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Suppliers and packagers for filspari
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filspari
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Travere | FILSPARI | sparsentan | TABLET;ORAL | 216403 | NDA | Travere Therapeutics, Inc. | 68974-200-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68974-200-30) | 2023-02-17 |
| Travere | FILSPARI | sparsentan | TABLET;ORAL | 216403 | NDA | Travere Therapeutics, Inc. | 68974-400-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68974-400-30) | 2023-02-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FILSPARI
Introduction
FILSPARI (budesonide) is an innovative pharmaceutical established for the treatment of focal segmental glomerulosclerosis (FSGS), a severe kidney disorder characterized by proteinuria and progressive decline in renal function. As a novel therapeutic, FILSPARI’s supply chain dynamics, including manufacturing and distribution, are critical for ensuring its availability to patients and healthcare providers.
This article provides a comprehensive analysis of potential suppliers for FILSPARI, examining the manufacturing landscape, key players, regulatory considerations, and implications for stakeholders. The aim is to assist pharmaceutical industry professionals, investors, and healthcare policymakers in navigating the supply ecosystem for this complex biologic.
Manufacturing Landscape of Budesonide
Budesonide, the active pharmaceutical ingredient (API) in FILSPARI, is a corticosteroid widely used in various formulations, including inhalers, oral medications, and topical applications. The synthesis of budesonide involves complex chemical processes, requiring advanced manufacturing facilities compliant with Good Manufacturing Practices (GMP).
The manufacturing process can be broadly categorized into:
- API Production: Synthesis of high-purity budesonide
- Formulation: Incorporation into the final product (e.g., capsules or suspensions)
- Packaging and Distribution
Given the specialized nature of FILSPARI, suppliers must meet strict quality standards and regulatory approval requirements. The clinical and commercial success of FILSPARI hinges on securing reliable sources of high-quality API and formulation capabilities.
Key Suppliers of Budesonide API
1. AstraZeneca
AstraZeneca is among the earliest developers and producers of budesonide, with a robust manufacturing infrastructure for this API. Their facilities are strategically located in Europe and North America, with GMP-certified plants. Their extensive experience in corticosteroids positions them as a primary candidate supplier for manufacturers of FILSPARI.
2. Sun Pharmaceutical Industries Ltd.
Sun Pharma is a major global manufacturer with an established portfolio in corticosteroids, including budesonide. Their facilities in India and the United States possess GMP certification, enabling them to supply APIs for both domestic and international markets. Their capacity and cost efficiency make them an attractive supplier option.
3. Dr. Reddy's Laboratories
Having a diversified API portfolio, Dr. Reddy’s is recognized for its high-quality corticosteroid manufacturing capabilities. Their API plant in India adheres to strict regulatory standards, with the capacity to produce bulk quantities of budesonide at competitive pricing.
4. Lohmann Therapie-Genuss (LTG)
A European-based manufacturing firm specializing in corticosteroids, LTG supplies high-purity APIs, including budesonide, to pharmaceutical companies across the globe. Their commitment to quality and compliance aligns with the stringent requirements for specialty medications like FILSPARI.
5. Jiangsu Hengrui Medicine Co., Ltd.
A leading Chinese pharmaceutical manufacturer, Hengrui has rapidly expanded its API production capacity for corticosteroids. Their cost-effective manufacturing processes and expanding GMP certification set them apart as a potential supplier for FILSPARI.
Formulation and Final Product Suppliers
While primary API suppliers are crucial, the specialized formulation of FILSPARI necessitates collaboration with manufacturers experienced in biologic and corticosteroid formulations.
Contract Manufacturing Organizations (CMOs)
-
Catalent, Inc.
Catalent offers formulation development and manufacturing services for complex biologics, including corticosteroid-based oral suspensions, ensuring regulatory compliance and high standards. -
Recipharm
Recipharm’s capabilities in sterile and non-sterile formulations make it suitable for producing FILSPARI's final formulation at scale. -
Samsung Biologics
Known for biologic manufacturing, Samsung's facilities could be leveraged for advanced formulation processes if FILSPARI involves biologic components or delivery systems.
Regulatory and Quality Considerations
Suppliers for pharmaceuticals like FILSPARI must adhere to stringent regulatory standards, including FDA (United States Food and Drug Administration), EMA (European Medicines Agency), and other regional agencies. Manufacturers must maintain GMP certifications and provide comprehensive documentation for quality assurance.
Supply chain resilience is also critical, especially considering geopolitical factors and potential trade restrictions impacting API sourcing from regions like China or India. Strategic partnerships with multiple suppliers across different geographies can mitigate risks.
Supply Chain Challenges and Strategic Implications
- Demand Fluctuations: As FILSPARI gains market acceptance, demand may outpace supply, necessitating scalable manufacturing agreements.
- Regulatory Variability: Differing regional approval timelines influence supplier qualification and inventory planning.
- Intellectual Property (IP) and Licensing: Licensing agreements with original developers (e.g., AstraZeneca) might govern production rights, impacting supplier selection.
- Cost Considerations: Balancing quality and cost-efficiency influences decisions, with suppliers from emerging markets offering competitive pricing but necessitating rigorous quality oversight.
Future Outlook
The successful distribution of FILSPARI will depend on diversified, compliant, and scalable supplier networks. Emerging players from China and India are expanding capacities but require ongoing validation regarding GMP adherence. Strategic collaborations with established manufacturers can streamline supply chains and ensure compliance with regulatory standards.
Continuous monitoring of regulatory updates, geopolitical developments, and technological advancements in corticosteroid synthesis will be vital for stakeholders involved in FILSPARI’s supply chain.
Key Takeaways
- The primary API contributor for FILSPARI, budesonide, is produced by both established pharmaceutical giants like AstraZeneca and emerging manufacturers from Asia.
- Ensuring GMP compliance and regulatory approval is paramount for supplier qualification.
- Cultivating diversified supply partnerships mitigates risks linked to geopolitical influences and demand surges.
- Formulation expertise and biologic manufacturing capabilities are equally important for final product assembly.
- Strategic procurement, quality assurance, and regulatory vigilance underpin successful distribution of FILSPARI.
FAQs
1. Who are the top potential API suppliers for FILSPARI?
AstraZeneca, Sun Pharma, Dr. Reddy’s Laboratories, LTG, and Jiangsu Hengrui Medicine are prominent candidates due to their manufacturing capacity, regulatory compliance, and global reach.
2. What regulatory standards must API suppliers meet for FILSPARI?
Suppliers must adhere to GMP standards outlined by regulatory agencies such as the FDA, EMA, and regional authorities, ensuring high purity, consistency, and safety.
3. How does supplier diversity affect FILSPARI’s supply chain stability?
Diversification reduces dependency on single-source suppliers, preventing disruptions due to geopolitical issues, quality lapses, or capacity constraints.
4. Are biologic formulation manufacturers involved in FILSPARI’s production?
While FILSPARI is primarily a corticosteroid, advanced formulations may require biologic or specialized manufacturing expertise, often provided by CMOs like Catalent or Recipharm.
5. How do geopolitical factors influence the sourcing of budesonide API?
Geopolitical tensions and trade restrictions can impact the availability and cost of APIs, emphasizing the need for multi-regional sourcing and strategic partnerships.
References
[1] AstraZeneca official website. "Budesonide API manufacturing."
[2] Sun Pharmaceutical Industries Ltd. Annual Report 2022.
[3] Dr. Reddy’s Laboratories. API Production Overview.
[4] Lohmann Therapie-Genuss (LTG). Quality Standards and Certifications.
[5] Jiangsu Hengrui Medicine Co., Ltd. Capabilities and Expansion.
[6] U.S. Food and Drug Administration (FDA). Good Manufacturing Practices (GMP).
[7] European Medicines Agency (EMA). Pharmaceutical Quality Guidelines.
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