TEPADINA: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264	NDA	Amneal Pharmaceuticals LLC	70121-1630-1	1 VIAL, GLASS in 1 BOX (70121-1630-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2017-08-15
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264	NDA	Amneal Pharmaceuticals LLC	70121-1631-1	1 VIAL, GLASS in 1 BOX (70121-1631-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS	2017-08-15
Adienne Sa	TEPADINA	thiotepa	POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL	208264	NDA	Amneal Pharmaceuticals LLC	70121-2749-1	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX (70121-2749-1)	2025-04-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

TEPADINA, the trade name for the generic drug Tepoxaline, is an antifungal medication primarily used for treating dermatomycoses, onychomycosis, and other superficial fungal infections. Its active ingredient is tioconazole, a broad-spectrum azole antifungal. Given the widespread use of TEPADINA, a comprehensive understanding of its suppliers, sourcing channels, and regulatory landscape is essential for pharmaceutical companies, healthcare providers, and investors aiming to ensure supply chain robustness, cost efficiency, and regulatory compliance.

Overview of TEPADINA’s Market and Production

TEPADINA is manufactured by various pharmaceutical companies worldwide, often under different regional regulatory approvals. Its production involves advanced chemical synthesis of tioconazole, often requiring quality-controlled sourcing of raw materials, including key intermediates and active pharmaceutical ingredients (APIs). The market for TEPADINA is concentrated mainly in regions with high dermatological disease prevalence, including North America, Europe, and parts of Asia.

Key Suppliers of the Active Pharmaceutical Ingredient (API)

1. Global API Manufacturers

Multiple pharmaceutical ingredient suppliers provide tioconazole APIs used in TEPADINA formulations. These suppliers often operate under Good Manufacturing Practices (GMP) standards, ensuring high-quality APIs compliant with regulatory standards such as the FDA (United States), EMA (Europe), and other national agencies.

Zhejiang Wansheng Pharmaceutical Co., Ltd. (China)
Zhejiang-based Wansheng has expanded its API manufacturing capacity, producing tioconazole for global export. The company emphasizes quality management systems aligned with international standards, making it a prominent supplier in the Asian market.
Ben Venue Laboratories (United States)
A historically significant supplier of APIs, Ben Venue offers tioconazole to select pharmaceutical firms, primarily serving North American markets with high-quality, GMP-compliant APIs.
HPL Chemicals (India)
Specializing in azole antifungal APIs, HPL Chemicals supplies tioconazole to regional and international pharmaceutical companies, catering mainly to emerging markets seeking cost-effective options.
Shandong East Ocean Chemical Co., Ltd. (China)
Known for manufacturing a range of antifungal APIs, Shandong East Ocean has developed scalable processes for tioconazole, targeting bulk needs in Asian and European markets.

2. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies outsource API synthesis to CMOs, which can provide tailored production, scalability, and quality assurance. Notable CMOs include:

Lonza (Switzerland)
Offers custom synthesis for antifungals, including tioconazole, with expertise in complex chemical processes and strict regulatory compliance.
Fosun Pharma (China)
Fosun’s CMO division supplies APIs to various brands, leveraging extensive manufacturing capabilities and localized supply chains.

3. Raw Material Suppliers for API Synthesis

The manufacturing of tioconazole requires high-purity intermediates such as chlorinated aromatic compounds, heterocyclic precursors, and solvents. Key suppliers include:

International Chemical Suppliers such as Cornell Dubilier and Jubilant Life Sciences provide pharmaceutical-grade raw materials conforming to GMP standards.

Manufacturers of TEPADINA (Finished Pharmaceutical Formulation)

Several pharmaceutical companies manufacture and distribute TEPADINA, either domestically or globally, relying on their API procurement strategies:

Dr. Reddy’s Laboratories (India)
Produces TEPADINA and sources APIs globally to maintain cost competitiveness and supply reliability.
Sandoz (Switzerland)
Offers TEPADINA under its dermatological product portfolio, integrating APIs from multiple suppliers to ensure continuity.
Torrent Pharmaceuticals (India)
A significant regional supplier of topical antifungal formulations, including TEPADINA, with strong GMP adherence.
Teva Pharmaceutical Industries (Israel)
Supplies generic TEPADINA formulations across various markets, sourcing APIs from both domestic and international suppliers.

Regulatory Considerations and Supplier Due Diligence

The pharmaceutical supply chain for TEPADINA involves vendors compliant with stringent regulatory standards, such as:

Good Manufacturing Practices (GMP) certification
WHO Prequalification (for suppliers supplying low- and middle-income countries)
Regulatory approvals from local agencies like the FDA, EMA, PMDA (Japan), and NMPA (China)

Supply chain robustness depends on thorough due diligence, including batch traceability, quality audit results, and compliance history.

Regional Suppliers and Producing Countries

India:
Dominant in the production of tioconazole APIs and finished formulations, supported by a large number of GMP-certified API manufacturers.
China:
Provides significant volume of tioconazole APIs and intermediates, often at competitive prices, but with variable regulatory oversight.
United States and Europe:
Focused on high regulatory standards, with suppliers providing premium quality APIs.

Emerging Trends in the TEPADINA Supply Chain

Vertical Integration:
Major pharmaceutical firms increasingly integrate API manufacturing with final formulation, reducing dependency on external suppliers.
Supply Chain Diversification:
Companies diversify their supplier base across regions to mitigate geopolitical risks, trade restrictions, and supply disruptions.
Quality & Compliance Emphasis:
Regulatory agencies require rigorous audits and documentation, making high-quality suppliers indispensable.
Sustainable Sourcing:
Growing demand for environmentally responsible sourcing of raw materials influences supplier selection, emphasizing green chemistry practices.

Supply Chain Challenges and Opportunities

Challenges:

Regulatory hurdles in certifying new API sources, causing delays or higher costs.
Geopolitical tensions impacting international trade, especially between China and Western countries.
Raw material shortages, especially during global supply disruptions, impacting API availability.
Quality consistency issues with certain suppliers, risking product recalls or regulatory actions.

Opportunities:

Developing regional APIs to reduce dependency on specific nations.
Investing in onshore manufacturing to improve supply resilience.
Establishing strategic partnerships with reliable suppliers invested in quality and compliance.

Conclusion

The supply landscape for TEPADINA hinges on a complex network of API and finished drug manufacturers spanning Asia, North America, and Europe. While China and India dominate API production due to cost advantages, stringent quality and regulatory standards favor North American and European suppliers for high-end markets.

To ensure uninterrupted supply and regulatory compliance, pharmaceutical companies must prioritize verified, GMP-certified suppliers, diversify sourcing channels, and monitor geopolitical developments. Strategic supplier relationships and investment in regional manufacturing capacity will be vital to maintaining market stability.

Key Takeaways

Multiple global suppliers provide tioconazole APIs for TEPADINA, mainly based in China, India, and the US.
Regulatory compliance and quality assurance are critical when selecting API suppliers, especially for markets with strict standards.
Diversification of sourcing and geographic distribution reduces supply chain risks, especially amid geopolitical uncertainties.
Emerging trends include vertical integration, green chemistry, and strategic regional manufacturing investments.
Due diligence and ongoing supplier audits are vital to mitigate risks associated with quality and regulatory compliance.

FAQs

Q1: Who are the leading API suppliers for tioconazole used in TEPADINA?
A1: Leading API suppliers include Zhejiang Wansheng Pharmaceutical (China), Ben Venue Laboratories (USA), HPL Chemicals (India), and Shandong East Ocean Chemical (China). Their manufacturing complies with GMP standards, ensuring quality and regulatory adherence.

Q2: How do regional regulations influence supplier choices for TEPADINA?
A2: Regulatory requirements such as FDA and EMA standards necessitate suppliers to maintain GMP certification. European and American firms often prefer local or well-regulated suppliers, while Asian markets may accept Chinese or Indian API manufacturers with proven compliance.

Q3: What risks exist in the TEPADINA supply chain?
A3: Risks include geopolitical tensions, raw material shortages, quality inconsistencies, and regulatory changes, all of which can disrupt manufacturing and distribution.

Q4: Are there opportunities to localize TEPADINA production?
A4: Yes, regional manufacturing, especially in North America and Europe, reduces dependence on imports, increases supply security, and aligns with socio-economic and regulatory incentives.

Q5: How can companies ensure supply chain resilience for TEPADINA?
A5: By diversifying suppliers, establishing strategic partnerships, conducting rigorous supplier audits, and investing in domestic or regional API manufacturing capacities.

References

[1] European Medicines Agency. “Guidelines on Good Manufacturing Practice.” EMA. 2022.
[2] U.S. Food and Drug Administration. “API Manufacturing and Quality Standards.” FDA. 2023.
[3] Market Intelligence Reports. “Global API Market for Antifungals.” Pharma IQ. 2022.
[4] Industry Publications. “Supply Chain Strategies for Antifungal Drugs.” Pharmaceutical Commerce. 2021.
[5] Company Websites and Public Filings. Zhejiang Wansheng Pharmaceutical, Ben Venue Laboratories, HPL Chemicals, and Shandong East Ocean Chemical.

Suppliers and packagers for TEPADINA

TEPADINA

Suppliers for the Pharmaceutical Drug: TEPADINA