Bulk Pharmaceutical API Sources for ECONAZOLE NITRATE

Bulk Pharmaceutical API Sources for ECONAZOLE NITRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		68589
ISpharm		I06-189
MP Biomedicals		157897
ISpharm		I06-0189
MolPort		MolPort-003-666-381
Hangzhou APIChem Technology		AC-1113
ISpharm		I06-1860

Econazole Nitrate API Sourcing Landscape

Last updated: February 19, 2026

This report analyzes the current bulk active pharmaceutical ingredient (API) sourcing landscape for Econazole Nitrate, focusing on key manufacturers, production capacities, regulatory compliance, and pricing trends. The data presented aids stakeholders in R&D, procurement, and investment in making informed strategic decisions.

Who Are the Primary Global Manufacturers of Econazole Nitrate API?

The global supply of Econazole Nitrate API is concentrated among a limited number of manufacturers, primarily located in China and India, with some European producers also active. These companies possess the necessary chemical synthesis capabilities and comply with international pharmaceutical manufacturing standards.

Key manufacturers include:

• Asiatic Laboratories (India): A significant producer with established export channels.
• Huzhou Botai Chemical Co., Ltd. (China): Known for substantial production volume and competitive pricing.
• Jubilant Pharmova Limited (India): A diversified pharmaceutical company with a dedicated API manufacturing arm.
• Lianyungang Kede Chemical Co., Ltd. (China): Another major Chinese supplier contributing to global volume.
• Ningbo Orient Chemical Co., Ltd. (China): Offers a consistent supply with adherence to quality specifications.
• Sun Pharmaceutical Industries Ltd. (India): While a large finished dosage form manufacturer, they also produce select APIs, including Econazole Nitrate.
• TAPI Co. (India): A prominent API manufacturer with a broad product portfolio.
• Xi'an Tianrui Biotech Co., Ltd. (China): Emerging as a competitive supplier in the market.
• Zhejiang NHU Co., Ltd. (China): A large chemical conglomerate with pharmaceutical API operations.

These manufacturers vary in their production scales, ranging from hundreds to thousands of kilograms annually. Their capacity utilization is influenced by market demand, raw material availability, and regulatory approvals.

What Are the Regulatory Requirements for Econazole Nitrate API Production and Supply?

Manufacturing and supplying Econazole Nitrate API requires strict adherence to Good Manufacturing Practices (GMP) as defined by major regulatory bodies. Compliance with these standards is essential for API acceptance by pharmaceutical companies and for its use in finished drug products.

Key regulatory considerations include:

• ICH Q7 Guidelines: This guideline provides the "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients," which is the international standard. Manufacturers must demonstrate compliance through regular audits.
• U.S. Food and Drug Administration (FDA): APIs intended for use in drugs marketed in the United States must comply with FDA regulations. This includes facility registration and potential site inspections.
• European Medicines Agency (EMA): For APIs used in products sold in the European Union, compliance with EMA guidelines and national competent authorities' requirements is mandatory. This often involves the issuance of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP).
• Pharmacopoeial Standards: API must meet the purity and quality specifications outlined in the relevant pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or Japanese Pharmacopoeia (JP).
• Drug Master Files (DMFs): Manufacturers typically file DMFs with regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality control of the API. This allows drug product manufacturers to reference the DMF in their own marketing authorization applications without disclosing proprietary API manufacturing details.

The ability of a manufacturer to provide comprehensive regulatory documentation, including Certificates of Analysis (CoA), stability data, and supporting regulatory filings (DMFs, CEPs), is a critical factor for sourcing decisions.

What is the Current Production Capacity and Market Volume for Econazole Nitrate API?

Estimating precise global production capacity for Econazole Nitrate API is challenging due to proprietary information. However, industry analysis suggests a total global annual capacity exceeding 500 metric tons. The actual market volume consumed is lower, estimated between 150 to 250 metric tons annually, reflecting a healthy capacity buffer.

Production capacity is distributed as follows:

• China: Accounts for approximately 60-70% of the global manufacturing capacity.
• India: Represents about 25-35% of the global manufacturing capacity.
• Europe and Other Regions: Contribute the remaining 5-10%.

Factors influencing market volume include:

• Demand for Topical Antifungal Treatments: Econazole Nitrate is primarily used in topical formulations (creams, powders, sprays) for treating fungal skin infections. The prevalence of these conditions drives demand.
• Generic Drug Market Penetration: As a well-established molecule, Econazole Nitrate is widely available as a generic, contributing to its sustained demand.
• Competition from Alternative Antifungals: The market for antifungals includes other active ingredients, influencing the specific demand for Econazole Nitrate.

The market is characterized by a steady demand, with growth rates typically aligning with the overall pharmaceutical market for topical treatments, generally in the low single digits annually.

How Do Pricing and Cost Structures Vary Among API Suppliers?

Econazole Nitrate API pricing is influenced by several factors, including raw material costs, manufacturing efficiency, regulatory compliance overhead, production scale, and geographical location of the supplier.

Typical price ranges per kilogram, depending on order volume and quality specifications:

• Large Volume Orders (1000 kg+): \$50 - \$120 USD/kg
• Medium Volume Orders (100 kg - 1000 kg): \$70 - \$150 USD/kg
• Small Volume Orders (less than 100 kg): \$90 - \$200+ USD/kg

Key cost drivers for manufacturers:

• Raw Material Procurement: The cost of key starting materials and intermediates, such as 1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol and 4-chlorobenzyl chloride, is a significant component. Fluctuations in these precursor markets directly impact API costs.
• Energy and Utilities: Chemical synthesis is an energy-intensive process.
• Labor Costs: Manufacturing labor costs vary significantly by region, with China and India generally offering lower labor expenses than Europe.
• Quality Control and Assurance (QC/QA): Robust QC/QA systems, including analytical testing and documentation, add to the cost.
• Regulatory Compliance: Maintaining GMP certification, preparing and updating DMFs, and undergoing audits represent substantial operational expenses.
• Scale of Operation: Larger production volumes generally lead to lower per-unit manufacturing costs due to economies of scale.

Suppliers in China and India often offer more competitive pricing due to lower manufacturing overheads compared to European manufacturers. However, European suppliers may command higher prices due to stringent regulatory adherence and perceived higher quality assurance.

What Are the Key Risks and Mitigation Strategies in Sourcing Econazole Nitrate API?

Sourcing Econazole Nitrate API involves inherent risks that necessitate careful management to ensure supply chain stability and product quality.

Key risks include:

• Supply Chain Disruptions:
  • Causes: Geopolitical instability, natural disasters, pandemics, transportation issues, single-source dependency on critical raw materials.
  • Mitigation: Diversify supplier base across different geographic regions. Maintain safety stock of API and critical raw materials. Develop strong relationships with multiple raw material suppliers.
• Quality and Regulatory Non-Compliance:
  • Causes: Inadequate GMP adherence, poor quality control, insufficient documentation, unannounced regulatory observations.
  • Mitigation: Conduct thorough supplier qualification and audits (both remote and on-site). Review all regulatory documentation (DMFs, CEPs, CoAs) meticulously. Implement stringent incoming material testing. Stay updated on evolving regulatory requirements.
• Price Volatility:
  • Causes: Fluctuations in raw material costs, changes in manufacturing capacity, currency exchange rate shifts, increased regulatory burdens.
  • Mitigation: Negotiate long-term supply agreements with fixed or capped price escalation clauses. Monitor raw material markets. Explore hedging strategies where applicable.
• Intellectual Property (IP) Risks:
  • Causes: Patent expiry issues, counterfeit products, trade secret infringement. While Econazole Nitrate is a well-established generic, its synthesis pathways can still have associated patents.
  • Mitigation: Conduct thorough freedom-to-operate (FTO) analyses for manufacturing processes. Ensure suppliers have clear IP ownership and do not infringe on third-party rights.
• Lead Time Variability:
  • Causes: Production scheduling conflicts, shipping delays, customs clearance issues.
  • Mitigation: Establish realistic lead times with suppliers and build buffer into production planning. Utilize expedited shipping options if necessary. Maintain close communication with logistics providers.

A proactive risk management approach, including dual sourcing, robust supplier audits, and continuous monitoring of market and regulatory landscapes, is crucial for securing a stable and compliant supply of Econazole Nitrate API.

Key Takeaways

• The global Econazole Nitrate API market is primarily served by manufacturers in China and India, with significant production capacity exceeding current demand.
• Regulatory compliance, including GMP standards and pharmacopoeial specifications, is paramount. Manufacturers must provide comprehensive documentation such as DMFs and CoAs.
• Pricing is sensitive to raw material costs, manufacturing scale, and regional labor expenses, with Asian suppliers generally offering more competitive rates.
• Key sourcing risks include supply chain disruptions, quality non-compliance, and price volatility, which can be mitigated through diversification, rigorous audits, and proactive risk management.

Frequently Asked Questions

1. What is the typical purity specification for Econazole Nitrate API required for pharmaceutical formulations? The purity typically required is NLT 98.0% and NMT 102.0% on the anhydrous basis, as per pharmacopoeial standards such as USP and Ph. Eur. Specific impurity profiles are also critical.
2. Which regulatory bodies grant Certificates of Suitability (CEP) for Econazole Nitrate API? The European Directorate for the Quality of Medicines & HealthCare (EDQM) grants CEPs, which are recognized in many countries that have adopted the European Pharmacopoeia.
3. Are there any significant patent barriers for generic Econazole Nitrate API manufacturing? Econazole Nitrate is an off-patent molecule. However, specific synthesis routes or polymorphic forms might have been subject to patent protection, though these are generally expired or not universally adopted.
4. What is the approximate shelf life of Econazole Nitrate API under recommended storage conditions? Under controlled conditions (typically protected from light and moisture at room temperature), Econazole Nitrate API typically has a shelf life of 2 to 3 years. Specific stability studies by the manufacturer should be consulted.
5. How do import duties and tariffs in major pharmaceutical markets affect the landed cost of Econazole Nitrate API? Import duties and tariffs vary significantly by country and trade agreements. For example, tariffs on APIs imported into the U.S. or EU from China or India can range from 0% to over 10%, impacting the final landed cost.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidance-industry [2] European Medicines Agency. (n.d.). Guidance documents. Retrieved from https://www.ema.europa.eu/en/science-research/guidelines-recommendations [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Q7 Guideline. Retrieved from https://www.ich.org/page/quality-guidelines [4] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from https://www.uspnf.com/ [5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of suitability (CEP). Retrieved from https://www.edqm.eu/en/certificates-suitability-cep