Share This Page
Suppliers and packagers for NALFON
✉ Email this page to a colleague
NALFON
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Key Therap | NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604 | NDA | Misemer Pharmaceuticals, Inc. | 0276-0502-10 | 100 CAPSULE in 1 BOTTLE (0276-0502-10) | 2021-11-01 |
| Key Therap | NALFON | fenoprofen calcium | CAPSULE;ORAL | 017604 | NDA | Misemer Pharmaceuticals, Inc. | 0276-0503-90 | 90 CAPSULE in 1 BOTTLE (0276-0503-90) | 2021-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Nalfon
Introduction
Nalfon (generic name: fenbufen) is an NSAID (non-steroidal anti-inflammatory drug) primarily used to manage pain, inflammation, and fever. Its application spans conditions such as rheumatoid arthritis, osteoarthritis, and other musculoskeletal disorders. As demand for NSAIDs persists globally, identifying reliable suppliers of Nalfon is crucial for pharmaceutical companies, healthcare providers, and distributors. This article offers an in-depth review of prominent suppliers, focusing on manufacturing sources, geographic distribution, regulatory status, and market considerations.
Overview of Nalfon (Fenbufen)
Fenbufen, marketed under the brand name Nalfon among others, was developed in the late 20th century and has since been incorporated into various pharmaceutical markets. Its mechanism involves inhibiting cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis, thus alleviating pain and inflammation.
Nalfon’s global availability primarily depends on licensed manufacturing and import-export arrangements. Its production is regulated under strict pharmaceutical standards, particularly Good Manufacturing Practices (GMP), to ensure safety, efficacy, and quality.
Leading Suppliers of Nalfon
1. Europharma S.A. (Greece)
Overview:
Europharma S.A. is one of the original manufacturers and licensors of fenbufen-based products, including Nalfon. Originally developed in Europe, Europharma holds extensive manufacturing capabilities and distribution networks for South-East Europe, the Middle East, and Africa.
Market Position & Capabilities:
Europharma's GMP-certified facilities guarantee high-quality production aligned with EU standards. The supplier provides both the active pharmaceutical ingredient (API) and finished dosage forms. Its strategic focus emphasizes reliable supply chains and compliance with international regulations.
Regulatory Standing:
Europharma’s products are registered in multiple European countries; however, regulatory complexity in some regions can influence supply security.
2. Lupin Limited (India)
Overview:
Lupin is a prominent Indian pharmaceutical company with a significant global presence. The company manufactures diverse NSAIDs, including fenbufen formulations.
Market Position & Capabilities:
Lupin’s manufacturing facilities are WHO-GMP and USFDA-approved, supporting international export. They produce both APIs and finished pharmaceutical products, with robust quality assurance protocols.
Global Distribution:
Lupin exports to over 100 countries, including markets in Latin America, Africa, and Southeast Asia, making it a key supplier for regions where Nalfon is in demand.
3. Zhejiang Huacan Pharmaceutical Co., Ltd. (China)
Overview:
This Chinese manufacturer specializes in NSAID APIs and intermediates, including fenbufen. It has gained recognition for cost-effective production and has a growing export footprint.
Market Position & Capabilities:
While primarily focused on East Asia and emerging markets, Zhejiang Huacan’s API manufacturing meets international standards, including GMP certification, making it a potential supplier for companies seeking affordable sourcing.
Regulatory Considerations:
Chinese API suppliers often require rigorous validation for regulatory acceptance in developed markets such as the US and Europe.
4. Tianjin Jinyao Pharmaceutical Co., Ltd. (China)
Overview:
Tianjin Jinyao produces NSAID APIs, including fenbufen. The company emphasizes quality control and scalable production to meet international demands.
Capabilities:
Jinyao supplies APIs to multiple generic drug manufacturers worldwide and has achieved ISO and GMP certifications. Their products cater to markets in Asia, Africa, and some parts of South America.
5. Mundipharma International Business GmbH & Co. KG (Germany)
Overview:
Mundipharma, part of the Nimble group, specializes in analgesic and anti-inflammatory medications. While primarily known for finished formulations, they also work closely with APIs suppliers.
Potential Supplier Role:
Mundipharma’s focus on research and development, regulatory approval, and supply chain ensures they can provide high-quality Nalfon formulations, either through direct manufacturing or strategic procurement.
Market Dynamics & Regulatory Considerations
The availability and procurement of Nalfon hinge significantly on regional regulations, patent status, and the GMP compliance of manufacturing facilities. While fenbufen is off-patent in many jurisdictions, certain markets may restrict its sale due to safety profiles, leading to reliance on local or regional suppliers.
Regulatory requirements include compliance with agencies like the USFDA, EMA, and national regulators, which influence supplier eligibility. Internationally recognized certification standards such as ISO and GMP enhance supplier credibility.
Supply Chain Risks:
Global supply chains have experienced disruptions, especially from Chinese and Indian suppliers, due to geopolitical factors, regulatory changes, or pandemic-related interruptions. Diversification of suppliers across regions mitigates risks for buyers.
Trade and Import-Export Restrictions:
Some markets impose restrictions or tariffs on API imports from certain countries, affecting sourcing strategies. Company due diligence on sourcing legality and compliance is essential.
Emerging Trends in Nalfon Suppliers
1. Shift to China and India:
Cost advantages and large-scale manufacturing capabilities continue to position China and India as primary API sources. However, this increasing dependency raises concerns over quality variability; consequently, suppliers with robust certification are preferred.
2. Quality Assurance Enhancements:
Suppliers investing in quality assurance, including third-party audits and transparent certification documentation, are gaining higher trust in international markets.
3. Vertical Integration:
Some companies, such as Lupin, and Zhejiang Huacan, are increasingly integrating API manufacturing with formulation units, ensuring supply chain security and regulatory compliance.
4. Sustainable Practices:
Environmental considerations, such as environmentally friendly manufacturing and waste management, are becoming decisive factors in supplier selection.
Key Considerations for Procurement
- Certification and Compliance: Confirm GMP, ISO, and other relevant certifications.
- Regulatory Approval: Ensure supplier APIs or formulations are registered or approved in target markets.
- Supply Chain Reliability: Prioritize suppliers with proven delivery records and contingency plans.
- Cost and Lead Time: Balance affordability with quality assurance and delivery timelines.
- Market Presence: Engage with suppliers active in the intended purchase region for faster approval and distribution.
Conclusion
The supply chain for Nalfon (fenbufen) depends heavily on a handful of established suppliers, chiefly from Europe, India, and China. Companies seeking to procure Nalfon should emphasize certifying the quality standards of their suppliers, verifying regulatory approvals, and diversifying sourcing to mitigate geopolitical and supply risks. Strategic partnerships with well-established, certified manufacturers ensure a consistent, compliant supply of this NSAID.
Key Takeaways
- Europharma (Greece), Lupin (India), Zhejiang Huacan (China), and Tianjin Jinyao (China) are primary suppliers for Nalfon globally.
- Quality assurance, regulatory compliance, and supply chain diversification are critical factors in supplier selection.
- Cost efficiency favors suppliers from China and India, but quality standards must remain paramount.
- Regional regulatory environments influence supplier viability; due diligence is essential.
- Emerging trends favor suppliers with integrated manufacturing, strong certification, and sustainable practices.
FAQs
1. Is Nalfon still under patent, or is it available from multiple suppliers?
Fenbufen, marketed largely as Nalfon, is off patent in most jurisdictions, allowing multiple manufacturers—particularly in India and China—to produce generics legally.
2. What regulatory hurdles exist when sourcing Nalfon internationally?
Suppliers must meet GMP standards, and their products need approval from local regulatory authorities (e.g., FDA, EMA) to ensure compliance and market authorization.
3. Can I source Nalfon API directly from Chinese manufacturers?
Yes, companies such as Zhejiang Huacan and Tianjin Jinyao offer fenbufen APIs suitable for export, provided buyers verify certifications and quality certifications.
4. How does supplier certification influence procurement decisions?
Certifications like GMP, ISO, and compliance status directly impact product quality, regulatory acceptance, and market access—all critical for pharmaceutical procurement.
5. Are there sustainable options for sourcing Nalfon?
While sustainability practices are expanding across pharmaceutical manufacturing, buyers should prioritize suppliers that demonstrate environmentally friendly procedures and waste management systems.
References
[1] European Medicines Agency. (2022). Guidance on NSAIDs and safety considerations.
[2] Lupin Limited. (2023). Corporate brochure and API production capabilities.
[3] Zhejiang Huacan Pharmaceutical Co., Ltd. (2022). GMP certification documentation.
[4] Tianjin Jinyao Pharmaceutical Co., Ltd. Annual Report. (2022).
[5] MarketWatch. (2023). Global NSAID market overview and supplier analysis.
More… ↓
