Suppliers and packagers for PEMETREXED

PEMETREXED

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419	NDA	Teva Pharmaceuticals, Inc.	0480-4514-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4514-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2022-05-31
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419	NDA	Teva Pharmaceuticals, Inc.	0480-4515-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4515-01) / 40 mL in 1 VIAL, SINGLE-DOSE	2022-05-31
Actavis	PEMETREXED	pemetrexed	SOLUTION;INTRAVENOUS	208419	NDA	Teva Pharmaceuticals, Inc.	0480-4516-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01) / 4 mL in 1 VIAL, SINGLE-DOSE	2022-06-01
Shilpa	PEMETREXED	pemetrexed disodium	SOLUTION;INTRAVENOUS	215179	NDA	Shilpa Medicare Limited	63759-3048-1	1 VIAL in 1 CARTON (63759-3048-1) / 10 mL in 1 VIAL	2024-01-01

Suppliers for the Pharmaceutical Drug: PEMETREXED

Last updated: July 29, 2025

Introduction

Pemetrexed, a chemotherapy agent primarily used to treat mesothelioma and non-small cell lung cancer (NSCLC), has gained significant importance in oncological therapies. As a multi-target antifolate agent, pemetrexed disrupts folate-dependent metabolic processes essential for DNA synthesis, leading to cell death in rapidly dividing cancer cells. The global supply chain for pemetrexed involves a complex network of raw material providers, active pharmaceutical ingredient (API) manufacturers, and finished drug producers. Understanding the key suppliers and supply chain dynamics is crucial for healthcare providers, pharmaceutical companies, and investors seeking to ensure consistent drug availability and strategic sourcing.

Raw Material Suppliers for Pemetrexed

The manufacturing of pemetrexed API depends on high-purity raw materials, including folic acid analogs and specialized chemical intermediates. The raw material supplier landscape is characterized by a mix of global chemical firms and regional specialty chemical manufacturers.

Major Raw Material Suppliers:

• BASF SE
  BASF supplies various chemical intermediates used in the synthesis of pemetrexed. Its extensive portfolio includes chemical building blocks and specialty chemicals required in complex drug manufacturing processes. BASF's global footprint ensures a reliable supply chain, although specific procurement data for pemetrexed intermediate precursors remains proprietary.

• Jubilant Life Sciences
  An Indian pharmaceutical and chemical manufacturer, Jubilant produces chemical intermediates used in antifolate synthesis. They supply raw materials to several API producers and have ramped up capacities to meet increasing global demand.

• Jiangsu Hengrui Medicine Co., Ltd.
  Primarily a pharmaceutical company, Hengrui also produces chemical intermediates, including those used in pemetrexed synthesis. Their integration into the supply chain reduces dependency on external raw material suppliers.

• AbbVie and Other Contract Manufacturers
  Some contract manufacturing organizations (CMOs) engage in the procurement of raw chemicals sourced from multiple suppliers, often consolidating raw material sourcing to optimize costs and quality.

Active Pharmaceutical Ingredient (API) Manufacturers

The core of pemetrexed supply lies in the manufacturing of the API itself. Due to its complexity, only a handful of companies possess the capacity to produce high-quality pemetrexed API at scale.

Key API Suppliers:

• Hospira (A Pfizer Company)
  Historically, Hospira was among the primary suppliers of pemetrexed. After Pfizer's acquisition of Hospira, the API production consolidated under Pfizer’s global manufacturing network, notably at facilities in the United States and Europe. These manufacturing sites adhere to strict cGMP standards and supply pemetrexed API to authorized generic and branded drug producers.

• Mitsubishi Tanabe Pharma Corporation
  Japan-based Mitsubishi Tanabe has developed its own production processes for pemetrexed and supplies the API to regional markets, particularly in Asia. They hold patents and manufacturing approvals for their formulations.

• Cephalon (Subsidiary of Teva Pharmaceutical Industries)
  Teva, through its acquisition of Cephalon, has engaged in pemetrexed API production, primarily for its generic formulations, leveraging manufacturing sites across Europe and North America.

• Shanghai Fosun Pharmaceutical Group
  Chinese pharmaceutical company's involvement in pemetrexed API production has increased, especially following the broadening of China's API manufacturing capabilities. Their plants meet international standards, and they supply both domestic and international markets.

Manufacturing Challenges and Opportunities

The complexity of pemetrexed synthesis—entailing multi-step chemical processes—limits the number of capable API producers. Supply chain disruptions can arise from manufacturing delays, quality issues, or regulatory hurdles, emphasizing the importance of having multiple sources. Notably, recent initiatives to diversify suppliers in response to global supply chain vulnerabilities are reshaping the pemetrexed API landscape.

Finished Drug Manufacturers and Supply Chain Dynamics

Beyond raw materials and APIs, the final drug product’s sourcing depends on pharmaceutical companies that procure APIs and assemble the finished formulations.

• Eli Lilly and Company
  Eli Lilly markets pemetrexed under the brand name Alimta, with manufacturing and distribution managed globally. Their supply chain integrates API procurement from multiple sources, maintaining high-quality standards compliant with regulatory agencies like the FDA and EMA.

• Teva Pharmaceuticals
  As a leading generic drug manufacturer, Teva produces pemetrexed formulations across several regions. They utilize APIs from multiple suppliers, including regional producers, ensuring drug availability worldwide.

• Hospira (Pfizer)
  Hospira, now part of Pfizer, supplied both the API and finished formulations, with manufacturing facilities in Europe and North America.

Market and Supply Chain Challenges

The supply landscape for pemetrexed is susceptible to various challenges:

• Regulatory Compliance: Suppliers must meet stringent cGMP standards and undergo regular inspections by the FDA, EMA, and other authorities.

• Manufacturing Complexity: The multi-step synthesis process requires high precision and quality assurance, limiting the number of suppliers who can reliably produce pemetrexed API.

• Geopolitical Factors: Trade tensions, export restrictions, and regional manufacturing preferences influence supplier diversity and availability.

• Supply Chain Disruptions: Manufacturing delays, raw material shortages, or regulatory issues can cause supply shortages, impacting patient access.

Emerging Trends and Strategic Sourcing

The ongoing push towards regional manufacturing capabilities, especially in Asia and Europe, aims to mitigate supply risks. Companies are also exploring biotechnology-based synthesis to streamline production and reduce reliance on complex chemical processes. Strategic alliances, such as joint ventures or licensing agreements, are shaping the supplier landscape, fostering diversification.

Conclusion

The supply of pemetrexed hinges on a small cluster of specialized API manufacturers, raw material suppliers, and finished drug producers operating within a tightly regulated environment. Key players such as Pfizer (Hospira), Mitsubishi Tanabe, Teva, and regional Chinese manufacturers dominate the landscape. Ensuring supply security requires continuous diversification of sources, investment in manufacturing capacity, and adherence to regulatory standards. Stakeholders must monitor geopolitical developments and technological advancements to adapt effectively.

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Key Takeaways

• Major API suppliers include Pfizer (Hospira), Mitsubishi Tanabe, Teva, and Chinese manufacturers like Shanghai Fosun.
• Raw material sourcing is primarily from global chemical giants such as BASF and regional specialty chemical firms.
• The complexity of pemetrexed's synthesis constrains the number of reliable high-quality API producers.
• Regulatory compliance and geopolitical factors heavily influence supply chain stability.
• Diversification and regional manufacturing initiatives are critical strategies to mitigate potential supply disruptions.

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FAQs

1. Why is the supply chain for pemetrexed relatively limited compared to other chemotherapies?
Because pemetrexed’s complex multi-step synthesis requires specialized expertise and facilities, only a handful of manufacturers possess compliant production capacity, resulting in limited supply sources.

2. Are there regional differences in pemetrexed suppliers?
Yes. While Western companies like Pfizer and Teva dominate global supplies, regional manufacturers in China and Japan are increasingly contributing to the API market, driven by local regulations and manufacturing capabilities.

3. How do regulatory standards impact pemetrexed suppliers?
Suppliers must comply with stringent cGMP standards enforced by agencies such as the FDA and EMA. Non-compliance can lead to delays, production halts, or market bans, emphasizing the importance of regulatory adherence.

4. Are there any emerging suppliers or manufacturers in the pemetrexed supply chain?
Yes. Chinese and Indian companies are expanding their production capacities, aiming to diversify and strengthen supply chains amidst global shortages and geopolitical uncertainties.

5. How might supply chain disruptions affect patients receiving pemetrexed?
Disruptions can lead to shortages, delays in treatment, or increased costs. Maintaining a diversified and robust supply chain is essential to ensure consistent patient access to this critical therapy.

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Sources:
[1] Pharma Manufacturing Reports, 2022.
[2] GlobalData, 2023.
[3] U.S. Food and Drug Administration (FDA) Database.
[4] European Medicines Agency (EMA) Documentation.
[5] Company annual reports and official disclosures from Pfizer, Teva, Mitsubishi Tanabe, and regional Chinese manufacturers.