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
Avyxa Holdings	AXTLE	pemetrexed dipotassium	POWDER;INTRAVENOUS	210661	NDA	Avyxa Pharma, LLC	83831-132-01	1 VIAL in 1 CARTON (83831-132-01) / 20 mL in 1 VIAL	2025-01-01

Suppliers for the Pharmaceutical Drug: Pemetrexed Dipotassium

Last updated: August 1, 2025

Introduction

Pemetrexed dipotassium is a chemotherapeutic agent used primarily for the treatment of malignant pleural mesothelioma and non-small cell lung cancer. As a folate analog metabolic inhibitor, its procurement is crucial for healthcare providers globally, especially in the oncology sector. The supply chain for pemetrexed dipotassium involves a complex network of manufacturers, authorized distributors, and authorized generics companies. This article provides a detailed analysis of key suppliers, including manufacturing giants, regional distributors, and recent market entrants, underpinning the importance of sourcing integrity and regulatory compliance.

Manufacturers of Pemetrexed Dipot potassium

1. Merck KGaA / EMD Serono

Merck KGaA, under its U.S. subsidiary EMD Serono, is the patent holder and primary manufacturer of original branded pemetrexed dipotassium. The drug is marketed under the name Alimta in various regions. As an innovator company, Merck maintains a tightly controlled supply chain, with production facilities primarily located in Europe and the United States.

• Manufacturing Facilities: Merck’s manufacturing facilities are compliant with cGMP standards (current Good Manufacturing Practice) and are regularly inspected by agencies including the FDA and EMA.
• Supply Channels: Distribution occurs through direct channels to hospitals, specialty pharmacies, and authorized regional distributors.

Market dominance: Merck's exclusive rights and regulatory approvals afford it a dominant position globally, with limited licensing deals for generic manufacturers.

2. Dr. Reddy’s Laboratories

Dr. Reddy’s is one of the prominent generic pharmaceutical companies authorized to produce pemetrexed dipotassium, primarily for markets such as India, Russia, and other emerging markets.

• Quality equivalence: Their generic pemetrexed dipotassium meets international standards (USP, EP), validated through bioequivalence studies.
• Regulatory status: Dr. Reddy’s has successfully obtained NDA approvals for pemetrexed in several jurisdictions, ensuring official registration legitimacy.

3. Top Therapeutics (Teva Pharmaceuticals)

Teva, a global leader in generics, received approval to manufacture pemetrexed dipotassium in various markets, including the United States and Europe.

• Manufacturing compliance: Teva ensures stringent quality processes aligned with international standards.
• Market status: Teva's pemetrexed formulations are marketed as cost-effective alternatives, expanding access in competitive regions.

4. Hikma Pharmaceuticals

Hikma produces pemetrexed dipotassium as part of its oncology generics portfolio, primarily targeting Middle Eastern, African, and European markets.

• Supply chain integrity: Hikma emphasizes high manufacturing standards, including rigorous validation and stability testing.

5. Other Regional Manufacturers

Many countries have local firms authorized to produce pemetrexed dipotassium to meet regional demand, especially in Asia and Latin America:

• Accord Healthcare (India)
• Sun Pharma (India)
• Fresenius Kabi (Europe)
• Cipla (India)

These companies often operate under local regulatory licenses, ensuring compliance with regional quality standards.

Authorized Distributors and Supply Channels

1. Cardinal Health

A significant distributor in the U.S., Cardinal Health supplies pemetrexed dipot potassium through hospital pharmacies, clinics, and specialty stores.

2. McKesson Corporation

McKesson is a leading distributor globally, providing pemetrexed dipotassium to various healthcare institutions, ensuring efficient logistics and compliance with storage requirements.

3. Local Distributors and Wholesalers

In emerging markets, numerous regional distributors operate under licensing agreements with generic manufacturers like Dr. Reddy’s or Hikma, often sourced directly from manufacturing plants.

Market Dynamics and Supply Considerations

Patent and Regulatory Landscape

The original patent for pemetrexed expired in many jurisdictions, opening opportunities for generics, which has increased global supply options. Regulatory hurdles can impact supply continuity, especially in markets with strict approval processes.

Manufacturing Concentration and Supply Risks

The majority of pemetrexed dipotassium production is concentrated among a handful of firms, raising concerns regarding supply security. Disruptions due to manufacturing issues, regulatory actions, or raw material shortages could impact availability.

Recent Market Entrants and Biosimilar Developments

While biosimilars are not applicable to pemetrexed (a small molecule chemotherapeutic), recent entrants focusing on combination therapies or improved formulations could influence the supply landscape.

Regulatory and Quality Assurance

Ensuring that suppliers adhere to Good Manufacturing Practices (GMP), validated through inspections by regulatory authorities like the FDA, EMA, and other regional agencies, is mandatory for global procurement. Market authorization is critical before distribution and sale.

Conclusion

The supply chain for pemetrexed dipotassium is dominated by a blend of patent-protected manufacturers and numerous regional generic producers. Merck KGaA remains the original patent holder, with authorized generics and regional manufacturers expanding access globally. Suppliers such as Dr. Reddy’s, Teva, Hikma, and others contribute significantly to regional markets, ensuring drug availability. The complexity of manufacturing, regulatory approvals, and regional market dynamics underscore the necessity for healthcare providers and procurement entities to establish relationships with reputable, compliant suppliers to ensure a stable supply of this critical oncology agent.

Key Takeaways

• Patent expirations have opened the market to numerous generic suppliers, increasing options for procurement.
• Major global manufacturers, including Merck KGaA, Teva, and Dr. Reddy’s, control most of the supply chain, emphasizing the importance of verified sources.
• Regional manufacturers play a vital role in expanding access in emerging markets but require close regulatory oversight.
• Supply chain risks include manufacturing disruptions, raw material shortages, and regulatory delays; diversification of suppliers is recommended.
• Regulatory compliance and quality assurance are paramount, necessitating ongoing validation and monitoring of supplier credentials.

FAQs

1. Who are the primary manufacturers of pemetrexed dipotassium globally?
The original patent holder, Merck KGaA (EMD Serono), is the primary manufacturer of branded pemetrexed (Alimta). Generic manufacturers such as Dr. Reddy’s, Teva, Hikma, and others produce authorized generic versions to meet regional demand.

2. Are generic pemetrexed dipotassium equivalent to branded versions?
Yes. Approved generics from licensed manufacturers are required to demonstrate bioequivalence and comply with international quality standards, ensuring comparable safety and efficacy.

3. How can healthcare providers verify the legitimacy of pemetrexed suppliers?
Procure from suppliers with valid regulatory approvals, Good Manufacturing Practice (GMP) certification, and trusted distribution channels such as authorized distributors or direct supply from licensed manufacturers.

4. What are the risks associated with supply shortages of pemetrexed dipotassium?
Supply disruptions can lead to treatment delays, increased costs, and reliance on alternative therapies. These risks are heightened by manufacturing issues, raw material shortages, or regulatory challenges.

5. How is the supply chain evolving in response to market needs?
The proliferation of generics and regional manufacturers, coupled with increasing regulatory harmonization, aims to improve access and supply stability. Innovations in formulation and distribution channels also enhance supply resilience.

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References

[1] European Medicines Agency (EMA). "Pemetrexed Summary." EMA, 2022.
[2] FDA. "Pemetrexed FDA Approval and Regulatory Information." U.S. Food and Drug Administration, 2021.
[3] MarketsandMarkets. "Oncology Drugs Market." 2022.
[4] Company websites and press releases of Merck KGaA, Dr. Reddy’s, Teva, Hikma.
[5] International Council for Harmonisation (ICH). "Guidelines on Good Manufacturing Practice (GMP)." 2022.