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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Perrigo	TIOCONAZOLE	tioconazole	OINTMENT;VAGINAL	075915	ANDA	L. Perrigo Company	0113-0426-54	1 POUCH in 1 CARTON (0113-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR	2019-10-22
Perrigo	TIOCONAZOLE	tioconazole	OINTMENT;VAGINAL	075915	ANDA	Walgreen Company	0363-0426-54	1 POUCH in 1 CARTON (0363-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR	2007-12-19
Perrigo	TIOCONAZOLE	tioconazole	OINTMENT;VAGINAL	075915	ANDA	Combe Incorporated	11509-0426-1	1 POUCH in 1 CARTON (11509-0426-1) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR	2020-07-29
Perrigo	TIOCONAZOLE	tioconazole	OINTMENT;VAGINAL	075915	ANDA	Target Corporation	11673-426-54	1 POUCH in 1 CARTON (11673-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR	2009-07-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

Tioconazole is a broad-spectrum antifungal agent primarily used for treating fungal infections such as vulvovaginal candidiasis, athlete’s foot, and ringworm. As a member of the imidazole class, tioconazole impedes fungal cell membrane synthesis by inhibiting the enzyme lanosterol 14α-demethylase, making it an effective topical and systemic antifungal. The global demand for tioconazole spans pharmaceutical formulations, over-the-counter products, and compounded medications, creating a complex supply chain involving multiple active pharmaceutical ingredient (API) producers and specialized chemical suppliers.

This article provides a comprehensive overview of the key suppliers of tioconazole, evaluating their manufacturing capabilities, geographic presence, regulatory status, and market positioning. Understanding the supplier landscape enables pharmaceutical companies, formulators, and investors to make strategic sourcing decisions, ensure supply continuity, and comply with regulatory standards.

Manufacturers of Tioconazole API

The production of tioconazole API involves complex chemical synthesis, requiring specialized facilities compliant with Good Manufacturing Practices (GMP). Several pharmaceutical API manufacturers worldwide produce tioconazole at varying scales, primarily focusing on regional markets.

1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Zhejiang Hisun is among the leading Chinese API manufacturers, with a diverse portfolio that includes antifungal agents like tioconazole. Its capabilities encompass large-scale synthesis, rigorous quality control, and compliance with international standards, making it a reliable supplier for global pharmaceutical companies.

Product focus: Tioconazole API, with extensive R&D capabilities.
Certifications: GMP certified, ISO 9001, and other relevant certifications.
Market presence: Supplies to North America, Europe, and Asia.

2. Fosun Pharmaceutical Industry (China)

Fosun is recognized for its integrated approach to pharmaceutical manufacturing, including the synthesis of antifungal APIs like tioconazole. The company's facilities are compliant with global regulatory standards, and it emphasizes quality assurance.

Production capacity: Significant, capable of fulfilling large-volume orders.
Regulatory compliance: GMP-certified with international audit acceptance.

3. Jiangsu Top Shine Pharmaceutical Co., Ltd. (China)

This manufacturer specializes in antifungal and antimicrobial APIs, including tioconazole. It offers competitive pricing and reliable supply chains, with a focus on Asian and emerging markets.

Key features: Custom synthesis, excipient compatibility, stable supply.
Regulatory standing: GMP certified, with good documentation practices.

4. Others: European and US-Based APIs Suppliers

While Asian manufacturers dominate the market due to cost and scale advantages, some European and North American companies also produce tioconazole API, often for niche or specialized applications:

BASF SE (Germany)

Known for its high-quality chemical manufacturing, BASF supplies APIs to various pharmaceutical companies though specific tioconazole production details are proprietary.
Eli Lilly (USA)

Historically involved in antifungal APIs, Eli Lilly’s manufacturing capabilities include tioconazole, mainly for internal use or strategic partnerships.

Contract Manufacturing Organizations (CMOs) and Custom Synthesis

Apart from dedicated API manufacturers, Contract Manufacturing Organizations (CMOs) and chemical synthesis service providers facilitate custom synthesis of tioconazole for pharmaceutical firms:

Lonza (Switzerland)

Offers custom synthesis services adhering to stringent regulatory standards, supporting scale-up from lab to commercial production.
Thermo Fisher Scientific (United States)

Provides synthesis and analytical services, often collaborating with pharmaceutical companies for formulation-specific needs.
Bachem (Switzerland)

Engages in specialized chemical synthesis, including antifungal APIs, with a focus on innovation and compliance.

Distribution and Regional Suppliers

Regional suppliers often focus on the downstream supply chain, providing finished formulations, bulk API, or intermediates tailored to local markets:

India-based Suppliers

Companies like Aarti Drugs Ltd. and Aurobindo Pharma supply tioconazole APIs and formulations across Asia, Africa, and parts of Europe. Their competitive pricing and robust supply chains make them attractive partners.
Latin American Suppliers

Companies such as Laferm Pharma (Mexico) and Laboratorios Pisa (Peru) produce regional supplies for local markets.

Regulatory Considerations and Quality Standards

Suppliers must adhere to strict regulatory standards, including:

Good Manufacturing Practice (GMP): Ensures consistent quality suitable for pharmaceutical applications.
ISO Certifications: Demonstrates adherence to internationally recognized quality systems.
Regulatory approvals: For global markets, APIs must meet FDA, EMA, or other regional regulatory body requirements.

Choosing suppliers with validated manufacturing processes, batch-to-batch consistency, and comprehensive documentation mitigates regulatory risks and ensures product efficacy.

Emerging Trends in Tioconazole Supply

The expanding antifungal market, driven by increased awareness of fungal infections and OTC demand, prompts suppliers to invest in capacity expansion and process innovations. Growth in generic formulations and the rising prevalence of infections like athlete’s foot have increased the importance of supply chain resilience. The COVID-19 pandemic underscored the need for diversification of suppliers, geopolitical considerations, and the importance of quality assurance.

Manufacturers are also exploring continuous manufacturing and green synthesis techniques to reduce environmental impact, meet regulatory standards, and improve cost efficiencies.

Conclusion

The global supply chain of tioconazole involves a mix of Asian API manufacturers, regional suppliers, and specialized CMOs. China leads in API production capacity, with companies such as Zhejiang Hisun Pharmaceutical, Fosun Pharmaceutical, and Jiangsu Top Shine dominating the landscape. European and US-based firms support niche markets and provide high-quality standards for regulated markets.

Strategic sourcing from well-certified suppliers ensures product quality, regulatory compliance, and supply stability. As demand persists and the antifungal market evolves, collaboration with reputable manufacturers and investment in supply chain resilience will be critical for pharmaceutical companies.

Key Takeaways

China’s established API manufacturers, including Zhejiang Hisun and Fosun, are core suppliers for tioconazole, offering scalability and cost competitiveness.
European and US-based companies provide high-quality APIs suitable for regulated markets, albeit at a premium.
CMOs play a strategic role in custom synthesis, scaling production, and ensuring compliance with international standards.
The antifungal market’s growth underscores the importance of diversifying suppliers and maintaining quality assurance practices.
Regulatory compliance, GMP certification, and supply chain transparency remain critical factors in supplier selection.

Frequently Asked Questions

Q1: What are the primary regions producing tioconazole API?
A1: China dominates tioconazole API manufacturing, with significant contributions from India and some European countries. North American production is limited but exists for specialized applications.

Q2: What should pharmaceutical companies consider when selecting a tioconazole supplier?
A2: Companies should evaluate GMP compliance, regulatory certifications, manufacturing capacity, quality control processes, and supply stability.

Q3: Are there differences in API quality between regional suppliers?
A3: Yes. European and US suppliers often adhere to stricter regulatory standards, potentially offering higher consistency, while Asian suppliers provide cost-effective options with variable compliance depending on GMP certification status.

Q4: Which certifications are most important for tioconazole API suppliers?
A4: GMP certification, ISO 9001, and region-specific approvals (FDA, EMA, WHO) are vital for ensuring regulatory acceptance.

Q5: How does the COVID-19 pandemic influence tioconazole supply strategies?
A5: The pandemic highlighted vulnerabilities in global supply chains, prompting companies to diversify suppliers, increase stockpiles, and explore regional sourcing options to mitigate disruptions.

References

[1] Market research reports on antifungal active pharmaceutical ingredients.
[2] Zhejiang Hisun Pharmaceutical official website.
[3] Fosun Pharmaceutical Industry documentation.
[4] Global pharmaceutical supply chain analyses, IQVIA reports.
[5] GMP guidelines from WHO and regional health authorities.

Note: The information listed reflects the current landscape based on publicly available data and industry analysis as of 2023.

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