Bulk Pharmaceutical API Sources for NALFON

Bulk Pharmaceutical API Sources for NALFON

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		3342
MolPort		MolPort-003-666-345
AAA Chemistry		AR-1J0752

Bulk Active Pharmaceutical Ingredient (API) Sources for Nalfon

Last updated: July 29, 2025

Introduction

Nalfon (generic: fenoprofen calcium) is a non-steroidal anti-inflammatory drug (NSAID) used primarily for relieving pain, inflammation, and fever associated with rheumatic and musculoskeletal conditions. As a critical component in pharmaceutical manufacturing, sourcing high-quality bulk Active Pharmaceutical Ingredients (APIs) is fundamental for ensuring drug efficacy, safety, and regulatory compliance. This article provides a comprehensive review of global API suppliers capable of supplying fenoprofen calcium (Nalfon’s API), emphasizing quality standards, regulatory considerations, and market dynamics.

Overview of Nalfon API: Fenoprofen Calcium

Fenoprofen calcium belongs to the propionic acid class of NSAIDs. Its chemical composition necessitates synthesis routes adhering to stringent quality control procedures to meet pharmacopeial standards. The API must comply with specifications outlined in the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other relevant pharmacopeias, ensuring purity, potency, and stability.

Global API Manufacturers for Fenoprofen Calcium

1. Established Chemical andAPI Manufacturers

• BASF SE
  BASF is a leading global chemical company with extensive capabilities in pharmaceutical intermediates and APIs. While primarily known for custom synthesis and intermediates, BASF has the infrastructure to produce NSAID APIs, including fenoprofen calcium, under contract manufacturing or licensing agreements. Their rigorous quality systems align with regulatory expectations, making them a strategic partner for bulk API sourcing.

• Sigma-Aldrich / Merck KGaA
  Sigma-Aldrich, now part of Merck, supplies a variety of pharmaceutical-grade APIs. While their focus has historically centered on research-grade chemicals, Merck offers cGMP-compliant APIs for clinical and commercial use, including NSAID intermediates, that may include fenoprofen derivatives or related compounds.

• Dr. Reddy’s Laboratories
  This Indian pharmaceutical giant manufactures a range of NSAID APIs. Their production facilities are GMP-certified, and they supply APIs globally. Although fenoprofen calcium specifically is not widely cataloged, through custom synthesis or partnerships, they may serve as a reliable API source.

• Hangzhou Sunflower Pharmaceutical Co., Ltd.
  A notable Chinese API manufacturer specializing in NSAIDs, including propionic acid derivatives. They possess cGMP facilities and export APIs that meet international standards, often serving as OEM suppliers for global pharmaceutical companies.

• Macleods Pharmaceuticals
  Macleods offers a range of NSAID APIs, with manufacturing facilities compliant with international regulatory standards. They focus on cost-efficiency and supply consistency, making them a significant source for NSAID APIs including various derivatives.

2. Contract Manufacturing Organizations (CMOs)

Numerous CMOs partner with pharmaceutical companies to produce fenoprofen calcium on a contract basis, offering flexibility in supply, scale, and quality:

• Jubilant Life Sciences
  A global leader in pharmaceutical manufacturing, Jubilant offers API synthesis services for NSAIDs, with cGMP-compliant facilities and extensive quality management systems.

• Aenova Group
  Specializing in pharmaceutical manufacturing, Aenova provides custom API production with a focus on quality and compliance, including NSAID APIs.

• Hovione
  Hovione offers both proprietary and custom synthesis of APIs, with an emphasis on complex chemical processes and strict regulatory compliance.

3. Emerging and Regional API Providers

Regional API producers in India, China, and Eastern Europe continue to expand their capabilities:

• Shandong Yulong Chemical Co., Ltd. (China)
  Specializes in NSAID intermediates and APIs, including propionic acid derivatives, with GxP-certified production lines.

• Rugao Tianming Pharmaceutical Co., Ltd. (China)
  Offers a range of NSAID APIs, with a focus on cost-effective bulk supply for generic pharmaceuticals.

• Viatris (formerly Mylan)
  Viatris has a robust API manufacturing footprint, supplying various NSAIDs globally, and may produce fenoprofen calcium under CI; partnering could ensure regulatory compliance.

Quality and Regulatory Considerations

Securing a reliable API source requires rigorous evaluation of quality systems, including cGMP compliance, batch-to-batch consistency, impurity profile, and stability data. Suppliers should provide comprehensive Certificates of Analysis (CoA), stability data, and regulatory dossiers demonstrating compliance with relevant standards (e.g., USP, EP, ICH Q7).

Moreover, geopolitical considerations, intellectual property rights, and logistics influence supplier selection. Many overseas suppliers have achieved mutual recognition agreements (MRAs) with agencies such as the FDA or EMA, facilitating smoother import/export procedures.

Market Dynamics and Trends

The demand for NSAID APIs, including fenoprofen calcium, is influenced by factors such as the rise in osteoarthritis, rheumatoid arthritis prevalence, and the expansion of generic markets. Cost-effective manufacturing in China and India makes these regions primary sources for bulk APIs. However, recent regulatory tightenings have increased the emphasis on supplier audits and quality assurance.

Additionally, players are investing in process optimization and green chemistry practices to improve sustainability and reduce costs, which is likely to benefit buyers by providing more consistent, cost-efficient API supplies.

Supply Chain Challenges

The major challenges in sourcing fenoprofen calcium API include:

• Ensuring supplier compliance with international quality standards.
• Navigating geopolitical and trade barriers.
• Addressing supply chain disruptions caused by pandemics or geopolitical conflicts.
• Managing long lead times and ensuring inventory readiness.

Proactive engagement with multiple suppliers and early qualification processes mitigate risks associated with supply interruptions.

Conclusion

The sourcing landscape for fenoprofen calcium API underscores a diverse array of regional and multinational manufacturers capable of meeting stringent regulatory and quality requirements. As the market evolves, strategic partnerships with certified API manufacturers, robust quality assurance, and a focus on supply chain resilience remain paramount for pharmaceutical stakeholders.

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Key Takeaways

• Global flexibility: Sourcing fenoprofen calcium from reputable suppliers in India, China, and Europe provides options balancing cost, quality, and regulatory compliance.
• Regulatory alignment: Prioritize suppliers with GMP certification, transparent documentation, and proven track records with regulatory agencies.
• Supply chain resilience: Establish relationships with multiple suppliers to mitigate disruptions, especially amid geopolitical and logistical challenges.
• Quality assurance: Continuous qualification, auditing, and validation processes are vital to ensure API consistency and accelerate regulatory approvals.
• Emerging trends: Green chemistry initiatives and digital quality systems are enhancing API manufacturing efficiency and compliance.

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FAQs

1. What are the main regions supplying high-quality fenoprofen calcium APIs globally?
   Primarily China and India serve as the leading regions for cost-effective, high-volume fenoprofen calcium APIs, with established GMP-compliant facilities. European and North American suppliers focus on high-quality, specialty production and regulatory compliance.

2. How do I validate a new API supplier for fenoprofen calcium?
   Perform comprehensive audits, review quality certifications (cGMP compliance), verify stability and impurity data, and conduct pilot batches to confirm consistency before full-scale procurement.

3. Are there notable differences in fenoprofen calcium APIs from different suppliers?
   Variations can exist in purity, impurity profiles, and excipient compatibility; hence, rigorous testing and supplier qualification are essential to ensure equivalence.

4. What are the regulatory considerations when importing fenoprofen calcium APIs?
   Comply with importing country regulations, including FDA or EMA registration requirements, import licenses, and certification of GMP compliance, supported by detailed CoAs and stability data.

5. Can fenoprofen calcium APIs be custom synthesized?
   Yes. Many CMOs offer custom synthesis services, allowing manufacturers to tailor APIs to specific purity and impurity specifications, often including process development and scale-up services.

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Sources:

[1] United States Pharmacopeia. USP Monograph for Fenoprofen Calcium.
[2] European Pharmacopoeia. Fenoprofen Calcium Monograph.
[3] Global API Market Analysis, IQVIA Reports, 2022.
[4] PharmaCompass. API Manufacturer Directory.
[5] Regulatory Considerations for APIs, WHO Guidelines, 2021.