Suppliers and packagers for generic pharmaceutical drug: OXICONAZOLE NITRATE

OXICONAZOLE NITRATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharma Canada	OXICONAZOLE NITRATE	oxiconazole nitrate	CREAM;TOPICAL	205076	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1359-1	1 TUBE in 1 CARTON (51672-1359-1) / 15 g in 1 TUBE	2016-03-07
Sun Pharma Canada	OXICONAZOLE NITRATE	oxiconazole nitrate	CREAM;TOPICAL	205076	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1359-2	1 TUBE in 1 CARTON (51672-1359-2) / 30 g in 1 TUBE	2016-03-07
Sun Pharma Canada	OXICONAZOLE NITRATE	oxiconazole nitrate	CREAM;TOPICAL	205076	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1359-3	1 TUBE in 1 CARTON (51672-1359-3) / 60 g in 1 TUBE	2016-03-07
Sun Pharma Canada	OXICONAZOLE NITRATE	oxiconazole nitrate	CREAM;TOPICAL	205076	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1359-8	1 TUBE in 1 CARTON (51672-1359-8) / 90 g in 1 TUBE	2016-03-07
Fougera Pharms	OXISTAT	oxiconazole nitrate	CREAM;TOPICAL	019828	NDA AUTHORIZED GENERIC	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0358-30	30 g in 1 TUBE (0168-0358-30)	2016-03-09
Fougera Pharms	OXISTAT	oxiconazole nitrate	CREAM;TOPICAL	019828	NDA AUTHORIZED GENERIC	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0168-0358-60	60 g in 1 TUBE (0168-0358-60)	2016-03-09

Oxiconazole Nitrate Suppliers: Global Landscape and Key Considerations

Last updated: February 19, 2026

This report analyzes the global supply landscape for oxiconazole nitrate, a topical antifungal medication. It identifies key manufacturers, assesses production capacity, and outlines regulatory and quality requirements critical for sourcing. The analysis aims to inform pharmaceutical companies on strategic supplier selection for oxiconazole nitrate.

Who are the primary global manufacturers of oxiconazole nitrate?

The global supply of oxiconazole nitrate is concentrated among a limited number of manufacturers, primarily located in Asia and Europe. These companies specialize in Active Pharmaceutical Ingredient (API) production and adhere to stringent quality standards.

• Anhui Pangtong Fine Chemical Co., Ltd. (China): A significant producer, Anhui Pangtong specializes in APIs and pharmaceutical intermediates. The company supplies oxiconazole nitrate and other antifungal agents.
• Jiangsu Kaimen Pharmaceutical Co., Ltd. (China): This manufacturer is recognized for its production of various APIs, including oxiconazole nitrate. They focus on meeting international pharmacopeial standards.
• Vivimed Labs Limited (India): Vivimed Labs is a global pharmaceutical company with a strong API division. They produce oxiconazole nitrate as part of their broader portfolio of dermatological APIs.
• Neumedicines S.A. (Spain): Neumedicines is a European supplier of APIs. Their involvement in oxiconazole nitrate production signifies a presence in the Western hemisphere market.
• Other Manufacturers: Several smaller or regional manufacturers in China and India also contribute to the global supply, often catering to specific market needs or contract manufacturing agreements.

The production capacity for oxiconazole nitrate is not publicly disclosed in granular detail by most manufacturers. However, based on market presence and reported export volumes, Anhui Pangtong and Jiangsu Kaimen are considered major suppliers with substantial production capabilities. Vivimed Labs also possesses significant capacity due to its established global footprint in API manufacturing.

What are the key regulatory and quality standards for oxiconazole nitrate API?

Sourcing oxiconazole nitrate API necessitates adherence to several critical regulatory and quality standards to ensure product safety, efficacy, and market compliance. These standards are enforced by regulatory bodies worldwide and are essential for finished drug product approval.

• Pharmacopeial Standards: Oxiconazole nitrate API must meet the specifications outlined in major pharmacopeias, including:
  • United States Pharmacopeia (USP): The USP monograph for oxiconazole nitrate defines identity, purity, strength, and quality characteristics. Compliance ensures suitability for the U.S. market.
  • European Pharmacopoeia (Ph. Eur.): Similar to the USP, the Ph. Eur. provides detailed specifications for oxiconazole nitrate, crucial for products intended for European Union member states.
  • Japanese Pharmacopoeia (JP): For products targeting the Japanese market, compliance with JP standards is mandatory.
• Good Manufacturing Practices (GMP): All API manufacturers must operate under current Good Manufacturing Practices (cGMP). This is a regulatory requirement enforced by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). GMP compliance covers all aspects of production, including:
  • Quality management systems
  • Personnel training and qualification
  • Facility and equipment design and maintenance
  • Raw material control
  • Process validation and control
  • Packaging and labeling
  • Laboratory controls and testing
  • Record-keeping and documentation
• Drug Master Files (DMFs): Manufacturers often submit DMFs to regulatory agencies (e.g., FDA, EMA). A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. Pharmaceutical companies reference these DMFs in their own drug applications, simplifying the regulatory review process.
• Certificates of Analysis (CoAs): Each batch of oxiconazole nitrate API supplied must be accompanied by a comprehensive CoA. This document details the results of all quality control tests performed on the batch, confirming it meets specified parameters (e.g., assay, impurities, residual solvents, heavy metals).
• Impurity Profiling: Manufacturers must rigorously control and characterize impurities. Regulatory guidelines, such as those from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), set limits for known, unknown, and genotoxic impurities.

Table 1 details common quality attributes and acceptance criteria for oxiconazole nitrate API.

Attribute	Typical Specification Range	Testing Method (Example)
Appearance	White to off-white crystalline powder	Visual Inspection
Identification	Conforms to USP/Ph. Eur.	IR Spectroscopy, HPLC
Assay	98.0% – 102.0% (on dried basis)	HPLC
Water Content	≤ 1.0%	Karl Fischer Titration
Residue on Ignition	≤ 0.1%	Gravimetry
Heavy Metals	≤ 20 ppm	USP/Ph. Eur. Methods
Related Substances	Meets pharmacopeial limits	HPLC
Residual Solvents	Meets ICH Q3C limits	GC

Note: Specific acceptance criteria can vary based on the pharmacopeia and the intended market.

What are the critical considerations for supplier qualification and risk management?

Selecting and managing suppliers for oxiconazole nitrate API involves a thorough qualification process and robust risk management strategies to ensure supply chain reliability and product quality.

Supplier Qualification Process

The qualification of an oxiconazole nitrate API supplier should encompass a multi-faceted evaluation:

1. Regulatory Compliance Audit:
   • Verification of cGMP compliance through on-site audits.
   • Review of regulatory filings (e.g., DMF status, inspection history by FDA, EMA, or other authorities).
   • Assessment of quality agreements and their enforceability.
2. Technical Capability Assessment:
   • Evaluation of manufacturing processes, including process validation and control strategies.
   • Review of analytical testing capabilities and validation of analytical methods.
   • Assessment of the supplier's impurity control strategy and historical impurity data.
   • Evaluation of change control procedures and notification processes for significant changes.
3. Quality Management System (QMS) Review:
   • Assessment of the supplier's QMS documentation, including SOPs, batch records, and deviation management.
   • Review of CAPA (Corrective and Preventive Actions) effectiveness.
   • Evaluation of internal audit programs.
4. Supply Chain and Business Continuity:
   • Assessment of raw material sourcing and supplier qualification by the API manufacturer.
   • Evaluation of production capacity and lead times.
   • Review of business continuity plans, including disaster recovery and contingency planning for supply disruptions.
   • Financial stability assessment of the supplier.
5. Ethical and Social Responsibility:
   • Assessment of labor practices and compliance with ethical standards.
   • Evaluation of environmental compliance.

Risk Management Strategies

Implementing comprehensive risk management is crucial for mitigating potential disruptions and quality issues:

• Dual Sourcing Strategy: Establishing relationships with at least two qualified suppliers, preferably from different geographic regions, can provide a critical backup in case of supply interruptions. This mitigates single-point-of-failure risks.
• Inventory Management: Maintaining adequate safety stock of oxiconazole nitrate API to cover potential lead time variations or unforeseen supply disruptions.
• Proactive Communication: Fostering open and transparent communication channels with suppliers regarding production schedules, potential issues, and regulatory changes.
• Regular Audits and Performance Monitoring: Conducting periodic re-audits and continuously monitoring supplier performance against agreed-upon Key Performance Indicators (KPIs) such as on-time delivery, quality defect rates, and responsiveness.
• Contractual Safeguards: Ensuring robust supply agreements that clearly define quality specifications, delivery terms, change control notifications, intellectual property protection, and dispute resolution mechanisms.
• Geopolitical and Economic Risk Assessment: Monitoring geopolitical stability, trade policies, currency fluctuations, and economic conditions in the regions where suppliers are located.
• Contingency Planning: Developing documented contingency plans for various scenarios, including natural disasters, transportation disruptions, or regulatory actions against a supplier.

Table 2 outlines key risk factors and potential mitigation strategies for oxiconazole nitrate API supply.

Risk Factor	Potential Impact	Mitigation Strategies
Regulatory Non-Compliance	API batch rejection, import/export restrictions	Thorough initial qualification, ongoing regulatory monitoring, proactive engagement with regulatory agencies, robust QMS verification.
Quality Defects/Impurity Excursions	Finished product recalls, patient safety concerns	Rigorous analytical testing, process validation, impurity profiling, batch-to-batch consistency checks, supplier change control management.
Supply Chain Disruptions (Logistics, Raw Mat.)	Production delays, stock-outs, increased costs	Dual sourcing, safety stock, diversified logistics providers, pre-qualification of secondary raw material suppliers, geopolitical risk assessment.
Geopolitical Instability	Trade restrictions, increased tariffs, supply halts	Diversified supplier base across regions, monitoring of trade agreements and political climate, flexible logistics planning.
Supplier Financial Instability	Production stoppage, inability to fulfill orders	Financial health assessments during qualification and periodically, contractual clauses for bankruptcy protection, secondary supplier validation.
Intellectual Property Infringement	Legal disputes, product development delays	Robust IP clauses in supply agreements, due diligence on supplier's IP compliance, secure data handling protocols.

How does the supply chain for oxiconazole nitrate compare to other topical antifungal APIs?

The supply chain dynamics for oxiconazole nitrate share similarities with other topical antifungal APIs, but with distinct characteristics influenced by market size, patent status, and manufacturing complexity.

• Market Volume and Competition: Oxiconazole nitrate, while established, may have a smaller global market volume compared to widely used antifungals like clotrimazole or miconazole. This can lead to fewer, more specialized API manufacturers, potentially impacting price competitiveness and lead times. APIs with larger market volumes typically attract more manufacturers, fostering greater competition and potentially lower prices.
• Patent Expiration and Generics: Oxiconazole nitrate is an older molecule, and its primary patents have long expired. This has allowed for the proliferation of generic drug products and, consequently, a stable demand for the API from multiple generic manufacturers. However, the number of API suppliers may not be as extensive as for APIs used in blockbuster drugs with ongoing patent protection or those with simpler synthesis routes.
• Manufacturing Complexity and Cost: The synthesis of oxiconazole nitrate involves multiple chemical steps. Manufacturers with optimized processes and economies of scale in regions with lower manufacturing costs (e.g., China, India) tend to dominate the supply. APIs with simpler synthesis or those requiring highly specialized biotechnology production can exhibit different supply chain structures. For instance, complex biologic APIs often have a highly concentrated supplier base due to significant R&D investment and specialized manufacturing infrastructure.
• Regulatory Scrutiny: As a pharmaceutical API, oxiconazole nitrate is subject to strict regulatory oversight regardless of its market volume. However, APIs used in broad-spectrum or first-line treatments might face even more intense scrutiny from regulatory agencies due to their widespread use and potential for resistance development. The qualification process for oxiconazole nitrate suppliers, as detailed earlier, is generally consistent across most APIs, emphasizing GMP, impurity control, and robust quality systems.
• Geographic Concentration: Similar to many APIs, oxiconazole nitrate production is geographically concentrated, primarily in Asia. This is driven by cost efficiencies, established chemical manufacturing infrastructure, and skilled labor. Other topical antifungals may also exhibit similar geographic concentration, although the specific dominant regions might shift based on manufacturing expertise and historical investment.

The supply chain for oxiconazole nitrate is characterized by established, GMP-compliant manufacturers, primarily in Asia, serving a global generic market. While not as high-volume as some other antifungals, its stable demand ensures a consistent, albeit less competitive, supply base.

Key Takeaways

• Global oxiconazole nitrate API production is primarily concentrated in China and India, with key manufacturers including Anhui Pangtong Fine Chemical, Jiangsu Kaimen Pharmaceutical, and Vivimed Labs. European supplier Neumedicines also plays a role.
• Compliance with USP, Ph. Eur., and JP pharmacopeial standards, along with stringent cGMP, is mandatory for oxiconazole nitrate API intended for pharmaceutical use. Drug Master Files (DMFs) are common submission tools.
• Supplier qualification must encompass regulatory compliance, technical capability, QMS review, and supply chain reliability. Robust risk management strategies include dual sourcing, inventory management, proactive communication, and contractual safeguards.
• The oxiconazole nitrate supply chain reflects its status as an established, off-patent API with a focus on cost-effective, GMP-compliant manufacturing in Asia, similar to many other generic topical antifungal APIs.

FAQs

1. What is the typical lead time for an order of oxiconazole nitrate API? Typical lead times for oxiconazole nitrate API can range from 8 to 16 weeks, depending on the manufacturer's production schedule, order volume, and current market demand. Rush orders may be possible with expedited fees.

2. Are there specific requirements for the packaging and shipping of oxiconazole nitrate API? Yes, oxiconazole nitrate API must be packaged in robust, inert containers that protect it from light, moisture, and contamination. Shipping conditions must maintain specified temperature and humidity controls to prevent degradation, and all shipments must comply with international hazardous materials transportation regulations if applicable.

3. How can a pharmaceutical company verify a supplier's GMP compliance remotely? Remote verification can involve reviewing audit reports from recognized third-party auditors, inspecting regulatory inspection history (e.g., FDA EudraGMDP database), requesting detailed quality agreements, and conducting virtual audits via video conferencing to observe operations and documentation practices.

4. What are the most common impurities found in oxiconazole nitrate API, and how are they controlled? Common impurities can include related substances from synthesis (e.g., unreacted starting materials, intermediate byproducts) and degradation products. Control is achieved through optimized synthesis processes, rigorous in-process controls, validated analytical testing according to pharmacopeial methods, and strict adherence to ICH guidelines for impurity limits.

5. Does the geographic origin of oxiconazole nitrate API significantly impact its quality? While manufacturing quality is dictated by adherence to GMP and pharmacopeial standards rather than country of origin, geographic origin can influence supply chain risks (e.g., geopolitical stability, logistics) and cost. Reputable manufacturers in any region that meet global quality standards will produce API of equivalent quality.

Citations

[1] United States Pharmacopeial Convention. (n.d.). United States Pharmacopeia. Retrieved from usp.org

[2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from edqm.eu

[3] Japanese Pharmacopoeial Society. (n.d.). Japanese Pharmacopoeia. Retrieved from jp.pharmaceutical-dictionary.info

[4] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from fda.gov

[5] European Medicines Agency. (n.d.). Good Manufacturing Practice. Retrieved from ema.europa.eu

[6] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from ich.org