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Suppliers and packagers for fentora
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fentora
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | NDA AUTHORIZED GENERIC | Mayne Pharma | 51862-636-28 | 28 BLISTER PACK in 1 CARTON (51862-636-28) / 1 TABLET in 1 BLISTER PACK (51862-636-01) | 2019-06-14 |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | NDA AUTHORIZED GENERIC | Mayne Pharma | 51862-637-28 | 28 BLISTER PACK in 1 CARTON (51862-637-28) / 1 TABLET in 1 BLISTER PACK (51862-637-01) | 2019-06-14 |
| Cephalon | FENTORA | fentanyl citrate | TABLET;BUCCAL, SUBLINGUAL | 021947 | NDA AUTHORIZED GENERIC | Mayne Pharma | 51862-638-28 | 28 BLISTER PACK in 1 CARTON (51862-638-28) / 1 TABLET in 1 BLISTER PACK (51862-638-01) | 2019-06-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FENTORA
Introduction
FENTORA, a transdermal buccal fentanyl product, is a potent opioid analgesic used primarily for managing breakthrough pain in patients with opioid-tolerant cancer. As a Schedule II controlled substance, its distribution and manufacture are tightly regulated. Understanding its current supplier landscape is essential for stakeholders involved in pharmaceutical procurement, distribution, and research. This article analyzes the primary suppliers of FENTORA, explores the manufacturing landscape, and examines market trends influencing its supply chain.
Overview of FENTORA
FENTORA, marketed by Jazz Pharmaceuticals, is supplied under the brand name Fentora (generic name: fentanyl buccal tablet). It was approved by the FDA in 2011 as a treatment for breakthrough pain in cancer patients, requiring strict adherence to prescribing guidelines due to the drug’s high potency and risk of misuse [1].
The manufacturing of FENTORA involves complex processes typical of high-potency opioids, involving specialized facilities compliant with Good Manufacturing Practices (GMP). The drug's supply chain encompasses active pharmaceutical ingredient (API) sourcing, formulation, packaging, and distribution.
Primary Suppliers of FENTORA
1. Jazz Pharmaceuticals
Manufacturer and Proprietor
Jazz Pharmaceuticals holds exclusive rights to manufacture and distribute FENTORA. The company manages the entire supply chain, from API procurement to final product distribution, maintaining strict compliance with regulatory standards. Their manufacturing facilities are located in the United States and Europe, ensuring consistent product quality and supply [2].
Key Points
- Manufacturing Expertise: Jazz Pharmaceuticals has invested in specialized facilities equipped to handle potent opioids.
- Regulatory Compliance: The company adheres to global GMP and DEA regulations, ensuring product integrity.
- Supply Security: As the sole manufacturer, Jazz controls the supply chain, affecting global availability.
2. API Suppliers for Fentanyl
The active pharmaceutical ingredient (API) for FENTORA is fentanyl, a synthetic opioid. Multiple chemical manufacturers globally produce pharmaceutical-grade fentanyl in compliance with regulatory standards. Major API suppliers include:
- Fanam Pharmaceuticals (India): Known for captive API production for opioids, with certifications aligning with international standards.
- Mölnlycke Health Care (Sweden): Produces fentanyl for medical use, with high purity standards.
- Fresenius Kabi (Germany): An established manufacturer of fentanyl API, supporting various formulations globally.
- ACIC Pharmaceutical (China): An emerging supplier with increasing API production capacity, albeit with heightened regulatory scrutiny.
Regulatory Oversight
API sources must comply with the Drug Master File (DMF) submissions to agencies like FDA and EMA. The API’s quality, purity, and consistency are critical to ensuring the safety and efficacy of FENTORA [3].
3. Contract Manufacturing Organizations (CMOs)
While Jazz Pharmaceuticals primarily handles manufacturing, some components of the formulation or packaging may involve CMOs. These third-party facilities operate under strict regulatory oversight, specifically:
- Baxter International: Known to contract out certain formulation steps for specialty pharmaceuticals.
- Recipharm: An established CMO with expertise in potent drug formulations, potentially involved in components of fentanyl-based products.
Market Dynamics Influencing Supply
Global Demand and Supply Constraints
The demand for opioid analgesics like FENTORA is driven by the increasing prevalence of cancer-related pain. However, supply constraints often arise from:
- Regulatory Restrictions: Stringent controls on fentanyl manufacturing and distribution due to abuse concerns [4].
- API Supplier Limitations: Limited producers of pharmaceutical-grade fentanyl contribute to supply bottlenecks.
- Manufacturing Capacity: High-potency opioid manufacturing requires specialized facilities, with capacity constraints impacting availability.
Generic Competition and Market Entry
Currently, FENTORA remains under patent protection and is supplied solely by Jazz Pharmaceuticals. However, generic fentanyl buccal tablets or alternative formulations are in development, which could alter the supply landscape. Regulatory pathways for generics demand rigorous bioequivalence studies and compliance with controlled substance regulations.
Supply Chain Risks and Mitigation Strategies
- Regulatory Compliance Risks: Non-compliance from API suppliers or manufacturers can lead to supply interruptions.
- Geopolitical Risks: Political instability in API-producing countries (e.g., China, India) can disrupt supply chains.
- Quality Assurance: Strict validation and quality control are compulsory for late-stage manufacturing to prevent recalls or shortages.
Proactive engagement with multiple API suppliers and maintaining strategic stockpiles are critical to mitigate these risks.
Conclusion
The supply chain for FENTORA is highly concentrated, with Jazz Pharmaceuticals serving as the primary manufacturer and distributor. The active pharmaceutical ingredient fentanyl is sourced from a limited number of qualified API manufacturers, predominantly in the US, Europe, and increasingly in Asia. Given the drug’s potency and regulatory scrutiny, ensuring a resilient supply chain demands strict compliance, diversified API sourcing, and advanced manufacturing capabilities.
Key Takeaways
- Jazz Pharmaceuticals is the exclusive producer and distributor of FENTORA, underscoring the importance of their manufacturing stability for product availability.
- The fentanyl API supplied by select global manufacturers significantly influences the overall supply chain reliability.
- Global regulatory regimes impose strict controls, impacting production and distribution, especially amidst rising concerns over opioid misuse.
- Supply interruptions are possible due to capacity constraints, geopolitical factors, or regulatory non-compliance, necessitating strategic planning.
- The evolving market landscape, including potential generics, could diversify supply sources in the future, enhancing availability but emphasizing the need for regulatory vigilance.
Frequently Asked Questions (FAQs)
1. Who are the main manufacturers of FENTORA?
Jazz Pharmaceuticals is the sole manufacturer of FENTORA, with quality control and distribution managed internally and via approved third-party facilities.
2. Where is the fentanyl API for FENTORA sourced from?
The API is primarily produced by manufacturers in the US, Europe, and Asia, including companies like Fresenius Kabi (Germany), Mölnlycke (Sweden), and emerging producers in China and India.
3. What are the main regulatory challenges affecting FENTORA supply?
Regulatory challenges stem from strict controls on opioid manufacturing, distribution limitations due to abuse concerns, and the necessity of GMP compliance across the supply chain.
4. Can the supply of FENTORA be impacted by geopolitical factors?
Yes. Political instability, trade restrictions, or regulatory changes in API-producing countries can disrupt supply chains, necessitating contingency planning.
5. Are there any plans to introduce generic versions of FENTORA?
While no generic formulations are currently on the market, regulatory pathways and ongoing research could facilitate future generic entry, potentially diversifying supply sources.
References
[1] U.S. Food and Drug Administration. Fentora (fentanyl buccal tablets) approval documentation. 2011.
[2] Jazz Pharmaceuticals. Annual Reports and Regulatory Filings. 2022.
[3] World Health Organization. Guidelines on the procurement of pharmaceutical opioids. 2020.
[4] U.S. DEA. Controlled Substance Schedules and Regulations. 2023.
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