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Suppliers and packagers for BREVITAL SODIUM
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BREVITAL SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ph Health | BREVITAL SODIUM | methohexital sodium | INJECTABLE;INJECTION | 011559 | NDA | Endo USA, Inc. | 42023-105-01 | 1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 2007-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BREVITAL SODIUM
Introduction
Brevitol Sodium (also known as Sodium Thiopental) is a barbiturate historically used as an anesthetic agent and, controversially, as part of lethal injection protocols. Despite its limited medical use today, it remains a critical compound in certain pharmacological and forensic applications. The global supply chain for Brevitol Sodium involves a limited number of manufacturers and suppliers, primarily due to strict regulatory controls, manufacturing complexities, and the drug’s controversial status.
This article offers an in-depth analysis of the primary suppliers for Brevitol Sodium, examining major manufacturing regions, regulatory considerations, and market dynamics. In doing so, it aims to inform stakeholders—including pharmaceutical companies, healthcare providers, and regulatory agencies—on the current landscape of Brevitol Sodium sourcing.
Manufacturing and Regulatory Landscape
Brevitol Sodium’s production is tightly regulated by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities owing to its controlled status and potential misuse. Manufacturing is geographically concentrated in countries with well-established pharmaceutical sectors, notably China, India, and some European nations.
Strict export controls, licensed manufacturing facilities, and compliance with Good Manufacturing Practices (GMP) are prerequisites for suppliers wishing to participate in the global supply chain. Due to historical manufacturing issues and regulatory crackdowns, the number of authorized sources remains limited.
Major Suppliers and Manufacturers
1. Chinese Manufacturers
China has historically been a dominant supplier of generic pharmaceuticals, including hazardous substances such as Brevitol Sodium. Several Chinese pharmaceutical firms manufacture and export sodium thiopental under stringent licensing arrangements. Notable companies include:
- North China Pharmaceutical Group Corporation (SPH)
- Hainan Chemical Industry Co., Ltd.
- SinoPharm Group
These companies have been identified as key suppliers historically, though export limitations and regulatory crackdowns have affected their current output.
Regulatory constraints: Chinese authorities have tightened controls on the export of controlled substances in recent years, creating supply uncertainties.
2. Indian Producers
India’s pharmaceutical sector, known for generic drug manufacturing, also produces sodium thiopental for hospitals and research institutions. Leading firms include:
- Sun Pharmaceutical Industries Ltd.
- Kusum Healthcare
- Auro Chemicals
Indian firms tend to focus on domestic needs and licit export markets; however, export regulations often restrict the movement of controlled substances like Brevitol Sodium.
Regulatory environment: The Drug Controller General of India (DCGI) enforces strict controls, with some manufacturers shifting away from production due to international regulatory pressure.
3. European Sources
European pharmaceutical companies have historically included:
- Baxter International (formerly involved in anesthetic production)
- Fresenius Kabi (known for anesthetic and intravenous drugs)
European suppliers often operate under stringent GMP standards, ensuring high quality but come with higher costs and limited availability. Due to ethical controversies surrounding its use in executions and regulatory restrictions, European companies have largely ceased production or export.
4. U.S. Market
The U.S. FDA has severely restricted the use and import of sodium thiopental due to legal and ethical issues linked to capital punishment. Although some specialty pharmacies or compounding pharmacies could hold limited stock, official manufacturing and authorized suppliers are virtually nonexistent in the U.S. today.
Market Dynamics and Challenges
Supply Chain Disruptions
The supply of Brevitol Sodium has faced significant disruptions, especially following the 2010s crackdown on the export of controlled substances by Chinese authorities and the U.S. declining toward domestic production. This has led to shortages in hospitals and research institutions worldwide.
Regulatory Restrictions
The Drug Enforcement Administration (DEA) classifies sodium thiopental as a Schedule III controlled substance in the U.S., necessitating strict licensing and reporting protocols for import and distribution. Similar controls exist across Europe and in Asian markets, further constraining supply channels.
Controversial Use and Ethical Debates
The drug’s use in lethal injections has led to bans and restrictions in multiple jurisdictions, prompting many manufacturers to cease production. Consequently, legal and ethical debates affect ongoing availability and supply chain stability.
Emerging Alternatives
Advances in anesthetic agents, such as propofol and etomidate, have reduced the reliance on sodium thiopental, diminishing market demand and influencing supplier focus.
Emerging Trends and Future Outlook
- Shift toward licensed, GMP-certified manufacturing in regulated jurisdictions is expected to continue, reducing smuggling and black-market activity.
- Potential resumption of licensed production in jurisdictions with evolving regulatory views may address shortages.
- Increased scrutiny on export controls could limit supply availability unless manufacturers obtain government licenses.
- Development of alternatives for anesthetic and execution purposes will further decrease reliance on Brevitol Sodium.
Key Takeaways
- The global supply of Brevitol Sodium is limited and heavily regulated, with primary manufacturing in China, India, and Europe.
- Regulatory restrictions and ethical debates have significantly impacted the availability and production of sodium thiopental.
- Current supplies are primarily sourced from a few authorized manufacturers, which increases supply chain vulnerability.
- The declining demand in medical and legal contexts, coupled with emerging alternatives, could further diminish supply opportunities.
- Stakeholders should monitor evolving regulatory policies and geopolitical factors influencing manufacturing licenses and export permissions.
FAQs
1. Who are the main suppliers of Brevitol Sodium today?
Main suppliers historically include Chinese manufacturers like North China Pharmaceutical and Indian firms such as Sun Pharmaceuticals, but current active licenses and exports are limited due to regulatory restrictions.
2. Why has the supply of Brevitol Sodium declined?
Supply decline stems from strict regulatory controls, ethical considerations related to its use in executions, and manufacturers' decisions to cease production amid legal pressures.
3. Can hospitals procure Brevitol Sodium legally?
Procurement is highly restricted. In most countries, it is only available through licensed suppliers for specific medical purposes, with many jurisdictions banning or severely limiting its use.
4. Are there alternatives to Brevitol Sodium?
Yes, alternative anesthetic agents like propofol and etomidate are increasingly used due to regulatory and ethical concerns surrounding sodium thiopental.
5. Will Brevitol Sodium re-enter the market?
Its future depends on regulatory decisions, ethical debates, and the development of alternative drugs. Currently, its market presence remains limited.
Sources
- [1] U.S. Drug Enforcement Administration (DEA) Controlled Substances List.
- [2] International Journal of Pharmacology and Toxicology.
- [3] Regulatory updates from Chinese and Indian pharmaceutical authorities.
- [4] European Medicines Agency reports on anesthetic drug regulations.
- [5] Industry analyses on pharmaceutical supply chain disruptions.
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