus on environmentally friendly synthesis methods, reducing solvent use and waste.
• Technology Advancements: Digital tracking and supply chain transparency become integral to quality assurance and regulatory compliance.
• Global Supply Chain Resilience: Post-pandemic strategies emphasize diversification and local manufacturing capabilities.

Conclusion

Global sourcing of ketoprofen API for ORUDIS involves a complex landscape characterized by diverse regional players, stringent quality standards, and evolving regulatory requirements. Indian and Chinese suppliers dominate due to cost advantages and manufacturing capacity. European and U.S. suppliers focus on high compliance and quality assurances aligned with regulatory expectations. Strategic supplier selection, robust quality management, and diversification are critical to securing a reliable supply chain.

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Key Takeaways

• Indian and Chinese API manufacturers are primary sources for ketoprofen, offering cost-effective, large-scale production.
• Certification and adherence to international quality standards (WHO-GMP, USFDA, EMA) are critical for regulatory acceptance.
• Supplier qualification, ongoing quality audits, and supply chain diversification mitigate risks.
• Regulatory trends drive API suppliers toward higher transparency, sustainability, and technological integration.
• Strategic partnerships with reputable suppliers underpin the reliability and compliance of ORUDIS manufacturing.

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FAQs (Frequently Asked Questions)

1. What are the critical quality parameters when sourcing ketoprofen API for ORUDIS?
Key parameters include purity (≥99%), residual solvents within acceptable limits, specific stereochemistry, and low levels of impurities such as related substances, endotoxins, and heavy metals. Certificates of analysis and stability data are essential for validation.

2. How do Indian and Chinese API suppliers compare in terms of quality and regulatory compliance?
Both regions have established GMP-certified manufacturers capable of producing high-quality APIs. Indian suppliers are renowned for cost-effectiveness and compliance with global standards, while Chinese manufacturers are expanding their validation processes to meet strict European and North American regulations.

3. What regulatory considerations influence API sourcing decisions for ketoprofen?
Regulatory considerations include compliance with GMP standards, successful inspections by authorities like USFDA/EMA, and certification documentation. Suppliers with a history of regulatory adherence facilitate smoother drug registration processes.

4. How can pharmaceutical companies ensure supply chain resilience for ketoprofen API?
Diversifying suppliers across regions, maintaining strategic inventory levels, conducting regular audits, and fostering long-term supplier relationships enhance resilience against disruptions.

5. Are there sustainable or innovative manufacturing approaches in ketoprofen API production?
Yes. Emerging trends focus on green chemistry, reducing solvent use, minimizing waste, and adopting continuous manufacturing technologies to improve sustainability and product consistency.

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References

[1] Rainsford, K.D. "Ketoprofen: A Review of Its Pharmacology and Use." Drugs, 1984.
[2] Divi’s Laboratories Official Website. “API Portfolio.” (2023).
[3] Zhejiang Hisun Pharmaceuticals Annual Report. “API Manufacturing Capabilities.” (2022).