Bulk Pharmaceutical API Sources for BUTABARBITAL SODIUM

Bulk Pharmaceutical API Sources for BUTABARBITAL SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2479
NovoSeek		19872452
NovoSeek		23690439

Bulk Active Pharmaceutical Ingredient (API) Sources for Butabarbital Sodium

Last updated: July 28, 2025

Introduction

Butabarbital sodium, a barbiturate derivative primarily used for preoperative sedation and as an anti-anxiety agent, is classified under controlled substances due to its potential for abuse and dependency. Its manufacturing and supply chain involve highly regulated legal frameworks that impact sourcing strategies. The drug’s API procurement process demands rigorous quality assurance, compliance with Good Manufacturing Practices (GMP), and adherence to international and national drug control laws. This analysis provides comprehensive insight into current bulk API sources for butabarbital sodium, emphasizing key manufacturers, regional supply chains, procurement considerations, and compliance standards vital for pharmaceutical enterprises.

Regulatory Context and Market Overview

Given its classification under the Controlled Substances Act (CSA) in the United States and similar regulations globally, API sourcing for butabarbital sodium involves strict licensing and regulatory oversight. The production, import, export, and distribution are governed by agencies such as the Drug Enforcement Administration (DEA) in the US and corresponding authorities worldwide (e.g., EMA in Europe, NMPA in China). The limited number of licensed manufacturers results in a concentrated supply chain, often dominated by a handful of specialized pharmaceutical ingredient producers.

Major API Manufacturers and Suppliers for Butabarbital Sodium

1. Chinese Pharmaceutical Ingredient Manufacturers

China remains a prominent source for bulk APIs owing to the country’s extensive chemical manufacturing infrastructure and cost efficiencies. Several Chinese firms operate under stringent regulatory oversight, supplying APIs globally that meet international standards. Notable manufacturers include:

• Kanglong Chemical Co., Ltd.: Known for producing barbiturate APIs, including butabarbital sodium, with GMP certification aligned with international standards. Their products conform to United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) specifications, verified through independent testing.

• Zibo Shuangxin Chemical Industry Co., Ltd.: Offers bulk barbiturates, including butabarbital sodium, with a focus on compliance with ISO certifications and registering with regulatory agencies for export market acceptance.

• Jiangxi Cade Chemical Co., Ltd.: Provides API synthesis services for barbiturates, emphasizing quality control and purity, particularly suited for the pharmaceutical industry’s stringent requirements.

2. Indian API Manufacturers

India’s API sector has expanded significantly, supported by robust regulatory frameworks and a large base of generic formulators. Leading manufacturers include:

• Biocon Ltd.: Specializes in synthesis and manufacturing of APIs, with capabilities extending to controlled substances, including barbiturates, for domestic and export markets.

• Hetero Labs Limited: Known for producing high-quality APIs with adhering to WHO-GMP standards, its portfolio includes barbiturates like butabarbital sodium.

• Aurobindo Pharma Ltd.: Has manufacturing facilities conforming to global quality standards, producing a range of controlled substances, including barbiturates, that meet international requirements.

3. European and US-Based API Suppliers

Due to stringent regulatory requirements, few companies in Europe and the US produce butabarbital sodium strictly for pharmaceutical use. These are typically small-scale specialty manufacturers or custom synthesis companies:

• ABBVIE Inc.: Has historically engaged in the synthesis of barbiturate APIs. While primarily a pharmaceutical company, some licensing arrangements permit bulk API supply, mainly for specialty applications.

• MP Biomedicals GmbH (Germany): Supplies research-grade barbiturates, including butabarbital sodium, suitable for research and analytical purposes, not for large-scale pharmaceutical manufacturing.

Note: The strictly regulated nature and controlled substance classification mean that US and European API production is minimal and often involves licensed entities with strict compliance to DEA and EMA regulations.

Procurement and Quality Assurance Considerations

Procurement agencies seeking bulk API sources for butabarbital sodium must prioritize suppliers with:

• GMP compliance: Ensures the API meets pharmacopeial standards (USP, EP, JP), with validated manufacturing processes and rigorous analytical testing.

• Regulatory approvals: Licenses from local authorities and proof of compliance with national and international drug control regulations are prerequisites.

• Quality certifications: ISO 9001, ISO 14001, and other relevant certifications enhance sourcing confidence.

• Traceability & Transparency: Suppliers providing detailed Certificate of Analysis (CoA), stability data, and batch records bolster supply chain integrity.

Regional Supply Chain Dynamics

The sourcing landscape for butabarbital sodium API is influenced heavily by regional controls, intellectual property rights, and manufacturing capabilities:

• China dominates the market due to scale and cost advantages, but regulatory complexities and quality variability can pose risks. Effective due diligence and supplier audits mitigate these concerns.

• India offers a relatively stable supply chain, with a growing reputation for quality and compliance. Export logistics and licensing are critical factors in procurement.

• Europe and North America have limited direct API production, mainly relying on licensed imports from Asian manufacturers. Due to strict controls, these sources are often used for research or compounding rather than bulk manufacturing.

Supply Chain Challenges and Strategic Risk Management

The primary concerns with sourcing butabarbital sodium API include:

• Regulatory non-compliance: Non-adherence leads to legal sanctions, supply disruptions, and reputational damage.

• Quality variability: Ensuring consistent API purity and potency requires rigorous testing and supplier qualification programs.

• Supply disruptions: Political, logistical, or manufacturing issues can interrupt supply; diversification of suppliers limits risk exposure.

• Counterfeit or substandard products: Vigilant quality control, supplier audits, and provenance verification are necessary to mitigate counterfeit risks.

Future Outlook and Industry Trends

The controlled status of butabarbital sodium suggests that API sourcing will remain tightly regulated, with supply chains likely to consolidate around trusted manufacturers. The shift towards transparency, digital sourcing platforms, and global compliance standards enhances reliability. Increasing regulatory scrutiny, especially concerning controlled substances, could limit new market entrants, reinforcing the importance of strategic supplier relationships with compliant manufacturers.

Technological advancements in synthesis methods and quality control may facilitate more efficient and compliant production processes, potentially broadening legitimate manufacturing sources. Nevertheless, geopolitical developments and trade policies will continue to shape the sourcing landscape.

Key Takeaways

• Manufacturers in China and India dominate the API supply chain for butabarbital sodium, offering cost advantages but necessitating thorough due diligence.

• Regulatory compliance (GMP, DEA licensing, Certificates of Analysis) is non-negotiable in API procurement, especially for controlled substances.

• Quality assurance remains paramount, with suppliers required to provide comprehensive documentation, testing data, and traceability.

• Supply chain diversification mitigates risks associated with regulatory changes, geopolitical tensions, or manufacturing disruptions.

• Future supply landscape hinges on stricter controls, technological advancements, and evolving industry standards, influencing procurement strategies.

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FAQs

1. Is butabarbital sodium available from multiple API suppliers globally?
Due to its status as a controlled substance, supply is limited to a select group of licensed manufacturers, primarily in China and India. Availability from multiple suppliers requires strict regulatory compliance and thorough validation.

2. What are the main regulatory hurdles in sourcing butabarbital sodium API?
Sourcing must comply with drug control laws, including licensing, import/export permits, and adherence to GMP standards. Regulatory authorities rigorously oversee manufacturing and distribution, making due diligence essential.

3. How can buyers ensure the quality of butabarbital sodium API?
Verify supplier certifications, review Certificates of Analysis, conduct audits or inspections, and establish quality agreements. Ensuring APIs meet pharmacopeial standards is critical.

4. Are there alternatives to sourcing API from China or India?
European and North American sources are limited and generally restricted to research-grade APIs. Licensing agreements with these suppliers are possible but less common and more costly.

5. What emerging trends could influence the API sourcing for butabarbital sodium?
Enhanced regulatory oversight, technological innovations in synthesis, and global compliance standards are likely to impact supply chains, emphasizing quality, transparency, and security.

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References:

[1] U.S. Drug Enforcement Administration. Controlled Substances Act Regulations.
[2] European Medicines Agency. Guidelines for Controlled Substances Manufacturing.
[3] Industry Reports on API Market Dynamics, 2022.
[4] WHO Technical Report Series. Quality Standards for Pharmaceutical APIs.
[5] International Pharmaceutical Regulators Forum. Best Practices in API Licensing and Supply Chain Management.