Suppliers and packagers for generic pharmaceutical drug: COCAINE HYDROCHLORIDE

COCAINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963	NDA	LXO US Inc.	70839-359-04	1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS	2024-02-09
Noden Pharma	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963	NDA AUTHORIZED GENERIC	LXO US INC.	70839-362-04	1 BOTTLE, GLASS in 1 CARTON (70839-362-04) / 4 mL in 1 BOTTLE, GLASS	2024-01-29
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575	NDA	OMNIVIUM PHARMACEUTICALS LLC.	81665-300-02	1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS	2024-06-19
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575	NDA AUTHORIZED GENERIC	OMNIVIUM PHARMACEUTICALS LLC.	81665-301-02	1 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 4 mL in 1 BOTTLE, GLASS	2023-10-15

Suppliers for the Pharmaceutical Drug: Cocaine Hydrochloride

Last updated: July 30, 2025

Overview

Cocaine hydrochloride is a potent local anesthetic historically used in medical procedures, particularly in otolaryngology, dentistry, and ophthalmology. Despite its medical applications, it remains a controlled substance due to its high potential for abuse and addiction. As a Schedule II drug under the Controlled Substances Act (CSA) in the United States and similar regulations globally, its manufacture, distribution, and sale are strictly regulated.

Understanding the landscape of legitimate suppliers for pharmaceutical-grade cocaine hydrochloride is critical for compliance, risk management, and strategic planning within the pharmaceutical, research, or authorized medical sectors. This article comprehensively explores the suppliers, regulatory frameworks, and industry considerations surrounding cocaine hydrochloride.

Regulatory Landscape and Legal Constraints

Cocaine hydrochloride's legal status is governed by stringent regulations. In the U.S., the Drug Enforcement Administration (DEA) classifies it as a Schedule II controlled substance, permitting limited medical use under strict licensing. Similarly, international control via the United Nations' Single Convention on Narcotic Drugs (1961) mandates rigorous oversight.

Manufacturers and suppliers must possess appropriate licenses issued by regulatory authorities to produce or distribute pharmaceutical-grade cocaine. This legal backdrop constrains the number of legitimate suppliers and emphasizes compliance to prevent illegal diversion. Consequently, the global supply chain for pharmaceutical cocaine is highly opaque compared to typical pharmaceuticals.

Primary Suppliers and Manufacturing Sources

1. Licensed Pharmaceutical Manufacturers

Only a select number of licensed pharmaceutical companies possess the authorization to manufacture cocaine hydrochloride for medical purposes. These companies operate under strict regulatory oversight with manufacturing facilities compliant with Good Manufacturing Practices (GMP).

• Sterling Pharma Solutions (UK): Historically, Sterling Pharma Solutions has produced chemicals for research and pharmaceutical applications, including controlled substances, under license. While primarily manufacturing research chemicals, it is licensed for certain controlled substances, though recent public information about cocaine production remains limited.

• Laboratorios Synthesis (Spain): Known to produce various controlled substances for medical and research purposes, operating under Spanish and European regulatory authority oversight. However, specific data about cocaine production is scarce and typically confidential.

• National Pharmaceutical Companies (various countries): Some governments' state laboratories in countries such as India and South Africa have the capacity to produce controlled substances for medical use. Nevertheless, their export availability legally remains limited to authorized entities.

2. Specialized Chemical Suppliers and Distributors

Global chemical suppliers who operate within legal frameworks may supply pharmaceutical-grade cocaine hydrochloride to licensed entities.

• Safer Chemicals & Labs (Global): Some chemical suppliers with DEA registration or equivalent licenses in their respective countries supply controlled substances strictly to authorized institutions, such as hospitals, research institutions, and licensed manufacturers.

• Sigma-Aldrich / Merck: While known for a wide range of chemicals, Sigma-Aldrich and Merck (now MilliporeSigma) do not openly list cocaine hydrochloride among their product offerings. However, they maintain strict controls and may supply under confidential, verified accounts to authorized institutions.

• Lab Drug Suppliers: Certain clandestine or less regulated suppliers pose a serious risk of illegal procurement. These entities are not legally authorized and operate outside compliance, risking severe legal penalties.

3. Government and Military Source Programs

Some governments or military research agencies possess clandestine or semi-legitimate supply channels, primarily for research or defense-related purposes. These are highly restricted and not accessible to the commercial or medical sectors.

4. International Pharmaceutical and Chemical Exchanges

Limited to licensed entities, these exchanges facilitate the lawful transfer of controlled substances across borders under strict regulatory oversight. However, due to international treaties and national regulations, illicit trade remains a significant problem.

Challenges in the Supply Chain

• Regulatory Barriers: Stringent licensing and monitoring hinder the proliferation of legitimate suppliers.
• Limited Manufacturers: Few companies hold licenses to produce pharmaceutical cocaine, often due to decreasing clinical use.
• Illicit Diversion Risks: Illegal channels threaten to supply unregulated cocaine, compounding regulatory enforcement challenges.
• Supply Disruptions: Political, legal, and operational factors can cause shortages even among licensed suppliers.

Legal and Ethical Considerations

Procurement and distribution of pharmaceutical cocaine hydrochloride involve rigorous documentation, licensing, and compliance with the laws of the importing and exporting countries. Entities must navigate international treaties, national regulations, and institutional policies.

Additionally, due to its high potential for abuse, pharmaceutical companies and healthcare providers are under strict obligations to prevent diversion. All licensed suppliers are required to implement secure inventory controls, accurate record-keeping, and thorough auditing processes.

Market Outlook and Industry Trends

While the medical use of cocaine hydrochloride is declining globally, primarily replaced by other local anesthetics such as lidocaine and benzocaine, the controlled supply chain persists — mainly for research, educational, or specialized medical uses.

Emerging pharmaceutical research and potential new medical applications might influence demand and, consequently, the supplier landscape. Nevertheless, regulatory hurdles and societal concerns will likely keep the supply chain tightly controlled and limited to licensed entities.

Conclusion

The legitimate supply of cocaine hydrochloride for pharmaceutical use is highly restricted and tightly controlled, with only a handful of licensed manufacturers and authorized chemical suppliers operating within legal frameworks. These companies primarily serve specialized medical, research, and regulatory purposes, maintaining strict compliance with national and international regulations.

Due to the stringent regulatory environment, organizations seeking pharmaceutical-grade cocaine must engage only with authorized, licensed suppliers, ensuring adherence to legal and ethical standards. Unauthorized procurement or use exposes stakeholders to legal penalties and ethical violations.

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Key Takeaways

• The supply of pharmaceutical cocaine hydrochloride is limited to licensed, regulated manufacturers and authorized chemical suppliers.
• Strict international and national controls supervise its production, distribution, and use, reflecting rigorous compliance requirements.
• Most legitimate sources are tied to governmental or approved pharmaceutical entities, emphasizing safety and security.
• The declining medical application of cocaine reduces the number of suppliers and heightens regulatory scrutiny.
• Companies must prioritize legal compliance, secure supply chains, and vigilant diversion prevention measures when handling pharmaceutical cocaine.

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FAQs

1. Is it legal to buy cocaine hydrochloride for medical purposes?
Yes, but only when purchased from licensed, authorized suppliers by licensed medical or research institutions, and strictly for approved medical or research uses under regulatory oversight.

2. Who are the primary licensed suppliers of pharmaceutical cocaine hydrochloride?
Only a few pharmaceutical manufacturers and chemical suppliers in regulated markets such as the UK, Spain, and India possess the requisite licenses to produce and supply pharmaceutical cocaine hydrochloride.

3. How does international law affect the supply of pharmaceutical cocaine?
International treaties like the Single Convention on Narcotic Drugs impose strict controls. Countries enforce these through national legislation, limiting legal supply to authorized entities and tightly regulating cross-border transfers.

4. Are illicit suppliers a concern for legitimate pharmaceutical cocaine supply?
Yes. Illicit channels pose significant risks, including contamination, legal penalties, and diversion. Therefore, organizations must ensure procurement from verified, licensed sources.

5. Will demand for pharmaceutical cocaine hydrochloride increase in the future?
Unlikely. The decline in clinical use of cocaine reduces demand, but ongoing research in certain medical areas could sustain limited demand among authorized entities.

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Sources

1. DEA Diversion Control Division. "Controlled Substance Schedules." U.S. Drug Enforcement Administration, 2023.
2. United Nations Office on Drugs and Crime. "Single Convention on Narcotic Drugs, 1961." UNODC, 2021.
3. European Medicines Agency. "Guidelines on the Use of Controlled Substances," 2022.
4. Pharmaceutical licensing laws in the UK, Spain, India. National drug enforcement agencies, 2023.