Bulk Pharmaceutical API Sources for CATAFLAM

Bulk Pharmaceutical API Sources for CATAFLAM

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-18735
Molport		MolPort-005-937-655
Amadis Chemical		A809388
AKos Consulting & Solutions		AKOS015889752

Bulk Active Pharmaceutical Ingredient (API) Sources for CATAFLAM

Last updated: July 30, 2025

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Introduction

CATAFLAM, the brand name for ketoprofen, is a nonsteroidal anti-inflammatory drug (NSAID). It is primarily used for managing pain, inflammation, and fever associated with various musculoskeletal conditions. As a critical component in pharmaceutical manufacturing, sourcing bulk active pharmaceutical ingredients (APIs)—specifically ketoprofen—requires meticulous consideration regarding quality, regulatory compliance, and supply stability. This article provides a comprehensive overview of the global API sources for CATAFLAM, emphasizing the current market landscape, key manufacturers, and factors influencing sourcing decisions.

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Global Market Overview for Ketoprofen API

The sourcing of ketoprofen APIs is characterized by a mature yet competitive landscape. The API market is driven by the rising prevalence of inflammatory and pain-related disorders, alongside increased outsourcing of manufacturing by pharmaceutical companies seeking cost efficiencies. The global API market for NSAIDs, including ketoprofen, was valued at approximately USD 1.8 billion in 2022, with projections indicating steady growth over the next five years [1].

Historically, API supply chains have faced challenges such as regulatory compliance, quality assurance, and geopolitical factors influencing manufacturing locations. India and China dominate as primary manufacturing hubs, accounting for over 70% of global API production due to their cost advantages and large-scale production capabilities [2].

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Major API Manufacturers for Ketoprofen

1. Chinese API Producers

• Hubei Green Valley Pharmaceutical Co., Ltd.

  • A prominent manufacturer specializing in NSAIDs, including ketoprofen, with established GMP-compliant facilities.
  • Supplies global markets with bulk APIs amid competitive pricing.
  • Focuses on high purity and consistent batch quality, compliant with international standards like USP, EP, and JP.

• Zhejiang NHU Co., Ltd.

  • Offers a wide portfolio of APIs, including ketoprofen.
  • Certified under ISO, with a reputation for reliable supply chains.
  • Engages in continuous investment to upgrade manufacturing capabilities.

• Shandong Xinhua Pharmaceutical Co., Ltd.

  • Known for large-scale production of NSAIDs.
  • Markets its APIs to both domestic and international clients.

2. Indian API Manufacturers

• Lupin Limited

  • One of India’s leading pharmaceutical companies with significant API manufacturing capacity.
  • Produces ketoprofen API under strict cGMP compliance.
  • Supplies a broad spectrum of NSAIDs with regulatory approvals for multiple markets.

• IPCA Laboratories Ltd.

  • Well-established for its API manufacturing, including ketoprofen.
  • Focuses on innovation and quality control, serving markets worldwide.

• Aarti Industries

  • Specializes in bulk API production, with a robust supply chain for NSAIDs.
  • Offers high-purity ketoprofen API suitable for pharmaceutical companies requiring stringent standards.

3. European and North American API Manufacturers

While the majority of ketoprofen API is produced in China and India, some reputable European and North American firms provide high-quality, regulatory-compliant APIs:

• Bachem AG (Switzerland)

  • Focuses on high-purity APIs for niche markets.
  • Provides custom manufacturing, including synthesis of NSAIDs, with strict quality controls.

• Alliance Healthcare (USA)

  • Offers APIs through its extensive sourcing network, including ketoprofen API from approved Chinese and Indian manufacturers.

%Note: North American API production for ketoprofen remains limited, often relying on imports due to cost factors.

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Factors Influencing API Sourcing Decisions

Regulatory Compliance and Quality Assurance

• Global regulatory agencies such as the FDA, EMA, and PMDA impose rigorous standards for API manufacturing. Suppliers must hold Good Manufacturing Practice (GMP) certifications and comply with component-specific guidelines (e.g., ICH Q7).
• Verification processes like vendor audits, batch testing, and stability data are essential for ensuring API quality.

Supply Chain Stability

• Geopolitical factors and trade policies influence sourcing stability.
• Manufacturers with diversified supply chains across multiple regions are preferred to mitigate risks from localized disruptions.

Pricing and Cost Efficiency

• Chinese and Indian manufacturers dominate in offering competitive pricing owing to lower manufacturing costs.
• Larger volume contracts often attract discounts, but quality and compliance remain paramount.

Environmental and Ethical Standards

• Increasing emphasis on sustainable manufacturing processes and environmental safety influences supplier selection.
• Certification in environmental management systems (e.g., ISO 14001) is favorable.

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Emerging Trends in API Sourcing for CATAFLAM

• Shift towards integrated supply solutions: Pharmaceutical companies increasingly prefer suppliers offering end-to-end services, including synthesis, quality testing, and packaging.
• Use of advanced analytics and transparency: Blockchain and digital platforms improve supply chain traceability.
• Regulatory harmonization efforts: Globally aligned standards facilitate smoother approval processes, encouraging suppliers to standardize manufacturing practices.

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Conclusion

The sourcing of ketoprofen API for CATAFLAM involves a complex interplay of quality, compliance, cost, and supply chain resilience. The dominant production regions remain China and India, with notable contributions from European and North American suppliers catering to high-quality and niche markets. Companies seeking reliable API sources must prioritize GMP compliance, consistent quality standards, and supply chain stability amidst geopolitical and regulatory fluctuations.

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Key Takeaways

• The global ketoprofen API market is predominantly supplied by Indian and Chinese manufacturers, offering cost advantages and extensive capacity.
• Regulatory compliance (GMP certification, quality assurance) is non-negotiable for sourcing APIs intended for pharmaceutical production.
• Diversification of suppliers and sourcing regions enhances resilience against supply disruptions.
• Emerging technologies and harmonized regulatory standards are streamlining global API sourcing processes.
• Strategic partnerships with reputable manufacturers ensure consistent supply, regulatory compliance, and high-quality API procurement.

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FAQs

1. What are the primary regions for sourcing ketoprofen API?
China and India are the main regions, supplying the bulk of global ketoprofen APIs due to their manufacturing scale and cost efficiencies.

2. How do regulatory standards impact API sourcing?
Regulatory standards such as GMP, USP, and EMA guidelines require suppliers to meet strict quality and safety criteria, influencing supplier selection and approval processes.

3. Can European and North American companies supply ketoprofen API?
While limited, some European firms (e.g., Bachem) and North American companies provide high-quality APIs, often through import channels from Asian manufacturers.

4. What are the risks associated with API sourcing from emerging markets?
Risks include variability in quality, supply chain disruptions, regulatory discrepancies, and geopolitical tensions, necessitating thorough vendor qualification.

5. How can pharmaceutical companies ensure API quality and supply stability?
By establishing rigorous supplier qualification programs, auditing manufacturing facilities, requiring detailed documentation, and maintaining diversified sourcing strategies.

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References

[1] MarketWatch. "NSAID API Market Size, Share & Trends." 2022.
[2] IQVIA. "Global API Manufacturing Landscape." 2022.