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Bulk Pharmaceutical API Sources for BUTISOL SODIUM
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Bulk Pharmaceutical API Sources for BUTISOL SODIUM
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| NovoSeek | ⤷ Get Started Free | 19872452 | ⤷ Get Started Free |
| NovoSeek | ⤷ Get Started Free | 23690439 | ⤷ Get Started Free |
| AAA Chemistry | ⤷ Get Started Free | AR-1I1114 | ⤷ Get Started Free |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for: BUTISOL SODIUM
Introduction
Butisol Sodium, also known as secobarbital sodium, is a barbiturate sedative and hypnotic used historically for anesthesia, sedation, and sleep induction. Despite its declining clinical use, it remains a relevant compound in specific pharmaceutical and research contexts. The sourcing of bulk active pharmaceutical ingredients (APIs) such as Butisol Sodium is critical for pharmaceutical manufacturers, researchers, and compounding entities. This article evaluates the global suppliers of Butisol Sodium API, highlighting sourcing trends, key manufacturers, and factors influencing supply chain decisions.
Understanding Butisol Sodium API
Butisol Sodium (secobarbital sodium) is a barbiturate derivative with sedative, hypnotic, anticonvulsant, and anesthetic properties. Its chemical formula is C12H17N2NaO3, with a molecular weight of approximately 242.27 g/mol (United States Pharmacopeia - USP). It functions primarily by enhancing GABAergic inhibitory effects in the central nervous system.
Historically, Butisol Sodium was widely used in the United States until safety concerns and the development of alternative agents led to decreased prescribing. Nonetheless, its manufacturing persists, primarily through specialized bulk API producers catering to compounding pharmacies or research facilities.
Global API Manufacturing Landscape
The API manufacturing market involves a complex web of chemical synthesis, regulatory compliance, and quality assurance. For controlled substances like secobarbital sodium, manufacturers require appropriate licenses, strict Good Manufacturing Practice (GMP) compliance, and regulatory approvals in target markets. The key sources for Butisol Sodium API are concentrated in a few regions, primarily China, India, and certain European countries, due to their pharma manufacturing infrastructure.
Major API Suppliers of Butisol Sodium
1. Chinese API Manufacturers
China remains the dominant producer of numerous APIs, including controlled substances like secobarbital sodium. Chinese firms leverage advanced chemical synthesis capabilities, often offering competitive pricing and large production capacities. Notable Chinese API manufacturers include:
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Zhangjiagang Lian Pharmaceutical Co., Ltd.
Specializes in controlled substance APIs, including various barbiturates, with adherence to GMP standards. They supply bulk secobarbital sodium to international markets, primarily to API intermediaries and research entities. -
Qingdao Yiqing Pharmaceutical Co., Ltd.
Known for producing an array of sedative and hypnotic APIs, including barbiturates, operating under strict regulatory compliance with export licenses for controlled substances.
2. Indian API Manufacturers
India’s API sector has expanded to include controlled substances, with companies maintaining robust GMP certifications:
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Sun Pharmaceutical Industries Ltd. (via subsidiary or contract manufacturers)
While primarily a pharmaceutical producer, Sun Pharmaceutical has engaged in API manufacturing, including sedatives like secobarbital, for both domestic and export markets through licensed channels. -
Granules India Ltd.
Offers APIs across a broad spectrum, including controlled substances, with stringent quality controls suitable for research and API intermediates. -
Hetero Labs Ltd.
Known for manufacturing various APIs, including sedatives, with export licenses for controlled substances to compliant markets.
3. European and North American Sources
Due to regulatory constraints, few European or North American manufacturers produce secobarbital sodium API. However, some specialized chemical suppliers in Europe may offer intermediates or import via licensing agreements:
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Sigma-Aldrich / MilliporeSigma (Merck) (historical suppliers)
Historically supplied research-grade secobarbital, but current availability of bulk APIs is limited due to regulatory constraints. -
Contract manufacturing organizations (CMOs) in North America may produce secobarbital sodium on a custom basis, contingent on strict licensing and GMP compliance.
Factors Influencing API Sourcing
Regulatory Compliance:
Controlled substances like secobarbital sodium require strict licensing, DEA registration (in the US), and compliance under international regulations (e.g., EU, WHO). This limits supplier options to licensed entities.
Quality Standards:
Manufacturers must adhere to USP, European Pharmacopoeia (Ph. Eur.), or other regional pharmacopeias’ standards. Quality assurance processes, including impurity profiling and stability testing, are critical.
Pricing and Lead Times:
Chinese manufacturers often provide competitive pricing and flexible lead times. Indian suppliers balance cost with quality certifications and regulatory compliance.
Supply Chain Security:
Given the regulatory sensitivity, sourcing from established, reputable suppliers reduces legal and safety risks, especially for controlled substances.
Emerging Trends and Challenges
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Regulatory tightening:
Stricter international controls on controlled substances have decreased the number of authorized suppliers, increasing reliance on a few compliant producers. -
Manufacturing restrictions:
Some manufacturers have scaled back controlled substance APIs production due to compliance costs or regulatory scrutiny, leading to potential supply disruptions. -
Research and compounding needs:
Many entities turn to chemical trading firms or chemical suppliers that offer non-regulated intermediates or research grades, albeit with limitations for pharmaceutical production.
Conclusion
The primary bulk suppliers of Butisol Sodium API today are predominantly Chinese and Indian companies operating within tightly regulated frameworks. The scarcity of North American or European APIs is due to stringent controlled substances laws and manufacturing complexities. Companies sourcing Butisol Sodium API should prioritize suppliers with verified GMP compliance, proper licensing, and robust quality assurance programs to mitigate regulatory and operational risks.
Key Takeaways
- The global supply of Butisol Sodium API is concentrated mainly in China and India, with few regional players due to regulatory constraints on controlled substances.
- Licensed API manufacturers offering high-quality secobarbital sodium are critical for compliance and safety, especially in pharmaceutical manufacturing.
- Supply chain stability depends on regulatory adherence, licensing, and quality assurances — due diligence is paramount.
- Market shifts, regulatory policies, and manufacturing costs influence API availability and pricing.
- Collaboration with reputable, licensed suppliers reduces legal risks and ensures API integrity for specialized applications.
FAQs
1. Is Butisol Sodium API readily available in the global market?
Availability is limited due to strict regulations governing controlled substances, with most supply originating from licensed Chinese and Indian manufacturers.
2. What should I consider when sourcing Butisol Sodium API?
Verify GMP compliance, regulatory licensing, supplier reputation, purity standards, and supply chain transparency.
3. Are there alternative suppliers outside China and India?
Limited availability exists from European or North American firms, typically through specialized CMOs, but licensing and legal restrictions apply.
4. How does regulatory change impact Butisol Sodium API supply?
Stricter controls can constrain or reduce production, leading to tighter supply and elevated costs.
5. Can research-grade Butisol Sodium be used for pharmaceutical development?
Research-grade APIs may be available from chemical suppliers, but pharmaceutical-grade API requires proper licensing and compliance, especially for controlled substances.
References
[1] United States Pharmacopeia (USP) – Butisol Sodium Monograph.
[2] Regulatory guidance on controlled substances manufacturing and licensing.
[3] Industry reports on API manufacturing trends in China and India.
[4] WHO guidelines on the production and quality standards of controlled substances.
[5] Chemical suppliers and licensing databases.
Note: This article emphasizes the importance of regulatory compliance and quality assurance in sourcing APIs for controlled substances. Business professionals are advised to conduct due diligence and consult regulatory authorities before engaging suppliers.
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