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Suppliers and packagers for nulibry
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nulibry
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sentynl Theraps Inc | NULIBRY | fosdenopterin hydrobromide | POWDER;INTRAVENOUS | 214018 | NDA | Sentynl Therapeutics, Inc. | 42358-295-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2021-03-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug NULIBRY: A Comprehensive Overview
Introduction
NULIBRY (ferric carboxymaltose injection) is a prescription medication developed to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD). As an essential therapeutic agent, the drug's supply chain is critical for ensuring consistent patient access, regulatory compliance, and market stability. This article provides a detailed overview of the primary suppliers involved in the manufacturing, sourcing, and distribution of NULIBRY, with insights into the manufacturing process, key players, and supply chain dynamics.
Manufacturing and Supply Chain of NULIBRY
NULIBRY is produced by Vifor Pharma, a global leader in iron therapies, in collaboration with other manufacturing partners. The drug's active component, ferric carboxymaltose, is made through complex chemical synthesis involving controlled environments to meet stringent pharmaceutical quality standards. The supply chain encompasses raw material sourcing, manufacturing, quality assurance, packaging, and distribution.
Raw Material Suppliers
The foundation of NULIBRY's production relies on the procurement of high-grade raw materials, primarily iron salts and carbohydrate components used to synthesize ferric carboxymaltose. These raw materials are sourced globally from specialized chemical suppliers, including:
- Iron Salts: Suppliers such as BASF, Merck (EMD Millipore), and local chemical manufacturers provide pharmaceutical-grade ferric salts, ensuring purity and stability necessary for injection formulations.
- Carbohydrate Complexing Agents: Carbohydrates like maltodextrin used in the synthesis are sourced from suppliers including Cargill and Archer Daniels Midland (ADM).
The quality control standards for these raw materials are dictated by international pharmacopoeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP).
Manufacturers of Ferric Carboxymaltose
The actual production of ferric carboxymaltose involves specialized facilities adhering to Good Manufacturing Practice (GMP). Vifor Pharma itself manages or contracts manufacturing to approved facilities in Europe, primarily in Switzerland, Germany, and Ireland.
Secondary manufacturers include contract manufacturing organizations (CMOs) equipped with high-containment facilities. These CMOs are responsible for:
- Final formulation adjustments
- Sterile filling
- Packaging
Key manufacturing partners are selected based on their compliance with regulatory standards, capacity, and technological capabilities.
Major Suppliers and Collaboration Networks
Vifor Pharma
Vifor Pharma is the primary developer and marketer of NULIBRY. It maintains strategic relationships with several suppliers to ensure a resilient supply chain:
- Raw Material Providers: Multiple global chemical companies supply essential ingredients, enabling diversification and risk mitigation.
- Manufacturing Partners: Vifor collaborates with CMOs, primarily in Europe, adhering to international GMP standards.
Contract Manufacturing Organizations (CMOs)
CMOs play a pivotal role in NULIBRY's production lifecycle:
- Patheon (Thermo Fisher Scientific): Known for sterile injectable manufacturing, Patheon has facilities optimized for large-volume biologics and small-molecule pharmaceuticals.
- Samsung Biologics: An emerging player in sterile drug manufacturing, Samsung has been involved in supply partnerships for iron therapies.
- Lonza: Specializes in complex chemical syntheses and sterile manufacturing, with facilities in Switzerland and the US.
The choice of CMOs is guided by capacity, expertise, and compliance with regulatory standards like FDA and EMA approvals.
Distribution Channels and Logistic Suppliers
Once manufactured, NULIBRY's distribution involves multiple stages:
- Wholesalers: Major wholesale distributors like McKesson, Cardinal Health, and AmerisourceBergen serve as the primary channels to hospitals and clinics.
- Logistics Providers: Cold chain logistics companies, such as DHL Supply Chain and FedEx Custom Critical, maintain temperature-controlled environments crucial for injectable drugs.
- Regional Distributors: Local distributors in various geographies ensure timely delivery and inventory management.
The reliance on reliable logistics providers ensures the drug's stability, efficacy, and safety during transit, crucial for parenteral medications like NULIBRY.
Regulatory and Quality Assurance
Effective supply hinges on stringent quality assurance protocols. Suppliers must comply with international standards:
- GMP Compliance: Ensured for raw materials, manufacturing, and packaging.
- Regulatory Approvals: Suppliers and manufacturers must hold approvals from agencies such as the FDA (US Food and Drug Administration), EMA (European Medicines Agency), and Health Canada.
Vifor Pharma conducts regular audits and validation processes to align with these standards, minimizing supply disruptions.
Emerging Trends and Supply Chain Challenges
The global supply chain for injectable pharmaceuticals like NULIBRY faces challenges:
- Raw Material Scarcity: Fluctuations in chemical raw material availability can impact supply continuity.
- Regulatory Variances: Different regional approval processes can delay manufacturing or distribution extensions.
- Geopolitical Risks: Trade tensions and tariffs impact procurement and logistics planning.
To counter these risks, companies are:
- Diversifying suppliers
- Increasing regional manufacturing hubs
- Investing in supply chain visibility technologies
Key Takeaways
- NULIBRY’s supply chain relies on a network of global raw material suppliers, specialized CMOs, and logistics providers to ensure consistent delivery.
- Vifor Pharma manages strategic partnerships with multiple manufacturing organizations to mitigate risks associated with supply disruptions.
- The regulatory landscape necessitates rigorous quality assurance, influencing supplier selection and operational processes.
- Supply chain resilience is increasingly prioritized, especially given challenges like raw material scarcity and geopolitical risks.
- Access to real-time data and diversified sourcing are crucial strategies to maintain a steady supply of NULIBRY in a competitive global market.
FAQs
1. Who are the primary raw material suppliers for NULIBRY?
Major suppliers include chemical companies like BASF, Merck, Cargill, and Archer Daniels Midland, providing high-quality iron salts and carbohydrate components.
2. Does Vifor Pharma manufacture ferric carboxymaltose in-house?
Vifor Pharma primarily collaborates with contract manufacturing organizations (CMOs) in Europe and maintains some in-house manufacturing facilities, adhering strictly to GMP standards.
3. How do logistic providers ensure the quality of NULIBRY during transit?
Specialized cold chain logistics providers like DHL Supply Chain and FedEx offer temperature-sensitive transportation, with real-time monitoring and validated shipping protocols to preserve drug integrity.
4. What are the risks to the NULIBRY supply chain?
Risks include raw material shortages, manufacturing disruptions, regulatory delays, geopolitical tensions, and logistical failures, all of which can impact drug availability.
5. Are there regional differences in NULIBRY suppliers?
Yes. Suppliers and manufacturing partners vary regionally, reflecting local regulatory, economic, and infrastructural factors, but global coordination ensures supply continuity across markets.
References
[1] Vifor Pharma Official Website. (2023). Corporate and product information on NULIBRY.
[2] European Medicines Agency (EMA). (2022). Summary of Product Characteristics for NULIBRY.
[3] U.S. Food and Drug Administration (FDA). (2022). Approval documents for ferric carboxymaltose.
[4] Industry Reports. (2022). Global Supply Chain Analysis for Parenteral Iron Treatments.
[5] Contract Manufacturing Organizations Data Sheets. (2023). GMP Compliance and Capacity Details.
In summary, the supply of NULIBRY involves a complex, multi-tiered network of raw material suppliers, specialized manufacturing partners, and logistics providers. Ensuring a resilient supply chain requires strategic diversification, rigorous quality control, and adherence to evolving regulatory standards, particularly in a global health landscape increasingly affected by geopolitical and logistical challenges.
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