Suppliers and packagers for alimta

alimta

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462	NDA	Eli Lilly and Company	0002-7623-01	1 VIAL in 1 CARTON (0002-7623-01) / 20 mL in 1 VIAL	2004-02-04
Lilly	ALIMTA	pemetrexed disodium	POWDER;INTRAVENOUS	021462	NDA	Eli Lilly and Company	0002-7640-01	1 VIAL in 1 CARTON (0002-7640-01) / 4 mL in 1 VIAL	2007-09-07

Suppliers for the Pharmaceutical Drug: Alimta

Last updated: July 27, 2025

Introduction

Alimta (pemetrexed disodium) is a chemotherapy agent primarily indicated for non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. Manufactured by Eli Lilly and Company, Alimta plays a critical role in oncology treatment regimens. As demand for this drug surges with increasing cancer incidence, understanding its supply chain landscape becomes vital for stakeholders, including healthcare providers, distributors, and policymakers. This analysis delineates the key suppliers involved in the production and distribution of Alimta, examining manufacturing sources, supply chain dynamics, and market implications.

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Manufacturing and Raw Material Suppliers

Active Pharmaceutical Ingredient (API) Production

At the core of Alimta’s supply chain lies the manufacturing of pemetrexed disodium’s API. Eli Lilly, as the patent holder and primary producer, oversees the API synthesis process. However, the complex chemical synthesis of pemetrexed necessitates sourcing high-quality raw materials from specialized chemical suppliers globally.

Major chemical intermediates used in pemetrexed synthesis are procured from:

• Global specialty chemical companies specializing in heterocyclic compounds.
• Contract manufacturing organizations (CMOs) that provide custom synthesis of API intermediates.

Many of these raw materials are synthesized in regions with established chemical manufacturing expertise, including Europe, China, and India. The sourcing strategy emphasizes quality control, regulatory compliance, and supply reliability to meet strict pharmaceutical standards.

API Manufacturing Sites

Eli Lilly operates multiple API manufacturing facilities. Notably:

• Indianapolis, Indiana, USA: Primary for formulation and final API production.
• Spanish facilities: Some API intermediates are produced at Lilly’s sites in Spain.
• Contract Manufacturers: Eli Lilly leverages partnerships with CMOs in China, India, and Europe to diversify production and prevent supply disruptions.

Recent trends indicate an increasing reliance on CMOs for API synthesis, especially due to capacity constraints, cost efficiencies, and geographic diversification.

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Formulation and Packaging Suppliers

Following API production, Alimta’s formulation occurs in Eli Lilly’s specialized manufacturing plants focusing on sterile, injectable drugs. These plants are often located in:

• United States and Europe: For high-quality sterile production.
• Contract formulation facilities across various regions as dictated by supply commitments.

Packaging suppliers are responsible for final product units, including vials and secondary packaging components sourced globally and subjected to stringent regulatory standards.

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Distribution and Supply Chain Logistics

Global Distributors

Once manufactured, Alimta distributes through a network of authorized distributors adhering to Good Distribution Practice (GDP). Leading distributors include:

• McKesson Corporation
• AmerisourceBergen
• Cardinal Health

These distributors ensure the drug’s timely delivery to hospitals, oncology clinics, and specialty pharmacies across North America, Europe, and other markets.

Supply Chain Challenges

Supply chain resilience is frequently tested by:

• Regulatory changes affecting import/export restrictions.
• Raw material shortages impacting API availability.
• Manufacturing disruptions due to quality or capacity issues.
• Pandemic-related logistics hurdles, especially in maintaining international freight flows.

Eli Lilly actively manages these risks through inventory buffers and diversified supplier networks.

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Regional Suppliers and Market-Specific Considerations

In markets like China and India, local manufacturers are permitted to produce biosimilar or generic versions post-patent expiry. While these are not branded Alimta, their existence influences market dynamics and supply competitiveness.

However, for the proprietary brand, Eli Lilly maintains exclusive rights and collaborates with regional warehouses, logistics partners, and authorized pharmacies to ensure compliance and integrity of the product.

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Market and Strategic Implications

The supply landscape for Alimta exemplifies a controlled yet complex network involving:

• High-quality API sourcing from globally dispersed chemical suppliers and CMOs.
• Manufacturing concentrations in North America and Europe, with strategic use of Indian and Chinese CMOs.
• Robust distribution channels ensuring safe and consistent delivery to end-users.

Future supply dynamics may shift due to patent expirations, emergence of biosimilars, and technological advances in synthesis. Additionally, Eli Lilly’s strategic partnerships with Asian suppliers are likely to optimize cost efficiencies without compromising quality.

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Conclusion

Alimta’s supply chain comprises a combination of Eli Lilly’s proprietary manufacturing, supplemented by global API sourcing and strategic partnerships with CMOs. The key suppliers include specialized chemical producers for raw materials, manufacturing facilities in North America, Europe, and Asia, and global supply chain partners for distribution. Maintaining supply security demands ongoing risk mitigation centered on capacity management, regulatory compliance, and geopolitical stability.

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Key Takeaways

• Eli Lilly remains the primary API manufacturer for Alimta, with extensive reliance on CMOs worldwide.
• Raw material suppliers are predominantly located in Europe, China, and India.
• Diversified manufacturing sites enable supply resilience but require tight quality controls.
• Distribution is managed through leading medical supply chains such as McKesson, Cardinal Health, and AmerisourceBergen.
• Market competition from biosimilars and generics post-patent expiry may influence future supply landscape and pricing.

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FAQs

1. Who are the main manufacturers of Alimta’s API?
Eli Lilly produces the API primarily in the USA and Spain, supported by contract manufacturing organizations in China and India.

2. Are there regional differences in Alimta suppliers?
While Eli Lilly’s proprietary manufacturing is global, regional distribution and supply logistics differ, with localized suppliers and distributors optimized for respective markets.

3. Can alternative suppliers replace Eli Lilly’s API manufacturers?
Potentially, but only regulators authorize such changes if quality standards are met. Currently, Eli Lilly maintains exclusive rights to manufacture Alimta’s API.

4. How does supply chain disruption impact Alimta availability?
Disruptions in raw material supply, manufacturing issues, or logistics hurdles can delay delivery, impacting treatment continuity. Eli Lilly mitigates this via strategic stockpiles and diversified sourcing.

5. Are biosimilars or generics affecting Alimta’s market?
Post-patent expiry, biosimilars and generics may enter the market, potentially reducing demand for branded Alimta, but current suppliers remain dominant in regulated markets.

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Sources:

1. Eli Lilly official website and product information.
2. Pharmaceutical supply chain reports.
3. Patent and regulatory filings pertinent to Alimta.
4. Market analyses on oncology drug supply and distribution networks.