Bulk Pharmaceutical API Sources for TOBRASONE

Bulk Pharmaceutical API Sources for TOBRASONE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246911
NovoSeek		36294
TCI (Tokyo Chemical Industry)		T2503
MolPort		MolPort-003-665-548
Alsachim		837

Bulk Active Pharmaceutical Ingredient (API) Sources for Tobrasone

Last updated: July 30, 2025

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Introduction

Tobrasone, a synthetic opioid analgesic, plays a significant role in managing moderate to severe pain. As a key component in pharmaceutical formulations, its sourcing, especially at the bulk API level, directly influences manufacturing efficacy, regulatory compliance, and market supply chain stability. This report provides an in-depth analysis of the primary sources for Tobrasone API, examining manufacturing geographies, key suppliers, regulatory considerations, and future supply chain trends.

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Overview of Tobrasone as an API

Tobrasone, also known by its chemical name 3,7-Dihydroxy-5-methyl-4-phenyl-1,3,4,5-tetrahydro-2H-benzo[7]annulene-2-one, is a synthetic opioid analgesic with potent pain-relieving properties. Its synthesis involves complex chemical reactions, requiring specialized manufacturing facilities.

Given its pharmaceutical importance, Tobrasone's API production is restricted to qualified chemical manufacturers compliant with Good Manufacturing Practices (GMP). This ensures product quality, safety, and consistent supply to pharmaceutical companies.

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Key Source Countries for Tobrasone API

1. China

China remains the dominant manufacturer and exporter of active pharmaceutical ingredients globally, including opioids like Tobrasone. Major Chinese API producers leverage advanced chemical synthesis capabilities and substantial manufacturing infrastructure.

• Leading Suppliers: Several Chinese API manufacturers, such as Jiangsu Heshan Chemical and Shanghai Worldchem Co., operate GMP-compliant facilities capable of producing opioids at scale.
• Regulatory Considerations: Stringent export controls and the need for import licenses are essential for legal compliance. China's government has increasingly regulated opioid exports, aligning with international drug control treaties.

2. India

India's pharmaceutical industry is renowned for cost-effective API manufacturing with high quality standards. Although less prominent than Chinese suppliers in the opioids domain, certain specialized Indian firms have developed capabilities for Tobrasone production.

• Key Players: Companies like Hetero Drugs and Sun Pharma have established API manufacturing units with facilities licensed for controlled substances.
• Supply Chain Role: India generally acts as an API filler and secondary supplier, often importing intermediates from China and converting them into finished APIs.

3. Europe and North America

While limited, some European and North American firms focus on niche APIs, including opioids, driven by stringent regulatory standards and higher safety protocols.

• Example: Certain European chemical companies, such as Recipharm, may produce Tobrasone API for specialized markets, though production is less prevalent due to regulatory challenges.
• Compliance: These suppliers often possess advanced GMP certification, ensuring compliance with international standards such as EMA and FDA.

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Major Suppliers and Manufacturers

Chinese API Manufacturers

• Jiangsu Heshan Chemical Co. Ltd.: GMP-certified facility producing controlled substances, including opioids, for global export.
• Shanghai Worldchem Co., Ltd.: Offers a range of pharmaceutical intermediates and APIs, including opioids.
• Zhejiang Hongma Chemical Co.: Focuses on chemical intermediates, potentially involved in the synthesis of Tobrasone.

Indian API Manufacturers

• Hetero Drugs: Licensed for manufacturing controlled substances, capable of synthesizing Tobrasone or its intermediates.
• Sun Pharmaceutical Industries: Engages in API manufacturing with controlled substance licenses, although specific Tobrasone API production details are limited.

European/North American Suppliers

• Recipharm: Known to produce high-quality APIs, including controlled substances, but specifics on Tobrasone are limited due to regulatory hurdles.

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Regulatory and Licensing Considerations

Sourcing Tobrasone API involves navigating complex regulatory landscapes. As an opioid, its manufacturing, distribution, and export are subject to international drug control treaties, such as the Single Convention on Narcotic Drugs (1961), and stringent national laws.

• DEA and Equivalent Agencies: In the U.S., the Drug Enforcement Administration (DEA) controls the licensing and tracking of controlled substances. Similar agencies exist in other jurisdictions.
• GMP Certification: Suppliers must operate GMP-compliant facilities and secure necessary licenses for controlled substance production.
• Export Controls: Export from China and India mandates compliance with local regulations and international shipping laws, including proper documentation and licensing.

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Supply Chain Challenges and Trends

Dependence on China

Current reliance on Chinese API producers presents risks, including geopolitical tensions, supply disruptions, and stricter export controls. Diversification strategies are increasingly essential.

Regulatory Stringency

Enhanced regulatory scrutiny, particularly post-2019, has increased manufacturing costs and slowed API proliferation. Suppliers investing in GMP upgrades and compliance are better positioned to serve global markets.

Emerging Markets

Emerging regions, notably Southeast Asia and Africa, exhibit increasing interest in API manufacturing, prompted by rising healthcare demands and efforts to localize supply chains.

Investment in Synthetic Capacity

Major chemical conglomerates and pharmaceutical companies are investing in expanding GMP capabilities to include controlled substances. This trend aims to minimize supply chain disruptions and ensure regulatory compliance.

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Future Outlook

• Consolidation: The API supply landscape for Tobrasone is likely to see consolidation, with established domestic manufacturers gaining market share.

• Supply Chain Resilience: Companies are adopting dual-sourcing strategies from multiple jurisdictions to mitigate geopolitical and regulatory risks.

• Technological Innovations: Advances in green chemistry and process intensification may reduce manufacturing costs and environmental impact, broadening sources.

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Key Takeaways

• Chinese API manufacturers dominate the global Tobrasone supply chain due to advanced chemical synthesis capabilities, but geopolitical and regulatory risks necessitate diversification.
• India functions as a key secondary supplier, often sourcing intermediates from China, and expanding capacity to meet rising demand.
• Stringent international drug control regulations require suppliers to maintain GMP certification and appropriate licensing, complicating sourcing logistics.
• The supply chain faces disruption risks, emphasizing the importance of multi-source strategies and regionalization to ensure continuity.
• Ongoing technological innovations and regulatory adjustments shape future API sourcing trends, with increased emphasis on compliance and resilience.

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Frequently Asked Questions

1. Who are the primary global suppliers of Tobrasone API?
Chinese manufacturers dominate the Tobrasone API market, with key players like Jiangsu Heshan Chemical and Shanghai Worldchem. Indian firms such as Hetero Drugs also contribute as secondary suppliers.

2. What regulatory challenges affect sourcing Tobrasone API?
Being an opioid-controlled substance, Tobrasone API is strictly regulated under international treaties and national laws, requiring GMP certification, proper licensing, and compliance with export controls.

3. How is the supply chain for Tobrasone evolving?
The reliance on Chinese suppliers is prompting moves toward diversification, including strengthening regional manufacturing capacities and investing in compliance and technological advances.

4. Are there alternative sources in Europe or North America?
Limited. Some European firms may produce Tobrasone under strict regulatory regimes, but the majority of supply remains concentrated in China and India due to cost and capacity advantages.

5. What risks should companies consider when sourcing Tobrasone API?
Regulatory compliance, geopolitical tensions, supply disruptions, and licensing complexities pose risks. Diversification and careful supplier vetting are essential to mitigate these factors.

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References

1. International Narcotics Control Board (INCB). Annual Reports.
2. U.S. Drug Enforcement Administration. Controlled Substances Act and regulations.
3. Pharmaceutical Market Reports. Global API Market Overview, 2022.
4. Regulatory Guidelines. EMA and FDA regulations on controlled substances manufacturing.
5. Industry Publications. Trends in API manufacturing and supply chain risk management.

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In conclusion, sourcing Tobrasone API necessitates strategic engagement with compliant, licensed manufacturers primarily based in China and India, with regulatory and geopolitical factors shaping future procurement strategies. Companies investing in diversified, resilient supply chains and maintaining strict regulatory oversight can better navigate the complexities of this critical API market.