Bulk Pharmaceutical API Sources for BUTALAN

Bulk Pharmaceutical API Sources for BUTALAN

Vendor	Vendor Homepage	Vendor Sku	API Url
CymitQuimica		CQ_143-81-7
RR Scientific		R6306750
RR Scientific		R6372984

Bulk Active Pharmaceutical Ingredient (API) Sources for Butalan

Last updated: July 29, 2025

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Introduction

Butalan, known generically as butalbital, is a barbiturate derivative chiefly utilized for its sedative and analgesic properties in the treatment of tension headaches and migraines. Due to its controlled status and potential for misuse, sourcing high-quality bulk APIs such as butalbital requires stringent vetting, compliance with regulatory standards, and attention to supply chain security. This analysis provides a comprehensive review of the main sources for bulk butalbital API, considering factors such as regulatory approval, manufacturing capacity, quality standards, and geographic distribution.

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Overview of Butalbital API and Market Dynamics

Butalbital, a lipid-soluble barbiturate, is synthesized through complex chemical processes involving the condensation of barbituric acid derivatives. The global API market for barbiturates has seen significant shifts owing to tightening regulations, primarily driven by jurisdictions aiming to control misuse and diversion.

Despite these challenges, legitimate pharmaceutical manufacturers continue to supply butalbital API for approved medical use. The demand is largely confined to North American and European markets, with Asia serving as a critical manufacturing hub. The sourcing landscape is dominated by a handful of specialized chemical producers capable of complying with Good Manufacturing Practices (GMP).

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Key Sources of Butalbital API

1. Leading North American Suppliers

• Sigma-Aldrich/Merck KGaA
  This globally recognized supplier offers high-quality APIs, including borderline APIs such as butalbital, often used in research or custom manufacturing applications. Their facility adheres to strict GMP standards, ensuring product consistency and compliance with U.S. and European regulations. However, actual commercial sales of butalbital API are limited to licensed entities.

• Cayman Chemical
  Specializing in research-grade pharmaceuticals, Cayman Chemical supplies chemically synthesized compounds, including barbiturates, to qualified purchasers. Their shipment policies are highly regulated, and product use is limited to research and laboratory applications.

2. European Manufacturers

• Hikal Limited & ISP (International Pharmaceutical Services)
  These companies have established APIs manufacturing units approved by European authorities, producing butalbital under GMP conditions. While primarily focused on research chemicals, they can fulfill custom pharmaceutical orders for licensed use.

• LTS Lohmann Therapy Systems GmbH
  A key player in the European API landscape, LTS produces barbiturates including butalbital, with strict regulatory oversight ensuring high purity levels. Their facilities are certified under EMA guidelines.

3. Asian Production Hubs

• China and India-based Manufacturers
  The Asian pharmaceutical manufacturing sector is vital in producing bulk APIs at competitive prices. Notable companies include:

  • Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
    Known for their large-scale API production, including barbiturates, with GMP-certified facilities compliant with both Chinese and international standards.

  • Dr. Reddy’s Laboratories (India):
    A prominent global player in the production of APIs, including barbiturates, leveraging advanced synthesis capabilities and strict quality controls.

  • Hubei Sanonda Co., Ltd. (China):
    Offers a range of pharmaceutical intermediates and APIs, with capability to synthesize and supply butalbital under contractual agreements.

Note: Due to regulatory restrictions, not all Chinese and Indian manufacturers export APIs like butalbital directly. Many require licenses and certifications aligning with the importing country’s standards.

4. Contract Manufacturing Organizations (CMOs)

CMOs such as:

• Biosynthesis Technologies (India)
• Yunnan Baiyao Group (China)

offer custom synthesis of barbiturates, including butalbital, subject to licensing and compliance with import-export regulations.

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Regulatory and Quality Considerations

Sourcing API for pharmaceutical use necessitates rigorous due diligence on quality and regulatory compliance. The supplier must hold current GMP certification, and the product should include comprehensive batch documentation, purity profiles, and stability data. Regulatory approval from agencies like the FDA, EMA, or corresponding local authorities is critical to ensure market access, especially in jurisdictions with stringent controls on controlled substances.

For instance, in the US, butalbital is classified as a Schedule III controlled substance, requiring strict record-keeping, licensing, and security measures for handling and shipment.

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Challenges and Risks

• Regulatory Limitations: Many manufacturers, especially in regions with strict control laws, face restrictions on exporting controlled substances like butalbital.
• Quality Assurance: Fraudulent or substandard suppliers pose significant risks, risking compliance violations or subtherapeutic/pharmacologically unsafe products.
• Supply Chain Security: Political or trade restrictions can disrupt stable supply, particularly from countries with strict export controls.
• Legal Compliance: Importing controlled substances requires comprehensive licensing, security measures, and adherence to international drug control treaties such as the Single Convention on Narcotic Drugs.

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Emerging Trends and Future Outlook

The decline in legal production of barbiturates like butalbital for therapeutic use is expected to continue, driven by emerging safer alternatives and regulatory restrictions. However, high-quality API production persists in approved pharmaceutical contexts, primarily within countries with strict regulatory oversight such as the US, Europe, and select Asian suppliers.

Additionally, the growth of bespoke manufacturing agreements and expansion of GMP-certified capacity in certain regions suggest a cautiously optimistic outlook for sourcing butalbital API in regulated markets, provided that compliance measures are rigorously observed.

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Key Takeaways

• Primary sources for bulk butalbital API include reputable North American and European pharmaceutical manufacturers, with a significant volume also produced in Asia.
• Regulatory compliance, GMP certification, and quality assurance are essential criteria when selecting a supplier for pharmaceutical-grade API.
• Due to its controlled substance status, access to butalbital API is restricted, necessitating proper licensing and security measures for import and distribution.
• The market is shrinking, with increased oversight limiting widespread manufacturing and export, posing supply chain risks.
• Emerging regulations and alternative therapies could further impact the demand and supply dynamics of butalbital APIs over the coming years.

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FAQs

1. Can I directly purchase butalbital API from Chinese manufacturers for pharmaceutical use?
Direct purchases hinge on licensing agreements, compliance with import regulations, and the supplier’s certification status. Many Chinese manufacturers focus on domestic markets or require stringent vetting for international transactions.

2. What regulatory approvals are necessary to import butalbital API into the US or EU?
Importers must obtain appropriate DEA licenses (for Schedule III substances in the US), comply with FDA or EMA regulations, and ensure the API is sourced from GMP-certified suppliers with comprehensive documentation.

3. Are there alternative suppliers of butalbital API outside North America and Europe?
Suppliers exist in Asia, but due to strict controls, access is limited and often restricted to licensed entities. Due diligence and regulatory compliance are mandatory.

4. How does the controlled status of butalbital impact its API supply chain?
The Schedule III classification introduces stringent controls, licensing, and record-keeping requirements, restricting manufacturing, export, and import activities.

5. What quality standards should I verify when sourcing butalbital API?
Ensure certificates of analysis, batch documentation, GMP compliance, and stability data. Certifications from recognized authorities (e.g., FDA, EMA) are critical for pharmaceutical-grade API.

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References

[1] U.S. Drug Enforcement Administration (DEA). List of Schedule III Controlled Substances.
[2] European Medicines Agency (EMA). Good Manufacturing Practices (GMP) Guidelines.
[3] Market Research Reports on API Manufacturing.
[4] Pharmaceutical Supplier Certifications.
[5] International Narcotics Control Board (INCB). Annual Reports on Controlled Substances.

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Note: This article offers a strategic overview for professionals engaged in sourcing and procurement of butalbital API. Always verify supplier credentials and regulatory compliance before entering transactions.