DIAZEPAM INTENSOL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	DIAZEPAM INTENSOL	diazepam	CONCENTRATE;ORAL	071415	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3185-44	1 BOTTLE in 1 CARTON (0054-3185-44) / 30 mL in 1 BOTTLE	1987-04-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Diazepam Intensol is a liquid formulation of diazepam, a benzodiazepine used primarily for the treatment of anxiety, seizures, muscle spasms, and alcohol withdrawal symptoms. Its widespread clinical utility has fostered a global supply network comprising pharmaceutical manufacturers, generic drug producers, and specialized formulators. Understanding the key suppliers for Diazepam Intensol is crucial for stakeholders involved in procurement, regulatory compliance, and supply chain risk management.

Manufacturers of Diazepam Active Pharmaceutical Ingredient (API)

The foundation for Diazepam Intensol production is the high-purity Active Pharmaceutical Ingredient (API). Several pharmaceutical companies specialize in synthesizing and distributing diazepam API, which is then compounded into liquids for end-use. Major API suppliers include:

ICN Polfa Rzeszów (Poland): A significant European producer known for manufacturing diazepam API. The company supplies to global markets, adhering to stringent pharmaceutical standards ([1]).
Hikma Pharmaceuticals (Jordan): While primarily active in generic formulations, Hikma also supplies diazepam API to contracted manufacturers worldwide.
Changzhou Pharmaceutical Co., Ltd. (China): A prominent Chinese manufacturer producing diazepam API, often supplying to both domestic and international generic pharmaceutical companies ([2]).
Siegfried AG (Switzerland): Known for complex APIs, including benzodiazepines, with a reputation for high-quality manufacturing.
Lupin Limited (India): An established Indian pharmaceutical company producing diazepam API for export markets.

Formulation and Finishing Suppliers

Post-API synthesis, the compounded liquids, such as Diazepam Intensol, are produced by specialized pharmaceutical formulators and contract manufacturing organizations (CMOs). These entities package diazepam in various formulations, including liquids, injectables, and tablets.

Mundipharma International (UK): Notably produces Diazepam Intensol, implementing quality control protocols consistent with regulatory standards. They often source API from multiple suppliers ([3]).
Reddy's Laboratories (India): Provides generic diazepam formulations, including liquid concentrates, serving both domestic and export markets.
Aurobindo Pharma (India): Produces diazepam-based products, including solutions, with potential supply lines for Intensol formulations.
Teva Pharmaceuticals (Israel): Supplies diazepam formulations globally, including liquids, leveraging a robust supply chain.

Contract Manufacturing and OEM (Original Equipment Manufacturer) Partners

Many pharmaceutical companies outsource production to Contract Manufacturing Organizations (CMOs), which produce Diazepam Intensol under various brand names. These include:

Recipharm (Sweden): Specializes in liquid pharmaceuticals and often partners for benzodiazepine formulations.
Hikma Pharmaceuticals (Jordan): Besides API, they also undertake formulation and packaging.
Pharmaron (China): Offers comprehensive production services, including formulation and bottling.

Regulatory and Quality Considerations

For Diazepam Intensol, suppliers must comply with strict regulatory standards. The API producers are often certified under Good Manufacturing Practices (GMP) according to the US FDA, EMA, or other regulatory bodies. These certifications ensure the safety, quality, and efficacy of the API supplied for formulation.

Conditioned APIs from regions like Europe, the US, and Japan are often preferred for high-grade formulations due to their rigorous quality standards. Conversely, suppliers from China and India have increasingly obtained GMP certifications, expanding their presence in global markets.

Market Dynamics and Supplier Selection Factors

Regulatory Approvals: The key determinant for pharmaceutical companies when choosing suppliers. Suppliers with regulatory approvals in target markets (e.g., FDA, EMA) face fewer hurdles.
Supply Chain Reliability: Consistent supply, scalability, and logistical robustness influence supplier selection.
Cost Competitiveness: Price points impact sourcing decisions, especially for generics or bulk procurement.
Quality Assurance: Strict adherence to GMP, stability data, and documentation are non-negotiable.

Key Suppliers Summary

Supplier	Role	Region	Notable Certifications	Notes
ICN Polfa Rzeszów	API production	Europe	GMP	Major European API provider
Changzhou Pharmaceutical	API production	China	GMP	Cost-effective API supplier
Lupin Limited	API	India	GMP	Expanding global API production
Hikma Pharmaceuticals	API & Formulation	Jordan	GMP	Integrated API and formulation provider
Mundipharma	Final formulation	UK	GMP	Produces Diazepam Intensol

Challenges and Risks

Regulatory Variability: Differing regulatory standards across countries can impede supply continuity.
Quality Variations: Variability in API quality from different suppliers necessitates rigorous QC measures.
Geopolitical Factors: Trade restrictions and import tariffs can influence supplier availability, especially from high-risk regions.
Supply Chain Disruption: Global events, such as pandemics or geopolitical tensions, threaten consistent API procurement.

Conclusion

The supply of Diazepam Intensol hinges on a well-established network of API manufacturers, formulation specialists, and contract manufacturers. Top API providers such as ICN Polfa Rzeszów, Changzhou Pharmaceutical, and Lupin are primary sources. Formulation and finished product manufacturing are often handled by companies like Mundipharma, Hikma, and Teva. Ensuring regulatory compliance, quality assurance, and supply chain resilience is paramount for stakeholders seeking reliable suppliers.

Key Takeaways

Global API production for diazepam is concentrated among companies in Europe, Asia, and India, with certifications ensuring compliance with international standards.
Contract manufacturers specializing in liquid pharmaceuticals play a vital role in producing Diazepam Intensol, often sourcing API from multiple suppliers based on regulatory, cost, and quality considerations.
Supply chain robustness depends on supplier regulatory approvals, quality standards, and geopolitical stability.
Due diligence and continuous quality audits are essential to mitigate risks associated with API variability and regulatory compliance.

FAQs

1. Who are the leading API suppliers for diazepam globally?
Leading API suppliers include ICN Polfa Rzeszów (Europe), Changzhou Pharmaceutical (China), Lupin Limited (India), and Hikma Pharmaceuticals (Jordan), each providing high-quality diazepam API compliant with GMP standards.

2. How does supplier certification influence Diazepam Intensol production?
Certifications like GMP ensure APIs meet safety and purity standards required for pharmaceuticals, enabling seamless registration and marketing across regulated markets.

3. What factors should companies consider when selecting a supplier for Diazepam Intensol?
Prime considerations include regulatory approvals, supply stability, API quality, cost efficiency, and supplier track record.

4. Are there regulatory restrictions on sourcing diazepam API from certain regions?
Yes, regulatory agencies may restrict or scrutinize imports from regions with less stringent GMP enforcement, affecting supply options.

5. How might geopolitical events impact the supply chain for Diazepam Intensol?
Trade restrictions, tariffs, political instability, or pandemics can disrupt API supply chains, emphasizing the need for diversified sourcing strategies.

Sources:

[1] European Medicines Agency. "Manufacturers of diazepam API." EMA Database.
[2] Changzhou Pharmaceutical Co., Ltd. Official Website.
[3] Mundipharma International. Product Portfolio.

Suppliers and packagers for DIAZEPAM INTENSOL