Bulk Pharmaceutical API Sources for ONFI

Bulk Pharmaceutical API Sources for ONFI

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C8414_SIGMA
AKos Consulting & Solutions		AKOS025401921
Clearsynth		CS-O-11314
MedChemexpress MCE		HY-A0041
AbaChemScene		CS-6756

Bulk Active Pharmaceutical Ingredient (API) Sources for ONFI: A Strategic Overview

Last updated: July 27, 2025

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Introduction

Onfi (clobazam) is a benzodiazepine-class medication primarily indicated for adjunctive treatment of epilepsy in both children and adults. As a crucial component in pharmaceutical formulations, the supply chain of its active pharmaceutical ingredient (API) remains central to ensuring consistent medication availability and regulatory compliance. This report provides a comprehensive assessment of bulk API sources for ONFI, emphasizing manufacturing strategies, key suppliers, quality standards, and geopolitical considerations impacting supply security.

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Understanding the API Landscape for ONFI

The production of ONFI’s API, clobazam, involves complex synthetic pathways requiring advanced chemical manufacturing capabilities. The API supply chain is characterized by a limited number of reputable manufacturers with validated quality systems, given the stringent regulatory environment dictated by agencies such as the FDA, EMA, and other global regulators.

Key considerations include:

• Regulatory certifications (PIC/S, ISO, cGMP compliance)
• Manufacturing capacity and scalability
• Geopolitical stability
• Cost competitiveness
• Supply chain resilience

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Leading API Manufacturers for ONFI

1. Global Pharmaceutical API Contract Manufacturers

Major contract manufacturing organizations (CMOs) and API suppliers possess the expertise for producing controlled-substance APIs like clobazam. Notable among them are:

• Hikma Pharmaceuticals (Jordan)
  Hikma’s active API production facilities are certified ISO 9001 and cGMP compliant. They operate advanced synthesis lines for benzodiazepine APIs, including clobazam, with FDA and European GMP approvals.

• Shri Shakti Pharmaceuticals (India)
  Specialized in custom synthesis of psychoactive APIs, Shri Shakti offers high-purity, certified APIs for domestic and international markets, conforming to global regulatory standards.

• Zhejiang Hisun Pharmaceutical (China)
  Their API manufacturing division offers large-scale synthesis capabilities for benzodiazepines, including clobazam, with proven quality compliance, extensive validation, and a robust supply chain.

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2. Major Chemical Companies with API Production Capabilities

Some chemical suppliers focus on bulk chemical synthesis rather than finished API manufacturing but remain integral parts of the supply chain.

• AbbVie (USA)
  While primarily a pharmaceutical innovator, AbbVie supplies certain benzodiazepine APIs through strategic partnerships with dedicated API producers, ensuring high-quality standards and regulatory compliance.

• Lupin Pharmaceuticals (India)
  Lupin’s API manufacturing unit, compliant with international standards, produces benzodiazepine APIs, including potentially clobazam, for global partners under rigorous Quality Agreements.

• Taj Pharmaceuticals (India)
  Taj offers bulk APIs with extensive cGMP facilities, targeting regional and international markets, emphasizing regulatory adherence and reliable supply.

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3. Regional API Producers and Strategic Suppliers

Regional suppliers often serve local markets, offering cost advantages and faster delivery. However, their capacity for strict regulatory compliance and large-scale production varies.

• Dr. Reddy’s Laboratories (India)
  Offers a diverse range of APIs, including benzodiazepines; their facilities are compliant with global quality standards, making them a strategic regional source.

• YN Hua Pharmaceutical (China)
  Provides bulk benzodiazepine APIs with competitive pricing, though verifying their regulatory status remains crucial.

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Quality and Regulatory Standards

Ensuring API quality is non-negotiable, especially for controlled substances like clobazam. Manufacturers must adhere to:

• Current Good Manufacturing Practice (cGMP)
• International standards (ICH Q7 for APIs)
• Validated synthesis processes with impurity profiles meeting pharmacopoeial specifications
• Robust quality control and analytical testing regimes

APIs supplied by certified manufacturers typically carry European GMP (EU GMP), U.S. FDA, or PIC/S certifications, assuring regulatory acceptance in global markets.

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Supply Chain and Geopolitical Considerations

The API landscape for ONFI is influenced by geopolitical factors, regulatory audits, and global trade policies:

• India and China dominate API manufacturing, accounting for over 80% of the global API production capacity, which offers cost advantages but introduces geopolitical risks and supply vulnerabilities.
• Business continuity plans include diversifying suppliers and qualifying multiple facilities across regions.
• Trade tensions, export restrictions, and regulatory sanctions can disrupt supply continuity, prompting companies to adopt dual-sourcing strategies.

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Emerging Trends and Strategic Sourcing

In response to industry dynamics, pharmaceutical firms are increasingly:

• Investing in domestic API manufacturing to reduce dependency on international suppliers.
• Engaging in vertical integration, establishing their manufacturing facilities.
• Partnering with API CDMOs for flexible and scalable production capabilities.
• Implementing digital quality assurance systems for transparent supply chain oversight.

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Conclusion

The API supply landscape for ONFI is characterized by a limited pool of high-quality, regulated suppliers, predominantly based in India, China, and select regions. Strategic sourcing involves balancing cost, regulatory compliance, supply security, and geopolitical stability. Companies seeking reliable API partners must emphasize validated manufacturing processes, comprehensive quality systems, and diversified supply networks.

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Key Takeaways

• Top-tier API manufacturers for ONFI include Hikma Pharmaceuticals, Shri Shakti Pharmaceuticals, Zhejiang Hisun, Lupin, and Taj Pharmaceuticals.
• Ensuring cGMP compliance and regulatory certifications is critical for API acceptance in international markets.
• Geopolitical risks require strategic diversification across multiple countries and suppliers.
• Vertical integration and investment in domestic API manufacturing are becoming increasingly prevalent to mitigate supply disruptions.
• Ongoing supply chain scrutiny and quality assurance are fundamental in maintaining continuous access to high-grade clobazam API.

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FAQs

1. What are the primary regions producing API for ONFI?
India, China, and the Middle East host the majority of API manufacturing facilities for ONFI, driven by cost efficiencies and established chemical synthesis capabilities.

2. How do regulatory standards impact API sourcing strategies?
Manufacturers must comply with cGMP and international standards such as ICH Q7. Non-compliant suppliers pose significant regulatory and quality risks, which can lead to supply delays or rejections.

3. Are there API manufacturing options for small or emerging pharmaceutical companies?
Yes, several CDMOs and regional API suppliers offer scaled manufacturing services tailored for smaller batches, provided they meet quality and regulatory requirements.

4. What risks are associated with sourcing APIs from China and India?
Geopolitical tensions, trade restrictions, and quality variability pose risks. Diversification and supply chain audits mitigate these vulnerabilities.

5. Is vertical integration common in the production of ONFI’s API?
Increasingly, pharmaceutical companies are investing in or acquiring API manufacturing capabilities to secure supply chains, reduce dependency, and improve quality control.

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Sources

[1] U.S. Food and Drug Administration. Current Good Manufacturing Practice (cGMP) regulations.
[2] International Council for Harmonisation (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
[3] IQVIA API Market Report, 2022.
[4] GlobalData. API Manufacturing and Supply Chains, 2021.
[5] Pharmaceutical Technology. "Strategies for API supply chain resilience," 2022.

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Note: This analysis synthesizes publicly available information and industry insights to provide a comprehensive overview of API sourcing for ONFI. Businesses should conduct specific supplier audits and regulatory assessments aligned with their strategic needs.