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Suppliers and packagers for ondansetron
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ondansetron
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 090469 | ANDA | NorthStar Rx LLC | 16714-200-30 | 3 BLISTER PACK in 1 CARTON (16714-200-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (16714-200-10) | 2021-04-27 |
| Aurobindo Pharma | ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 090469 | ANDA | NorthStar Rx LLC | 16714-201-10 | 1 BLISTER PACK in 1 CARTON (16714-201-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-04-27 |
| Aurobindo Pharma | ONDANSETRON | ondansetron | TABLET, ORALLY DISINTEGRATING;ORAL | 090469 | ANDA | NorthStar Rx LLC | 16714-201-30 | 3 BLISTER PACK in 1 CARTON (16714-201-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2021-04-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ondansetron
Introduction
Ondansetron, a potent anti-emetic agent primarily used to prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgical procedures, is vital within oncology and post-operative care. Its widespread application has fostered an extensive network of suppliers globally. Understanding the landscape of ondansetron suppliers reveals how manufacturing capabilities, regulatory compliance, patent landscapes, and market dynamics influence procurement strategies. This analysis explores the key suppliers, market trends, and implications for stakeholders.
Global Supplier Landscape
Major Manufacturers of Ondansetron
Multiple pharmaceutical companies dominate the manufacturing and distribution of ondansetron, ranging from originators to generic producers. The industry has experienced significant shifts due to patent expiries, regulatory approvals, and market demand.
1. Originator Companies
GlaxoSmithKline (GSK):
GSK originally developed ondansetron and introduced it to the market under brand names such as Zofran. Although patent protections have largely expired globally, GSK remains a significant name due to its early entry and reputation.
Sanofi-Aventis:
Sanofi, through its acquisition of Zentiva and other entities, also plays a role in ondansetron supply, especially in European markets.
2. Leading Generic Manufacturers
Teva Pharmaceutical Industries:
As one of the world's largest generic drug manufacturers, Teva supplies ondansetron in various formulations, including oral tablets, oral disintegrating tablets, and injections. Its manufacturing facilities adhere to strict cGMP standards, ensuring quality and regulatory compliance.
Dr. Reddy's Laboratories:
An active player in the generic oncology and anti-emetic space, Dr. Reddy's offers affordable ondansetron options globally, particularly in emerging markets.
Cipla Limited:
Based in India, Cipla supplies ondansetron to numerous developing economies, expanding access due to cost-effective manufacturing.
Mylan (Now part of Viatris):
Viatris continues Mylan’s legacy, offering oral and injectable forms of ondansetron with broad distribution networks.
Sun Pharmaceutical Industries:
Sun Pharma supplies ondansetron, primarily focusing on the Indian and Asian markets with extensive formulations.
Formulation and Patent Considerations
Formulations and Market Segments
-
Injection (Intravenous):
Typically used in hospital settings for rapid administration during chemotherapy or surgery. Major suppliers include Teva, Fresenius Kabi, and Hospira. -
Oral Tablets and Disintegrating Tablets:
Common in outpatient settings; brands like Zofran have been replaced by generics from numerous suppliers. -
Syrups and Solutions:
Typically used in pediatric care, supplied by various generics.
Patent and Regulatory Landscape
The original patents for ondansetron expired in most jurisdictions by the mid-2000s, leading to a surge in generic production. However, some formulations or delivery methods (e.g., injectable formulations with proprietary excipients) may still be under patent protection or regulatory exclusivity.
Regulatory approvals by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and China's NMPA ensure consistent standards among suppliers, fostering trust in available products.
Market Dynamics and Supply Chain Considerations
Market Demand Drivers
- Oncology Treatments: Increasing cancer incidences globally drive consistent demand for ondansetron.
- Chemotherapy Protocols: Standard anti-emetic component in treatment regimens.
- Surgical Procedures: Post-operative nausea management sustains steady market needs.
Geographical Distribution of Suppliers
- North America & Europe: Dominated by multi-national pharmaceutical companies with established manufacturing and distribution networks.
- Asia-Pacific: A hub for generic manufacturing, notably India and China, providing cost-effective options with robust regulatory compliance.
- Emerging Markets: Rely predominantly on Indian and Chinese generic producers, emphasizing affordability and local regulatory approvals.
Supply Chain Challenges
- Regulatory Variability: Ensuring compliance across jurisdictions can delay approvals or impact supply consistency.
- Manufacturing Capacity Constraints: Sudden surges in demand or disruptions (e.g., supply chain disruptions, geopolitical issues) can impact availability.
- Quality Assurance: Maintaining high-quality standards is vital, particularly when sourcing from emerging markets.
Emerging Trends and Future Outlook
- Biosimilars and Injectable Innovations: Increasing interest in developing new formulations enhances therapeutic options.
- Quality Standards Enhancement: Amid global supply chain complexities, regulatory agencies tighten oversight to ensure product integrity.
- Market Entry of New Suppliers: As patents expire, new generic manufacturers are entering markets, diversifying supply and potentially reducing costs.
- Sustainability and Manufacturing Innovation: Focus on environmentally responsible manufacturing processes and scalable production to meet global demand.
Strategic Sourcing Implications
Stakeholders must assess supplier stability, adherence to quality standards, and regulatory compliance. Diversifying suppliers can mitigate risks associated with over-reliance on specific regions or manufacturers. Long-term contracts and rigorous quality audits serve as best practices for procurement teams.
Key Takeaways
- The ondansetron supply chain is globally diversified, with key players spanning origins from multinational corporations to regional generic manufacturers.
- Expired patents and regulatory approvals have broadened the supplier base, increasing competition and lowering prices.
- Asia-Pacific, particularly India and China, remain dominant in generic ondansetron manufacturing for emerging markets.
- Quality assurance and regulatory compliance are critical factors in supplier selection, particularly due to the drug’s essential nature in cancer care.
- Future supply stability depends on innovations in formulations and manufacturing, alongside geopolitical and trade considerations.
FAQs
1. Who are the leading global suppliers of ondansetron?
Teva, Dr. Reddy’s, Cipla, Mylan (Viatris), and Sun Pharma are prominent suppliers, with large-scale manufacturing facilities and distribution networks worldwide.
2. Are there significant patent barriers remaining for ondansetron?
Most patents expired by the mid-2000s, opening markets to numerous generic manufacturers, though some formulations or delivery methods may still be under patent protection.
3. How do regional regulations impact ondansetron suppliers?
Regulatory approval by agencies such as the FDA, EMA, and NMPA ensures supplier compliance and influences manufacturing standards, impacting global supply consistency.
4. What are the current trends affecting ondansetron supply?
Growing demand from oncology, advances in formulations (like disintegrating tablets), and increased entry of new generics bolster supply stability and reduce prices.
5. How can healthcare providers ensure reliable ondansetron procurement?
By establishing relationships with reputable suppliers, conducting regular quality audits, diversifying supply sources, and staying informed on regulatory updates.
References
- [1] U.S. Food and Drug Administration (FDA). “Ondansetron Approval and Regulatory Status.”
- [2] European Medicines Agency (EMA). “Ondansetron Summary of Product Characteristics.”
- [3] Market Research Future. “Global Ondansetron Market Analysis, Trends & Forecasts (2022-2027).”
- [4] GlobalData. “Pharmaceutical Industry Report: Oncology Medications and Support Drugs.”
- [5] Indian Pharmaceutical Alliance. “India's Role in Generic Oncology Drugs and Anti-Emetics.”
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