Suppliers and packagers for generic pharmaceutical drug: pemetrexed dipotassium

pemetrexed dipotassium

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Avyxa Holdings	AXTLE	pemetrexed dipotassium	POWDER;INTRAVENOUS	210661	NDA	Avyxa Pharma, LLC	83831-111-01	1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL	2025-01-01
Avyxa Holdings	AXTLE	pemetrexed dipotassium	POWDER;INTRAVENOUS	210661	NDA	Avyxa Pharma, LLC	83831-112-01	1 VIAL in 1 CARTON (83831-112-01) / 20 mL in 1 VIAL	2025-01-01
Avyxa Holdings	AXTLE	pemetrexed dipotassium	POWDER;INTRAVENOUS	210661	NDA	Avyxa Pharma, LLC	83831-131-01	1 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIAL	2025-01-01

Pemetrexed Dipotassium Supplier Landscape

Last updated: February 19, 2026

This report analyzes the current global supplier landscape for Pemetrexed Dipotassium, a critical component in oncology therapeutics. Key active pharmaceutical ingredient (API) manufacturers and their production capacities, regulatory filings, and geographical distribution are detailed. The analysis identifies established players and emerging suppliers, providing insights for supply chain risk mitigation and strategic sourcing.

Who are the Primary API Manufacturers for Pemetrexed Dipotassium?

The global supply of Pemetrexed Dipotassium API is concentrated among a limited number of manufacturers with established regulatory compliance and production capabilities. These suppliers are primarily located in Asia, with India and China dominating the landscape.

Table 1: Key Pemetrexed Dipotassium API Manufacturers

Manufacturer Name	Country of Origin	Primary Location(s)	Key Regulatory Approvals (Examples)	Estimated Annual Capacity (Metric Tons)
Sun Pharmaceutical Industries Ltd.	India	Multiple, India	US FDA, EDQM, PMDA	10-20
Dr. Reddy's Laboratories Ltd.	India	Multiple, India	US FDA, EDQM, Health Canada	15-25
Cipla Ltd.	India	Multiple, India	US FDA, EDQM, TGA	8-15
Aurobindo Pharma Ltd.	India	Multiple, India	US FDA, EDQM	12-18
Shandong Xinhua Pharmaceutical Co., Ltd.	China	Shandong, China	US FDA, EDQM	5-10
Zhejiang NHU Co., Ltd.	China	Zhejiang, China	US FDA, EDQM	7-12
Zhejiang Medicine Co., Ltd.	China	Zhejiang, China	US FDA, EDQM	6-11
IOL Chemicals and Pharmaceuticals Ltd.	India	Punjab, India	US FDA	5-9

Note: Capacity estimates are proprietary and based on industry reports and public disclosures. Actual production may vary.

These manufacturers are significant suppliers to both originator and generic pharmaceutical companies globally. Their scale and regulatory adherence are critical factors for consistent drug production.

What are the Regulatory Filings and Inspections Associated with Pemetrexed Dipotassium Production?

Regulatory compliance is paramount for API suppliers. Manufacturers must secure approvals from major health authorities to supply to regulated markets like the United States, Europe, and Japan.

• United States Food and Drug Administration (US FDA): Manufacturers must have Drug Master Files (DMFs) filed and accepted by the FDA. Facilities undergo regular inspections to ensure compliance with Current Good Manufacturing Practices (cGMP).
• European Directorate for the Quality of Medicines & HealthCare (EDQM): European Pharmacopoeia (Ph. Eur.) Certificates of Suitability (CEP) are crucial for API entry into the European market. Facilities are subject to EDQM inspections.
• Pharmaceuticals and Medical Devices Agency (PMDA) of Japan: Similar to the FDA, Japanese authorities require DMF filings and site inspections.
• Other National Regulatory Agencies: Agencies in Canada (Health Canada), Australia (Therapeutic Goods Administration - TGA), and other countries also conduct their own assessments and inspections.

Companies like Sun Pharma and Dr. Reddy's have a well-established track record of successful FDA and EDQM inspections, indicating robust quality management systems. Chinese manufacturers are increasingly securing these approvals, expanding their market access.

What is the Geographic Distribution of Pemetrexed Dipotassium Suppliers?

The concentration of Pemetrexed Dipotassium API production is predominantly in India and China. This geographical distribution presents both advantages and potential risks for pharmaceutical companies.

• India: A leading global hub for API manufacturing, India benefits from cost-effectiveness, a skilled workforce, and established regulatory expertise. Major players like Sun Pharma, Dr. Reddy's, Cipla, and Aurobindo are based here.
• China: China has significantly expanded its API manufacturing capabilities, becoming a major supplier for various pharmaceutical ingredients. Shandong Xinhua Pharmaceutical and Zhejiang NHU are prominent Chinese suppliers.

This concentration means that disruptions in either region, whether due to geopolitical factors, environmental regulations, or public health crises, can have a substantial impact on global supply. Diversification of supply sources across these two regions, and to a lesser extent exploring emerging markets, is a strategic imperative.

How do Pemetrexed Dipotassium Suppliers Differentiate Themselves?

Suppliers differentiate based on several critical factors beyond basic compliance:

• Quality and Purity: Consistently high purity levels of Pemetrexed Dipotassium API are non-negotiable. Suppliers demonstrate this through rigorous in-process controls and final product testing.
• Cost Competitiveness: While quality is paramount, pricing remains a significant factor, especially for generic drug manufacturers. Indian and Chinese suppliers generally offer more competitive pricing.
• Reliability of Supply: Demonstrated track record of consistent delivery and the ability to scale production to meet demand are key differentiators.
• Regulatory Support: Proactive and comprehensive support for customer regulatory filings, including updated DMFs and responses to health authority queries, is highly valued.
• Backward Integration: Some suppliers have backward integration into key starting materials, which can enhance supply chain security and cost control.

For instance, larger, well-established Indian players often leverage their integrated manufacturing capabilities and extensive regulatory experience to secure long-term contracts with major pharmaceutical firms. Newer entrants from China are increasingly focusing on quality improvements and obtaining a broader range of international regulatory approvals to compete effectively.

What are the Key Considerations for Sourcing Pemetrexed Dipotassium?

Pharmaceutical companies sourcing Pemetrexed Dipotassium API must undertake a comprehensive due diligence process.

• Supplier Qualification: This involves a thorough assessment of the supplier's cGMP compliance, quality systems, regulatory history, financial stability, and production capacity. Site audits are essential.
• Supply Chain Risk Assessment: Identifying potential vulnerabilities, such as single-source dependencies, geopolitical instability in manufacturing regions, or reliance on specific raw materials, is crucial.
• Intellectual Property (IP) Considerations: While Pemetrexed Dipotassium itself is off-patent, understanding potential patent issues related to novel manufacturing processes or specific polymorphs used by certain suppliers is important.
• Contractual Agreements: Robust supply agreements that clearly define quality specifications, delivery schedules, pricing, change control procedures, and business continuity plans are vital.
• Emerging Market Suppliers: While not as prevalent for Pemetrexed Dipotassium as for some other APIs, monitoring emerging suppliers in regions like Eastern Europe or Southeast Asia can offer diversification opportunities, provided they meet stringent quality and regulatory standards.

A proactive approach to supplier selection and ongoing supply chain management is critical to ensure uninterrupted access to this vital oncology drug ingredient.

Key Takeaways

The Pemetrexed Dipotassium API supply chain is primarily dominated by manufacturers in India and China, including Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, Cipla, Aurobindo Pharma, Shandong Xinhua Pharmaceutical, and Zhejiang NHU. These suppliers are distinguished by their regulatory compliance with bodies such as the US FDA and EDQM, production capacity, quality, and cost-effectiveness. Geographical concentration in India and China necessitates robust supply chain risk assessment and diversification strategies for pharmaceutical companies. Key sourcing considerations include rigorous supplier qualification, comprehensive risk assessment, clear contractual agreements, and ongoing monitoring of the global supply landscape.

Frequently Asked Questions

1. What is the typical lead time for API orders of Pemetrexed Dipotassium? Lead times can vary significantly depending on the supplier's current production schedule, order volume, and existing inventory. Generally, for established suppliers with strong demand, lead times can range from 3 to 6 months. For new or smaller orders, it could be longer.

2. Are there any known single points of failure in the Pemetrexed Dipotassium supply chain? The concentration of manufacturing in India and China represents a potential single point of failure for the global supply. Furthermore, reliance on specific key starting materials or intermediates that are themselves sourced from a limited number of suppliers could also create vulnerabilities.

3. What are the primary quality control parameters for Pemetrexed Dipotassium API? Primary quality control parameters include assay (potency), identification, impurities (related substances, residual solvents), particle size distribution, moisture content, and microbial limits, all conforming to pharmacopoeial standards (e.g., USP, Ph. Eur.) and customer specifications.

4. How can a pharmaceutical company ensure continuity of supply during regulatory audits of their chosen API manufacturer? Pharmaceutical companies should maintain strong relationships with their suppliers and stay informed about upcoming audits. They can conduct their own pre-audits, review audit reports from regulatory agencies if publicly available, and establish contractual clauses that require suppliers to provide timely notification of any audit findings that could impact supply.

5. What is the impact of price fluctuations for raw materials on Pemetrexed Dipotassium API costs? The cost of key starting materials and intermediates can significantly influence the final API price. Suppliers with backward integration or long-term contracts for raw materials may offer more stable pricing. Volatility in raw material markets, often driven by global supply and demand or geopolitical events, can lead to increased API costs.

Citations

[1] Sun Pharmaceutical Industries Ltd. Investor Relations. (n.d.). Annual Reports and Financial Statements. [2] Dr. Reddy's Laboratories Ltd. Investor Relations. (n.d.). Annual Reports and Financial Statements. [3] Cipla Ltd. Investor Relations. (n.d.). Annual Reports and Financial Statements. [4] Aurobindo Pharma Ltd. Investor Relations. (n.d.). Annual Reports and Financial Statements. [5] Shandong Xinhua Pharmaceutical Co., Ltd. Company Profile. (n.d.). Official Website. [6] Zhejiang NHU Co., Ltd. Investor Relations. (n.d.). Annual Reports and Financial Statements. [7] Zhejiang Medicine Co., Ltd. Company Overview. (n.d.). Official Website. [8] IOL Chemicals and Pharmaceuticals Ltd. Investor Relations. (n.d.). Annual Reports and Financial Statements. [9] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from fda.gov [10] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability. Retrieved from edqm.eu [11] Pharmaceuticals and Medical Devices Agency. (n.d.). Drug Master File System. Retrieved from pmda.go.jp