Suppliers and packagers for RESTORIL

RESTORIL

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

Suppliers for the Pharmaceutical Drug: RESTORIL

Last updated: August 2, 2025

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Introduction

Restoril, the brand name for temazepam, is a benzodiazepine widely prescribed for short-term treatment of insomnia. Its sedative-hypnotic properties make it a staple in managing sleep disorders, yet its manufacturing involves a complex network of suppliers that ensures compliance with regulatory standards for safety, quality, and efficacy. This article explores the key suppliers involved in the cultivation, synthesis, formulation, and distribution of Restoril, providing insights into the pharmaceutical supply chain and its implications for stakeholders.

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Manufacturing and Active Pharmaceutical Ingredient (API) Suppliers

1. API Manufacturers of Temazepam

The core component of Restoril is temazepam, an API synthesized through multi-step chemical processes. Prominent API suppliers include both domestic and international pharmaceutical companies specializing in controlled substance synthesis, complying with stringent regulatory standards such as WHO Good Manufacturing Practices (GMP) and the U.S. Food and Drug Administration (FDA) guidelines.

• Laboratoires Léa (France): Known for synthesizing benzodiazepine APIs, Léa has historically supplied temazepam to global markets, adhering to high GMP standards.

• Glenmark Pharmaceuticals (India): As a major API manufacturer, Glenmark produces temazepam via authorized manufacturing units, ensuring compliance with international control measures.

• Sun Pharmaceutical Industries (India): Engaged in the production of benzodiazepine APIs, Sun Pharmaceutical’s facilities operate under extensive quality control systems, making it a reliable source for temazepam API.

• Impax Laboratories (U.S.): Specializes in generic formulations, with API supply chains that include temazepam production, often sourcing intermediates from certified third-party manufacturers.

2. Synthetic Chemical Suppliers

In addition to direct API manufacturers, vendors providing building block chemicals—such as ortho- and para-chlorobenzaldehyde, isocyanates, and other intermediates—play critical roles in API synthesis. These chemical suppliers source raw materials globally, emphasizing quality assurance for controlled substances.

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Formulation and Finished Dosage Form Suppliers

1. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource the formulation and filling of Restoril capsules to specialized CMOs to optimize production and regulatory compliance.

• Catalent Pharma Solutions: A leading CMO globally, Catalent has facilities capable of manufacturing Temazepam capsules, adhering to FDA and EMA standards.

• Famar Production: Based in Greece, Famar offers comprehensive formulation services for controlled substances, including final product packaging and labeling.

• Aenova Group: Operating in Europe and North America, Aenova provides formulation, encapsulation, and packaging for sleep aid medications like Restoril.

2. Brand-Name and Generic Manufacturers

While Pfizer originally developed Restoril, today several generics manufacturers produce temazepam capsules following API compliance.

• Mylan (now part of Viatris): Supplies generic temazepam, utilizing APIs from certified suppliers and adhering to strict manufacturing standards.

• Teva Pharmaceuticals: Offers generic temazepam products, with manufacturing sites compliant with international regulatory frameworks.

• Sandoz: A division of Novartis, Sandoz manufactures authorized generics and follows rigorous quality controls.

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Distribution and Supply Chain Stakeholders

1. Wholesale Distributors

Post-production, Restoril reaches pharmacies via regional and national distributors:

• McKesson Corporation: One of the largest pharmaceutical distributors in North America, sourcing Restoril from licensed manufacturers.

• AmerisourceBerrx: Supplies a broad portfolio of controlled substances to healthcare providers, adhering to DEA strictures and track-and-trace requirements.

• Celesio/Apollo (Germany): European distributor engaged in the supply of Restoril to pharmacies within the EU.

2. Regulatory and Logistics Support

Controlled substances like temazepam demand meticulous logistics, including Secure Shipping, tamper-evident packaging, and real-time inventory tracking. Distributors operate under strict compliance with regulations such as DEA scheduling and international export controls.

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Regulatory and Compliance Considerations

The entire supply chain for Restoril is tightly regulated, reflecting its status as a Schedule IV controlled substance. Manufacturers and suppliers are required to:

• Maintain rigorous GMP compliance.
• Conduct regular audits and quality assessments.
• Implement track-and-trace systems to prevent diversion.
• Comply with international anti-money laundering (AML) and controlled substance treaties.

Opportunities and Risks in Supplier Selection

Dependence on a limited set of API manufacturers or formulation providers can pose risks, such as supply disruptions or quality issues. Conversely, diversification of suppliers enhances resilience but necessitates robust quality assurance protocols. Strategic partnerships with certified suppliers streamline compliance and ensure continuous formulation capacity.

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Emerging Trends and Future Outlook

The global pharmaceutical landscape is witnessing increasing consolidation among suppliers, driven by regulatory pressures and technological innovations. Moreover, the focus on sustainable sourcing—particularly for chemical intermediates—could influence supplier choices. Regulatory agencies may tighten compliance expectations, prompting manufacturers to audit and verify supplier credentials more rigorously.

Advances in synthetic biology and alternative sourcing methods could reshape the supply chain landscape for benzodiazepines, including temazepam. The integration of digital supply chain management systems further offers opportunities for enhanced traceability, risk mitigation, and regulatory compliance.

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Key Takeaways

• Diverse Supplier Ecosystem: Restoril’s production involves API manufacturers (e.g., Glenmark, Sun Pharma), chemical suppliers, formulation specialists, and distributors, each integral to the supply chain.

• Regulatory Stringency: All suppliers must adhere to strict GMP and controlled substance regulations, underscoring the importance of compliance for uninterrupted supply.

• Supply Chain Resilience: Manufacturers should diversify sources of APIs and formulations to mitigate risks associated with supply disruptions or regulatory changes.

• Emerging Technologies: Innovations such as digital traceability and synthetic biology are transforming supply chain management, offering improved compliance and transparency.

• Market Dynamics: Consolidation among suppliers and a focus on sustainability are shaping the future of Restoril’s global supply network.

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FAQs

1. Who are the primary API suppliers for temazepam used in Restoril?
Major API suppliers include Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Impax Laboratories, all manufacturing temazepam under strict GMP compliance to ensure quality and regulatory adherence.

2. How is the supply chain for Restoril regulated?
The supply chain is governed by regulations such as the Controlled Substances Act (CSA) in the U.S., and equivalent EU regulations, requiring licensing, strict record-keeping, and security measures at all stages.

3. Are there risks associated with relying on a limited number of suppliers for Restoril?
Yes. Dependency on few suppliers can lead to supply disruptions, regulatory non-compliance issues, or quality lapses—highlighting the need for supply chain diversification and rigorous supplier audits.

4. What role do CMOs play in Restoril’s manufacturing process?
CMOs handle formulation, encapsulation, and packaging, enabling pharmaceutical companies to outsource production while adhering to regulatory standards and optimizing capacity.

5. How might future technological advancements impact Restoril’s supply chain?
Innovations like digital traceability systems enhance transparency and compliance, while synthetic biology could alter raw material sourcing. These developments may improve efficiency, security, and sustainability in the supply network.

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References

1. U.S. Food and Drug Administration (FDA). [GMP guidelines for pharmaceuticals].
2. World Health Organization. (2021). Guidelines on Good Manufacturing Practices.
3. DEA Diversion Control Program. Controlled Substance Schedules.
4. Pharmaceutical Technology. (2022). "Supply Chain Resilience in Controlled Substances."
5. Company websites and official filings of Glenmark, Sun Pharma, Impax, Catalent, Famar, Aenova, Mylan, Teva, Sandoz, McKesson, AmerisourceBerrx, and Celesio.