Suppliers and packagers for generic pharmaceutical drug: temazepam

temazepam

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9914-03	30 CAPSULE in 1 BOTTLE (0406-9914-03)	1981-02-27
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9915-01	100 CAPSULE in 1 BOTTLE (0406-9915-01)	1981-02-27
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9915-03	30 CAPSULE in 1 BOTTLE (0406-9915-03)	1981-02-27
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9916-01	100 CAPSULE in 1 BOTTLE (0406-9916-01)	1981-02-27
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9917-01	100 CAPSULE in 1 BOTTLE (0406-9917-01)	1981-02-27
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9959-03	30 CAPSULE in 1 BOTTLE (0406-9959-03)	2010-02-23

Suppliers for the Pharmaceutical Drug: TEMAZEPAM

Last updated: July 29, 2025

Introduction

Temazepam, a benzodiazepine derivative primarily prescribed for short-term management of insomnia, commands significant importance within the pharmaceutical landscape. Its controlled status underscores the necessity for reliable suppliers who meet stringent regulatory and quality standards. This article provides a comprehensive overview of the primary suppliers for Temazepam, analyzing the manufacturing landscape, compliance considerations, and strategic sourcing insights crucial for pharmaceutical companies, healthcare providers, and stakeholders navigating the drug’s supply chain.

Overview of Temazepam Production and Market Dynamics

Temazepam’s synthesis involves complex chemical processes, with manufacturers often situated in regions with advanced pharmaceutical industries, notably Europe, Asia, and North America. The demand for Temazepam remains steady in global markets, driven by clinical guidelines and prescription patterns, despite increasing scrutiny of benzodiazepine use due to dependency concerns.

Manufacturers operate within a tightly regulated framework, adhering to Good Manufacturing Practices (GMP), ensuring product safety and efficacy. As a controlled substance classified under Schedule IV in many jurisdictions (e.g., United States), its supply chain is subject to strict oversight by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Major Suppliers and Manufacturers of Temazepam

1. European Manufacturers

a. LGC Standards (UK)

LGC is a prominent provider of reference standards, including pharmaceutical raw materials and active pharmaceutical ingredients (APIs). While primarily serving analytical needs, LGC collaborates with manufacturer partners to supply high-quality Temazepam APIs to batch producers.

b. ChemCon A/S (Denmark)

ChemCon specializes in chemical synthesis and supplies APIs worldwide, including benzodiazepine compounds like Temazepam. Their manufacturing facilities adhere to GMP, and they serve both generic pharmaceutical companies and research institutions.

2. Asian API Producers

a. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Huahai is a leading Chinese API manufacturer with extensive experience in benzodiazepines, including Temazepam. Their facilities are GMP-certified, and they export APIs globally, complementing Western pharmaceutical supply chains.

b. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Hisun provides a broad spectrum of APIs, including controlled substances. Their manufacturing processes meet international standards, making them a key component in the global Temazepam supply chain.

c. Zhejiang Shiyao Group (China)

Known for synthesizing benzodiazepines, Shiyao supplies APIs to both domestic and international markets, with a growing presence in regulated markets due to their compliance standards.

3. North American Suppliers

a. Cambrex Corporation (USA)

Cambrex, based in the United States, supplies high-quality APIs and intermediates, including benzodiazepines. Their manufacturing facilities are FDA-certified, emphasizing quality control and regulatory compliance.

b. NorthWest Pharma USA

While smaller in scale, NorthWest Pharma is known for manufacturing and distributing controlled substances, including Temazepam, primarily catering to North American markets with strict regulatory adherence.

4. Contract Manufacturing Organizations (CMOs) and Generics Companies

Several global CMOs and generics manufacturers source API or produce finished doses of Temazepam under license:

• Mylan (now part of Viatris): Historically produced Temazepam formulations with robust manufacturing for global markets.

• Sandoz (Novartis): Provides generics, including controlled substance formulations, under strict regulatory oversight.

• Alvogen: Engages in the manufacturing and distribution of benzodiazepine medications, including Temazepam, leveraging global manufacturing sites.

Regulatory and Quality Considerations for Suppliers

Suppliers of Temazepam must comply with multiple regulatory frameworks:

• GMP Certification: Global standards mandated by FDA, EMA, or other regional authorities.

• Controlled Substance Regulations: Strict compliance with Drug Enforcement Administration (DEA) rules in the US, and equivalent agencies worldwide.

• Quality Assurance: Extensive documentation, stability data, and batch testing to ensure potency, purity, and safety.

Failing to meet these standards can result in product recalls, legal penalties, and supply disruptions.

Supply Chain Challenges and Strategies

a. Regulatory Variability

Different countries have varying regulatory requirements for benzodiazepines. Suppliers must navigate these complexities, ensuring their manufacturing and documentation satisfy all regional standards.

b. Source Diversification

To mitigate risks from geopolitical tensions, regulatory changes, or shortages, pharmaceutical companies often diversify suppliers across regions, balancing Chinese, European, and North American sources.

c. Quality and Traceability

As Temazepam is a controlled substance, traceability and transparency are vital. Suppliers must maintain rigorous batch records, compliance documentation, and undergo periodic audits.

d. Price and Lead Time Management

Price fluctuations can be significant due to regulatory scrambles, raw material costs, and global demand. Establishing long-term contracts and transparent communication improves supply stability.

Emerging Trends and Future Outlook

1. Increased Localization

Regulatory pressures are prompting pharmaceutical firms to establish regional manufacturing hubs, reducing dependence on distant suppliers, especially with geopolitical considerations.

2. Supply Chain Digitization

Implementing blockchain and other digital platforms enhances traceability, compliance, and transparency for Temazepam supplies.

3. Focus on Sustainable and Ethical Sourcing

Environmental and ethical considerations influence supplier choices, with an emphasis on compliant, sustainable production practices.

4. Innovation in Formulation and Delivery

Developments in formulations, such as sustained-release versions, may influence supplier requirements and manufacturing specifications.

Conclusion

The supply landscape for Temazepam is characterized by a diverse set of regional manufacturers, each adhering to rigorous regulatory standards. European, Chinese, and North American suppliers form the backbone of the global supply chain, offering a combination of high-quality APIs and finished dosage forms. Navigating this complex environment requires strategic sourcing, rigorous compliance, and proactive risk management.

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Key Takeaways

• Reliable Temazepam sourcing hinges on suppliers with strict GMP compliance and proven track records in regulatory adherence, particularly for controlled substances.

• Diversification of suppliers across regions minimizes supply disruptions caused by geopolitical, regulatory, or manufacturing issues.

• The Chinese API manufacturing sector is vital to global Temazepam supply, but Western companies prioritize suppliers with established GMP certifications.

• Transparency and traceability, facilitated by digital tools, enhance compliance and consumer safety in Temazepam supply chains.

• Future trends include regional manufacturing hubs, digital traceability systems, and sustainability-focused sourcing.

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FAQs

1. Who are the leading manufacturers of Temazepam globally?
Leading manufacturers include Zhejiang Huahai Pharmaceutical and Zhejiang Hisun Pharmaceutical from China, supported by European firms like ChemCon A/S and North American suppliers such as Cambrex.

2. What regulatory standards must Temazepam suppliers adhere to?
Suppliers must comply with Good Manufacturing Practices (GMP), Controlled Substance regulations (e.g., DEA in the US), and regional licensing requirements established by agencies like the FDA and EMA.

3. How does geopolitical influence affect Temazepam supply?
Geopolitical factors, such as trade tensions and regulatory clashes, can disrupt supply chains. Diversifying sources and establishing regional manufacturing helps mitigate these risks.

4. What role do Contract Manufacturing Organizations (CMOs) play in Temazepam supply?
CMOs produce and often distribute Temazepam formulations, enabling pharmaceutical companies to outsource manufacturing while maintaining compliance and quality control standards.

5. What technological advancements are improving Temazepam supply chain management?
Digital platforms like blockchain improve traceability and compliance, while automation enhances manufacturing efficiency and quality assurance.

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References

[1] U.S. Food and Drug Administration (FDA). Controlled Substance Act Regulations.
[2] European Medicines Agency (EMA). Good Manufacturing Practice guidelines.
[3] Market analysis reports on benzodiazepine APIs.
[4] Industry sources on Chinese API manufacturing standards.
[5] Regulatory compliance documentation for pharmaceutical APIs.