Suppliers and packagers for fentanyl-75

fentanyl-75

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-75	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-75	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-75	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

Suppliers for the Pharmaceutical Drug: Fentanyl-75

---

Introduction

Fentanyl-75, a potent synthetic opioid analgesic, remains a critical component in pain management, notably in surgical and palliative care settings. Market dynamics for pharmaceutical-grade fentanyl, especially the 75 micrograms (mcg) formulation, involve a complex network of licensed manufacturers, authorized distributors, and regulatory oversight. This analysis explores the primary suppliers, regulatory requirements, and the landscape shaping the global fentanyl supply chain, providing actionable insights for stakeholders navigating this highly controlled pharmaceutical market.

---

Overview of Fentanyl-75 in Medical Use

Fentanyl-75 micrograms is typically administered via transdermal patches, injectable forms, or lozenges. Its pharmacological potency—approximately 50 to 100 times more powerful than morphine—necessitates strict regulation and secure supply channels [1]. Its essential role in pain relief underscores the critical need for reliable, licensed suppliers adhering to international standards, including those set by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies.

---

Legal and Regulatory Framework Governing Fentanyl Suppliers

Given the high abuse potential, fentanyl is classified as a Schedule II controlled substance in the United States and similarly regulated in other jurisdictions. Strict import/export controls, licensing requirements, and surveillance mechanisms underpin the lawful supply chain [2]. Suppliers must acquire special licenses, demonstrate adherence to Good Manufacturing Practices (GMP), and document traceability at each transaction point.

The scope and transparency of regulatory oversight influence supplier credibility and market stability. Unauthorized or illicit sources pose significant risks, including adulteration, falsification, and diversion.

---

Leading Pharmaceutical Manufacturers of Fentanyl-75

1. Johnson & Johnson (Janssen Pharmaceuticals)
Janssen, a subsidiary of Johnson & Johnson, is among the dominant international producers, manufacturing patented formulations such as Duragesic transdermal patches containing fentanyl. Their global distribution network ensures broad availability within legal channels [3].

2. Novartis AG
Novartis supplies fentanyl formulations, including 75 mcg patches, under strict GMP adherence. Their extensive global manufacturing facilities and regulatory compliance facilitate reliable supply chains, especially in Europe and North America [4].

3. Teva Pharmaceuticals
Teva is a prominent generic drug manufacturer offering fentanyl-75 patches and injectable forms. Their focus on cost-effective production and compliance with regional regulations makes them a key player in the generics segment [5].

4. Sandoz (Novartis division)
Specializing in biosimilars and generics, Sandoz supplies fentanyl in various doses, including 75 mcg patches, primarily to European and American markets under regulatory compliance [6].

5. Hikma Pharmaceuticals
Hikma manufactures injectable fentanyl and patches, playing a significant role in the Middle East, Africa, and European markets. Their manufacturing facilities are certified to GMP standards [7].

---

Major Distributors and Supply Chain Intermediaries

While manufacturers hold licenses for production, the distribution of fentanyl-75 involves authorized pharmaceutical wholesalers and specialty distributors. These entities are licensed, monitored by national agencies, and often operate under strict supply agreements with manufacturers.

Key licensed distributors include:

Last updated: July 30, 2025

• McKesson Corporation (U.S.)
• AmerisourceBergen (U.S.)
• Cardinal Health (U.S.)
• Alfasigma (European markets)
• STADA Arzneimittel

These organizations ensure supply chain integrity, compliance with pharmacovigilance policies, and prevent diversion to illicit channels.

---

Global Manufacturing Footprint

Manufacturing is concentrated in regions with established pharmaceutical regulatory infrastructure, notably North America, Europe, and parts of Asia (India and China). Regulatory harmonization facilitates international trade, but geopolitical and regulatory changes can influence supply stability.

Notable manufacturing sites include:

• West-Ward Pharmaceuticals (U.S.)
• Mundipharma (Europe)
• Teva's facilities across Israel and Europe
• Sandoz's production units globally

The complexity of global supply chains emphasizes the necessity for due diligence, regulatory compliance, and market monitoring to mitigate shortages, counterfeit risks, and diversion.

---

Challenges Affecting Supplier Stability

• Regulatory restrictions: Stricter controls, such as Australia's recent Schedule 8 reclassification, impact supply channels and market entry [8].
• Illicit market interference: Diversion, smuggling, and counterfeit fentanyl pose significant health and legal risks. Enforcement agencies worldwide continue ramping efforts to curtail illegal fentanyl trade.
• Manufacturing disruptions: Supply chain interruptions due to geopolitical tensions, pandemics, or quality control issues can impact delivery schedules.
• Pricing and market access: Patent protections, pricing policies, and reimbursement models influence the dynamics of licensed suppliers.

---

Emerging Trends and Future Outlook

• Expansion of generic manufacturing is likely, driven by increasing demand and regulatory shifts in emerging markets, such as Southeast Asia.
• Advancements in formulation technology—including novel transdermal systems—may influence supplier offerings.
• Enhanced regulatory cooperation could streamline licensing, oversight, and quality compliance across jurisdictions.
• Control measures are expected to tighten further, with authorities implementing more rigorous monitoring to minimize diversion risks.

---

Key Takeaways

• Licensed manufacturing is essential for legal fentanyl-75 supply, with global leaders including Johnson & Johnson (Janssen), Novartis, Teva, Sandoz, and Hikma.
• Distribution channels are highly regulated, involving approved wholesalers and specialty distributors ensuring traceability and compliance.
• Regulatory frameworks significantly impact supplier stability, with stricter controls potentially constraining supply but enhancing safety.
• Market dynamics are shaped by geopolitical, legal, and technological factors, with ongoing efforts to balance legitimate access and diversion prevention.
• Stakeholders must exercise caution—verifying supplier credentials, ensuring compliance, and monitoring regulatory environments are crucial in managing fentanyl-75 procurement.

---

FAQs

1. How can healthcare providers ensure they source fentanyl-75 legally?
Providers must procure from licensed manufacturers and authorized distributors compliant with local and international regulations. Verification of supplier licensing and adherence to GMP standards is essential.

2. Are there risks associated with unlicensed fentanyl suppliers?
Yes. Unlicensed sources risk supplying counterfeit or adulterated products, which can cause patient harm, legal liabilities, and regulatory penalties.

3. Does the global supply of fentanyl-75 face shortages?
Occasionally, supply disruptions occur owing to manufacturing issues, regulatory changes, or geopolitical tensions. However, licensed manufacturers generally maintain contingency plans to mitigate shortages.

4. What are the primary regulatory authorities overseeing fentanyl distribution?
In the U.S., the DEA (Drug Enforcement Administration) and FDA oversee fentanyl. In Europe, agencies like the EMA and national authorities play key roles. Most jurisdictions enforce strict licensing and prescribing regulations.

5. Is there a trend toward alternative formulations to fentanyl-75?
Yes. Researchers and manufacturers develop non-opioid analgesics and novel delivery systems to reduce dependence on high-potency opioids, but fentanyl remains central in specific clinical applications due to its efficacy.

---

References

[1] Center for Drug Evaluation and Research (CDER). Fentanyl: An Overview. FDA; 2022.
[2] UNODC. World Drug Report 2022. United Nations Office on Drugs and Crime.
[3] Janssen Pharmaceuticals. Product portfolio. Johnson & Johnson.
[4] Novartis AG Annual Report 2021.
[5] Teva Pharmaceuticals. Corporate Overview.
[6] Sandoz. Commitment to Quality and Safety. Novartis.
[7] Hikma Pharmaceuticals. Annual Report 2022.
[8] Australian Government Department of Health. Scheduling reforms for opioids.

Note: Data provided reflects the latest publicly available information and does not substitute for legal or regulatory advice.