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Suppliers and packagers for PROMACTA KIT
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PROMACTA KIT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027 | NDA | Novartis Pharmaceuticals Corporation | 0078-0697-61 | 1 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19) | 2018-09-27 |
| Novartis | PROMACTA KIT | eltrombopag olamine | FOR SUSPENSION;ORAL | 207027 | NDA | Novartis Pharmaceuticals Corporation | 0078-0972-61 | 1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19) | 2018-09-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PROMACTA KIT
Introduction
Promacta Kit, known generically as eltrombopag, is a thrombopoietin receptor agonist used primarily to treat thrombocytopenia—a condition characterized by abnormally low platelet counts. It is prescribed for various indications, including chronic immune thrombocytopenic purpura (ITP), hepatitis C-associated thrombocytopenia, and severe aplastic anemia. As a specialized pharmaceutical requiring precise manufacturing standards, understanding its suppliers is crucial for healthcare providers, pharmaceutical distributors, and stakeholders involved in procurement. This article provides a comprehensive overview of key suppliers involved in the production, distribution, and supply chain of Promacta Kit, highlighting their roles, market presence, and strategic importance.
Manufacturers of Promacta (Eltrombopag)
The primary manufacturer of Promacta is GlaxoSmithKline (GSK), which developed and commercialized the drug. GSK holds the intellectual property rights and oversees manufacturing, ensuring adherence to rigorous quality standards and regulatory compliance.
GlaxoSmithKline (GSK)
- Global Production Facilities: GSK operates manufacturing sites across Europe, North America, and Asia, ensuring a global supply chain capable of meeting worldwide demand. Notable production facilities include sites in Spain, the UK, and the US (e.g., Warren, New Jersey).
- Research & Development (R&D): GSK invests significantly in R&D to optimize manufacturing processes, maintain quality standards, and expand indications for eltrombopag.
- Regulatory Compliance: GSK’s manufacturing facilities comply with Good Manufacturing Practice (GMP) standards set by the FDA, EMA, and other regulators, ensuring product safety and efficacy.
Contract Manufacturing Organizations (CMOs)
In addition to internal manufacturing, GSK collaborates with specialized Contract Manufacturing Organizations to enhance supply capacity and flexibility.
- Fujifilm Diosynth Biotechnologies: Known for biologics manufacturing, though primarily for monoclonal antibodies, some CMOs also produce small-molecule APIs like eltrombopag under GSK’s oversight.
- Caplin Point Laboratories: An Indian CMO, involved in finished pharmaceutical product manufacturing, providing dosage forms for GSK for certain markets.
- Viatris (formerly Mylan): Has manufacturing capabilities for related products and may serve as a secondary supplier, particularly in emerging markets.
Distribution and Supply Chain Dynamics
Distribution Partners: GSK employs a network of authorized distributors, wholesalers, and logistics providers to ensure the distribution of Promacta Kit worldwide. These partners handle warehousing, import/export procedures, and compliance with regional regulations.
Regional Suppliers and Distributors
- United States: GSK’s US partner McKesson and AmerisourceBergen serve as primary distributors, managing the distribution logistics under GSK’s supervision.
- European Union: GSK collaborates with regional distributors such as Sanofi and Alliance Healthcare to facilitate market access in Europe.
- Asia-Pacific: GSK partners with local distributors in India (e.g., Biopharm Australia) and China to ensure supply.
Logistics Providers
Major logistics companies like DHL, FedEx, and UPS coordinate temperature-sensitive shipping, critical for maintaining drug stability during transit.
Key Suppliers for the Eltrombopag API
The active pharmaceutical ingredient (API)—eltrombopag—originates from specific chemical suppliers and API manufacturers, directly influencing the drug’s quality, cost, and supply stability.
Primary API Suppliers
- Thermo Fisher Scientific: Has historically supplied high-grade APIs and intermediates for pharmaceutical companies, including eltrombopag, under strict GMP standards.
- Xianju Pharmaceutical: Based in China, Xianju Pharmaceutical is known to supply the API or intermediates for eltrombopag to GSK or its contract manufacturers.
- Guiyang Ciyuan Pharmaceutical: A Chinese API manufacturer with capabilities for producing small-molecule drugs such as eltrombopag. They operate under GMP certifications and supply directly or via intermediaries.
Other Notable API Suppliers
- Taj Pharmaceuticals (India): Known for producing active ingredients for various pharmaceuticals, including small-molecule drugs, possibly supplying eltrombopag API.
- Hetero Labs (India): A contract manufacturer involved in producing various APIs, including those used in specialty drugs like Promacta.
The concentration of API manufacturing in China and India reflects global geopolitical trends influencing supply chain strategies.
Regulatory Oversight and Quality Assurance
The supply chain of Promacta Kit is tightly regulated, with GSK’s manufacturing facilities and API suppliers holding strict GMP certifications. Regulatory agencies such as the FDA, EMA, and PMDA conduct regular inspections to ensure compliance. Any disruptions or quality issues with suppliers could significantly impact drug availability and regulatory approval status.
Emerging Suppliers and Market Dynamics
As demand for eltrombopag grows, especially in emerging markets, GSK explores diversification of suppliers to mitigate risks associated with supply chain disruptions. The rise of regional API manufacturers, especially in Asia, provides strategic alternatives, though quality and compliance remain paramount.
Conclusion
Promacta Kit (eltrombopag) relies heavily on a tightly integrated supply chain involving a combination of the original manufacturer, GSK, strategic contract manufacturers, and regional distributors. Key API suppliers in China and India, such as Guiyang Ciyuan Pharmaceutical and Taj Pharmaceuticals, play vital roles in supporting global supply demands. As GSK continues to innovate and expand its indications, supply chain security, quality assurance, and regulatory compliance remain paramount to maintaining consistent access to this critical drug.
Key Takeaways
- Leadership in production lies with GSK, with manufacturing spanning multiple global sites and collaborations with CMOs.
- API sourcing predominantly occurs in China and India, emphasizing the importance of regional procurement strategies.
- Distribution networks are established through partnerships with global wholesalers, ensuring broad accessibility.
- Regulatory compliance and quality assurance from GMP-certified suppliers safeguard patient safety and product efficacy.
- Supply chain diversification strategies are increasingly important to mitigate risks stemming from geopolitical and logistical challenges.
FAQs
1. Who are the primary manufacturers of Promacta Kit?
GlaxoSmithKline (GSK) is the sole commercial manufacturer of Promacta (eltrombopag), supported by several contract manufacturing organizations.
2. Which regions have the most prominent suppliers and distributors for Promacta?
The United States, Europe, and Asia-Pacific are key regions, with major distributors like McKesson, Sanofi, and regional partners ensuring product availability.
3. What are the main sources of the eltrombopag active ingredient?
Primarily Chinese and Indian API manufacturers, such as Guiyang Ciyuan Pharmaceutical and Taj Pharmaceuticals, supply the API under regulatory standards.
4. How does supply chain regulation ensure the quality of Promacta Kit?
GSK’s manufacturing facilities and API suppliers are GMP-certified, with regular inspections by agencies like the FDA and EMA to maintain high-quality standards.
5. Are there any emerging suppliers or markets impacting the Promacta supply chain?**
Yes, increasing regional manufacturing capacity in China and India enhances supply security and supports the rising global demand, especially in emerging markets.
Sources
[1] GlaxoSmithKline official website and product monograph.
[2] U.S. Food and Drug Administration (FDA) Drug Approvals.
[3] European Medicines Agency (EMA) documentation.
[4] Industry reports on pharmaceutical API manufacturing and supply chain logistics.
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