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Suppliers and packagers for generic pharmaceutical drug: CARFILZOMIB
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CARFILZOMIB
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714 | NDA | Onyx Pharmaceuticals, Inc. | 76075-101-01 | 1 VIAL, SINGLE-USE in 1 CARTON (76075-101-01) / 30 mL in 1 VIAL, SINGLE-USE | 2012-07-20 |
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714 | NDA | Onyx Pharmaceuticals, Inc. | 76075-101-21 | 1 VIAL, SINGLE-USE in 1 CARTON (76075-101-21) / 30 mL in 1 VIAL, SINGLE-USE | 2012-07-20 |
| Onyx Pharms Amgen | KYPROLIS | carfilzomib | POWDER;INTRAVENOUS | 202714 | NDA | Onyx Pharmaceuticals, Inc. | 76075-102-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-102-01) / 15 mL in 1 VIAL, SINGLE-DOSE | 2016-07-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Carfilzomib
Introduction
Carfilzomib, marketed under the brand name Kyprolis, is a proteasome inhibitor primarily prescribed for the treatment of multiple myeloma. Approved by the U.S. Food and Drug Administration (FDA) in 2012, it plays a pivotal role in managing relapsed or refractory multiple myeloma. Its complex chemical synthesis, high manufacturing standards, and exclusive patent protections have created a specific landscape of suppliers within the global pharmaceutical supply chain. Recognizing the key suppliers, their geographic distribution, manufacturing capabilities, and regulatory compliance is crucial for stakeholders aiming to understand supply stability, market trends, or regulatory risks.
Manufacturers and Suppliers of Carfilzomib
Original Developers and Patent Holders
Amgen Inc., the originator of Carfilzomib, is the principal stakeholder in its development, manufacturing, and supply. The company holds the proprietary rights associated with Kyprolis, including patents and manufacturing know-how. As a biopharmaceutical giant headquartered in Thousand Oaks, California, Amgen maintains dedicated manufacturing facilities for the drug, ensuring quality and compliance with global standards.
Manufacturing Facilities
Amgen's manufacturing of Carfilzomib is concentrated in their facilities in the United States, with substantial capacity investments to support global demand. The company adheres to stringent Good Manufacturing Practices (GMP), inspected and approved by regulatory authorities such as the FDA and the European Medicines Agency (EMA). These facilities utilize complex chemical synthesis processes amid ongoing process optimizations to improve yield and purity.
Contract Manufacturing Organizations (CMOs)
While Amgen directly manufactures the bulk of its supply, it also partners with CMOs for certain components of production. These CMOs are predominantly located in North America and Europe, offering scalable manufacturing solutions to meet increasing global demand. CMOs involved include pharmaceutical manufacturing specialists with expertise in peptide synthesis, sterile fill-finish, and cold chain logistics.
Key Suppliers in the Supply Chain
Though Amgen remains the primary manufacturer, certain critical raw materials and intermediates are sourced from specialized suppliers globally. These suppliers include:
- Amino acid derivatives suppliers: Critical for peptide chain assembly.
- Sterile components manufacturers: vials, stoppers, and syringes sourced from established medical device suppliers.
- Chemical intermediates: Specialized chemical companies providing high-purity reagents.
However, the exact identities of many of these raw material suppliers remain confidential due to competitive and regulatory reasons.
Global Distribution and Supply Dynamics
Regional Manufacturing and Distribution
The availability and distribution of Carfilzomib are primarily managed through Amgen’s regional hubs. In the United States and Europe, the drug is supplied directly from Amgen’s manufacturing facilities. In Asian markets, especially in Japan and China, local partnerships or authorized distributors facilitate importation and distribution, following local regulatory approvals.
Generic Competition and Supply
Currently, Carfilzomib remains under patent protection, with limited generic manufacturers entering the market. Nevertheless, as patents expire, generic manufacturing is anticipated. Key generic pharmaceutical companies likely to enter or already involved in producing Carfilzomib or similar proteasome inhibitors include:
- Sandoz (Novartis): As a leader in biosimilars, Sandoz may pursue biosimilar versions.
- Natco Pharma: Active in biosimilar development, including proteasome inhibitors.
- Dr. Reddy’s Laboratories: Engaged in biosimilar and generic oncology drugs.
Potential local manufacturers in India and China could supply raw intermediates or eventual biosimilar versions, contingent on patent expiration and market demand.
Regulatory Considerations and Compliance
Suppliers involved in the manufacture of Carfilzomib must adhere to rigorous regulatory standards. Amgen maintains compliance with the FDA’s cGMP standards and complies with international regulations for global distribution, including EMA and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Contract manufacturers and raw material suppliers must also meet these standards to ensure the drug’s safety, efficacy, and consistent supply.
Emerging Trends and Supply Chain Risks
- Supply Chain Concentration: Limited manufacturers (primarily Amgen) pose risks related to supply disruptions, manufacturing delays, or geopolitical issues.
- Patent Expirations & Biosimilar Development: Expiring patents will open opportunities for biosimilar manufacturers, potentially altering supply dynamics.
- Raw Material Scarcity: Specialized chemicals and peptides involved in synthesis are subject to global supply chain constraints, affecting production continuity.
- Regulatory Changes: Stringent or evolving regulations may influence manufacturing processes and supplier qualification protocols.
Conclusion
The supply landscape for Carfilzomib is characterized by the dominant role of Amgen, which operates state-of-the-art manufacturing facilities under strict regulatory oversight. While raw materials supplier confidentiality limits transparency, the overall supply chain includes specialized chemical and biologic intermediates sourced globally. The potential entry of biosimilars following patent expiration could diversify the supplier base, impacting pricing and availability. Ensuring supply chain resilience and compliance remains central for all stakeholders involved in Carfilzomib’s manufacturing and distribution.
Key Takeaways
- Primary Manufacturing: Amgen dominates global Carfilzomib production, with facilities in North America and Europe.
- Supply Chain Dependencies: Raw materials are sourced from specialized, often opaque, suppliers, highlighting potential vulnerabilities.
- Regulatory Compliance: Strict adherence to GMP standards by all involved suppliers ensures supply stability and drug safety.
- Market Evolution: Patent expiration and biosimilar development will diversify suppliers and could influence market dynamics.
- Risk Mitigation: Diversification of suppliers and regional manufacturing can mitigate risks associated with supply disruptions.
FAQs
1. Who are the main manufacturers of Carfilzomib?
Amgen Inc. is the primary manufacturer, operating dedicated facilities mainly in the United States for Carfilzomib production.
2. Are there any generic versions of Carfilzomib available?
As of now, Carfilzomib remains under patent protection, with no approved generic versions. Biosimilars are expected in the future post-patent expiry.
3. What raw materials are essential for Carfilzomib synthesis?
High-purity amino acids, chemical intermediates, and sterile components are vital, sourced from specialized chemical and pharmaceutical suppliers.
4. How does supply chain regulation impact Carfilzomib distribution?
Manufacturers and suppliers must comply with GMP and international quality standards, influencing licensing, distribution, and market availability.
5. Will biosimilars impact the supply landscape for Carfilzomib?
Yes, biosimilar development following patent expiration will introduce new manufacturing options, potentially expanding supply sources and reducing costs.
References
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