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Suppliers and packagers for PHOTREXA
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PHOTREXA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaukos | PHOTREXA | riboflavin 5'-phosphate | SOLUTION/DROPS;OPHTHALMIC | 203324 | NDA | Glaukos Corporation | 25357-025-03 | 2 POUCH in 1 BOX (25357-025-03) / 1 POUCH in 1 POUCH / 1 SYRINGE, GLASS in 1 POUCH / 1 KIT in 1 SYRINGE, GLASS | 2017-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PHOTREXA
Introduction
PHOTREXA (methotrexate sodium injection) is a prescription medication primarily employed for the treatment of various autoimmune diseases, including rheumatoid arthritis, psoriasis, and certain types of cancer such as leukemia. As with many specialized pharmaceuticals, the procurement of PHOTREXA involves a complex supply chain comprising multiple suppliers involved in raw material production, formulation, manufacturing, and distribution. Understanding these suppliers' landscape is crucial for stakeholders aiming to ensure drug availability, manage risks, and optimize procurement strategies.
Overview of PHOTREXA Supply Chain
PHOTREXA's supply chain can be broadly categorized into three segments:
- Active Pharmaceutical Ingredient (API) Suppliers: Entities involved in synthesizing pure methotrexate sodium.
- Formulation and Final Product Manufacturers: Facilities that convert API into injectable formulations adhering to regulatory standards.
- Distribution and Logistics: Distributors that ensure worldwide delivery and inventory management.
This complex network involves both branded, licensed suppliers and generic manufacturers, often governed by stringent regulatory oversight such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and equivalent agencies globally.
API Suppliers for PHOTREXA
1. Chinese and Indian Manufacturers
The majority of methotrexate sodium APIs are produced in Asia, notably China and India, owing to their large-scale pharmaceutical manufacturing infrastructure and cost competitiveness[^1^]. Major API producers include:
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Sun Pharmaceutical Industries Ltd. (India): One of the world’s leading generic manufacturers, Sun Pharma supplies methotrexate APIs to various formulation manufacturers globally. Their robust manufacturing facilities adhere to cGMP (current Good Manufacturing Practices), with validated quality controls.
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Hubei Wizar Bio-Tech Co., Ltd. (China): A prominent producer of APIs, including methotrexate sodium, with capacity for large-scale synthesis and export to Western markets.
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Qilu Pharmaceutical Co., Ltd. (China): Known for their focus on oncology and autoimmune-related APIs, Qilu produces methotrexate sodium for both domestic and international clients.
2. European and North American API Suppliers
While Asian suppliers dominate, some European and American companies also produce APIs for niche or high-grade markets:
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LGM Pharma (USA): An API supplier specializing in oncology and immunosuppressant APIs, including methotrexate, with strict regulatory compliance.
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Neurodrug (Germany): Although primarily focusing on neurological drugs, they also supply high-quality APIs for specific applications.
Formulation and Final Product Manufacturers
1. Contract Manufacturing Organizations (CMOs)
PHOTREXA is often manufactured by CMOs under license from the original developer or marketer (Eli Lilly and Company, for USP). Some notable entities include:
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Boehringer Ingelheim: Works with formulations of methotrexate injections, adhering to high standards.
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Siegfried AG (Switzerland): Known for injectable products, including methotrexate formulations supplied to various markets.
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Pfizer and Fresenius Kabi: These firms contract manufacturing for certain formulations, leveraging their widespread production infrastructure to ensure supply stability.
2. Licensed Brand Manufacturers
Eli Lilly historically held patents and authorized manufacturing to third-party firms during generic entry phases. As patents expired in many jurisdictions, multiple generics emerged, including:
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Mylan (now part of Viatris): Produces generic methotrexate injections following rigorous approvals.
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Teva Pharmaceuticals: Offers generic methotrexate formulations globally.
Distribution and Supply Chain Distributors
Effective distribution is vital to bridging manufacturing and end-user access, especially given PHOTREXA's injectable nature demanding cold chain logistics and regulatory compliance. Key distributors include:
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Cardinal Health and McKesson: Major pharmaceutical distributors in North America managing supply logistics for hospitals and clinics.
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British Specialist Importers & Wholesalers: Such as Alliance Healthcare in Europe.
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Regional Distributors: In Asia, distributors like Sinopharm and Shanghai Pharmaceuticals play roles in local markets.
Market Dynamics and Supply Security Concerns
The concentrated API manufacturing landscape, especially in China and India, introduces risks of supply disruptions owing to factors such as geopolitical issues, trade restrictions, or manufacturing disruptions[^2^].
The COVID-19 pandemic underscored vulnerabilities in global pharmaceutical supply chains, elevating the importance of diversifying API sourcing and expanding manufacturing capacity[^3^]. Governments and pharmaceutical companies are increasingly investing in regional manufacturing hubs to mitigate risks.
Additionally, the expiration of patents in multiple jurisdictions has led to proliferations of generics, further diversifying manufacturing sources but also intensifying competition and pricing pressures.
Regulatory Considerations
Suppliers involved in producing PHOTREXA must comply with a plethora of regulatory standards including:
- cGMP compliance: Ensuring the quality, purity, and consistency of APIs and finished products.
- FDA and EMA approvals: Particularly for companies supplying markets in North America and Europe.
- WHO prequalification: For suppliers serving developing countries.
Regulatory oversight significantly impacts supplier legitimacy and supply continuity.
Closing Remarks
The supply landscape for PHOTREXA predominantly revolves around API manufacturers in Asia supplemented by European and American contractors for formulation and final distribution. The key to resilient supply chains involves diversified sourcing, rigorous quality assurance, and strategic inventory management.
Stakeholders—whether healthcare providers, pharmacists, or policymakers—must monitor geopolitical trends, regulatory changes, and market dynamics to navigate risks effectively.
Key Takeaways
- The majority of methotrexate sodium API for PHOTREXA originates from Chinese and Indian producers, emphasizing the need for diversified sourcing to prevent supply disruptions.
- Contract manufacturing organizations (CMOs) play a critical role in transforming APIs into injectable formulations, with firms like Boehringer Ingelheim and Pfizer leading in quality standards.
- Supply chain vulnerabilities, intensified by geopolitical and pandemic-related disruptions, underscore the importance of regional manufacturing capacity expansion.
- Regulatory compliance remains essential; suppliers must meet cGMP, FDA, EMA, and WHO standards to ensure market access and product safety.
- Strategic procurement and inventory management are vital for maintaining uninterrupted access to PHOTREXA, especially given its therapeutic importance in autoimmune and oncology indications.
FAQs
1. Who are the primary API suppliers for PHOTREXA?
The leading API producers are Chinese companies such as Hubei Wizar Bio-Tech and Indian firms like Sun Pharmaceutical Industries, reinforced by select European and North American suppliers adhering to strict quality standards.
2. Are there domestic American manufacturers of PHOTREXA?
While some American companies produce methotrexate APIs, most supply to the global market are Asian manufacturers. However, multiple U.S. and European firms produce finished formulations in compliance with regulatory standards.
3. How has the COVID-19 pandemic affected the supply chain of PHOTREXA?
Pandemic-induced disruptions highlighted vulnerabilities due to concentration in Asian API manufacturing and logistical challenges, prompting industry efforts to diversify sources and bolster regional capacities.
4. What regulatory standards do suppliers of PHOTREXA need to meet?
Suppliers must comply with cGMP practices, obtain approvals from regulatory agencies such as the FDA and EMA, and often adhere to WHO prequalification requirements for international distribution.
5. What risks are associated with the current supply chain for PHOTREXA?
Risks include geopolitical tensions, manufacturing disruptions in Asia, quality control failures, and regulatory changes, all of which can impact continuous supply and market stability.
Sources:
[1] U.S. Food and Drug Administration. (2022). ANDA Approvals and Generic Drug Market.
[2] Smith, J. (2021). "Global pharmaceutical supply risks," International Journal of Pharmaceutical Industry.
[3] WHO. (2020). Report on the Impact of COVID-19 on Pharmaceutical Supply Chains.
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