pemetrexed disodium: Pharmaceutical manufacturers, suppliers, and packagers

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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
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	203485	ANDA	Accord Healthcare Inc.	16729-229-03	1 VIAL in 1 CARTON (16729-229-03) / 4 mL in 1 VIAL	2022-05-25
Accord Hlthcare	PEMETREXED DISODIUM	pemetrexed disodium	POWDER;INTRAVENOUS	203485	ANDA	Accord Healthcare Inc.	16729-230-11	1 VIAL in 1 CARTON (16729-230-11) / 20 mL in 1 VIAL	2022-05-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report identifies key global suppliers of pemetrexed disodium, a critical component for Alimta, a blockbuster chemotherapy drug. The analysis focuses on manufacturers with demonstrated capacity and established supply chains for the active pharmaceutical ingredient (API). Key considerations for procurement include regulatory compliance, manufacturing scale, and geographical distribution.

Who are the Primary Manufacturers of Pemetrexed Disodium API?

Multiple companies globally produce pemetrexed disodium API. These suppliers are crucial for both originator and generic drug manufacturers.

Indian Manufacturers: India is a significant hub for API production, and several companies in the country supply pemetrexed disodium.
- Dr. Reddy's Laboratories: A major Indian pharmaceutical company with established API manufacturing capabilities.
- Lupin Limited: Another prominent Indian pharmaceutical firm with a strong presence in API supply.
- Sun Pharmaceutical Industries: A large multinational Indian company known for its extensive API portfolio.
- Divi's Laboratories: A specialized API manufacturer with large-scale production facilities.
Chinese Manufacturers: China also plays a substantial role in global API supply chains for various therapeutic areas, including oncology.
- Hengdian Group: A significant Chinese conglomerate with pharmaceutical manufacturing interests.
- Zhejiang NHU Company: A key player in the Chinese pharmaceutical ingredient market.
European Manufacturers: While less prominent in sheer volume compared to Asian suppliers, some European entities also contribute to the pemetrexed disodium supply. Specific company names in Europe are often less publicly disclosed for API intermediates and finished API in competitive markets.

What is the Regulatory Status of Pemetrexed Disodium Suppliers?

Suppliers must adhere to strict regulatory standards to ensure the quality and safety of the API. Compliance with Good Manufacturing Practices (GMP) is a fundamental requirement.

US Food and Drug Administration (FDA): Facilities supplying to the United States market must be FDA-approved. This involves regular inspections and adherence to FDA regulations, including Current Good Manufacturing Practices (cGMP).
European Medicines Agency (EMA): Suppliers targeting the European Union must comply with EMA guidelines and be certified by competent authorities of EU member states.
Other National Regulatory Bodies: Manufacturers also need to meet the requirements of regulatory agencies in other major markets where their products are distributed, such as Japan's Pharmaceuticals and Medical Devices Agency (PMDA) or Health Canada.
Certificate of Suitability (CEP): Many suppliers obtain a Certificate of Suitability to the European Pharmacopoeia (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM). This document demonstrates that the quality of a substance is suitably controlled by the relevant monograph(s) of the European Pharmacopoeia.

Table 1: Key Regulatory Compliance for API Suppliers

Regulatory Body	Scope	Relevance to Pemetrexed Disodium
FDA	US market approval	Essential for US sales
EMA	European Union market approval	Essential for EU sales
EDQM (CEP)	European Pharmacopoeia compliance	Facilitates EU regulatory filings
PMDA	Japanese market approval	Essential for Japan sales
Health Canada	Canadian market approval	Essential for Canada sales

What is the Manufacturing Capacity and Scale of Key Suppliers?

The scale of production is a critical factor for ensuring a stable supply chain, especially for high-demand oncology drugs. Manufacturers are assessed on their installed capacity and ability to scale up production.

Large-Scale API Production: Companies like Divi's Laboratories and significant Indian and Chinese players are equipped for multi-ton production of complex APIs. Their facilities are designed for high throughput and efficient synthesis.
Process Chemistry Expertise: The synthesis of pemetrexed disodium involves multiple steps and requires sophisticated chemical engineering. Suppliers with a strong background in process optimization and sterile manufacturing are preferred.
Geographic Diversification of Manufacturing: Relying on a single manufacturing location carries supply chain risks. Companies often seek suppliers with multiple production sites or a diversified geographical footprint to mitigate disruptions.
Capacity Investments: Leading API manufacturers continuously invest in expanding their facilities to meet growing global demand and anticipate future market needs.

Table 2: Comparative Overview of Potential Pemetrexed Disodium API Suppliers

Supplier Name	Country of Origin	Primary Focus	Demonstrated Scale	Key Markets Served	Notes
Dr. Reddy's Laboratories	India	API & Finished Dosage Forms	Large	Global	Strong regulatory track record
Lupin Limited	India	API & Finished Dosage Forms	Large	Global	Extensive API portfolio, including oncology
Sun Pharmaceutical Industries	India	API & Finished Dosage Forms	Large	Global	Broad therapeutic range, significant API production
Divi's Laboratories	India	Custom Synthesis & API production	Very Large	Global	Specialized in complex APIs, high volume
Hengdian Group	China	Pharmaceuticals & other industries	Large	Global	Diverse manufacturing capabilities
Zhejiang NHU Company	China	API & Fine Chemicals	Large	Global	Focus on chemical synthesis and production

What are the Supply Chain Risks Associated with Pemetrexed Disodium?

Several factors can impact the stability and cost of pemetrexed disodium supply.

Geopolitical Instability: Reliance on specific regions for API manufacturing can expose supply chains to geopolitical risks, trade disputes, or export restrictions.
Raw Material Sourcing: The availability and cost of key starting materials and intermediates for pemetrexed disodium synthesis can fluctuate. Disruptions in the supply of these upstream components directly affect API production.
Regulatory Changes: New or stricter regulations from health authorities can necessitate costly process modifications or facility upgrades, potentially impacting supply or pricing.
Quality Control Failures: Any failure in quality control at a manufacturing site can lead to batch rejections, recalls, or temporary shutdowns, causing significant supply disruptions.
Intellectual Property Landscape: While the primary patents for pemetrexed disodium may have expired or are nearing expiry, specific manufacturing processes or polymorphic forms could still be under patent protection, influencing supplier choice and market entry for generics.
Competition and Pricing Pressures: The entry of multiple generic manufacturers into the market for finished drug products utilizing pemetrexed disodium can lead to increased demand for the API but also intense pricing pressure on API suppliers.

What is the Pemetrexed Disodium Market Outlook?

The market for pemetrexed disodium API is influenced by the demand for its branded and generic finished drug products.

Alimta (Pemetrexed Disodium) Market: Alimta, originally developed by Eli Lilly and Company, has been a significant revenue generator. The patent expiries for Alimta have led to increased generic competition.
Generic Penetration: The availability of generic pemetrexed disodium injections globally drives demand for API from a wider range of pharmaceutical companies. This trend supports continued demand for API suppliers.
Oncology Drug Market Growth: The broader oncology drug market is experiencing steady growth, driven by an aging global population, increasing cancer incidence, and advancements in treatment. Pemetrexed remains a relevant therapeutic option in certain cancer types, such as non-small cell lung cancer and mesothelioma.
Emerging Markets: As healthcare access expands in emerging markets, the demand for affordable generic oncology treatments, including pemetrexed disodium, is expected to rise.

Key Takeaways

Leading suppliers of pemetrexed disodium API are concentrated in India and China, with companies like Dr. Reddy's Laboratories, Lupin, Sun Pharma, Divi's Laboratories, Hengdian Group, and Zhejiang NHU Company being prominent.
Regulatory compliance, particularly with FDA, EMA, and adherence to cGMP, is paramount for API suppliers serving major pharmaceutical markets.
Manufacturing capacity and demonstrated ability to produce at scale are critical differentiators, with specialized API manufacturers possessing very large production capabilities.
Supply chain risks include geopolitical factors, raw material availability, regulatory shifts, quality control issues, and evolving intellectual property landscapes.
The market for pemetrexed disodium API is sustained by the ongoing demand for both branded Alimta and its increasingly prevalent generic alternatives, driven by the growth of the global oncology market and expanding access in emerging economies.

Frequently Asked Questions

1. What are the primary starting materials used in the synthesis of pemetrexed disodium?

The synthesis of pemetrexed disodium involves complex organic chemistry. Key intermediates and starting materials often include derivatives of folic acid, amino acids, and various heterocyclic compounds, which are then assembled through a multi-step synthetic route. Specific proprietary starting materials may vary between manufacturers [1].

2. How does the salt form (disodium) impact the API's properties and formulation?

The disodium salt form of pemetrexed is chosen for its improved solubility and bioavailability in aqueous formulations, such as intravenous injections. This salt form facilitates easier dissolution for parenteral administration, ensuring that the drug can be effectively delivered to patients [2].

3. What is the typical shelf life of pemetrexed disodium API?

The shelf life of pemetrexed disodium API is generally determined by stability studies conducted by the manufacturer. Under appropriate storage conditions (typically protected from light and moisture at controlled room temperatures), the API can maintain its quality and potency for several years, often ranging from two to five years [3].

4. Are there any specific polymorphic forms of pemetrexed disodium that are preferred or patented?

Pemetrexed disodium can exist in different crystalline or amorphous forms, known as polymorphs. While the disodium salt is the common form for formulation, specific polymorphic forms may be associated with differing stability, dissolution rates, and manufacturing characteristics. Manufacturers may identify and control specific polymorphs to ensure consistent product quality and potentially for intellectual property protection related to the manufacturing process [4].

5. What are the main therapeutic indications for drugs containing pemetrexed disodium?

Pemetrexed disodium is indicated for the treatment of certain types of cancer. Its primary uses include:

Malignant pleural mesothelioma in combination with cisplatin in patients who have not had prior chemotherapy for this condition.
Locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with cisplatin for patients whose disease has not progressed after initial platinum-based chemotherapy, or as a single agent for maintenance therapy for patients whose disease has not progressed after four cycles of initial platinum-based chemotherapy [5].

6. What quality control tests are typically performed on pemetrexed disodium API?

Quality control for pemetrexed disodium API includes a battery of tests to ensure identity, purity, strength, and quality. These typically include:

Assay: To determine the precise amount of pemetrexed disodium.
Related Substances/Impurities: To detect and quantify any process-related impurities or degradation products using techniques like High-Performance Liquid Chromatography (HPLC).
Water Content: Determined by Karl Fischer titration.
Residual Solvents: To ensure that levels of organic solvents used in manufacturing are within acceptable limits.
Particle Size Distribution: Important for formulation development.
Identification Tests: Such as Infrared Spectroscopy (IR) or Nuclear Magnetic Resonance (NMR).
Sterility and Endotoxin Testing: If manufactured under aseptic conditions for sterile API [3].

7. How does the pricing of pemetrexed disodium API typically compare between Indian and Chinese manufacturers?

Pricing for pemetrexed disodium API can vary significantly based on manufacturing scale, quality certifications, volume commitments, and specific supplier capabilities. Historically, Indian manufacturers have often been competitive due to large-scale production and established export infrastructure. Chinese manufacturers also offer competitive pricing, leveraging significant production capacities. However, price is only one factor, with regulatory compliance, quality consistency, and supply chain reliability being equally critical for pharmaceutical companies. Direct price comparisons are often subject to ongoing market dynamics and confidential supplier agreements [6].

Citations

[1] Patent WO2003010140A1. (2003). Process for the preparation of pemetrexed and salts thereof. Google Patents. [2] Eli Lilly and Company. (2004). Alimta (pemetrexed for injection) Prescribing Information. U.S. Food and Drug Administration. [3] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). General Information on Certificates of Suitability. Retrieved from https://www.edqm.eu/ (Specific EDQM guidelines on monographs and CEPs are publicly available but not directly linked to a single document for API quality control). [4] Li, X., Zhang, Y., Wang, X., & Zhou, L. (2017). A Comparative Study on the Polymorphs of Pemetrexed Disodium. Journal of Pharmaceutical Sciences, 106(10), 2882-2889. [5] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA Approved Drug Products. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/ (Search for Alimta or Pemetrexed Disodium for specific indications). [6] Global API Market Analysis Reports. (Various Publishers). (Reports from market research firms like Grand View Research, MarketsandMarkets, etc., regularly cover API market dynamics and pricing trends by region and product).

Suppliers and packagers for generic pharmaceutical drug: pemetrexed disodium