Suppliers and packagers for generic pharmaceutical drug: KETOPROFEN

KETOPROFEN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	KETOPROFEN	ketoprofen	CAPSULE, EXTENDED RELEASE;ORAL	075679	ANDA	Mylan Pharmaceuticals Inc.	0378-8200-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)	2003-09-04
Misemer	KETOPROFEN	ketoprofen	CAPSULE;ORAL	074014	ANDA	Misemer Pharmaceuticals, Inc.	0276-0504-10	100 CAPSULE in 1 BOTTLE (0276-0504-10)	2019-06-19
Misemer	KETOPROFEN	ketoprofen	CAPSULE;ORAL	074014	ANDA	Misemer Pharmaceuticals, Inc.	0276-0506-10	100 CAPSULE in 1 BOTTLE (0276-0506-10)	2022-09-13
Misemer	KETOPROFEN	ketoprofen	CAPSULE;ORAL	074014	ANDA	Misemer Pharmaceuticals, Inc.	0276-0507-10	100 CAPSULE in 1 BOTTLE (0276-0507-10)	2025-05-23

Suppliers for the Pharmaceutical Drug: KETOPROFEN

Last updated: July 28, 2025

Introduction

Ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID), is widely used to alleviate mild to moderate pain, reduce inflammation, and lower fever. Its capacity to inhibit cyclooxygenase (COX) enzymes, primarily COX-1 and COX-2, underpins its anti-inflammatory effects. Given its broad application in clinical and OTC products, a robust supply chain for ketoprofen is critical for pharmaceutical manufacturers. This article examines the leading suppliers of ketoprofen globally, analyzing manufacturing capacities, regional dominance, and market dynamics to inform industry stakeholders and decision-makers.

Global Manufacturing Landscape of Ketoprofen

The global supply of ketoprofen hinges on a handful of key chemical manufacturers specializing in the synthesis of active pharmaceutical ingredients (APIs). The majority of these suppliers operate within China, India, Europe, and North America, reflecting regional hubs for pharmaceutical excipient and API manufacturing. Each supplier’s prominence depends on their API quality standards, production scale, regulatory compliance, and cost efficiency.

Major Suppliers of Ketoprofen

1. Chinese Manufacturers

China remains the largest producer of ketoprofen API, driven by the country’s robust chemical manufacturing infrastructure, cost competitiveness, and regulatory support for API exports.

• Hunan Weikeqi Pharmaceutical Co., Ltd.
  As one of the leading Chinese API producers, Hunan Weikeqi supplies ketoprofen to a global market, emphasizing high purity standards and GMP compliance. The company has invested heavily in modern synthesis facilities, ensuring consistent quality for export and domestic use.

• Shandong Xinhua Pharmaceutical Co., Ltd.
  Shandong Xinhua has expanded its API portfolio to include ketoprofen, leveraging its extensive distribution channels in Asia and its strategic alliances with pharmaceutical companies worldwide. Their manufacturing process adheres to international quality standards.

2. Indian Manufacturers

India is a significant player in the API manufacturing sector, blending cost advantages with quality standards compliant with WHO and European GMP.

• Jubilant Pharmova Limited
  Jubilant is a prominent global API producer with a dedicated facility for NSAIDs, including ketoprofen. Their production facilities are EU-GMP and US-FDA approved, providing high-quality APIs to multinational pharmaceutical firms.

• Aarti Drugs Ltd.
  Aarti Drugs specializes in the manufacture of bulk APIs and intermediates, including ketoprofen. Its strategic focus on cost-effective synthesis and adherence to stringent regulatory norms makes it a key supplier for generic drug markets.

3. European and North American Suppliers

While these regions are less dominant in bulk API production—primarily due to higher operational costs—they focus on high-quality, specialized manufacturing and custom synthesis.

• Stada Arzneimittel AG (Germany)
  Stada, a pharmaceutical company with a diversified API portfolio, sources ketoprofen through partnerships and contracts with Asian manufacturers to ensure quality and supply stability.

• Madaus GmbH (Germany)
  Madaus supplies pharmaceutical-grade ketoprofen for niche applications, leveraging advanced manufacturing processes and rigorous quality control.

• Cambridge Commodities (UK)
  Specializing in high-purity APIs and pharmaceutical excipients, Cambridge Commodities sources ketoprofen for use in research and niche formulations. Their focus is on supply chain integrity and compliance standards.

Contract Manufacturing and Third-Party Suppliers

Many pharmaceutical companies engage in contract manufacturing organizations (CMOs) that produce ketoprofen APIs. These CMOs often operate across multiple regions, offering flexible capacity and regulatory-compliant manufacturing.

Examples include:

• Everest Organics (India)
  A CMO specializing in NSAIDs, including ketoprofen, offering scalable production aligned with global regulatory standards.

• Hetero Labs (India)
  Known for large-scale API manufacturing with high-quality output and ISO/GMP certifications.

Market Dynamics Influencing Supply

Several factors influence the global supply chain of ketoprofen:

• Regulatory Standards: Suppliers must comply with stringent international regulations, particularly for export to European and North American markets. GMP certification, stability data, and impurity profiles are critical.

• Pricing and Cost Structures: Chinese and Indian suppliers offer competitive pricing due to lower manufacturing costs, though quality and regulatory compliance are paramount.

• Supply Chain Risks: Political, logistical, and regulatory disruptions can impact supply continuity, prompting companies to diversify sources and maintain safety stocks.

• Technological Advancements: Innovations in synthesis and purification techniques improve API quality and yield, enabling suppliers to meet stricter quality demands.

Conclusion

The supply chain for ketoprofen heavily relies on Asian manufacturers, predominantly from China and India, complemented by European suppliers focusing on high-value niche markets. Multinational pharmaceutical companies prioritize suppliers with proven GMP compliance, quality assurance, and reliable delivery. Strategic diversification of suppliers and continuous quality monitoring are imperative to mitigate risks associated with geopolitical, logistical, and regulatory factors.

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Key Takeaways

• The majority of global ketoprofen supply originates from Chinese and Indian API manufacturers, offering cost-effective and high-quality production capacities.
• European and North American suppliers predominantly provide specialized or high-standard APIs, often through partnerships or contract manufacturing.
• Ensuring GMP compliance and regulatory adherence remains critical for supply stability and product quality.
• Diversification of sources and strategic partnerships mitigate risks from geopolitical and logistical disruptions.
• Continued technological improvements are enhancing API purity and production efficiency, shaping future supply dynamics.

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FAQs

1. Who are the top global suppliers of ketoprofen API?
Chinese companies like Hunan Weikeqi Pharmaceutical and Indian firms such as Jubilant Pharmova and Aarti Drugs are among the leading suppliers, owing to their large-scale manufacturing capabilities and cost advantages.

2. What quality standards do suppliers of ketoprofen need to meet?
Suppliers must comply with GMP regulations, obtain certifications like EU-GMP and US-FDA approvals, and demonstrate consistent impurity profiles, stability data, and traceability.

3. Are there regional differences in ketoprofen supply?
Yes. Asian manufacturers dominate in volume and cost efficiency, while European and North American suppliers focus on high-quality, niche, or research-grade APIs.

4. How do geopolitical factors impact ketoprofen supply chains?
Trade policies, tariffs, and political tensions can disrupt supply flows, making diversification and strategic sourcing essential for risk mitigation.

5. What future trends could influence the supply of ketoprofen?
Advances in manufacturing technology, stricter regulatory standards, and increasing demand for generic NSAIDs are likely to influence supply chain practices, emphasizing quality, efficiency, and supply resilience.

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References

[1] Global Pharmaceuticals API Market analysis, (2023).
[2] Chinese API Manufacturers Directory, Chemical Industry Reports, 2022.
[3] Indian Pharmaceutical Industry Overview, Department of Pharmaceuticals, Government of India, 2022.
[4] European GMP Standards, EMA Guidelines, 2022.
[5] Supply Chain Risks in Pharmaceutical Manufacturing, Parenteral Drug Association, 2021.