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Suppliers and packagers for FENTANYL-25
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FENTANYL-25
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Difgen Pharms | FENTANYL-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449 | ANDA | Aveva Drug Delivery Systems Inc. | 3215-7701-05 | 5 POUCH in 1 CARTON (3215-7701-05) / 1 PATCH in 1 POUCH (3215-7701-01) / 72 h in 1 PATCH | 2025-01-30 |
| Difgen Pharms | FENTANYL-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449 | ANDA | Aveva Drug Delivery Systems Inc. | 3215-7702-05 | 5 POUCH in 1 CARTON (3215-7702-05) / 1 PATCH in 1 POUCH (3215-7702-01) / 72 h in 1 PATCH | 2025-01-22 |
| Difgen Pharms | FENTANYL-25 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449 | ANDA | Aveva Drug Delivery Systems Inc. | 3215-7703-05 | 5 POUCH in 1 CARTON (3215-7703-05) / 1 PATCH in 1 POUCH (3215-7703-01) / 72 h in 1 PATCH | 2025-02-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FENTANYL-25
Introduction
Fentanyl-25, a potent synthetic opioid with a concentration of 25 micrograms per dose, is extensively used in clinical settings for anesthesia, pain management, and palliative care. Its high potency—approximately 80 to 100 times that of morphine—necessitates stringent manufacturing standards and a secure supply chain. Identifying reliable suppliers of Fentanyl-25 involves understanding the regulatory landscape, manufacturing capabilities, and global distribution channels. This article provides a comprehensive overview of the primary suppliers, their market strategies, and considerations for procurement professionals.
Regulatory Context and Market Dynamics
The manufacturing, distribution, and sale of Fentanyl-25 are tightly regulated by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and corresponding authorities globally. Due to its abuse potential, suppliers must adhere to narcotics control laws, enforce prescription monitoring programs, and comply with Good Manufacturing Practices (GMP).
The global demand for Fentanyl-25 is driven by the clinical necessity for precise analgesia, particularly in perioperative and pain management contexts. However, the illicit diversion of fentanyl analogs has heightened scrutiny on legal suppliers, impacting the market landscape.
Major Pharmaceutical Suppliers of Fentanyl-25
1. Johnson & Johnson (Janssen Pharmaceuticals)
Janssen, a subsidiary of Johnson & Johnson, holds a significant position in the production of fentanyl formulations, including Fentanyl-25 patches and injectables. Janssen’s manufacturing facilities operate under rigorous GMP standards, approved by regulatory authorities. The company's extensive global distribution network ensures steady supply to hospitals and clinics worldwide.
2. Sandoz (Novartis Group)
Sandoz specializes in generics and biosimilars and supplies Fentanyl-25 in various delivery forms, including injectable preparations. Their manufacturing units are certified under international GMP protocols, providing high-quality product consistency. Sandoz's competitive pricing and global reach make it a prominent supplier.
3. Teva Pharmaceutical Industries
Teva produces fentanyl products, including Fentanyl-25 patches and formulations for clinical use. Their production facilities are FDA-licensed, with a focus on maintaining high safety and quality standards. Teva's broad portfolio and distribution network support consistent supply for institutional clients.
4. Hikma Pharmaceuticals
Hikma supplies fentanyl medications as part of their analgesic portfolio. Their manufacturing processes are compliant with international regulations, with particular strength in supply chain stability across Middle Eastern, European, and African markets. Hikma emphasizes quality assurance in its pharmaceutical offerings.
5. Perrigo Company
Perrigo manufactures generic fentanyl products used in hospitals and clinics globally. Their GMP-compliant facilities enable supply of Fentanyl-25 formulations suitable for various administration routes. Perrigo’s strategic partnerships and distribution channels enhance their market presence.
6. Napp Pharmaceuticals
Napp focuses on specialty medicines, including fentanyl patches and injectables. Their manufacturing standards meet the strict criteria set by regulatory agencies, and their global supply chain ensures availability in multiple markets. Napp emphasizes innovation in delivery systems to improve patient outcomes.
Emerging and Contract Manufacturers
In addition to established pharmaceutical companies, several contract manufacturing organizations (CMOs) provide custom production of fentanyl-based products under strict regulatory oversight. These CMOs typically operate under licenses from brand-name patent holders or regulated generic producers, allowing for flexible scale-up and supply diversification.
7. WuXi AppTec
WuXi provides contract manufacturing services for fentanyl and related compounds. Their facilities adhere to international GMP standards, and they offer preclinical to commercial manufacturing, supporting supply chain resilience.
8. Biocon Limited
Biocon’s specialized facilities produce fentanyl products for various clients, emphasizing quality control and regulatory compliance. Their global footprint supports regional supply needs, especially in Asia.
Critical Considerations in Supplier Selection
Regulatory Compliance: Suppliers must possess valid manufacturing licenses from relevant authorities, demonstrating compliance with GMP regulations.
Quality Assurance: Product consistency, stability, and accurate dosage are paramount given fentanyl's high potency and risk profile.
Supply Chain Robustness: Given the global regulation and diversion risks, suppliers need resilient logistics, contingency plans, and secure distribution mechanisms.
Pricing and Contract Terms: Negotiating favorable terms without compromising quality or regulatory adherence is essential amid fluctuating demand.
Traceability and Monitoring: Implementing systems to track supply origins and adhere to prescription monitoring programs enhances safety and compliance.
Geographic Distribution and Import/Export Dynamics
China and India are significant manufacturing hubs for generic fentanyl products, including Fentanyl-25, due to their large pharmaceutical export industries. These countries host numerous GMP-certified facilities capable of producing both APIs (Active Pharmaceutical Ingredients) and finished formulations. Regulatory agencies in Europe and North America exercise strict oversight, often requiring rigorous documentation for imports.
The U.S. Office of National Drug Control Policy (ONDCP) scrutinizes fentanyl imports, stressing procurement from licensed, compliant suppliers. European markets have similar safeguards, requiring transparent supply chains.
Legal and Ethical Considerations
Procurement of Fentanyl-25 involves stringent legal scrutiny to prevent diversion and misuse. Healthcare providers must verify supplier credentials, ensure proper prescription practices, and comply with narcotics regulations. Ethical sourcing—favoring suppliers with transparent manufacturing processes and robust compliance records—is integral to safeguarding patient safety.
Market Challenges and Opportunities
Challenges include:
- Regulatory hurdles constraining supply chain flexibility.
- Heightened illicit fentanyl trafficking impacting legal supplier reputation.
- Fluctuations in manufacturing costs affecting pricing.
Opportunities involve:
- Partnering with emerging regional manufacturers to diversify supply sources.
- Investing in supply chain security technologies, such as blockchain.
- Engaging in strategic alliances for advanced formulation development.
Key Takeaways
- Reliable procurement of Fentanyl-25 necessitates partnering with global and regional manufacturers compliant with GMP and narcotics regulations.
- Leading suppliers include Johnson & Johnson (Janssen), Sandoz, Teva, Hikma, Perrigo, and Napp Pharmaceuticals, supported by a growing network of CMOs.
- Supply chain resilience is critical; diversification reduces risks posed by regulatory shifts, geopolitical issues, or diversion concerns.
- Emphasizing quality assurance, traceability, and compliance ensures safe and effective distribution.
- Vigilance against illicit diversion remains vital, requiring thorough due diligence and adherence to prescription monitoring protocols.
FAQs
1. What are the primary regulatory challenges in sourcing Fentanyl-25?
Regulatory challenges include navigating complex import/export controls, complying with narcotics laws, maintaining GMP standards, and ensuring secure supply chains to prevent diversion.
2. How can healthcare providers ensure the quality of Fentanyl-25 from suppliers?
By verifying supplier licenses, inspecting GMP certifications, requesting product batch testing results, and establishing long-term relationships with reputable manufacturers.
3. Are there regional differences in the availability of Fentanyl-25 suppliers?
Yes. North America and Europe typically source from established multinational companies, while Asia is home to numerous generic manufacturers. Regulatory standards vary regionally, impacting supplier selection.
4. What considerations should be made when contracting with contract manufacturers?
Ensure they possess appropriate licenses, adhere to GMP, have a robust quality control system, and provide traceability documentation, minimizing risks of contamination or diversion.
5. How does the illicit market influence the legal fentanyl supply chain?
Illicit fentanyl affects legal suppliers by increasing regulatory scrutiny, impacting pricing, and emphasizing the need for secure, transparent supply channels to prevent diversion and misuse.
References
[1] U.S. Food and Drug Administration (FDA). Drug Manufacturing and Quality Controls.
[2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) Guidelines.
[3] National Institute on Drug Abuse (NIDA). Fentanyl and Other Synthetic Opioids.
[4] Pharmaceutical Technology. Global Fentanyl Market Overview.
[5] International Narcotics Control Board (INCB). Monitoring the Supply Chain of Controlled Substances.
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