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Suppliers and packagers for METHOTREXATE LPF
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METHOTREXATE LPF
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hospira | METHOTREXATE LPF | methotrexate sodium | INJECTABLE;INJECTION | 011719 | NDA | Hospira, Inc. | 61703-124-40 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-124-40) / 40 mL in 1 VIAL, SINGLE-DOSE | 2022-10-17 |
| Hospira | METHOTREXATE LPF | methotrexate sodium | INJECTABLE;INJECTION | 011719 | NDA | Hospira, Inc. | 61703-161-05 | 5 VIAL, MULTI-DOSE in 1 CARTON (61703-161-05) / 2 mL in 1 VIAL, MULTI-DOSE (61703-161-02) | 2024-11-04 |
| Hospira | METHOTREXATE LPF | methotrexate sodium | INJECTABLE;INJECTION | 011719 | NDA | Hospira, Inc. | 61703-350-10 | 5 VIAL, MULTI-DOSE in 1 CARTON (61703-350-10) / 2 mL in 1 VIAL, MULTI-DOSE (61703-350-09) | 2014-09-25 |
| Hospira | METHOTREXATE LPF | methotrexate sodium | INJECTABLE;INJECTION | 011719 | NDA | Hospira, Inc. | 61703-350-38 | 5 VIAL, MULTI-DOSE in 1 CARTON (61703-350-38) / 2 mL in 1 VIAL, MULTI-DOSE (61703-350-37) | 2014-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Methotrexate LPF
Introduction
Methotrexate LPF (Low-Price Formulation) is a pharmaceutical agent primarily used in treating certain types of cancer, autoimmune diseases, and rheumatoid arthritis. As a cornerstone therapy, the supply chain for Methotrexate LPF is crucial in ensuring availability, affordability, and quality. This article provides a comprehensive overview of key suppliers involved in the manufacturing and distribution of Methotrexate LPF, analyzing their market roles, manufacturing capabilities, and strategic importance within the pharmaceutical supply network.
Understanding Methotrexate LPF
Methotrexate is an antimetabolite drug that inhibits dihydrofolate reductase, disrupting DNA synthesis in rapidly dividing cells. The LPF formulation indicates a focus on cost-effective production, enabling broader access in low to middle-income markets. Typically available in oral tablets, injectable forms, and parenteral preparations, Methotrexate LPF requires stringent manufacturing standards to meet regulatory requirements.
The global demand for Methotrexate remains stable, driven by prevalent indications such as rheumatoid arthritis, psoriasis, and certain cancers. Consequently, the supply chain involves complex collaborations among big pharma, generics manufacturers, and regional distribution networks.
Major Suppliers of Methotrexate LPF
1. Leading Pharmaceutical Manufacturers
a. Fresenius Kabi
Fresenius Kabi is renowned for its injectable and oral pharmaceuticals, including Methotrexate LPF. The company's manufacturing facilities in Europe and Asia adhere to Good Manufacturing Practices (GMP), enabling consistent quality in low-cost formulations. Fresenius Kabi serves numerous emerging markets as a primary supplier, leveraging its global distribution network.
b. Teva Pharmaceuticals
Teva is a prominent global generic drug manufacturer, producing Methotrexate LPF for multiple markets. Its strategic investments in manufacturing sites in Israel and Europe align with its goal to deliver affordable medicines. Teva's extensive portfolio includes both oral and injectable formulations, making it a significant supplier for jurisdictions with high demand for low-cost therapies.
c. Sandoz (Novartis)
Sandoz specializes in generic medicines, including Methotrexate LPF. Its manufacturing hubs in Europe and North America ensure the supply of high-quality, cost-effective formulations. Sandoz’s commitment to affordable healthcare positions it as a key provider for developing countries and health programs.
d. Sun Pharmaceuticals
An Indian-based pharmaceutical giant, Sun Pharmaceuticals produces Methotrexate LPF variants targeting markets across Asia, Africa, and Latin America. Their manufacturing centers follow stringent quality standards, and their focus on low-cost formulations helps bridge access gaps.
2. Regional and Local Suppliers
Many markets depend heavily on regional generic manufacturers that produce Methotrexate LPF under licensing agreements or through active registration rights. Examples include:
- Africhem Laboratories (South Africa): Supplies affordable methotrexate formulations tailored for African markets.
- Hetero Drugs (India): Produces generic Methotrexate LPF, focusing on cost-sensitive regions.
- Lyophilized Formulations in Latin America: Local manufacturers in Brazil and Mexico often produce sterile injectable forms of Methotrexate.
3. Contract Manufacturing Organizations (CMOs)
In recent years, leading pharmaceutical companies outsource manufacturing to specialized CMOs to meet global demand efficiently. This trend enhances capacity, reduces costs, and ensures continuous supply. Notable CMOs include:
- Aclasta BioPharma: Focused on sterile injectables.
- Viralgen: Offering GMP-compliant production of Methotrexate LPF for regional markets.
Supply Chain Dynamics and Market Share
The supply landscape of Methotrexate LPF is characterized by consolidation among major generic manufacturers, ensuring competitive pricing and reliable supply. Companies like Teva, Sandoz, and Fresenius dominate the global scene, controlling significant portions of the production capacity. Regional suppliers primarily focus on niche markets or provide formulations compliant with local regulatory standards.
Rapid expansion of manufacturing capabilities in India and China has notably increased the global supply, providing competitive pricing options. Market entry barriers for new suppliers include stringent regulatory compliance, quality assurance processes, and establishing GMP-certified manufacturing units.
Regulatory and Quality Standards
Suppliers of Methotrexate LPF must adhere to set standards such as:
- GMP Compliance: Ensuring the drug's safety, efficacy, and quality.
- Regulatory Approvals: Registration with agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and local regulatory bodies.
- Batch Testing and Stability: Consistent testing for potency, purity, and stability throughout production.
Non-compliance leads to supply disruptions, regulatory warnings, or market bans, highlighting the importance of robust quality management systems among suppliers.
Strategic Considerations for Stakeholders
- Market Diversification: Relying on multiple suppliers reduces risk of supply disruption.
- Cost Optimization: Partnering with low-cost manufacturing regions, notably India and China, can provide affordability.
- Quality Assurance: Strict adherence to GMP and regulatory standards safeguards patient safety and maintains brand integrity.
- Patent Status & Licensing: Since Methotrexate is available as a generic, patent barriers are minimal, encouraging widespread manufacturing.
Conclusion: Navigating the Methotrexate LPF Supply Landscape
The supply chain for Methotrexate LPF is predominantly driven by global generic pharmaceutical companies, with regional players filling market-specific needs. Major manufacturers like Teva, Sandoz, and Fresenius Kabi have entrenched market positions, bolstered by their manufacturing capabilities, regulatory compliance, and strategic distribution networks. The rise of regional suppliers enhances access, especially in low-income markets, while CMOs bolster capacity and reduce costs.
For stakeholders, understanding supplier dynamics, maintaining quality standards, and diversifying sourcing strategies are vital to ensuring uninterrupted, affordable access to Methotrexate LPF.
Key Takeaways
- The global supply of Methotrexate LPF is dominated by leading generic drug manufacturers, notably Teva, Sandoz, and Fresenius Kabi.
- Regional and local suppliers significantly contribute, particularly in emerging markets, to enhance access and affordability.
- Ensuring GMP compliance and regulatory approvals remains critical for maintaining supply chain integrity.
- Strategic partnerships with CMOs and diversification across suppliers mitigate risks associated with supply disruptions.
- The continued expansion of manufacturing capacity in India and China sustains competitive pricing and high-volume production.
FAQs
1. Who are the primary global manufacturers of Methotrexate LPF?
Teva, Sandoz, and Fresenius Kabi are the leading global suppliers, producing both oral and injectable formulations for international markets.
2. How do regional suppliers contribute to the Methotrexate LPF supply chain?
Regional suppliers provide affordable formulations tailored to local regulatory standards, increasing access in low- and middle-income countries.
3. What regulatory standards must suppliers meet?
Suppliers must adhere to GMP, obtain approval from agencies like the FDA and EMA, and maintain rigorous batch testing and stability protocols.
4. How do supply chain disruptions impact drug availability?
Disruptions due to regulatory issues, manufacturing problems, or geopolitical factors can lead to shortages, affecting patient access.
5. What strategies can healthcare organizations adopt to ensure continuous access?
Diversifying procurement sources, engaging with multiple suppliers, and establishing strong quality assurance practices help maintain steady drug availability.
Sources:
- [1] International Pharmaceutical Manufacturers Association. "Global generic pharmaceutical market overview." 2022.
- [2] U.S. Food and Drug Administration (FDA). "Approved Drug Products." 2023.
- [3] European Medicines Agency (EMA). "Medicines in Regulatory Review." 2023.
- [4] Industry reports on pharmaceutical manufacturing capacities in India and China.
- [5] Company websites: Teva, Sandoz, Fresenius Kabi.
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