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Suppliers and packagers for generic pharmaceutical drug: fentanyl
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fentanyl
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-100 | 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-100 | 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-100 | 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 |
| Difgen Pharms | FENTANYL-100 | fentanyl | FILM, EXTENDED RELEASE;TRANSDERMAL | 077449 | ANDA | Aveva Drug Delivery Systems Inc. | 3215-7704-05 | 5 POUCH in 1 CARTON (3215-7704-05) / 1 PATCH in 1 POUCH (3215-7704-01) / 72 h in 1 PATCH | 2025-01-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: FENTANYL
Introduction
Fentanyl, a potent synthetic opioid analgesic, is widely used in clinical settings for managing severe pain, particularly in cancer treatments and anesthesia. Due to its high potency—approximately 50 to 100 times stronger than morphine—fentanyl’s manufacturing, supply chain, and regulation are highly scrutinized. The global supply for pharmaceutical-grade fentanyl involves a complex network of licensed manufacturers, raw material suppliers, and distributors, primarily regulated by international and national agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and counterparts across Asia, Europe, and North America.
This article systematically explores the key suppliers of pharmaceutical-grade fentanyl, highlighting manufacturing hubs, regulatory compliance, supply chain dynamics, and emerging challenges. A comprehensive understanding of these elements informs stakeholders, from pharmaceutical companies and regulators to law enforcement agencies engaged in combating illicit fentanyl diversion.
1. Major Manufacturers and Suppliers of Pharmaceutical Fentanyl
1.1. Principal Countries and Regions
The dominant regions in fentanyl manufacturing are North America, Europe, and Asia, with China and India recognized as major producers of precursor chemicals and finished pharmaceutical products.
1.1.1. China
China remains a crucial supplier of fentanyl and its precursor chemicals. Several Chinese companies manufacture both finished pharmaceutical products and the essential precursor chemicals like N-Phenethyl-4-piperidone (NPP) and 4-Anilino-N-phenethylpiperidine (ANPP), which are critical in fentanyl synthesis.
Chinese firms often operate under licensing agreements and are subject to international regulations, with some facing scrutiny for illicit diversion. The Chinese government has taken steps to tighten controls post-2019, when the United States pressured China to curb illegal fentanyl exports.
1.1.2. India
India hosts numerous pharmaceutical manufacturers licensed for prescription fentanyl formulations, particularly transdermal patches and injectable forms. Companies such as Sun Pharmaceutical Industries Ltd. and others possess the required Good Manufacturing Practice (GMP) certifications and operate under strict domestic regulation.
1.1.3. Europe and the United States
While production within the U.S. is limited due to strict regulatory frameworks, some multinational pharmaceutical companies—such as Johnson & Johnson (Mylan) and Novartis—manufacture fentanyl-based medications, particularly for North American markets.
1.2. Leading Pharmaceutical Manufacturers
- Hospira (now part of Pfizer): Historically produced injectable fentanyl formulations, primarily serving the U.S. market.
- Johnson & Johnson / Janssen Pharmaceutica: Produces fentanyl patches and injectable forms.
- Mylan (now part of Viatris): Known for transdermal patches.
- Teva Pharmaceuticals: Offers fentanyl formulations, mainly patches.
1.3. Precursor Chemical Suppliers
Precursors like NPP and ANPP are mostly produced in China and India, often by specialized chemical companies. These chemicals are then supplied to licensed fentanyl manufacturing facilities, forming part of the global supply chain.
2. Regulatory Framework and Licensing
Due to fentanyl's high abuse potential, its production and distribution are tightly regulated under international conventions such as the Single Convention on Narcotic Drugs (1961) and domestic laws like The Controlled Substances Act (CSA) in the United States.
Manufacturers must obtain various licenses and are regularly audited for compliance with GMP standards. Non-compliance can lead to criminal penalties, product confiscation, and supply disruptions. The regulation of precursor chemicals is equally strict, with import/export controls implemented through the International Narcotics Control Board (INCB).
3. Supply Chain Dynamics and Challenges
3.1. Legitimate Pharmaceutical Supply
The legal supply chain originates from licensed manufacturers supplying end-user healthcare providers. These companies adhere to stringent quality standards, ensuring drug safety and efficacy.
3.2. Illicit Diversion and Dual-Use Manufacturing
A significant challenge is the diversion of pharmaceutical-grade fentanyl and its precursors to illegal markets. Illicit manufacturers mimic legitimate formulations or illegally import precursor chemicals, often exploiting regulatory gaps.
Chinese and Indian chemical manufacturers report increased scrutiny and implemented control measures. Nevertheless, the proliferation of illicit labs in Mexico and other regions continues to challenge regulatory oversight.
3.3. Counterfeit and Fake Fentanyl
Criminal networks produce counterfeit fentanyl products indistinguishable from legitimate drugs, posing severe health risks. These counterfeit products often originate from clandestine labs in China, Mexico, and other regions, and are distributed through dark web markets.
4. Emerging Trends in Fentanyl Supply
- Digital Infrastructure and Cryptomarkets: Cyber-enabled large-scale distribution of illicit fentanyl, often circumventing traditional regulatory channels.
- International Cooperation: Enhanced cross-border cooperation among law enforcement and regulatory agencies to curb precursor chemical trafficking.
- Technological Advancements: Use of blockchain and tracking technologies to secure the supply chain, ensuring authenticity and compliance.
- Regulatory Tightening: China's 2019 procedures, India’s stricter chemical export controls, and U.S. legislative acts like the Ensuring Patient Access and Drug Enforcement Act aim to mitigate diversion.
5. Key Players in the Fentanyl Manufacturing Ecosystem
| Region | Major Companies/Actors | Function |
|---|---|---|
| China | Zhengzhou Pharmaceutical Co., Ltd.; Yongjiang Pharmaceutical Co., Ltd. | Chemical synthesis and basic precursor production |
| India | Sun Pharmaceutical Industries Ltd.; Dr. Reddy’s Laboratories | Finished pharmaceutical formulation manufacturing |
| Europe | Johnson & Johnson (Janssen); Novartis | Prescription fentanyl products |
| North America | Pfizer (Hospira); Mylan (Viatris) | Injectable and transdermal fentanyl formulations |
6. Legal and Compliance Challenges
The international regulatory environment adapts swiftly in response to diversion trends. Notably, Chinese authorities have engaged in bilateral agreements with the U.S. to control fentanyl precursor exports more stringently.
Pharmaceutical companies face strict licensing and auditing procedures. Failure to comply not only risks legal penalties but also disrupts supply chains and damages brand reputation.
7. Conclusion
The global supply chain for pharmaceutical fentanyl is characterized by a dual landscape: legitimate manufacturing and distribution networks, regulated and compliant with international laws, and illicit channels that exploit regulatory gaps, often originating from China and India.
Legitimate suppliers predominantly include multinational pharmaceutical companies in North America and Europe, working within rigorous regulatory environments. Meanwhile, clandestine operations capitalize on unregulated chemical production, illicit labs, and dark web markets to meet burgeoning demand, particularly in illicit markets.
Strong international cooperation, technological advancements, and regulatory enforcement remain critical to ensuring the legitimacy of supply chains while curbing diversion. The evolving landscape necessitates vigilant monitoring by regulatory bodies, law enforcement, and industry stakeholders to balance medical needs and mitigate abuse potentials.
Key Takeaways
- Major legitimate suppliers include multinational pharmaceutical companies in North America and Europe, sourcing primarily from licensed facilities in China and India.
- Precursor chemicals are mainly produced in China and India, with strict international controls aiming to prevent diversion.
- Regulatory adherence is critical; non-compliance can lead to supply disruptions and legal consequences.
- Illicit manufacturing and diversion are significant concerns, driven by weaknesses in control over chemical precursors and clandestine labs.
- Advanced tracking, international cooperation, and regulatory tightening are essential strategies for maintaining a secure and legitimate fentanyl supply chain.
FAQs
Q1: How does China regulate the production of fentanyl and its precursors?
A1: China implemented stricter controls post-2019, requiring licensing and real-time monitoring of chemical exports. The Chinese government cooperates with international agencies to curb illicit diversion but continues facing challenges due to the dual-use nature of chemicals.
Q2: What distinguishes pharmaceutical-grade fentanyl from illicit fentanyl?
A2: Pharmaceutical-grade fentanyl is produced under strict GMP standards, ensuring quality and safe dosing. Illicit fentanyl is manufactured clandestinely, often with unknown purity, mislabeling, or adulteration, increasing overdose risks.
Q3: Are there specific regulations in North America governing fentanyl supply?
A3: Yes. In the U.S., the DEA classifies fentanyl as a Schedule II controlled substance, requiring licenses for manufacturing, prescribing, and distribution under the Controlled Substances Act. Similar regulations exist in Canada and Mexico.
Q4: How are illicit fentanyl producers sourcing precursor chemicals?
A4: Many illicit labs acquire precursors from unregulated or semi-regulated chemical suppliers in China and India, exploiting gaps in international oversight and oversight loopholes.
Q5: What steps are global regulators taking to prevent diversion?
A5: Measures include enhanced licensing procedures, real-time import/export tracking, international intelligence sharing, and implementing secure supply chain technologies like blockchain to ensure product integrity.
References
- U.S. Food and Drug Administration (FDA). Fentanyl: Drug Safety Communication.
- International Narcotics Control Board (INCB). Precursors report 2022.
- European Medicines Agency (EMA). Fentanyl product regulation.
- U.S. Drug Enforcement Administration (DEA). Diversion Control Program.
- Chinese National Narcotics Control Commission. Annual Report 2021.
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