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Suppliers and packagers for METHOTREXATE PRESERVATIVE FREE
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METHOTREXATE PRESERVATIVE FREE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | METHOTREXATE PRESERVATIVE FREE | methotrexate sodium | INJECTABLE;INJECTION | 040266 | ANDA | Fresenius Kabi USA, LLC | 63323-122-50 | 1 VIAL in 1 CARTON (63323-122-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 2000-01-22 |
| Hospira | METHOTREXATE PRESERVATIVE FREE | 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 PRESERVATIVE FREE | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Methotrexate Preservative-Free
Introduction
Methotrexate preservative-free formulations are critical in certain therapeutic contexts, particularly for patients with hypersensitivities or those requiring repeated intravenous or subcutaneous administration. Given the importance of sterile, preservative-free options, various manufacturers have developed and supplied methotrexate in preservative-free formats, primarily for oncology and autoimmune disease treatment. This report explores the key suppliers, their global reach, manufacturing capacities, and strategic positioning within the pharmaceutical landscape.
Global Manufacturing Landscape of Preservative-Free Methotrexate
The supply chain for preservative-free methotrexate encompasses both originator companies and a range of generic manufacturers. Originator companies often hold the patents and proprietary manufacturing processes, while generic producers aim to optimize cost-efficiency while maintaining strict quality standards.
The highly regulated environment for injectable drugs necessitates rigorous compliance with Good Manufacturing Practices (GMP). As such, suppliers are typically certified by agencies like the FDA, EMA, and other global regulatory bodies. The focus on preservative-free formulations adds complexity to manufacturing, requiring advanced aseptic techniques and sterile filtration processes.
Major Suppliers of Preservative-Free Methotrexate
1. Pfizer Inc.
Pfizer is a leading producer of methotrexate, offering the drug in preservative-free formulations. Their Methotrexate Sodium Injection is widely used for rheumatoid arthritis, psoriasis, and certain cancers. Pfizer's manufacturing facilities in the United States and Europe are GMP-certified, ensuring high quality and consistency. The company's product is available in multi-dose vials designed specifically to minimize preservative use, making it suitable for sensitive patient populations.
Key features:
- Extensive global distribution network
- Established reputation in oncology and autoimmune drugs
- Stringent quality control procedures
2. Teva Pharmaceutical Industries Ltd.
Teva is one of the largest generic pharmaceutical manufacturers globally, with a significant portfolio of injectable drugs, including preservative-free methotrexate. Their manufacturing plants in Israel, the US, and Europe meet stringent regulatory standards. Teva provides preservative-free methotrexate formulations tailored to institutional use, often at competitive prices, optimizing accessibility.
Key features:
- Strong presence in both developed and emerging markets
- Focus on cost-effective sterile products
- Long-standing expertise in aseptic manufacturing
3. Sandoz (Novartis Group)
Sandoz offers preservative-free methotrexate injections, primarily targeting oncology and rheumatology markets. Their manufacturing facilities comply with global GMP standards, emphasizing sterility and stability in preservative-free formulations. Sandoz's strategic positioning involves supplying both single-dose and multi-dose preservative-free options.
Key features:
- Integration within Novartis's global infrastructure
- Focused on biosimilar and sterile injectables
- Emphasis on patient safety and product stability
4. ROVI Pharmaceuticals
ROVI is a Spanish pharmaceutical company specializing in sterile injectable products. They manufacture preservative-free methotrexate formulations for both institutional and hospital-based use across Europe and Latin America. Their manufacturing processes emphasize minimal preservative use, with a focus on safety and efficacy.
Key features:
- Regional leadership in sterile injectables
- Customizable package sizes
- Compliance with European regulatory standards
5. SUN Pharmaceutical Industries Ltd.
This Indian-based pharmaceutical giant produces a range of sterile injectable drugs, including preservative-free methotrexate. Their manufacturing units in India and the US meet international GMP standards, and they target both local and global markets with cost-effective options.
Key features:
- Competitive pricing
- Expanding global footprint
- Focus on quality assurance in sterile manufacturing
Emerging and Regional Suppliers
While the aforementioned companies dominate the global market, numerous regional players provide preservative-free methotrexate, especially in emerging markets where access to affordable injectables is critical.
- Viatris (formerly Mylan) produces sterile injectables, including preservative-free methotrexate, for various regional markets.
- Hospira (Pfizer division) has historically been prominent in sterile injectable manufacturing and continues to supply preservative-free options.
- Sino Bioway and Shanghai Pharma in China develop generic sterile injectables for local and regional distribution.
Factors Influencing Supplier Selection
Regulatory Compliance: Ensuring the supplier meets international standards (FDA, EMA, WHO) is crucial for quality and safety.
Manufacturing Capacity: High-volume producers with GMP-compliant facilities offer reliability and supply security.
Product Portfolio: Suppliers with extensive sterile injectable portfolios can provide integrated procurement solutions.
Pricing and Contract Terms: Cost-effective options paired with reliable logistics and supply chain management influence procurement decisions.
Geographical Reach: Companies with regional manufacturing hubs minimize lead times and logistics costs, particularly important in urgent clinical needs.
Conclusion
The supply of preservative-free methotrexate is dominated by a handful of global pharmaceutical companies, primarily Pfizer, Teva, Sandoz, ROVI, and Sun Pharma. The selection of suppliers hinges on regulatory compliance, manufacturing capacity, quality assurance, and regional presence. As demand for safer, preservative-free formulations grows, especially in oncology and autoimmune therapy, these manufacturers will continue to enhance their offerings and expand accessibility.
Key Takeaways
- Global leaders like Pfizer, Teva, and Sandoz dominate the preservative-free methotrexate market, ensuring quality and availability.
- Manufacturing standards such as GMP compliance are non-negotiable and critical to supplier credibility.
- Regional manufacturers play vital roles in making preservative-free methotrexate accessible, especially in emerging markets.
- Pricing, supply reliability, and regulatory approvals are key considerations when selecting a supplier.
- Innovation in sterile manufacturing techniques will propel future availability and safety of preservative-free formulations.
FAQs
1. What distinguishes preservative-free methotrexate from conventional formulations?
Preservative-free methotrexate eliminates alcohols or other preservatives that may cause hypersensitivity or other adverse reactions, making it safer for repeated use and in sensitive populations.
2. Are all methotrexate formulations preservative-free?
No. Many older formulations contain preservatives like benzyl alcohol or parabens. Preservative-free versions are specifically manufactured to exclude these compounds, mainly for injectable and high-frequency use.
3. Which regulatory bodies approve preservative-free methotrexate formulations?
Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) Quality Assurance programs oversee approval and manufacturing standards.
4. How can healthcare providers ensure the quality of preservative-free methotrexate?
Providers should source from GMP-certified suppliers with a robust quality control process, proper documentation, and regulatory approvals, ensuring product sterility, stability, and efficacy.
5. What are the future trends in the supply of preservative-free methotrexate?
Increasing demand for safer injectable therapies will incentivize manufacturers to develop more stable, preservative-free formulations, with advancements in aseptic manufacturing technologies and regional production facilities.
References
- Pharmaceutical Technology. “Sterile Injectables: Critical Factors in Manufacturing.”
- U.S. FDA. “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing.”
- European Medicines Agency. “Guideline on the sterilisation of medicinal products.”
- IQVIA Institute. “The Global Use of Medicines in 2023.”
- McKinsey & Company. “The Future of Injectable Drug Manufacturing.”
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