Suppliers and packagers for sporanox

sporanox

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083	NDA	Patriot Pharmaceuticals	10147-1700-3	30 CAPSULE in 1 BOTTLE (10147-1700-3)	2005-02-01
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083	NDA	Janssen Pharmaceuticals, Inc.	50458-290-01	3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK	1992-09-11
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083	NDA	Janssen Pharmaceuticals, Inc.	50458-290-04	30 CAPSULE in 1 BOTTLE (50458-290-04)	1992-09-11

Suppliers for the Pharmaceutical Drug: Sporanox (Itraconazole)

Last updated: August 2, 2025

Introduction

Sporanox, whose active pharmaceutical ingredient is itraconazole, is a widely used antifungal medication indicated for treating various fungal infections, including aspergillosis, blastomycosis, histoplasmosis, and onychomycosis. As a pivotal asset in antifungal therapy, its procurement involves multiple suppliers across the pharmaceutical landscape, including ingredient manufacturers, bulk drug producers, and authorized distributors. Ensuring supply chain resilience for Sporanox is crucial for healthcare providers and pharmaceutical companies aiming to meet global demand, especially given the challenges posed by manufacturing complexities, regulatory hurdles, and market dynamics.

Global Supply Chain Overview for Itraconazole

1. Active Pharmaceutical Ingredient (API) Manufacturers

The foundation of Sporanox’s supply chain is the production of itraconazole API. Several multinational and regional chemical entities manufacture itraconazole as a generic API, which subsequently supplies to pharmaceutical companies.

• Major API Producers

  • Hetero Labs Ltd (India): Hetero is one of the leading generic pharmaceutical companies manufacturing itraconazole API. Their facilities are compliant with Good Manufacturing Practices (GMP), and they have a robust export network spanning North America, Europe, and Asia.

  • Sun Pharmaceutical Industries Ltd (India): A significant API supplier, Sun Pharma produces itraconazole as part of its extensive antifungal API portfolio, leveraging their global manufacturing footprint.

  • Mylan (now part of Viatris): Mylan’s API manufacturing operations include itraconazole, serving their generic drug portfolio worldwide.

  • Fangfang Pharma (China): An emerging API manufacturer offering competitive API supply, Fangfang’s GMP-certified facilities cater primarily to Asian markets but are expanding globally.

• Regional API Producers

  • Zhejiang Hisun Pharmaceutical Co., Ltd. (China): They manufacture generic APIs, including itraconazole, with a focus on Asian markets.

  • Glenmark Pharmaceuticals (India): Besides finished formulations, Glenmark contributes to API supply, supporting its own and partner formulations.

2. Finished Product Manufacturers and Contract Manufacturing Organizations (CMOs)

Once the API is produced, it is formulated into Sporanox capsules primarily by Pfizer, the original patent holder and marketer of the drug. However, with patent expirations and market liberalization, several contract manufacturers now produce generic equivalents.

• Pfizer: The original developer of Sporanox, maintains manufacturing facilities worldwide to support its marketed formulations, adhering to stringent quality standards.

• Generics and Outsourcing Manufacturers: Various approved CMOs globally produce generic itraconazole capsules for regional markets following regulatory clearances.

Key Suppliers and Market Dynamics

Original Manufacturer and Patent Holders

Pfizer remains the primary supplier of branded Sporanox, sourcing its API from approved producers and maintaining rigorous quality control standards. The company's manufacturing facilities in the US, Europe, and Asia support global distribution.

Generic Manufacturers

The expiration of patents in key markets (e.g., the U.S. in 2011) spurred entry by multiple generic pharmaceutical companies, utilizing API from regional manufacturers. These include:

• Sandoz (Novartis): Supplies generic itraconazole in several markets; known for quality and regulatory compliance.

• Mylan (Viatris): Offers generic itraconazole formulations, sourcing API from approved suppliers.

• Dr. Reddy's Laboratories: Produces generic versions, leveraging domestic API production and strategic partnerships.

• Actavis (Teva): Has expanded its antifungal portfolio with generic itraconazole, sourcing from multiple API manufacturers.

Regional Suppliers and Emerging Markets

In regions like Asia, Latin America, and Eastern Europe, smaller suppliers and local pharmaceutical companies source API from regional producers to manufacture generic formulations, including Sporanox equivalents. These suppliers often compete on price while maintaining compliance with local regulatory standards.

Supply Chain Challenges and Considerations

• Manufacturing Complexity: The synthesis of itraconazole involves multi-step chemical processes requiring specialized facilities, quality controls, and strict adherence to GMP. Disruptions in API manufacturing—due to supply chain disruptions or regulatory issues—can impact global availability.

• Regulatory Approvals: Suppliers must obtain and maintain approvals from regional regulators such as the FDA, EMA, and PMDA, influencing their capacity to participate in certain markets.

• Market Competition and Pricing: The proliferation of generic manufacturers has driven down prices but increased competitive pressure on API suppliers to ensure consistent supply and quality.

• Supply Chain Transparency: With global concerns over supply chain security, companies prioritize suppliers with transparent sourcing, quality certifications, and contingency planning.

Future Trends in Sporanox Supply

• API Diversification: Increased reliance on multiple API producers across different regions mitigates risks associated with geopolitical tensions, regulatory hurdles, and manufacturing issues.

• Local API Production: Some markets are encouraging local API manufacturing to reduce dependence on imports, shaping the supply dynamics for itraconazole.

• Sustainability and Quality Standards: Growing emphasis on sustainable manufacturing practices and compliance with international standards will influence supplier selection and procurement strategies.

Conclusion

The supply landscape for Sporanox is characterized by a mix of established multinational API producers, original patent holders, and regional generic manufacturers. Pfizer remains the primary supplier of the finished formulation, sourcing API from highly regulated, quality-certified producers. The global antifungal market's competitiveness and regulatory environment constantly reshape supplier priorities. Securing a resilient supply chain for Sporanox necessitates strategic sourcing from diversified, compliant API manufacturers, fostering robust relationships to mitigate risks of shortages and ensure sustained patient access.

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Key Takeaways

• Diverse Supplier Base: The Sporanox supply chain involves multiple API manufacturers spread across India, China, and regional markets, reducing dependency on a single source.

• Quality and Regulatory Compliance: Ensuring API and finished product quality is crucial; suppliers must meet GMP standards and obtain necessary approvals.

• Market Dynamics: Patent expirations have facilitated a proliferation of generic manufacturers, intensifying competition and affecting supply strategies.

• Supply Chain Resilience: Diversification, regional manufacturing, and strategic partnerships are vital for maintaining steady supply amid global disruptions.

• Future Focus: Emphasis on sustainable manufacturing, local API production, and regulatory compliance will shape the future of Sporanox supply chains.

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FAQs

1. Who are the primary API suppliers for itraconazole used in Sporanox?
Major API suppliers include Hetero Labs (India), Sun Pharma (India), Mylan (Viatris), and Fangfang Pharma (China), all operating GMP-compliant facilities.

2. Can regional generic manufacturers produce Sporanox?
Yes. Post-patent expiry, numerous regional manufacturers produce generic itraconazole, often sourcing API from approved regional producers.

3. How does supply chain stability impact Sporanox availability?
Disruptions in API manufacturing, regulatory issues, or geopolitical factors can lead to shortages of Sporanox, emphasizing the need for diversified sourcing.

4. Are there alternatives to sourcing API from international suppliers?
Some markets encourage local API production to reduce dependence on imports, improving supply security and compliance with regional regulations.

5. What trends will influence the future supply of Sporanox?
API diversification, local manufacturing, stricter quality standards, and sustainable practices will shape the supply landscape moving forward.

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References

1. Pharmaceutical Technology. "Global API Market." Accessed 2023.
2. U.S. Food and Drug Administration. "Generic Drug Approvals and Labeling."
3. Pfizer Annual Report 2022.
4. Global Data. "Pharmaceutical APIs Outlook 2023."
5. European Medicines Agency. "Manufacturing Authorizations for APIs."