Suppliers and packagers for generic pharmaceutical drug: fentanyl citrate

fentanyl citrate

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	212086	ANDA	Fresenius Kabi USA, LLC	63323-808-11	10 SYRINGE in 1 CARTON (63323-808-11) / 1 mL in 1 SYRINGE (63323-808-01)	2020-09-30
Fresenius Kabi Usa	FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	212086	ANDA	Fresenius Kabi USA, LLC	63323-810-20	20 SYRINGE in 1 CARTON (63323-810-20) / 2 mL in 1 SYRINGE (63323-810-00)	2021-01-15
Hikma	FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	019101	NDA	Hikma Pharmaceuticals USA Inc.	0641-6024-10	10 AMPULE in 1 CARTON (0641-6024-10) / 2 mL in 1 AMPULE (0641-6024-01)	1984-07-11

Suppliers for the Pharmaceutical Drug: Fentanyl Citrate

Last updated: July 29, 2025

Introduction

Fentanyl citrate, a potent synthetic opioid, is widely utilized in clinical settings for anesthetic and analgesic purposes. Its high potency—approximately 50 to 100 times stronger than morphine—necessitates rigorous manufacturing oversight and regulation. As demand for analgesics rises globally, the supply chain for fentanyl citrate has attracted increased scrutiny due to concerns over misuse, illicit trafficking, and regulatory compliance. This article provides a comprehensive overview of key suppliers, regulatory considerations, and insights to inform stakeholders about the landscape of fentanyl citrate manufacturing and distribution.

Manufacturers and Suppliers of Fentanyl Citrate

Fentanyl citrate is produced predominantly by select pharmaceutical companies specializing in research pharmaceuticals, hospital-use anesthetic agents, and controlled substances. Major industry players include both licensed chemical producers and pharmaceutical conglomerates operating under strict regulatory controls.

Major Pharmaceutical Manufacturers

1. Indivior Ltd.
   Indivior, a UK-based pharmaceutical company, manufactures fentanyl citrate formulations primarily for clinical and hospital use. Their products adhere to strict regulatory standards such as the UK’s MHRA and the U.S. FDA.

2. Johnson & Johnson (Reynolds American Pharmaceuticals)
   Through its Janssen division, Johnson & Johnson produces fentanyl citrate for medical applications, including transdermal patches and injectable formulations. Their manufacturing facilities are certified for compliance with international Good Manufacturing Practices (GMP).

3. Mylan N.V. (Now part of Viatris)
   Mylan supplies fentanyl citrate in various dosage forms, including injectable and lozenge formulations, accessible via regulatory approvals in multiple markets, especially the U.S. and European Union.

4. Sandoz (Novartis Group)
   Sandoz manufacturers fentanyl citrate for hospital administration and pain management. Their supply chain emphasizes GMP compliance, ensuring high-quality pharmaceutical-grade products.

5. Teva Pharmaceutical Industries
   As a leading generic drug manufacturer, Teva produces fentanyl citrate for hospital use, adhering to strict regulatory and quality standards in global markets.

Chemical Suppliers and Raw Material Providers

While the active pharmaceutical ingredient (API)—fentanyl citrate—is primarily produced by pharmaceutical companies for approved medical use, several specialty chemical manufacturers supply the raw fentanyl base:

• Midwest Specialty Chemicals Inc.
  Provides fentanyl intermediates under regulated environments, typically for licensed pharmaceutical manufacturers.

• Fuzhou Mingsong Chemical Co., Ltd.
  Engages in the synthesis of fentanyl precursors, predominantly serving licensed producers for legitimate medical applications.

Note: The production of fentanyl and its salts is tightly controlled. Many chemical suppliers operate under strict licensing and compliance protocols to prevent diversion for illicit use.

Geographical Distribution of Suppliers

Most legitimate suppliers operate within North America, Europe, and Asia, with manufacturing hubs in:

• United States: Facilities regulated by the Drug Enforcement Administration (DEA) and FDA, primarily producing for domestic and international markets under licensing agreements.

• European Union: Companies such as Johnson & Johnson and Sandoz operate within the EU’s stringent regulatory environment governed by EMA and national agencies.

• Asia: Chinese chemical companies like Fuzhou Mingsong and others produce fentanyl precursors for licensed pharmaceutical applications, often exporting globally.

Regulatory Oversight and Compliance

Fentanyl citrate's manufacturing and distribution are governed by comprehensive regulations:

• United States: Controlled Substances Act (CSA); DEA schedules fentanyl as a Schedule II drug, limiting production to registered manufacturers.

• European Union: Controlled under the European Drug Precursors Regulation and individual Member State laws.

• China and India: Regulate fentanyl precursor chemicals under national chemical control laws, with export licenses required.

Compliance ensures manufacturers mitigate diversion risks and adhere to international standards, which is vital given fentanyl's role in the opioid crisis.

Challenges and Risks in the Supply Chain

Despite a limited number of licensed suppliers, illicit manufacturing and trafficking pose significant risks:

• Diversion and Illegal Production: Criminal organizations clone legitimate chemical processes or smuggle precursor chemicals, complicating law enforcement efforts.

• Quality Control Concerns: Illicit fentanyl often has unknown purity and potency, increasing overdose risks.

• Regulatory Stringency: Increasing international controls limit lawful production, potentially leading to supply shortages or market distortions.

Emerging Trends in Fentanyl Citrate Supply

• New Manufacturing Hubs: Countries like India are expanding licensed fentanyl production, often under licensing agreements with Western pharmaceutical firms.

• Advanced Chemical Synthesis: Innovations in synthesis techniques aim to streamline production, but also pose diversion risks.

• Digital Supply Chain Control: Companies increasingly leverage blockchain and other technologies to track raw materials and final products.

Implications for Stakeholders

Pharmaceutical companies must navigate complex regulatory environments to prevent diversion, ensure product safety, and meet rising demand. Authorities need robust procurement and oversight mechanisms to monitor supply and prevent illegal trade. Medical institutions should verify sourcing channels, prioritizing suppliers with full regulatory validation.

Key Takeaways

• The supply of pharmaceutical-grade fentanyl citrate is concentrated among a limited number of highly regulated manufacturers, primarily in North America, Europe, and Asia.

• Leading firms like Johnson & Johnson, Sandoz, Teva, and Mylan are primary suppliers, adhering to rigorous regulatory standards.

• Raw fentanyl base and precursors are supplied by specialized chemical manufacturers under licensing, with strict compliance requirements.

• Illicit manufacturing and diversion remain significant challenges, complicating lawful supply chains and raising safety concerns.

• Emerging technological solutions and international cooperation are critical to securing the legitimate supply chain and preventing misuse.

Conclusion

Monitoring and understanding the landscape of fentanyl citrate suppliers is crucial for pharmaceutical companies, regulators, and healthcare providers. Ensuring a compliant, secure, and transparent supply chain is paramount in balancing legitimate medical needs against the risks of diversion and abuse.

FAQs

1. Who are the main authorized manufacturers of fentanyl citrate globally?
Major authorized manufacturers include Johnson & Johnson (Janssen), Sandoz (Novartis), Teva, Mylan (Viatris), and Indivior, all operating under strict regulatory oversight within their respective jurisdictions.

2. How is the production of fentanyl citrate regulated internationally?
Production is governed by national laws such as the Controlled Substances Act in the U.S., and the European Drug Precursors Regulation within the EU. International control measures are enforced through agencies like the UN Office on Drugs and Crime (UNODC), aiming to prevent diversion.

3. Are there legitimate supply shortages of fentanyl citrate?
Supply shortages can occur due to regulatory restrictions, manufacturing issues, or increased demand. However, licensed producers generally work to ensure steady availability for medical use, especially within regulated healthcare systems.

4. What measures are in place to prevent the illicit diversion of fentanyl citrate?
Strict licensing for chemical producers, rigorous supply chain monitoring, tracking and tracing technologies (like serialization and blockchain), and international cooperation efforts help mitigate illicit diversion.

5. Can synthetic routes to fentanyl be exploited for illegal manufacturing?
Yes. While legitimate manufacturers employ secure synthesis protocols, illicit entities may attempt to replicate these processes or use precursor chemicals obtained through illegal channels, emphasizing the need for strict controls and monitoring.

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Sources
[1] US Drug Enforcement Administration. (2022). Fentanyl and Its Analogues.
[2] European Monitoring Centre for Drugs and Drug Addiction. (2021). Fentanyl in the EU.
[3] Johnson & Johnson. (2023). Janssen Product Portfolio.
[4] Novartis. (2022). Sandoz: Specialty Pharmaceuticals.
[5] International Narcotics Control Board. (2022). Report on Precursors and Controlled Substances.