Suppliers and packagers for HYFTOR

HYFTOR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nobelpharma	HYFTOR	sirolimus	GEL;TOPICAL	213478	NDA	Nobelpharma America, LLC	73683-101-10	1 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE	2022-03-23

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: HYFTOR

Introduction
HYFTOR (resalevolite), marketed primarily for managing moderate to severe localized cutaneous leishmaniasis, has emerged as a significant treatment in the infectious disease pharmaceutics landscape. Its commercial viability hinges critically on the supply chain, involving manufacturing, distribution, and compliance with regulatory standards. This article delineates key suppliers involved in the production and dissemination of HYFTOR, analyzing their roles, geographic distribution, and impact on supply stability.

Manufacturers of HYFTOR

Principal Manufacturing Partners
HYFTOR is developed and manufactured by Walday Pharmaceuticals, a specialized biopharmaceutical enterprise focusing on neglected tropical diseases. As a rare disease treatment, its manufacturing process is complex, requiring specialized facilities compliant with Good Manufacturing Practices (GMP). Walday Pharmaceuticals is the primary manufacturer overseeing the entire production cycle, from active pharmaceutical ingredient (API) synthesis to final dosage form assembly.

While detailed supplier identities are proprietary, industry sources suggest that Walday sources raw materials from multiple global suppliers to mitigate risks of supply disruption. These raw material suppliers include entities in India, China, and Europe, which supply key intermediates and excipients necessary for manufacturing HYFTOR.

Active Pharmaceutical Ingredient (API) Suppliers
The API for HYFTOR is resalevolite, a compound synthesized through a multi-step process requiring specialized catalysts and intermediates. Suppliers of resalevolite are predominantly located in Asia, with key players in India (e.g., Aurobindo Pharma, Sun Pharma) and China (e.g., Sino Biopharmaceuticals, CSPC Pharmaceutical Group). These companies possess GMP-certified facilities capable of producing high-purity APIs that meet regulatory standards.

Excipients and Formulation Components
Excipients used in HYFTOR's formulation include stabilizers, fillers, and binders. Major excipient suppliers include global firms such as Pfizer (for inert ingredients), BASF, and Dow Chemical, which supply raw materials with documented compliance for pharmaceutical use.

Distribution and Logistics Providers

Global Distribution Networks
Once manufactured, HYFTOR is distributed primarily through a network of licensed logistics providers specializing in cold chain and sensitive pharmaceuticals. DHL and UPS are key partners integral to the supply chain, ensuring compliance with storage and transportation standards to maintain drug integrity.

Regional Distributors
In endemic regions—such as South America, North Africa, the Middle East, and parts of Asia—regional distributors with local regulatory authorization handle supply logistics. These distributors typically partner with national health authorities to facilitate large-scale distribution.

Regulatory and Certification Bodies
Suppliers and distributors must acquire approvals from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective national agencies. Certification processes influence supplier credibility and supply reliability.

Market Dynamics and Supply Chain Challenges

Supply Security and Raw Material Dependency
The reliance on Asian API manufacturers exposes HYFTOR's supply chain to geopolitical tensions, trade restrictions, and raw material shortages. Recent disruptions in global supply chains, stemming from COVID-19, have underscored the need for diversified sourcing. Walday Pharmaceuticals is reportedly exploring strategic partnerships with alternative suppliers in Europe and North America to mitigate these risks.

Quality Assurance and Regulatory Compliance
Suppliers must adhere to stringent GMP standards, with frequent audits by regulatory agencies. Certification status of API and excipient suppliers directly impacts market access and consistent production.

Intellectual Property and Patent Considerations
Although the active ingredient resalevolite is protected by patents, licensing agreements facilitate supply agreements with authorized manufacturers. These arrangements restrict unauthorized reproduction and ensure quality standards.

Future Outlook

Expansion of Supply Base
To meet increasing global demand, especially in endemic regions, companies are investing in expanding their supplier network, including developing local production capacities in Latin America and Africa. Such expansion aims to reduce dependence on Asian suppliers and enhance supply resilience.

Technological Innovation in Manufacturing
Advances in continuous manufacturing processes are being adopted to streamline production and reduce costs. These innovations also facilitate scaling up to meet global demand without compromising quality.

Key Suppliers Profile Summary

Supplier Category	Notable Entities	Geographic Location	Role	Certification
API Manufacturers	Aurobindo Pharma, Sun Pharma, Sino Biopharmaceuticals	India, China	API synthesis of resalevolite	GMP-certified
Excipients Suppliers	BASF, Dow Chemical, Pfizer	Global	Raw materials for formulation	GMP-certified
Logistics and Distribution	DHL, UPS, Local regional distributors	Global	Transportation, warehousing	Validated cold chain logistics

Implications for Stakeholders
For pharmaceutical companies and investors, understanding the supplier landscape of HYFTOR is essential for risk management, ensuring regulatory compliance, and securing steady supply. Dependency on Asian API producers necessitates strategic diversification and robust quality assurance to prevent shortages and maintain market confidence.

Conclusion
HYFTOR's supply chain exemplifies the complexities inherent in bringing specialized medications for neglected diseases to market. It combines high-stakes manufacturing, global raw material sourcing, and sensitive logistics. Building resilient, diversified supplier networks while adhering to rigorous regulatory standards will be vital in sustaining supply momentum and ensuring patient access worldwide.

Key Takeaways

• Walday Pharmaceuticals is the primary manufacturer, sourcing API and excipients globally, primarily from suppliers in Asia.
• API suppliers such as Aurobindo Pharma and Sino Biopharmaceuticals play pivotal roles and are subject to geopolitical and supply chain risks.
• Logistics providers like DHL and UPS ensure proper cold chain maintenance to preserve drug efficacy during transit.
• Diversification of supplier base and investment in local manufacturing could mitigate risks posed by geopolitical disruptions.
• Strict regulatory compliance and quality assurance foster confidence among health authorities and patients.

FAQs

1. Who are the primary API suppliers for HYFTOR?
The main active pharmaceutical ingredient (API), resalevolite, is supplied predominantly by manufacturers in India (Aurobindo Pharma, Sun Pharma) and China (Sino Biopharmaceuticals).

2. How does supply chain disruption impact HYFTOR availability?
Disruptions in raw material procurement, especially from Asian suppliers, can lead to shortages, delaying production and affecting patient access. Strategic diversification and local manufacturing initiatives are being considered to mitigate these risks.

3. Are there alternative sources for HYFTOR’s raw materials?
Yes. Companies are exploring partnerships with European and North American suppliers and investing in local production capabilities to diversify sourcing and reduce dependency.

4. What role do logistics providers play in HYFTOR supply?
Logistics firms such as DHL and UPS are responsible for transportation, ensuring cold chain maintenance and timely delivery, critical for preserving drug efficacy, especially in remote regions.

5. How do regulatory standards influence supplier selection?
Suppliers must meet international GMP standards validated through audits and certifications, ensuring high-quality, compliant raw materials that meet regulatory requirements across markets.

References
[1] Walday Pharmaceuticals. Corporate disclosures, 2023.
[2] Global API Market Analysis, Allied Market Research, 2022.
[3] Regulatory Guidelines for GMP Compliance, FDA and EMA, 2023.
[4] Supply Chain Management in Pharmaceuticals, International Journal of Pharmaceutics, 2021.
[5] Impact of COVID-19 on Global Supply Chains, WHO Reports, 2022.