Suppliers and packagers for pemfexy

pemfexy

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eagle Pharms	PEMFEXY	pemetrexed	SOLUTION;INTRAVENOUS	209472	NDA	Eagle Pharmaceuticals, Inc.	42367-531-33	1 VIAL in 1 CARTON (42367-531-33) / 20 mL in 1 VIAL	2022-02-01

Suppliers for the Pharmaceutical Drug: Pemfexy

Last updated: August 7, 2025

Introduction

Pemfexy, the intravenous (IV) formulation of pemetrexed disodium, is a chemotherapeutic agent primarily used in the treatment of malignant pleural mesothelioma and non-small cell lung cancer (NSCLC). Developed by Eli Lilly and Company, Pemfexy (pemetrexed disodium for injection) entered the market following regulatory approvals in multiple jurisdictions. As a specialized oncology drug, Pemfexy’s supply chain involves a select group of pharmaceutical manufacturers, distributors, and authorized suppliers. This article explores the landscape of Pemfexy suppliers, including manufacturing origins, distribution strategies, and the competitive dynamics influencing availability and procurement.

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Manufacturers of Pemfexy

Eli Lilly and Company's Role

Eli Lilly holds the sole patent rights and manufacturing process for Pemfexy. The pharmaceutical giant developed and owns the brand, ensuring quality standards aligned with regulatory requirements. Lilly's manufacturing facilities produce the active pharmaceutical ingredient (API) and assemble the final IV formulation. The drug’s production is subject to stringent Good Manufacturing Practices (GMP) abiding by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other relevant bodies.

Manufacturing Locations

While detailed manufacturing site disclosures are proprietary, it is understood that Eli Lilly maintains manufacturing campuses in the United States and Europe. These facilities are equipped with advanced biopharmaceutical manufacturing technology to ensure high-quality, reliable supply chains.

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Authorized Distributors and Supply Channels

Direct Procurement via Eli Lilly

Healthcare providers and hospitals typically procure Pemfexy directly through Eli Lilly’s specialized distribution network. Lilly’s global distribution encompasses a combination of:

• Exclusive wholesalers: In the United States, major wholesalers like McKesson, Cardinal Health, and AmerisourceBardeen serve as primary distributors for oncology medicines, including Pemfexy.
• Specialty pharmacies: Certain oncological specialty pharmacies are authorized to dispense Pemfexy directly to clinicians or patients in outpatient settings.

Third-Party Distributors

In addition to direct channels, third-party distributors authorized by Eli Lilly supply Pemfexy to regional markets, especially where local regulatory approvals or market conditions favor partnerships with established pharma logistics firms. These include regional pharmaceutical distribution companies in Europe, Asia-Pacific, and Latin America.

Regional Variations

• In North America, Eli Lilly’s distribution model ensures high control and supply security.
• In Europe, regional pharmaceutical wholesalers and hospital formulary arrangements manage Pemfexy supply.
• In emerging markets, authorized local importers and licensed distributors facilitate access under regulatory approval.

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Supply Chain Challenges and Mitigation

The supply of Pemfexy, like many chemotherapeutics, faces hurdles such as manufacturing complexity, regulatory delays, and global supply chain disruptions. Eli Lilly's strategic stockpiling, diversified manufacturing footprint, and adherence to high-quality standards mitigate risk. Nonetheless, shortages can occur due to manufacturing disruptions, regulatory delays, or fluctuating demand.

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Additional Suppliers and Market Dynamics

Generic and Biosimilar Competition

As patent exclusivity diminishes or if licensing agreements expire, generic manufacturers may seek to produce pemetrexed formulations. Currently, no widely marketed generic pemetrexed disodium injection exists due to patent protections and regulatory barriers. However, some regional companies may develop biosimilars or branded generics pending patent expirations or licensing agreements.

Licensing and Partnerships

Eli Lilly actively manages licensing arrangements and partnerships to expand Pemfexy’s availability globally. Licensees or authorized generic producers may emerge in markets with high demand or limited access to Lilly’s distribution network.

Emerging Market Actors

In certain regions, local pharmaceutical companies may import and distribute Pemfexy under regulatory authorization, often through import licenses or special access programs. These actors are subject to national drug approval processes and manufacturing compliance.

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Regulatory Status and Its Impact on Supply

In several jurisdictions, Pemfexy holds full regulatory approval, certifying manufacturing compliance and enabling authorized distribution. Regulatory authorities like the FDA (USA), EMA (EU), and others oversee the manufacturing, labeling, and safety monitoring. Restrictions or delays in approvals can impact supply continuity and market availability, prompting dependency on a limited supplier base.

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Future Outlook and Supplier Opportunities

Potential for Biosimilars

The evolving biosimilar landscape presents opportunities for additional suppliers to enter the Pemfexy market upon patent expiration and regulatory pathways maturing. This could diversify supply sources and reduce costs.

Supply Chain Innovation

Leveraging advanced manufacturing technologies, such as continuous manufacturing, and expanding global manufacturing footprint can improve supply resilience and reduce vulnerability to disruptions.

Collaborations and Partnerships

Strategic alliances between Eli Lilly and regional manufacturers may facilitate broader distribution channels, especially in emerging markets where access to novel cancer therapies remains a challenge.

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Key Takeaways

• Limited manufacturer base: Eli Lilly is the sole producer of Pemfexy, with the drug supplied through authorized distributors and wholesalers.
• Distribution channels: Major North American wholesalers and specialty pharmacies are key sources; regional distributors manage other markets.
• Supply challenges: Manufacturing complexity and regulatory factors affect availability; proactive supply chain management mitigates disruptions.
• Licensing and biosimilars: Patent expiration could introduce biosimilar competitors, broadening supply options and fostering affordability.
• Global expansion: Opportunities exist to expand supplier diversity through regional licensing, strategic partnerships, and innovative manufacturing.

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Frequently Asked Questions

1. Is Pemfexy available from multiple manufacturers?
Currently, Eli Lilly is the exclusive manufacturer of Pemfexy. No approved generic or biosimilar alternatives are widely available yet, but this may change after patent expiry.

2. How can healthcare providers procure Pemfexy?
Procurement is primarily through authorized wholesalers, directly via Eli Lilly, or specialty pharmacies under licensing agreements, depending on regional supply chains.

3. Are there regional differences in Pemfexy supply?
Yes. Developed markets like North America and Europe benefit from established distribution networks; emerging markets rely on importers and local licensing arrangements.

4. What factors could impact Pemfexy supply security?
Manufacturing disruptions, regulatory delays, global supply chain issues, or patent challenges can influence availability.

5. Are biosimilars or generics expected soon?
Pending patent expiration and regulatory approval, biosimilars or generics may enter the market, increasing supply options and competition.

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References

1. Eli Lilly and Company. Pemfexy (pemetrexed disodium for injection) prescribing information. [2022].
2. U.S. Food and Drug Administration. Approved drugs database. Pemfexy approval status. [2023].
3. European Medicines Agency. Summary of Product Characteristics for Pemfexy. [2023].
4. Market analysis reports on oncology drug distribution and supply chain management. [2022-2023].

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This comprehensive overview provides business professionals with vital insights into Pemfexy’s supply landscape, aiding strategic procurement, and market analysis endeavors.