Bulk Pharmaceutical API Sources for CHLORDIAZACHEL

Bulk Pharmaceutical API Sources for CHLORDIAZACHEL

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS015895152
Sigma-Aldrich		1110009_USP
Sigma-Aldrich		C1500000_SIAL
Sigma-Aldrich		C4782_SIGMA
LGC Standards		MM0028.00
Alfa Chemistry		438-41-5

Bulk Active Pharmaceutical Ingredient (API) Sources for Chlorodiazepam: An In-depth Overview

Last updated: July 29, 2025

Introduction

Chlorodiazepam, also known as Landax or Ro-5-4221, is a benzodiazepine derivative historically utilized for its sedative, anxiolytic, and anticonvulsant properties. Though less prevalent in contemporary medical practice, its pharmacological profile remains relevant in research contexts and specialized medicinal formulations. Ensuring reliable, high-quality bulk APIs represents a critical aspect of pharmaceutical manufacturing and research. This report provides a comprehensive overview of global sources for bulk Chlorodiazepam API, highlighting key suppliers, regulatory considerations, sourcing strategies, and quality assurance practices.

Pharmaceutical API Market Landscape

The active pharmaceutical ingredient market has experienced considerable growth driven by expanding therapeutic indications, increasing manufacturing capacities, and stringent quality standards. Chlorodiazepam, despite its niche status, is produced by a subset of specialized manufacturers often operating within regulated frameworks such as the United States, European Union, and other jurisdictions adhering to Good Manufacturing Practices (GMP).

Key factors influencing sourcing decisions include:

• Regulatory Compliance: Suppliers must possess relevant certifications, such as FDA approval or EMA validation.
• Quality Standards: Certificates of Analysis (CoA), batch consistency, and impurity profiles are non-negotiable.
• Supply Chain Reliability: Geographic diversification mitigates risks associated with geopolitical instability or supply disruptions.
• Pricing and Lead Time: Competitive pricing balanced with minimum order quantities and delivery lead times.

Global Sources for Chlorodiazepam API

1. Established Manufacturers in the United States

While the U.S. pharmaceutical market is highly regulated, domestic manufacturers specializing in benzodiazepines like Chlorodiazepam operate under strict GMP conditions.

• Sigma-Aldrich (now part of Merck Group): Historically supplies research-grade APIs, including benzodiazepines, under rigorous QC standards. Their focus remains on research quantities rather than bulk commercial quantities.
• LKT Laboratories: Based in Minnesota, LKT produces APIs for research and specialty medicinal use. Their portfolio includes various benzodiazepine derivatives, with capabilities to customize synthesis routes pending customer requirements.
• Piramal Enterprises: Offers custom synthesis services with GMP compliance, capable of producing niche APIs like chlorodiazepam for research or clinical development.

Note: Many U.S.-based suppliers cater primarily to research institutions and pharmaceutical companies on a contract basis, with limited stock availability for bulk commercial purchase.

2. European API Suppliers

Europe hosts numerous high-quality API manufacturers with a reputation for adherence to GMP norms:

• Evonik Industries (Germany): Provides specialty chemicals and APIs, including benzodiazepine derivatives, with robust quality assurance programs.
• BASF SE (Germany): Offers custom synthesis solutions, often focusing on intermediates and APIs with strict regulatory and quality standards.
• SYNTHRIA BIOCHEMICALS (UK): Specializes in custom API synthesis, and supplies to pharmaceutical and research sectors, maintaining compliance with EMA regulations.

Many European suppliers also facilitate export to global markets, often under comprehensive licensing agreements.

3. Indian API Manufacturing Sector

India maintains a significant presence in bulk API manufacturing, characterized by cost competitiveness and flexible production capabilities:

• Sun Pharmaceutical Industries Ltd.: Offers a broad portfolio of APIs, including benzodiazepines, with certified manufacturing facilities compliant with international standards.
• Dr. Reddy's Laboratories: Known for high-quality APIs and custom synthesis, with exported product certifications.
• Aurobindo Pharma: Provides bulk APIs for research and commercial uses, with extensive GMP facilities.

Importantly, Indian suppliers primarily cater to the global pharmaceutical industry, with a robust export infrastructure and compliance with USFDA and EMA standards.

4. Chinese API Vendors

China remains a pivotal player in the global API supply chain, offering competitive pricing and scalable manufacturing:

• North China Pharmaceutical Group (NCPC): Produces various benzodiazepine APIs, with a focus on bulk export.
• Shandong Xinhua Pharmaceutical Co.: Commercializes benzodiazepine derivatives, including for research purposes.
• Zhejiang NHU Co., Ltd.: Manufactures APIs across multiple therapeutic classes, with significant capacity for custom synthesis in benzodiazepines.

Regulatory considerations are critical with Chinese suppliers; buyers should verify GMP certification, comprehensive testing, and legal export licenses.

5. Specialized API Contract Manufacturers

Various contract manufacturing organizations (CMOs) worldwide offer bespoke synthesis of Chlorodiazepam, tailored to specific purity and quantity requirements:

• Carbogen Amcis (Switzerland): Focuses on complex chemical syntheses and high-value APIs.
• Chemcon Speciality Chemicals (India): Provides regulatory-compliant synthesis options.
• Amoris Pharmaceutical: Offers custom API synthesis with extensive QC testing for niche benzodiazepine derivatives.

Engaging with CMOs allows flexible production scales, ongoing quality assurance, and adherence to specific regulatory or safety standards.

Quality Assurance & Regulatory Considerations

Sourcing bulk Chlorodiazepam API demands rigorous validation of supplier credentials:

• GMP Certification: Ensure adherence to applicable regulatory standards (FDA, EMA, others).
• Certificate of Analysis (CoA): Review comprehensive batch-specific testing data covering potency, chemical purity, residual solvents, heavy metals, and microbial contamination.
• Impurity Profile: Confirm acceptable limits per pharmacopeial guidelines, with detailed analysis of potential toxic impurities.
• Documentation & Traceability: Maintain robust documentation for regulatory audits, batch tracking, and quality management.

Importantly, Chlorodiazepam's legal status varies across jurisdictions; buyers must verify licensing, import/export permissions, and compliance with controlled substance regulations.

Sourcing Strategy & Risk Management

Given the complex landscape, a strategic approach includes:

• Establishing relationships with multiple verified suppliers across regions to mitigate supply risks.
• Conducting site audits or reviewing third-party audit reports for supplier facilities.
• Implementing rigorous testing protocols for incoming raw materials.
• Ensuring supply chain transparency and compliance documentation.

Sourcing from reputable, established suppliers aligned with international standards ensures supply continuity and minimizes regulatory exposure.

Conclusion

While Chlorodiazepam is a specialized API with limited proliferation, multiple credible sources exist globally—particularly in the United States, Europe, India, and China. Pharmaceutical companies and research institutions seeking bulk API should prioritize suppliers with validated GMP compliance, transparent quality assurance processes, and reliable supply chains. Strategic sourcing involving multiple jurisdictions enhances security, cost-efficiency, and regulatory compliance.

Key Takeaways

• The global API supply landscape for Chlorodiazepam includes established Western manufacturers and sizable Asian producers.
• Rigorous supplier qualification—covering GMP compliance, comprehensive testing, and regulatory adherence—is essential.
• Contract manufacturing organizations provide flexible, customized synthesis options tailored to specific quality and quantity needs.
• Due diligence, including site audits and review of certification documents, mitigates supply and regulatory risks.
• Navigating the legal and regulatory framework of API import/export is critical, especially for controlled substances.

FAQs

Q1: Is Chlorodiazepam widely available from major pharmaceutical suppliers?
A1: No, Chlorodiazepam is a niche API mainly available through specialized manufacturers or contract synthesis providers; it is not broadly distributed like common benzodiazepines.

Q2: What regulatory considerations are essential when sourcing Chlorodiazepam API?
A2: Suppliers should possess GMP certification, provide detailed Certificates of Analysis, and comply with local import/export laws, especially due to its status as a controlled substance in many jurisdictions.

Q3: Can I source Chlorodiazepam from research chemical suppliers?
A3: While some research chemical vendors may offer Chlorodiazepam, quality, purity, and legal compliance vary; using reputable, certified suppliers is recommended.

Q4: How does geographic location influence the quality and reliability of API sources?
A4: Suppliers in regions with stringent regulatory oversight (e.g., US, Europe) typically maintain higher quality standards. However, Chinese and Indian suppliers can offer cost-effective options if properly validated.

Q5: What are the risks associated with sourcing from Chinese API manufacturers?
A5: Potential risks include variable quality control, regulatory non-compliance, and supply chain opacity. Due diligence and verification of GMP certification are vital before engagement.

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References:

[1] International Pharmaceutical Excipients Council, API Market Analysis, 2022.
[2] USP Monograph for Benzodiazepines, 2021.
[3] European Medicines Agency, Guidelines on API manufacturing, 2022.
[4] US FDA, Drug Master Files and API registration, 2023.
[5] Global API Suppliers Directory, PharmaCompass, 2023.