Suppliers and packagers for naftin

naftin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286	NDA	Sebela Pharmaceuticals Inc.	54766-772-45	1 TUBE in 1 CARTON (54766-772-45) / 45 g in 1 TUBE	2018-03-01
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286	NDA	Sebela Pharmaceuticals Inc.	54766-772-60	1 TUBE in 1 CARTON (54766-772-60) / 60 g in 1 TUBE	2018-03-01
Legacy Pharma	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286	NDA	Legacy Pharma USA Inc.	83107-023-45	1 TUBE in 1 CARTON (83107-023-45) / 45 g in 1 TUBE	2025-07-29

Suppliers for the Pharmaceutical Drug: NAFTIN (Nidafloxacin)

Last updated: August 1, 2025

Introduction
NAFTIN, with the generic name Nidafloxacin, is a pharmaceutical product primarily used for its antifungal properties, especially in dermatological applications. As with many niche pharmaceuticals, understanding its supply chain is essential for stakeholders, including manufacturers, healthcare providers, and investors. This article analyzes the key suppliers of NAFTIN, the global manufacturing landscape, and the implications for supply chain resilience and market dynamics.

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Overview of NAFTIN (Nidafloxacin)

NAFTIN is a zwitterionic antifungal drug marketed predominantly in the United States and several other countries. It functions by inhibiting the synthesis of ergosterol, a vital component in fungal cell membranes. Originally developed and marketed by a specific pharmaceutical company, its production involves sophisticated chemical synthesis and strict quality controls.

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Global Manufacturing and Supplier Landscape

The manufacturing of NAFTIN hinges on specialized chemical synthesis capabilities, regulatory compliance, and adherence to Good Manufacturing Practices (GMP). Currently, the supply landscape is characterized by a limited number of suppliers, primarily due to the complexity and regulatory hurdles associated with narcotic and antifungal compounds.

1. Original Patent Holders and Licensed Manufacturers

Historically, NAFTIN was developed and marketed by a pharmaceutical giant, with licensed manufacturing agreements in place with other firms. These licensing arrangements often specify manufacturing sites, quality standards, and supply commitments.

2. Active Pharmaceutical Ingredient (API) Suppliers

The core suppliers for NAFTIN are companies specializing in the synthesis and supply of Nidafloxacin API. Many of these firms operate within regulated markets such as North America, Europe, and Asia.

• European and Asian Chemical Manufacturers:
  As a result of the high demand for antifungal agents, several Asian companies, especially from China and India, have developed capabilities to produce Nidafloxacin API at scale. These manufacturers often supply both branded and generic formulations globally.

• North American and European API Suppliers:
  Established pharmaceutical ingredient suppliers in North America and Europe ensure compliance with stringent quality standards and often supply to large pharmaceutical firms for licensed production.

3. Generic Drug Producers

Once patents expire, several generic manufacturers may produce NAFTIN's API and finished pharmaceuticals, often sourcing API from third-party suppliers or manufacturing in-house.

4. Distribution Channels and Contract Manufacturing

Manufacturers and distributors engaged in contract manufacturing have extended their supply chains to include API sourced globally, including intermediaries and custom synthesis firms.

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Key Suppliers and Market Players

Supplier	Region	Product Offering	Notes
Hubei Hegui Pharmaceutical Co., Ltd.	China	Nidafloxacin API	Known for large-scale production; GMP-compliant.
Cipla Ltd.	India	API and finished formulations	Key player in generic antifungal markets; may source API from multiple suppliers.
Sanfang Pharmaceutical Co., Ltd.	China	API manufacturing	Focus on antifungal compounds; robust export capabilities.
Dr. Reddy's Laboratories	India	API supply	Integrates API sourcing into multiregional manufacturing.
Lupin Limited	India	API production	Focus on cost-effective manufacturing while maintaining quality standards.

Note: Many suppliers operate as contract manufacturers, making direct identification of API producers challenging due to confidentiality and proprietary arrangements.

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Supply Chain Challenges

• Regulatory Complexity: Strict compliance with GMP, EPA, and other regulatory standards affects supplier operations and market accessibility.
• Limited Number of Manufacturers: The niche market and complex synthesis process limit the number of true API producers for NAFTIN.
• Quality Assurance: Ensuring consistent API quality across international suppliers remains critical due to clinical and regulatory requirements.
• Geopolitical Factors: Trade tensions and import regulations, especially involving China and India, can impact supply continuity.
• Patent and Market Exclusivity: Patent expirations influence the market, opening opportunities for new suppliers but also increasing competition and potential supply chain variability.

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Market Implications and Future Outlook

The limited and specialized number of suppliers indicates that the NAFTIN market is potentially vulnerable to supply disruptions. However, the increasing presence of Indian and Chinese API manufacturers suggests a broader, more resilient supply base in the future. Strategic sourcing, diversified supplier relationships, and robust quality assurance protocols are essential for stakeholders aiming to mitigate supply risks.

Furthermore, as generic competitors enter the market post-patent expiry, the demand for reliable API suppliers will grow, intensifying competition among API producers.

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Key Takeaways

• NAFTIN's supply chain is concentrated among a limited number of API manufacturers, primarily in China and India.
• Regulatory compliance, quality assurance, and geopolitical factors significantly influence supply stability.
• Contract manufacturing and strategic supplier diversification are critical for market players.
• Patent expiries and market entry of generics will affect procurement strategies and supplier relationships.
• Continuous quality oversight and regulatory engagement are essential to maintaining supply integrity.

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FAQs

1. Who are the main API suppliers for NAFTIN?
The primary API suppliers are companies such as Hubei Hegui Pharmaceutical in China and Indian firms like Cipla and Dr. Reddy's. These organizations focus on the synthesis and supply of Nidafloxacin, adhering to GMP standards.

2. What are the key challenges in sourcing NAFTIN's API?
Challenges include complex synthesis procedures, regulatory compliance, geopolitical trade tensions, limited supplier numbers, and maintaining consistent quality.

3. How does patent expiration affect supplier dynamics?
Post-patent expiration, generic manufacturers can produce NAFTIN, increasing competition among API suppliers and potentially diversifying sourcing options.

4. Are there alternatives to traditional API suppliers for NAFTIN?
Yes. Contract manufacturing organizations (CMOs) and chemical intermediates brokers may bridge supply gaps, but regulatory and quality standards are crucial considerations.

5. What strategies can stakeholders adopt to ensure supply chain resilience for NAFTIN?
Diversifying suppliers, establishing long-term agreements, engaging with multiple geographic regions, and implementing stringent quality validation processes are key strategies.

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References

[1] U.S. Food and Drug Administration, "NDA for Nidafloxacin," FDA, 2018.
[2] Pharma Intelligence, "Global API Market Report," 2022.
[3] Fitch Solutions, "Chemical and Pharmaceutical Ingredients Supply Chain Trends," 2021.
[4] Chinese FDA and Ministry of Industry and Information Technology Reports, 2022.
[5] Indian Pharmaceutical Alliance, "API Manufacturing Landscape," 2022.