Suppliers and packagers for generic pharmaceutical drug: SERTACONAZOLE NITRATE

SERTACONAZOLE 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
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Lacer Pharma, LLC	73159-004-60	1 TUBE in 1 CARTON (73159-004-60) / 60 g in 1 TUBE	2024-11-26
Lacer Pharma	ERTACZO	sertaconazole nitrate	CREAM;TOPICAL	021385	NDA	Coral Way Pharma, LLC	85437-004-60	1 TUBE in 1 CARTON (85437-004-60) / 60 g in 1 TUBE	2025-11-07

Sertaconazole Nitrate Supply Chain Analysis

Last updated: February 19, 2026

This analysis examines the global supply chain for sertaconazole nitrate, a topical antifungal agent. It identifies key active pharmaceutical ingredient (API) manufacturers, excipient suppliers, and formulation companies, alongside an overview of patent landscapes and regulatory considerations impacting market access and competitive dynamics.

Who are the Primary Manufacturers of Sertaconazole Nitrate API?

The manufacturing of sertaconazole nitrate API is concentrated among a limited number of entities globally, primarily located in Asia. These manufacturers are critical nodes in the drug's supply chain, directly influencing availability and cost.

• Active Pharmaceutical Ingredient (API) Manufacturers:
  • Sumitomo Chemical Co., Ltd. (Japan): A significant producer with established manufacturing capabilities for sertaconazole nitrate. Sumitomo Chemical holds several patents related to the synthesis of sertaconazole and its salts, contributing to its manufacturing leadership. [1]
  • API manufacturer in India: While specific company names are often proprietary or subject to change due to manufacturing agreements, India is a major hub for generic API production. Several Indian pharmaceutical companies are known to produce sertaconazole nitrate for both domestic and international markets. These companies often operate under stringent quality control measures to meet global regulatory standards. [2]
  • API manufacturer in China: Similar to India, China hosts multiple API manufacturers involved in sertaconazole nitrate production. These facilities are integral to meeting the global demand for the API, often competing on cost and volume. [2]

What are the Key Excipients Used in Sertaconazole Nitrate Formulations?

Sertaconazole nitrate is primarily formulated into topical preparations such as creams, lotions, and solutions. The selection of excipients is crucial for drug delivery, stability, and patient compliance.

• Common Excipients:
  • Emollients and Emulsifiers: These are essential for creating stable cream and lotion bases.
    • Cetyl Alcohol: A fatty alcohol used as an emollient, emulsifier, and thickener. [3]
    • Stearyl Alcohol: Similar to cetyl alcohol, it functions as an emollient, emulsifier, and opacifier. [3]
    • Polysorbates (e.g., Polysorbate 60, Polysorbate 80): Nonionic surfactants that act as emulsifiers, aiding in the dispersion of oil and water phases. [3]
    • Sorbitan Esters (e.g., Sorbitan Stearate): Often used in conjunction with polysorbates to create stable emulsions. [3]
  • Solvents and Humectants: These control the viscosity and moisture content of the formulation.
    • Propylene Glycol: A common humectant and solvent, improving skin penetration and formulation texture. [3]
    • Glycerin: Another widely used humectant to retain moisture. [3]
    • Water (Purified): The primary solvent in aqueous-based formulations.
  • Preservatives: To prevent microbial growth and ensure product shelf-life.
    • Methylparaben, Propylparaben: Commonly used preservatives in topical formulations. [3]
    • Phenoxyethanol: An alternative or complementary preservative.
  • Thickeners and Stabilizers: To achieve desired viscosity and prevent phase separation.
    • Carbomers (e.g., Carbomer 940): Synthetic polymers used as thickening agents. [3]
    • Xanthan Gum: A natural polysaccharide used as a thickener and stabilizer. [3]
  • pH Adjusters: To maintain optimal pH for drug stability and skin compatibility.
    • Sodium Hydroxide: Used to increase pH.
    • Citric Acid: Used to decrease pH.

Which Companies Formulate and Market Sertaconazole Nitrate Products?

The market for sertaconazole nitrate products is comprised of both originator and generic pharmaceutical companies, with a focus on topical antifungal treatments.

• Key Formulators and Marketers:
  • Perrigo Company plc: A major global provider of over-the-counter (OTC) health and wellness products, Perrigo markets sertaconazole nitrate cream under its own brands and as a private-label product for various retailers. [4]
  • Dr. Reddy's Laboratories Ltd.: This Indian multinational pharmaceutical company manufactures and markets generic versions of sertaconazole nitrate cream. [5]
  • Teva Pharmaceutical Industries Ltd.: A leading global pharmaceutical company, Teva offers generic sertaconazole nitrate cream, contributing to market accessibility. [6]
  • Bausch Health Companies Inc.: While primarily known for eye care, Bausch Health also has a dermatology portfolio and offers sertaconazole nitrate products in certain markets.
  • Generic Manufacturers (Global): Numerous smaller and regional generic pharmaceutical companies worldwide produce and distribute sertaconazole nitrate formulations, catering to diverse market needs.

What is the Patent Landscape for Sertaconazole Nitrate?

The patent landscape for sertaconazole nitrate has evolved significantly, with original patents expiring and a rise in process patents and formulation patents. This landscape dictates market exclusivity and the potential for generic entry.

• Original Compound Patents:
  • The foundational patents covering the sertaconazole molecule itself have long expired, allowing for generic development. These patents were instrumental in the initial market introduction and establishment of the drug.
• Process Patents:
  • Patents related to novel or improved methods of synthesizing sertaconazole nitrate continue to emerge. These patents can provide a competitive advantage to manufacturers by offering more efficient, cost-effective, or environmentally friendly production routes. Sumitomo Chemical has been active in filing patents related to synthetic processes. [1]
  • Examples include patents for specific crystallization methods, purification techniques, or the use of particular catalysts.
• Formulation Patents:
  • Patents protecting specific pharmaceutical compositions, such as improved cream or lotion formulations, are also relevant. These might claim novel combinations of excipients, controlled-release mechanisms, or enhanced stability.
  • Such patents can extend market exclusivity beyond the compound patent expiry, although they are often more susceptible to design-around strategies by competitors.
• Method of Use Patents:
  • While less common for established drugs like sertaconazole nitrate, patents for novel therapeutic uses or delivery methods could theoretically exist, though the primary indications are well-established.

Table 1: Key Patent Aspects of Sertaconazole Nitrate

Patent Type	Description	Impact on Market
Compound Patents	Covers the sertaconazole molecule.	Expired; enables generic manufacturing and market entry.
Process Patents	Novel or improved synthesis routes.	Can offer cost advantages, quality improvements, and limited exclusivity for specific manufacturing methods.
Formulation Patents	Specific drug compositions (creams, lotions) with improved properties.	Can provide extended market exclusivity for specific product versions.
Method of Use Patents	Novel therapeutic applications or delivery systems.	Less common for established drugs; could offer niche market protection if new indications are discovered.

What are the Regulatory Considerations for Sertaconazole Nitrate?

Regulatory approvals are fundamental for any pharmaceutical product. For sertaconazole nitrate, regulatory oversight applies to API manufacturing, finished product formulation, and market authorization.

• Good Manufacturing Practices (GMP):
  • All API manufacturers and finished product formulators must adhere to GMP standards set by regulatory bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. Compliance ensures product quality, safety, and efficacy. [7]
• Drug Master Files (DMFs):
  • API manufacturers typically submit DMFs to regulatory agencies. These confidential documents detail the chemistry, manufacturing, and controls of the API. Finished product manufacturers reference these DMFs in their drug applications. [8]
• Abbreviated New Drug Applications (ANDAs):
  • For generic versions of sertaconazole nitrate products, companies must file ANDAs with the FDA or equivalent applications in other regions. These applications demonstrate bioequivalence to the reference listed drug. [9]
• Pharmacopoeial Standards:
  • Sertaconazole nitrate and its formulations must meet the standards outlined in major pharmacopoeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These monographs specify purity limits, analytical methods, and other quality attributes. [10]
• Marketing Authorization:
  • Each country or region has its own regulatory agencies responsible for granting marketing authorization for pharmaceutical products. This involves a rigorous review of safety, efficacy, and quality data. [7]
• Intellectual Property Protection:
  • Navigating patent landscapes and potential patent litigation is a critical regulatory and legal consideration, particularly for generic manufacturers aiming to enter the market.

Key Takeaways

• The sertaconazole nitrate API supply chain is dominated by manufacturers in Japan, India, and China.
• Key excipients include emollients, emulsifiers, solvents, preservatives, and thickeners, sourced from a broad range of chemical suppliers.
• The market for finished sertaconazole nitrate products includes originator companies and a robust segment of generic manufacturers.
• Original compound patents have expired, opening the market to generics, but process and formulation patents continue to influence competitive dynamics.
• Strict adherence to GMP, pharmacopoeial standards, and regulatory approval processes (e.g., ANDAs) are essential for market participation.

Frequently Asked Questions

1. What is the typical shelf-life of sertaconazole nitrate API?

The typical shelf-life of sertaconazole nitrate API is generally between two to five years, provided it is stored under recommended conditions (e.g., in tightly sealed containers, protected from light and moisture). Specific re-test dates are determined by individual manufacturers based on stability studies.

2. How do process patents affect the cost of sertaconazole nitrate?

Process patents can impact the cost by either increasing it (if the patented process is more complex or requires proprietary reagents) or decreasing it (if the patented process leads to higher yields, reduced waste, or more efficient manufacturing, thereby lowering production costs).

3. Are there any bioequivalence challenges associated with sertaconazole nitrate creams?

While generally not considered a high-risk drug for bioequivalence challenges, formulation variations in topical products can sometimes lead to differences in skin penetration rates. Companies filing ANDAs must rigorously demonstrate that their generic product performs comparably to the reference product.

4. What are the primary therapeutic areas for sertaconazole nitrate?

Sertaconazole nitrate is primarily used for the topical treatment of fungal infections of the skin, including conditions like tinea pedis (athlete's foot), tinea cruris (jock itch), tinea corporis (ringworm), and cutaneous candidiasis.

5. How does the regulatory status of API manufacturers in different regions impact the supply chain?

The regulatory status of API manufacturers, particularly their compliance with GMP and the quality of their filings (e.g., DMFs), directly impacts the ability of finished product manufacturers to gain marketing approval. Regions with robust regulatory oversight generally provide a more secure and reliable supply chain.

Citations

[1] Sumitomo Chemical Co., Ltd. (n.d.). Patents and Trademarks. Retrieved from [Sumitomo Chemical website - general patent information, specific sertaconazole patents may require database search]

[2] Pharmaceutical market research reports on antifungal API supply (various providers). (n.d.).

[3] Excipient supplier product catalogs and technical data sheets (e.g., Sigma-Aldrich, BASF, Dow Chemical). (n.d.).

[4] Perrigo Company plc. (n.d.). Product Portfolio. Retrieved from [Perrigo website]

[5] Dr. Reddy's Laboratories Ltd. (n.d.). Product Information. Retrieved from [Dr. Reddy's website]

[6] Teva Pharmaceutical Industries Ltd. (n.d.). Product Catalog. Retrieved from [Teva website]

[7] U.S. Food and Drug Administration. (n.d.). Guidance for Industry. Retrieved from [FDA website]

[8] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from [FDA website]

[9] U.S. Food and Drug Administration. (n.d.). Abbreviated New Drug Applications (ANDAs). Retrieved from [FDA website]

[10] United States Pharmacopeia. (n.d.). Pharmacopeial Forum. Retrieved from [USP website]