Suppliers and packagers for BREVITAL SODIUM

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	Par Health USA, LLC	42023-105-01	1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	2007-11-01

BREVITAL SODIUM: PRIMARY ACTIVE PHARMACEUTICAL INGREDIENT (API) AND EXCIPIENT SUPPLIER LANDSCAPE

Last updated: February 19, 2026

This report analyzes the global supplier landscape for Brevital Sodium, specifically focusing on active pharmaceutical ingredient (API) and key excipient suppliers. Brevital Sodium, the brand name for methohexital sodium, is an ultra-short-acting barbiturate used intravenously for anesthesia induction and maintenance. The supply chain is concentrated, with a limited number of manufacturers holding critical patents and regulatory approvals.

WHO ARE THE PRIMARY API MANUFACTURERS FOR BREVITAL SODIUM?

The manufacturing of methohexital sodium API is a specialized process with stringent quality control requirements. Historically, a few key players have dominated this market.

• Sanofi-Aventis: While Sanofi no longer manufactures Brevital Sodium under its brand name, it was a primary supplier for a significant period. Its role in the past highlights the concentration of API production. The discontinuation of its branded product in various markets due to economic or strategic reasons influenced the subsequent supplier landscape.
• Baxter International: Baxter has been a significant distributor and marketer of methohexital sodium formulations. While Baxter primarily sources the API from third-party manufacturers for its finished dosage forms, its involvement signifies a key node in the supply chain.
• Generic API Manufacturers: The current primary source of methohexital sodium API is from specialized generic API manufacturers. These companies often operate with a focus on niche or older drug classes, adhering to Good Manufacturing Practices (GMP). Specific company names are not always publicly disclosed due to proprietary manufacturing agreements, but regions with strong generic API production, such as India and China, are likely sources.

The regulatory pathway for API manufacturers includes obtaining Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP) or Drug Master Files (DMF) with the U.S. Food and Drug Administration (FDA). These dossiers detail the manufacturing process, quality control measures, and impurity profiles, ensuring compliance with international pharmacopoeial standards.

WHAT ARE THE CRITICAL EXCIPIENTS USED IN BREVITAL SODIUM FORMULATIONS?

Brevital Sodium is typically supplied as a sterile, lyophilized powder for reconstitution. The formulation requires specific excipients to ensure stability, solubility, and sterility upon reconstitution.

• Sodium Hydroxide: Used for pH adjustment during the manufacturing process to ensure the stability of the methohexital sodium salt.
• Diluents/Bulking Agents: For lyophilized products, bulking agents are crucial to form a stable cake structure. Mannitol is a common choice.
• Stabilizers: Although methohexital sodium is relatively stable, stabilizers may be incorporated to prevent degradation during storage, particularly in the lyophilized form.
• Sterile Water for Injection (WFI): Used as the vehicle for reconstitution.

The sourcing of these excipients is subject to pharmacopoeial standards (e.g., United States Pharmacopeia (USP), European Pharmacopoeia (EP)). Manufacturers must demonstrate the quality and consistency of excipients through supplier qualification programs and incoming material testing.

WHAT ARE THE KEY REGULATORY CONSIDERATIONS FOR BREVITAL SODIUM SUPPLY?

The supply of Brevital Sodium is subject to rigorous regulatory oversight due to its controlled substance status and use in critical care settings.

• Controlled Substance Classification: Methohexital is a Schedule IV controlled substance in the United States under the Controlled Substances Act. This classification imposes strict regulations on its manufacturing, distribution, and handling, including quotas, record-keeping, and security requirements managed by the Drug Enforcement Administration (DEA).
• FDA and EMA Approvals: Manufacturers of finished dosage forms and API suppliers must adhere to current Good Manufacturing Practices (cGMP) as enforced by regulatory bodies like the FDA in the U.S. and the European Medicines Agency (EMA) in Europe. This includes facility inspections, process validation, and robust quality management systems.
• Pharmacopoeial Standards: The API and finished product must meet the specifications outlined in relevant pharmacopoeias, such as the USP and EP. These monographs define identity, purity, potency, and other critical quality attributes.
• Patent Landscape: While the primary composition of matter patents for methohexital sodium have long expired, patents related to specific manufacturing processes, purification methods, or novel formulations could still influence market dynamics. A thorough patent landscape analysis is essential for new market entrants or those seeking to optimize production. For instance, patents concerning improved stability or methods for reducing impurities in the lyophilized product would be of significant interest.

WHICH GEOGRAPHICAL REGIONS ARE DOMINANT IN BREVITAL SODIUM API PRODUCTION?

The production of methohexital sodium API is concentrated in regions known for their established pharmaceutical manufacturing infrastructure and expertise in synthesizing complex organic molecules.

• India: India is a leading global hub for generic API manufacturing. Indian companies possess strong capabilities in chemical synthesis, process optimization, and adherence to international regulatory standards. Several Indian API manufacturers are likely to produce methohexital sodium, catering to global demand.
• China: Similar to India, China has a substantial API manufacturing sector. Chinese chemical manufacturers are often competitive on cost and possess the technical expertise to produce a wide range of APIs, including methohexital sodium.
• Europe: Some European countries, particularly those with a long history of pharmaceutical manufacturing, may also have niche manufacturers producing methohexital sodium API. These facilities often focus on high-value, complex APIs and adhere to stringent EU regulatory requirements.

The choice of geographical region for API sourcing is influenced by factors including cost of production, regulatory compliance, supply chain reliability, and intellectual property considerations.

WHAT ARE THE SUPPLY CHAIN RISKS ASSOCIATED WITH BREVITAL SODIUM?

The concentrated nature of Brevital Sodium API manufacturing presents specific supply chain risks.

• Limited Number of Suppliers: A reliance on a small number of API manufacturers can lead to vulnerabilities. Any disruption at a primary supplier's facility, whether due to regulatory issues, natural disasters, or geopolitical events, can have a significant impact on global availability.
• Regulatory Hurdles: Changes in GMP requirements or enforcement actions by regulatory agencies (e.g., FDA warning letters) at an API manufacturing site can immediately halt production and disrupt supply chains. The controlled substance classification adds an additional layer of regulatory complexity.
• Geopolitical Instability: Dependence on APIs sourced from specific regions makes the supply chain susceptible to geopolitical tensions, trade disputes, or export restrictions.
• Quality Control Failures: Any lapse in quality control at the API manufacturing level can lead to product recalls or batch rejections, causing significant supply shortages and impacting patient care.
• Economic Factors: The profitability of manufacturing older, niche drugs like methohexital sodium can be low, potentially leading manufacturers to discontinue production if market conditions become unfavorable, further reducing the supplier pool.

HOW CAN COMPANIES MITIGATE BREVITAL SODIUM SUPPLY CHAIN RISKS?

Mitigation strategies are crucial for ensuring the continuous availability of Brevital Sodium for healthcare providers.

• Supplier Diversification: Identifying and qualifying secondary or tertiary API suppliers, even if they represent a smaller portion of the overall supply, can provide redundancy. This requires significant investment in audits and quality agreements.
• Strategic Stockpiling: Maintaining adequate safety stock of both API and finished product can buffer against short-term supply disruptions. The optimal level requires a balance between inventory costs and risk.
• Robust Quality Agreements: Implementing comprehensive quality agreements with suppliers that clearly define responsibilities, audit rights, and change control procedures is essential.
• Supply Chain Visibility: Enhancing transparency throughout the supply chain, from raw material suppliers to the finished product, allows for early detection of potential issues.
• Regulatory Intelligence: Proactively monitoring regulatory updates and enforcement actions in key manufacturing regions can help anticipate and address potential compliance challenges.
• Long-Term Contracts: Negotiating long-term supply agreements can provide greater price stability and commitment from API manufacturers.

KEY TAKEAWAYS

• The Brevital Sodium API supply chain is concentrated, with a limited number of specialized manufacturers, primarily in India and China.
• Key excipients include pH adjusters like sodium hydroxide and bulking agents such as mannitol, sourced according to pharmacopoeial standards.
• Regulatory oversight is stringent due to methohexital sodium's controlled substance status (Schedule IV in the US) and cGMP requirements enforced by the FDA and EMA.
• Supply chain risks include reliance on few suppliers, regulatory changes, geopolitical instability, and quality control failures.
• Mitigation strategies involve supplier diversification, strategic stockpiling, robust quality agreements, and enhanced supply chain visibility.

FREQUENTLY ASKED QUESTIONS

1. Are there any patents currently protecting specific manufacturing processes for methohexital sodium API? While core patents for methohexital sodium have expired, patents related to novel synthesis routes, purification techniques, or methods to improve the stability of lyophilized formulations may still exist and influence production optimization.
2. What is the typical shelf life for a lyophilized Brevital Sodium product? The shelf life for lyophilized Brevital Sodium typically ranges from 2 to 3 years when stored under recommended conditions (e.g., controlled room temperature, protected from light).
3. How does the DEA's quota system impact the availability of methohexital sodium in the United States? The DEA sets annual quotas for Schedule IV substances to limit the total amount that can be manufactured and imported. These quotas can directly influence the availability of methohexital sodium for legitimate medical use.
4. What are the primary impurities that manufacturers must control in methohexital sodium API? Common impurities to control include related substances from the synthesis pathway (e.g., precursors, by-products) and degradation products. Specific impurity limits are defined by pharmacopoeial monographs.
5. Can finished dosage form manufacturers source methohexital sodium API from multiple suppliers simultaneously? Yes, finished dosage form manufacturers often qualify and utilize multiple API suppliers to ensure supply chain resilience, provided each supplier meets all regulatory and quality requirements.

CITATIONS

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry on Drug Master Files. Retrieved from [FDA website] (Note: Specific URL would be provided if publicly accessible and stable). [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability to the monographs of the European Pharmacopoeia (CEP). Retrieved from [EDQM website] (Note: Specific URL would be provided if publicly accessible and stable). [3] U.S. Drug Enforcement Administration. (n.d.). Schedules of Controlled Substances. Retrieved from [DEA website] (Note: Specific URL would be provided if publicly accessible and stable). [4] United States Pharmacopeial Convention. (n.d.). Methohexital Sodium. In United States Pharmacopeia and The National Formulary. (Note: Specific chapter/monograph reference is typically required for precise citation). [5] European Pharmacopoeia. (n.d.). Methohexital Sodium. In European Pharmacopoeia. (Note: Specific chapter/monograph reference is typically required for precise citation).