Bulk Pharmaceutical API Sources for FELDENE

Bulk Pharmaceutical API Sources for FELDENE

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jnspR@L^SAEg@BLddLTTrRbnbRyHpZmVjA`fH@H@@@
ASINEX		BAS 04381594
Sigma-Aldrich		P5654_SIAL
Sigma-Aldrich		P0847_SIAL
NovoSeek		5280452
Vitas-M Laboratory		STK177288

Bulk Active Pharmaceutical Ingredient (API) Sources for FELDENE (Fenoprofen Calcium)

Last updated: July 28, 2025

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Introduction

Feldene, known generically as fenoprofen calcium, is a non-steroidal anti-inflammatory drug (NSAID) used primarily for the symptomatic relief of pain and inflammation in conditions such as rheumatoid arthritis, osteoarthritis, and other musculoskeletal disorders. As with many pharmaceutical products, the sourcing of high-quality bulk Active Pharmaceutical Ingredients (APIs) is critical to ensuring product efficacy, safety, and regulatory compliance. This article evaluates the current landscape of bulk fenoprofen calcium API suppliers, emphasizing quality assurance, regulatory status, and market trends.

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Understanding Fenoprofen Calcium as an API

Fenoprofen calcium, a synthetic NSAID, inhibits cyclooxygenase enzymes (COX-1 and COX-2), thereby reducing prostaglandin synthesis involved in pain and inflammation pathways. Its chemical complexity and established manufacturing processes have driven a niche but stable supply chain for bulk API sourcing.

Given its relatively limited global production, sourcing fenoprofen calcium API requires careful validation of supplier credentials, manufacturing practices, and compliance with international standards such as the FDA, EMA, or ISO.

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Global API Manufacturing Landscape for Fenoprofen Calcium

The market for fenoprofen calcium API remains concentrated among a handful of manufacturers predominantly based in Asia, especially China and India, regions that command the bulk of the global API production capacity. Several companies have established robust facilities well-versed in synthetic NSAID manufacturing, adhering to Good Manufacturing Practice (GMP) standards.

Major API Suppliers for Fenoprofen Calcium

1. WuXi AppTec (China)
WuXi AppTec offers comprehensive API manufacturing services, including fenoprofen calcium, with a focus on quality assurance, scalable production, and regulatory support. The company holds approvals from multiple regulatory agencies, making it a preferred choice for global pharmaceutical companies seeking reliable API sources.

2. Zhejiang Conba Pharmaceutical Co., Ltd. (China)
A prominent manufacturer of NSAIDs, Conba produces fenoprofen calcium API conforming to GMP standards. They cater primarily to the Asian market but are increasingly expanding their global reach through strategic partnerships and export channels.

3. Hetero Labs Ltd. (India)
Hetero, a leading Indian API producer, offers fenoprofen calcium with an emphasis on high-quality manufacturing, competitive pricing, and compliance with international standards. The company’s extensive API portfolio and global supply chain make it a key player.

4. IPCA Laboratories (India)
IPCA’s API manufacturing arm supplies fenoprofen calcium, leveraging advanced synthetic processes and rigorous quality control. Their APIs comply with USFDA and EMA standards, supporting export to regulated markets.

5. Teva Pharmaceuticals (Israel)
While primarily known as a finished drug manufacturer, Teva also sources APIs globally; fenoprofen calcium may be procured via their authorized suppliers with GMP certification. Their procurement practices are stringent, aligning with global regulatory expectations.

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Regulatory and Quality Considerations

Ensuring API quality is paramount. Manufacturers with GMP certification, such as those listed above, enable supply chain integrity, batch-to-batch consistency, and compliance with pharmacopoeial standards (USP, EP, BP). Furthermore, APIs with ISO certification and documentation for stability, purity, and residual solvents are critical for regulatory approval in developed markets.

Regulatory agencies such as the US FDA, EMA, and MHRA impose strict documentation and testing requirements, obligating manufacturers to maintain comprehensive quality dossiers. International suppliers with such certifications are considered reliable sources for fenoprofen calcium API.

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Market Trends and Challenges

Despite a stable demand, the fenoprofen calcium API market faces challenges including:

• Supply Chain Disruptions: Geopolitical issues, COVID-19 pandemic implications, and export restrictions can impact supply availability.

• Regulatory Scrutiny: Increasing control over API manufacturing practices mandates continuous compliance, which can limit sourcing options for non-compliant suppliers.

• Pricing Pressures: Competition among suppliers, especially in Asia, drives down prices but can lead to concerns over quality if regulatory standards are not meticulously maintained.

The shift toward integrated supply chains and quality-centric procurement strategies is evident, with pharmaceutical companies increasingly prioritizing suppliers with proven regulatory compliance and consistent quality records.

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Emerging Sources and Future Outlook

Emerging API sources are gaining attention, particularly from suppliers in Southeast Asia and Eastern Europe who aim to meet stringent regulatory standards. Additionally, advancements in synthetic chemistry and process optimization promise improved yields and purity, potentially broadening the base of reliable suppliers for fenoprofen calcium API.

However, due to the relatively small market size compared to other NSAIDs like ibuprofen or naproxen, the market for fenoprofen calcium API remains niche, with supply predominantly from established manufacturers.

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Conclusion

Securing high-quality bulk fenoprofen calcium API requires meticulous supplier selection rooted in compliance, manufacturing robustness, and regulatory standards. Leading suppliers like WuXi AppTec, Hetero Labs, and IPCA Laboratories are industry stalwarts, providing GMP-certified APIs suitable for global markets. As manufacturing technologies evolve and regulatory oversight intensifies, the API sourcing landscape is expected to become more transparent, with increased emphasis on proven quality credentials.

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Key Takeaways

• Limited but reliable supply chain: The fenoprofen calcium API market is concentrated among Asian manufacturers with GMP certification, ensuring global compliance.
• Regulatory compliance is crucial: Only APIs conforming to GMP and pharmacopoeial standards should be considered for regulated markets.
• Quality assurance matters: Suppliers with robust quality controls, stable manufacturing processes, and transparency reduce regulatory and operational risks.
• Emerging suppliers may present opportunities: As regulations tighten, vetted new entrants from emerging markets could become viable sources.
• Supply chain resilience is vital: Diversifying suppliers and maintaining strategic stock levels mitigate risks from geopolitical and pandemic-related disruptions.

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FAQs

1. What are the primary manufacturing regions for fenoprofen calcium API?
The majority of fenoprofen calcium API is produced in China and India, with several reputable GMP-certified facilities capable of meeting international standards.

2. How do I verify the quality of fenoprofen calcium API?
Ensure the supplier possesses GMP certification, provides comprehensive analytical and stability data, and complies with pharmacopoeial standards such as USP or EP. Third-party audits and regulatory approvals further confirm quality.

3. What regulatory considerations should be addressed when sourcing fenoprofen calcium API?
Manufacturers must ensure API batch documentation meets FDA, EMA, or other relevant regulatory authority requirements. Proper documentation, stability data, and analytical certificates are essential.

4. Are there any recent innovations in fenoprofen calcium manufacturing?
While manufacturing processes remain largely traditional, efforts toward green chemistry, process intensification, and yield improvements are ongoing, aiming to reduce costs and enhance purity.

5. What future trends are anticipated in fenoprofen calcium API sourcing?
Growing emphasis on supply chain transparency, quality, and regulatory compliance will drive the adoption of validated suppliers with global certifications, alongside potential new entrants from emerging regions.

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References

1. U.S. Pharmacopoeia (USP). "Fenoprofen Calcium Monograph." [Accessed 2023].
2. European Pharmacopoeia (EP). "Fenoprofen (API) specifications." [Accessed 2023].
3. IQVIA. "Global APIs Market Report," 2022.
4. Industry Reports. "NSAID APIs: Market Dynamics and Key Players," 2022.
5. Manufacturer Websites and Regulatory Filings.

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This comprehensive review aims to guide pharmaceutical professionals and formulators in sourcing reliable, high-quality fenoprofen calcium API, aligning procurement strategies with regulatory and market realities.