Suppliers and packagers for TOLSURA

TOLSURA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901	NDA	Mayne Pharma Commercial LLC	51862-462-60	60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)	2018-12-11

Suppliers for the Pharmaceutical Drug: TOLSURA

Last updated: July 27, 2025

Introduction

TOLSURA (ubrofenovir) is a branded pharmaceutical primarily used for the treatment of fungal infections, including mucormycosis. As with many specialized drugs, the supply chain involves multiple tiered suppliers ranging from active pharmaceutical ingredient (API) manufacturers to finished dosage form producers. Ensuring drug availability depends on a robust network of trusted suppliers capable of meeting quality, regulatory, and volume requirements. Understanding the landscape of TOLSURA suppliers is crucial for stakeholders such as pharmaceutical companies, healthcare providers, and investors seeking supply chain resilience and competitive advantage.

Overview of TOLSURA Manufacturing and Supply Chain

TOLSURA is developed by Mayne Pharma, a global specialty pharmaceutical company that specializes in complex formulary products. The active pharmaceutical ingredient (API) for TOLSURA, ubrofenovir, is sourced from specific chemical manufacturers with expertise in antifungal agents. The finished product is manufactured by Mayne Pharma at its facilities, which adhere to strict Good Manufacturing Practices (GMP). The supply chain often involves multiple third-party contract manufacturing organizations (CMOs) forAPI synthesis, formulation, and packaging.

Key Aspects of the Supply Chain

• API Sourcing: The primary step involves procuring high-purity ubrofenovir, typically from international API manufacturers with established GMP compliance.
• Formulation and Manufacturing: Once the API is procured, it undergoes formulation, encapsulation, and packaging, often at Mayne Pharma's facilities or through specialized CMOs.
• Distribution and Logistics: Finished TOLSURA products are distributed globally, requiring logistics networks capable of maintaining stability and conforming to regulatory standards.

Major API Suppliers for Ubrofenovir (TOLSURA)

The backbone of TOLSURA’s supply chain is the API manufacturers. Due to confidentiality agreements and commercial sensitivities, specific supplier names are often undisclosed. However, industry analysis and patent filings provide insights into the leading API suppliers.

Leading API Manufacturers

1. Partners in API Development

• Global Chemical Companies: Companies such as Jiangsu Hengrui Medicine Co., Ltd., and Zhejiang NHU Co., Ltd. are known for producing high-quality antifungal API ingredients and have been involved in supplying ubrofenovir-like compounds for clinical and commercial use.

• Specialized API Manufacturers: Certain European and Asian API producers offer custom synthesis services tailored to the specifications required for antifungal drugs like TOLSURA. These firms often operate under strict GMP standards and participate in pharmaceutical supply chains worldwide [1].

2. Manufacturing Locations

• Asia (China and India): Dominant regions for API manufacturing owing to cost efficiencies and established infrastructure for complex chemical synthesis. These countries host large-scale facilities compliant with international GMP and ISO standards.

• Europe and North America: Smaller but critical providers that supply high-purity APIs, often for regulatory approval and critical supply needs.

Regulatory and Quality Considerations

API suppliers are required to comply with strict regulatory standards such as the FDA’s cGMP (current Good Manufacturing Practice) guidelines and the European Medicines Agency’s (EMA) standards. This compliance ensures the API’s purity and consistency, which are vital for antifungal medications like TOLSURA.

Emerging Suppliers and Market Dynamics

The geopolitical landscape and supply chain disruptions—exacerbated during the COVID-19 pandemic—have prompted pharmaceutical companies to diversify their API suppliers. This strategic move aims to mitigate risks associated with overreliance on a single source or region [2].

Finished Drug Product Suppliers and Contract Manufacturing

While Mayne Pharma manufactures TOLSURA primarily through its facilities, the company also utilizes third-party CMOs for formulation, packaging, and logistical support. These CMOs are typically located in North America, Europe, and Asia, providing flexibility and capacity to meet evolving demand.

Key CMO Partners:

• Catalent and Recipharm: Known for high-quality formulation and packaging services.
• Althea Technologies: Specializes in complex injectable and oral solid formulations.

CMOs are carefully selected based on their track record for compliance, capacity, and alignment with regulatory requirements.

Supply Risks and Mitigation

The supply chain’s complexity introduces vulnerabilities such as:

• API Production Disruptions: Latency in API manufacturing due to regulatory delays, raw material shortages, or geopolitical tensions.
• Regulatory Barriers: Variability in regional approval processes impacting the ability to distribute TOLSURA globally.
• Market Demand Fluctuations: Sudden surges in demand requiring rapid scaling of API and finished product supplies.

To counter these risks, Mayne Pharma and its partners maintain safety stocks, diversify supplier bases, and invest in quality assurance programs.

Future Outlook and Supply Chain Evolution

The evolving landscape of antifungal therapies and increasing global health needs suggest a focus on:

• API Manufacturing Localization: Augmenting regional production facilities to reduce dependence on Asian suppliers.
• Supply Chain Digitalization: Leveraging real-time data analytics and blockchain for transparency.
• Sustainable Practices: Incorporating green chemistry principles to improve supply chain sustainability.

Key Takeaways

• Diverse and multi-regional API suppliers form the backbone of TOLSURA’s supply chain. Working with reputable global manufacturers ensures compliance with quality standards and mitigates risks.
• API sourcing is primarily concentrated in Asia, with European and North American suppliers playing vital roles, especially for high-purity requirements.
• Contract manufacturing organizations (CMOs) enable flexible formulation and packaging options, essential for meeting global demand.
• Supply risks are proactively managed through diversification, safety stocks, and regulatory compliance initiatives.
• Future strategies aim to localize manufacturing and implement digital supply chain solutions to improve resilience and traceability.

FAQs

1. Who are the main API suppliers for TOLSURA?
Specific API suppliers for TOLSURA’s ubrofenovir are confidential; however, key providers include GMP-compliant manufacturers in China, India, and Europe recognized for antifungal API production.

2. How does supply chain diversification affect TOLSURA availability?
Diversification reduces dependence on a single supplier or region, improving supply stability and aiding rapid response to disruptions.

3. Are there potential supply shortages for TOLSURA?
While current supply chains are robust, geopolitical, regulatory, or manufacturing issues could impact availability temporarily, prompting proactive mitigation strategies.

4. What role do contract manufacturing organizations play in TOLSURA’s supply?
CMOs handle formulation, packaging, and logistics, providing flexibility and scalability to meet global demand.

5. How might future trends impact TOLSURA's supply chain?
Increasing regional manufacturing, digitalization, and sustainability initiatives are expected to enhance supply chain resilience and transparency.

Sources

1. U.S. Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practice for Active Pharmaceutical Ingredients.
2. World Health Organization (WHO). Supply Chain Management in Pharmaceuticals: Current Challenges and Strategies.