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
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

Restoril (Temazepam) API Manufacturing Landscape

Last updated: February 19, 2026

Restoril (temazepam) is a benzodiazepine used for the short-term treatment of insomnia. Its active pharmaceutical ingredient (API), temazepam, is manufactured by a limited number of specialized chemical synthesis companies. The production process is complex, requiring strict adherence to Good Manufacturing Practices (GMP) and regulatory oversight from bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Who Manufactures Temazepam API?

The global supply chain for temazepam API is concentrated among a select group of companies. These manufacturers possess the chemical synthesis expertise and the regulatory infrastructure to produce the API to pharmaceutical standards. Key players in this space include both established generic API producers and specialized fine chemical manufacturers.

• Major API Manufacturers: Several large-scale generic API manufacturers globally produce temazepam. These companies often have broad portfolios and supply multiple international markets.
• Specialized Chemical Synthesis Firms: A smaller number of niche chemical companies focus on the synthesis of complex organic molecules, including controlled substances like temazepam. These firms may offer custom synthesis services or produce API for specific clients.

While precise production volumes and client lists are proprietary, public regulatory filings, patent landscapes, and industry directories offer insights into the active participants. Companies with U.S. FDA and EMA GMP certifications are critical suppliers for regulated markets.

What Are the Key Chemical Synthesis Steps for Temazepam?

The synthesis of temazepam typically involves several multi-step chemical reactions. While specific proprietary processes vary, a common synthetic route involves the transformation of diazepam or related benzodiazepine precursors.

The general pathway includes:

1. Starting Material Preparation: Often begins with a precursor compound, such as nordazepam or a related intermediate.
2. Oxidation and Hydroxylation: Key steps involve oxidation and hydroxylation to introduce the hydroxyl group at the C3 position of the benzodiazepine ring system. This is a critical step that differentiates temazepam from other benzodiazepines.
3. Methylation: If not already present, a methyl group is introduced at the N1 position.
4. Purification and Isolation: Rigorous purification steps, including crystallization and chromatography, are essential to achieve the required pharmaceutical purity.
5. Quality Control: Extensive analytical testing is performed to confirm identity, purity, and potency, meeting pharmacopeial standards (e.g., USP, EP).

The synthesis requires careful control of reaction conditions, including temperature, pressure, and reagent stoichiometry, to maximize yield and minimize impurities. Safety protocols for handling hazardous chemicals and byproducts are paramount.

What Regulatory Requirements Govern Temazepam API Production?

The production of temazepam API is subject to stringent regulatory oversight due to its classification as a controlled substance and its use in pharmaceuticals. Compliance with GMP is mandatory for all API manufacturers supplying to regulated markets.

Key regulatory aspects include:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to cGMP guidelines as established by regulatory bodies such as the FDA (21 CFR Parts 210 and 211) and the EMA. This covers all aspects of production, from facility design and personnel training to quality control and documentation.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory authorities. A DMF contains detailed information about the manufacturing process, facilities, quality control procedures, and stability of the API. It is referenced by drug product manufacturers in their marketing applications.
• Controlled Substance Regulations: Temazepam is listed under Schedule IV of the U.S. Controlled Substances Act. Manufacturers must comply with regulations set by the U.S. Drug Enforcement Administration (DEA) regarding quotas, security, record-keeping, and reporting of production and distribution. Similar controls exist in other jurisdictions.
• Impurity Profiling and Control: Regulatory agencies require comprehensive identification, qualification, and control of process-related impurities and degradation products. Limits for specified and unspecified impurities are set based on toxicological assessments.
• Site Inspections: Manufacturing facilities are subject to periodic inspections by regulatory authorities to ensure ongoing compliance with GMP and other applicable regulations.

Failure to meet these requirements can result in warning letters, import alerts, or other enforcement actions, significantly impacting a manufacturer's ability to supply the market.

What is the Patent Landscape for Temazepam Synthesis?

The foundational patents for temazepam have long expired. However, the patent landscape is not entirely barren. Innovation continues in the synthesis process, focusing on improved efficiency, purity, yield, and cost reduction.

Relevant patent areas include:

• Novel Synthetic Routes: Patents may cover entirely new chemical pathways to synthesize temazepam, offering advantages over older, established methods.
• Improved Intermediates: Patents can protect novel intermediate compounds or improved methods for synthesizing existing intermediates.
• Crystallization and Polymorphism: Patents may claim specific crystalline forms (polymorphs) of temazepam API, which can influence stability, dissolution, and bioavailability. Methods for controlled crystallization or the isolation of specific polymorphs are often patented.
• Process Optimization: Patents can protect specific process conditions, reagent combinations, or purification techniques that enhance yield, reduce reaction times, or minimize hazardous waste.
• Chiral Synthesis: While temazepam is not chiral, patents related to stereoselective synthesis of related benzodiazepines can sometimes inform or influence manufacturing approaches.

For companies looking to enter or expand in the temazepam API market, a thorough review of the current patent landscape is essential to avoid infringement and identify opportunities for proprietary process development. The absence of broad composition-of-matter patents means that competition often centers on manufacturing efficiency, quality, and cost.

Who Are the Key Suppliers of Temazepam API?

Identifying all temazepam API suppliers is challenging due to the proprietary nature of this information. However, based on publicly available information, including DMF filings and market intelligence reports, several entities are known or likely producers.

Company Name	Country of Origin	Notes
Teva Pharmaceutical Industries Ltd.	Israel	Large generic API manufacturer with a broad portfolio, including benzodiazepines.
Sun Pharmaceutical Industries Ltd.	India	Significant global player in generics and API manufacturing.
Torrent Pharmaceuticals Ltd.	India	Indian pharmaceutical company with established API production capabilities.
Divi's Laboratories Ltd.	India	Known for complex chemistry and custom synthesis; potential supplier for intermediates or API.
Cambrex Corporation	USA	Contract development and manufacturing organization (CDMO) with API synthesis expertise.
Höganäs AB (now part of Evonik Industries)	Sweden/Germany	Historically involved in fine chemicals; Evonik has broad API manufacturing capabilities.
Zhejiang NHU Co., Ltd.	China	Major Chinese chemical and pharmaceutical company with API production.

Note: This list is not exhaustive and represents companies with known API manufacturing footprints. Specific temazepam production status for each company can fluctuate.

Market dynamics are influenced by factors such as cost of raw materials, regulatory compliance costs, manufacturing capacity, and global demand. Companies that can reliably produce high-quality API at competitive prices, while navigating complex regulatory environments, are best positioned.

What Are the Key Market Dynamics for Temazepam API?

The market for temazepam API is characterized by several key dynamics, primarily driven by its status as an established, off-patent drug and a controlled substance.

• Generic Competition: As temazepam is no longer protected by composition-of-matter patents, the market is largely served by generic manufacturers. This leads to significant price pressure on API.
• Regulatory Burden: The stringent regulatory requirements for controlled substances (DEA in the US, equivalent bodies elsewhere) and GMP add substantial costs and complexity to production. This acts as a barrier to entry for new manufacturers.
• Demand Stability: Demand for temazepam remains relatively stable, driven by the ongoing need for short-term insomnia treatment. However, the overall market size is moderate compared to blockbuster drugs.
• Supply Chain Consolidation: The high regulatory barriers and cost pressures can lead to consolidation among API manufacturers, favoring those with established infrastructure and strong compliance records.
• Geographic Production Concentration: A significant portion of global API production, including for many benzodiazepines, is concentrated in India and China due to lower manufacturing costs, although established Western manufacturers also retain market share.
• Quality and Reliability: For pharmaceutical companies purchasing temazepam API, consistent quality, reliable supply, and robust regulatory documentation (e.g., DMFs) are paramount, often outweighing minor price differentials.
• Risk of Diversion: As a controlled substance, API manufacturers face ongoing scrutiny and risk management protocols to prevent diversion into illicit channels. This includes enhanced security and tracking measures.

These factors collectively shape the competitive landscape, influencing pricing, supply availability, and strategic investment decisions for API producers and pharmaceutical companies alike.

What are the Risks and Challenges in Temazepam API Sourcing?

Sourcing temazepam API involves a distinct set of risks and challenges that pharmaceutical companies must carefully manage. These relate to regulatory compliance, supply chain integrity, and manufacturing quality.

• Regulatory Compliance Failures:
  • GMP Violations: Non-compliance with GMP can lead to product recalls, import bans, and severe reputational damage.
  • Controlled Substance Violations: Errors in DEA quota management, record-keeping, or security can result in substantial fines, license revocation, and criminal charges.
• Supply Chain Disruptions:
  • Geopolitical Instability: Reliance on single-source suppliers in regions prone to political unrest or trade disputes poses a risk.
  • Raw Material Volatility: Fluctuations in the price or availability of key starting materials can impact production costs and lead times.
  • Logistics Issues: International shipping delays, customs complications, and transportation security for controlled substances add complexity.
• Quality Control Deficiencies:
  • Impurity Excursions: The presence of unacceptable levels of process impurities or degradation products can render a batch unusable.
  • Inconsistent Batch Quality: Variability in API quality from one batch to the next can impact drug product performance and regulatory approval.
• Manufacturer Solvency and Reliability:
  • Financial Instability: The financial health of an API supplier is critical to ensure long-term, consistent supply.
  • Capacity Limitations: A supplier may experience capacity constraints, leading to extended lead times or an inability to meet demand.
• Counterfeit API Risk: Although less common for established, regulated APIs, the risk of counterfeit materials entering the supply chain, particularly in less regulated channels, remains a concern.
• Intellectual Property Issues: While foundational patents have expired, patents covering novel synthesis routes or polymorphic forms can still impact freedom to operate for certain manufacturing processes.

Pharmaceutical companies typically mitigate these risks through rigorous supplier qualification programs, dual-sourcing strategies where feasible, strong contractual agreements, and ongoing audits of manufacturing facilities.

Key Takeaways

The manufacturing of temazepam API is a highly regulated and specialized field dominated by a limited number of global producers. Key considerations for pharmaceutical companies include navigating stringent GMP and controlled substance regulations, understanding the patent landscape focusing on process improvements, and managing inherent supply chain and quality risks. Competitive advantage in this market is derived from robust regulatory compliance, manufacturing efficiency, and consistent product quality.

FAQs

1. What is the primary challenge in sourcing temazepam API for pharmaceutical manufacturers? The primary challenge is ensuring consistent compliance with stringent U.S. DEA and international controlled substance regulations, alongside FDA and EMA Good Manufacturing Practices (GMP), which significantly increases operational complexity and cost.

2. Are there any emerging trends in temazepam API synthesis? While temazepam is an established drug, trends focus on process optimization for higher yields, reduced environmental impact, and improved impurity profiles. Novel synthetic routes or more efficient purification methods may be protected by process patents.

3. How does the controlled substance status of temazepam affect its API suppliers? Suppliers must adhere to strict DEA regulations in the U.S. (and equivalents internationally) regarding quotas, security, inventory management, record-keeping, and reporting, which adds significant compliance overhead and security requirements.

4. What impact do patents have on the temazepam API market? With foundational patents expired, the market is largely generic. However, patents may exist for specific improved synthesis processes, novel intermediates, or unique polymorphic forms that could affect a manufacturer's freedom to operate or offer competitive advantages.

5. What are the main risks associated with relying on a single supplier for temazepam API? Risks include supply chain disruption due to geopolitical events, natural disasters, or the supplier's operational issues, as well as potential price increases or quality inconsistencies if competition is limited.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations, Title 21, Part 210 & 211. Retrieved from [FDA website] (Specific URL not provided as it changes, but accessed via FDA.gov)

[2] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from [DEA website] (Specific URL not provided as it changes, but accessed via DEA.gov)

[3] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP) Information. Retrieved from [EMA website] (Specific URL not provided as it changes, but accessed via EMA.europa.eu)

[4] Pharmaceutical industry reports and market analysis (Proprietary data, not publicly citable by specific title).

[5] Patent databases (e.g., USPTO, Espacenet, Google Patents) for temazepam synthesis and related technologies.