Suppliers and packagers for pedmark

pedmark

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937	NDA	Fennec Pharmaceuticals Inc.	73077-010-01	1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSE	2022-10-03

Suppliers for the Pharmaceutical Drug: Pedmark (sodium thiosulfate injection)

Last updated: July 27, 2025

Introduction

Pedmark is a pharmaceutical formulation of sodium thiosulfate, specifically developed for nephroprotection in pediatric patients receiving cisplatin chemotherapy. This drug has gained regulatory approval for its indication to prevent cisplatin-induced ototoxicity in children, offering a significant advancement in cancer supportive care. Identifying reliable, high-quality suppliers for Pedmark is critical for hospitals, oncology clinics, and pharmaceutical distributors aiming to ensure consistent availability and supply chain integrity.

Regulatory Status and Market Approval

Pedmark (formerly known as Inj. sodium thiosulfate) was approved by the U.S. Food and Drug Administration (FDA) in 2022, marking a pivotal milestone in pediatric oncology supportive care [1]. Its approval process involved rigorous clinical trials demonstrating efficacy and safety in preventing hearing loss caused by cisplatin therapy. As a specialized pediatric drug, its manufacturing and supply chain are subject to strict regulatory requirements, influencing supplier selection and qualification.

Manufacturers and Key Suppliers

1. Fennec Pharmaceuticals

Fennec Pharmaceuticals, a clinical-stage pharmaceutical company dedicated to developing and commercializing innovative therapies, is the originator and primary manufacturer of Pedmark. The company owns the rights for its production and distribution, establishing internal manufacturing facilities compliant with Good Manufacturing Practices (GMP) to ensure drug quality and safety [2].

• Manufacturing Capabilities: Fennec maintains its GMP-certified manufacturing plants, ensuring control over the entire production process. This enhances supply reliability and quality assurance.
• Supply Chain: As the exclusive supplier, Fennec Pharmaceuticals controls supply logistics directly to ensure consistent availability, particularly within the U.S. market.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity and high-quality requirements for pediatric oncology drugs, Fennec collaborates with several CMOs to scale manufacturing capacity and ensure supply continuity worldwide.

• Clinical-Grade and Commercial-Scale Production: These CMOs specialize in sterile injectable formulations, adhering to stringent GMP standards. Their roles include bulk sodium thiosulfate synthesis, formulation into injectable forms, sterilization, and packaging.
• Major CMO Partners: The specific identities of Fennec’s CMOs are generally proprietary, but known industry players in sterile injectable manufacturing include Catalent, Recipharm, and Baxter BioPharma Solutions.

3. Distributors and Wholesale Suppliers

For hospitals and healthcare providers, Pedmark usually reaches the end-user through regional and global pharmaceutical distributors authorized by Fennec. These distributors must meet regulatory and quality standards, including license validation, cold chain management, and traceability.

• Authorized Distributors: Fennec works with certified distributors across North America and other regions, such as McKesson, Cardinal Health, and AmerisourceBergen, which are major players in hospital and clinical distribution networks.
• Regional Suppliers: In addition to global entities, regional suppliers may also distribute Pedmark, subject to regulatory approval and licensing agreements.

Supply Chain Considerations

• Regulatory Compliance: Suppliers must comply with cGMP, USP standards, and local regulatory agencies such as the FDA, EMA, or other national agencies.
• Temperature Control: Pedmark requires cold chain logistics to ensure stability during storage and transportation.
• Manufacturing Capacity: Given its specialized nicheness, manufacturing capacity is limited. Supply shortages could occur if demand outpaces production, making supplier qualification critical.
• Quality Assurance: Suppliers undergo rigorous qualification processes, including audits, certifications, and batch testing, to ensure drug purity, potency, and safety.

Emerging and Future Suppliers

As demand for Pedmark increases, especially in global markets, there may be new entrants or authorized generic manufacturers. Fennec's collaboration with CMOs might expand, or other regional manufacturers may seek licensing agreements.

• Potential for Local Production: Some regions may develop local cGMP facilities capable of producing sodium thiosulfate injections aligned with Pedmark specifications, subject to regulatory approval.

Regulatory and Commercial Outlook

• Patent and Exclusivity: Fennec maintains exclusive rights to Pedmark in major markets, influencing the entry of alternative suppliers.
• Global Expansion: International approvals could lead to new suppliers licensed under Fennec’s authorization or through partnerships with local pharmaceutical firms.

Conclusion

The primary supplier of Pedmark is Fennec Pharmaceuticals, which produces the drug in GMP-certified facilities, ensuring high standards of quality and safety. The company collaborates with specialized CMOs for manufacturing scale-up and partners with authorized distributors to supply hospitals and clinics. While the supply chain is currently controlled and streamlined, emerging demands and regulatory developments necessitate continuous supplier qualification and diversification strategies to guarantee ongoing availability.

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Key Takeaways

• Fennec Pharmaceuticals is the exclusive and primary manufacturer of Pedmark, maintaining control over production quality.
• Partnerships with GMP-certified CMOs enable scaling and ensure global supply continuity.
• Authorized pharmaceutical distributors such as McKesson and Cardinal Health facilitate delivery to healthcare providers.
• Ensuring compliance with regulatory standards, cold chain logistics, and rigorous quality assurance is critical for Pedmark’s supply stability.
• Future market expansion could introduce new suppliers, emphasizing the importance of ongoing supplier qualification processes.

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FAQs

1. Who manufactures Pedmark?
Fennec Pharmaceuticals is the sole manufacturer of Pedmark, producing the drug in GMP-compliant facilities. They also collaborate with contract manufacturing organizations to meet global demand.

2. Are there generic versions of Pedmark available?
As of now, Pedmark is an FDA-approved brand name drug with no generic equivalents on the market, owing to patent protections and regulatory exclusivity.

3. How is Pedmark supplied to hospitals?
Healthcare providers typically obtain Pedmark through authorized distributors like McKesson, Cardinal Health, or AmerisourceBergen, which ensure cold chain logistics and regulatory compliance.

4. What quality standards do suppliers for Pedmark need to meet?
Suppliers must adhere to cGMP, USP standards, and meet the specific regulatory requirements of their respective markets, including sterilization, ingredient purity, and proper packaging.

5. Is there potential for new suppliers to enter the Pedmark supply chain?
While current supply is controlled by Fennec, future approvals and licensing agreements may lead to additional manufacturing partnerships or regional supplier development.

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Sources

[1] FDA. “Fennec Pharmaceuticals Announces FDA Approval of Pedmark (sodium thiosulfate injection) for Reducing the Risk of Cisplatin-Induced Hearing Loss in Pediatric Patients.” FDA, 2022.
[2] Fennec Pharmaceuticals. “Company Details & Manufacturing Capabilities,” Fennec.com, 2023.