Bulk Pharmaceutical API Sources for RESTORIL

Bulk Pharmaceutical API Sources for RESTORIL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		1643408_USP
Sigma-Aldrich		T8275_SIAL
Sigma-Aldrich		T-907_CERILLIAN
LGC Standards		LGCAMP0087.00-01
LGC Standards		LGCFOR0087.00
LGC Standards		MM0087.00

Bulk Active Pharmaceutical Ingredient (API) Sources for Restoril (Temazepam)

Last updated: July 31, 2025

Introduction

Restoril (brand name) is a widely prescribed benzodiazepine pharmaceutical primarily used for short-term management of insomnia. Its active ingredient, Temazepam, is commercially produced as a bulk Active Pharmaceutical Ingredient (API) for formulation into finished dosage forms. The integrity of supply chains for Temazepam is vital for pharmaceutical manufacturers, regulatory authorities, and supply chain stakeholders due to its therapeutic importance and potential misuse.

This report comprehensively explores the global landscape of API sourcing for Temazepam, highlighting key manufacturers, geographic considerations, regulatory dynamics, and supply chain integrity. Understanding these parameters is crucial for pharmaceutical companies, procurement specialists, and policymakers aiming to ensure uninterrupted supply, compliance, and quality standards.

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Global API Manufacturers for Temazepam

The production of Temazepam API is concentrated among a limited group of specialized manufacturers, predominantly based in regions with established pharmaceutical chemical sectors such as China, India, and certain European countries. The following sections detail the primary suppliers, their capacities, regulatory status, and market implications.

1. Chinese API Manufacturers

China remains a dominant player in the global pharmaceutical API supply chain, including benzodiazepines like Temazepam. Several Chinese companies possess established manufacturing plants compliant with Good Manufacturing Practices (GMP) and have secured regulatory approvals in multiple jurisdictions.

Key Chinese Suppliers

• Zhejiang Youbang Pharmaceutical Co., Ltd.: Known for producing a broad spectrum of CNS-active APIs, including Temazepam, with export licenses to North America and Europe.
• Shandong Xinhua Pharmaceutical Co., Ltd.: Operates GMP-certified facilities with consistent supply capabilities for Temazepam APIs.
• Yuan Xing Pharmaceutical: Engaged in the synthesis of benzodiazepine APIs, with a focus on quality control aligned with international standards.

Regulatory Note: Many Chinese API manufacturers have obtained certifications such as WHO-GMP and have exported to highly regulated markets, although ongoing scrutiny over quality control persists. The Chinese government has implemented measures to improve transparency and GMP compliance, influencing supplier credibility.

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2. Indian API Manufacturers

India’s pharmaceutical sector has expanded as a significant global API supplier, with several companies having capabilities for complex chemical synthesis, including benzodiazepines.

Notable Indian Suppliers

• Hikal Ltd.: Provides customized API manufacturing, including Temazepam, with a focus on quality and regulatory compliance.
• Aurobindo Pharma Ltd.: Known for large-scale API production and domestic export, with some divisions manufacturing benzodiazepines.
• Sanjivani Parenterals Ltd.: Offers APIs for CNS indications, including Temazepam, adhering to WHO-GMP standards.

Regulatory Landscape: Indian API manufacturers often pursue certifications from USFDA, EMA, and other authorities, elevating their credibility in global markets.

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3. European and North American API Producers

European and North American API producers primarily serve their local markets, with select companies fulfilling international supply needs under stringent regulatory oversight.

• BASF SE (Germany): Although primarily a chemical company, BASF has API manufacturing capacity for certain benzodiazepines, including Temazepam, under strict GMP conditions.
• Patheon / Thermo Fisher Scientific (United States/Europe): Provides custom API synthesis, including contract manufacturing for Temazepam, with high regulatory compliance standards.

Note: These companies tend to focus on large clients and proprietary formulations, which may limit market availability but ensure high-quality standards.

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Regulatory and Quality Considerations

The supply of Temazepam API involves adherence to strict regulatory standards due to its psychoactive properties and potential misuse. Manufacturers must comply with global GMP regulations, with certifications from agencies such as the USFDA, EMA, TGA (Australia), and WHO.

Importantly, API suppliers are frequently subjected to regulatory audits, and product quality (e.g., assay, residual solvents, impurities) is critical for market approval. Any lapses can threaten supply continuity and lead to supply chain disruption.

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Supply Chain Dynamics and Challenges

Supply Concentration and Risks

The API market for Temazepam hinges predominantly on Chinese and Indian manufacturers. This concentration introduces risks related to geopolitical tensions, trade restrictions, quality assurance, and intellectual property rights. Notably, regulatory crackdowns on certain Chinese APIs due to quality concerns have prompted importers to diversify sourcing strategies.

Quality Assurance and Due Diligence

Purchasers must verify supplier GMP certifications, conduct rigorous quality audits, and ensure compliance with international standards. For controlled substances like Temazepam, regulatory approval and licensing are mandatory features of the supply chain, adding layers of complexity.

Cost, Lead Time, and Scalability

Pricing varies based on supplier location, scale, and regulatory status. Chinese manufacturers generally provide cost-effective options with rapid lead times but may require extensive quality verification. Indian suppliers balance competitive pricing with regulatory diligence. European/US suppliers emphasize stringent standards but at higher costs and longer lead times.

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Emerging Trends and Future Outlook

• Diversification of suppliers: To mitigate geopolitical and regulatory risks, pharmaceutical companies seek diversified, reliable sources, including regional manufacturers with proven GMP compliance.
• Supply chain resilience: The COVID-19 pandemic underscored vulnerabilities; thus, strategic inventory and supplier qualification remain priorities.
• Regulatory transparency: Increasing efforts by Chinese and Indian regulators to improve manufacturing oversight are expected to enhance supplier credibility.

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Key Takeaways

• The primary bulk API sources for Temazepam are located in China and India, with European and North American suppliers serving niche markets.
• Regulatory compliance, GMP certification, and quality assurance are critical criteria for selecting Temazepam API suppliers, especially given its status as a controlled substance.
• Supply chain risks associated with concentrated origins necessitate proactive diversification and rigorous vendor qualification processes.
• Evolving regulatory landscapes and geopolitical factors influence supply stability, prompting manufacturers to explore alternative sourcing strategies.
• Long-term procurement strategies should incorporate supplier audits, regulatory vetting, and contingency planning to ensure uninterrupted API supply.

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FAQs

1. Who are the leading global suppliers of Temazepam API?
Chinese companies like Zhejiang Youbang Pharmaceutical and Shandong Xinhua Pharmaceutical lead in production capacity. Indian firms such as Hikal Ltd. and Aurobindo Pharma are also significant contributors, supported by European firms like BASF.

2. What regulatory standards must Temazepam API suppliers meet?
Suppliers should comply with GMP standards established by agencies like USFDA, EMA, and WHO-GMP certifications, especially for APIs intended for regulated markets.

3. Why is supplier diversification important in the Temazepam API market?
Diversification reduces dependence on a single country or manufacturer, mitigating risks from geopolitical issues, regulatory changes, or supply disruptions.

4. How do quality concerns influence Temazepam API sourcing?
Quality lapses can lead to regulatory action and supply rejections, emphasizing the importance of suppliers’ GMP certifications, audit histories, and compliance documentation.

5. What future trends are shaping the API supply landscape for Temazepam?
Enhanced regulatory oversight, increased demand for supply chain transparency, and geopolitical shifts are prompting diversification efforts and improvements in quality assurance protocols.

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References

[1] "Global API Market Trends," Pharmaceutical Technology, 2022.
[2] U.S. Food and Drug Administration (FDA). "Guidance for Industry: Control of Generics," 2021.
[3] World Health Organization. "WHO Good Manufacturing Practices," 2019.
[4] "Chinese Pharmaceutical Industry Report," China Pharmaceutical Industry Association, 2021.
[5] "Indian API Industry Outlook," Indian Pharmaceutical Alliance, 2022.