Suppliers and packagers for generic pharmaceutical drug: PROPOFOL

PROPOFOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-16	10 VIAL in 1 BOX (63323-269-16) / 10 mL in 1 VIAL (63323-269-06)	2009-11-17
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-37	10 VIAL in 1 BOX (63323-269-37) / 20 mL in 1 VIAL (63323-269-25)	2009-11-17
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-57	20 VIAL in 1 BOX (63323-269-57) / 50 mL in 1 VIAL (63323-269-23)	2009-11-17
Fresenius Kabi Usa	DIPRIVAN	propofol	INJECTABLE;INJECTION	019627	NDA	Fresenius Kabi USA, LLC	63323-269-67	10 VIAL in 1 BOX (63323-269-67) / 100 mL in 1 VIAL (63323-269-21)	2009-11-17

Suppliers for the Pharmaceutical Drug: PROPOFOL

Last updated: July 28, 2025

Introduction

Propofol, a highly versatile intravenous anesthetic agent, has become a cornerstone in surgical anesthesia, sedation intensive care units, and procedural sedation. Its rapid onset and short duration of action facilitate precise control over anesthetic depth, making it a preferred choice across medical settings. Conversely, the global supply chain of propofol hinges on a select group of manufacturers, primarily due to strict regulatory oversight, manufacturing standards, and intellectual property regimes. This report provides a comprehensive overview of key suppliers involved in the production of propofol, analyzing their market positions, manufacturing capabilities, and regulatory considerations critical for stakeholders seeking reliable procurement channels.

Global Manufacturing Landscape of Propofol

The manufacturing of propofol is confined to a limited number of pharmaceutical giants primarily headquartered in North America, Europe, and Asia. These entities operate under rigorous Good Manufacturing Practices (GMP) standards mandated by health authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and respective national agencies. The complex synthesis process, which involves the esterification of phenol derivatives, and the need for sterile, high-purity formulations, act as barriers to entry, consolidating production within established pharmaceutical organizations.

Major Suppliers of Propofol

1. Fresenius Kabi

Fresenius Kabi, a global leader in infusion and injectable pharmaceuticals, is among the prominent suppliers of propofol. The company operates manufacturing plants in Europe and Asia, with a robust portfolio that includes generic formulations of propofol for both hospital and outpatient settings. Their products are widely distributed across healthcare systems in Europe, North America, and Africa, leveraging extensive distribution networks and strict compliance with international pharmacopoeial standards.

2. Hospira (AbbVie)

Previously under the Hospira brand, now fully integrated into AbbVie, the company remains a key producer of propofol. The Hospira Propofol Ready-to-Use Injectable, a sterile, lipid-based formulation, achieved widespread adoption due to its convenience and clinical efficacy. AbbVie continues to manufacture and distribute propofol through its global manufacturing facilities, primarily targeting markets in North America, Europe, and emerging economies where hospital supply chains demand high-quality intravenous anesthetics.

3. Hikma Pharmaceuticals

Hikma, a leading generics and injectables manufacturer headquartered in the UK, sustains a sizeable portfolio of anesthetic agents, including propofol. Their manufacturing facilities adhere to stringent quality controls, and their products are typically supplied across the Middle East, Europe, and North Africa regions. Hikma’s strategic alliances and manufacturing capacity expansion efforts position it as a reliable supplier amid geopolitical and supply chain uncertainties.

4. Teva Pharmaceutical Industries

Teva’s global footprint in generic injectables includes propofol formulations catering to diverse markets. Their manufacturing operations, notably in Israel and the Netherlands, emphasize quality assurance and regulatory compliance. Teva’s extensive distribution network ensures broad access, but recent strategic shifts have prompted considerations of supply stability for high-demand anesthetic agents.

5. Sandoz (Novartis)

As a division of Novartis specializing in generics and biosimilars, Sandoz supplies propofol for institutional use. Their manufacturing facilities in Europe leverage Novartis' extensive research and development expertise, facilitating consistent product quality. Sandoz’s global reach ensures significant availability in Europe and North America.

Regional Considerations and Supply Chain Dynamics

Supply chain robustness varies regionally, influenced by regulatory policies, manufacturing capacity, and geopolitical factors. For instance, concentration of production facilities in specific countries increases vulnerability to regional disruptions, such as pandemics, political instability, or natural disasters. The COVID-19 pandemic underscored the fragility of global pharmaceutical supply chains, prompting healthcare providers to diversify procurement sources and reinforce stockpiling strategies. These dynamics demand vigilance in monitoring supplier stability and regulatory compliance.

Regulatory and Quality Assurance

Manufacturers of propofol must demonstrate compliance with multiple regulatory frameworks. The U.S. FDA’s approval process, for instance, necessitates adherence to rigorous standards concerning sterility, potency, and stability. Similarly, EMA guidelines dictate manufacturing and quality specifications to ensure product consistency across Europe. Suppliers often hold multiple certifications, including WHO-GMP, ISO 13485, and others, which serve as benchmarks for quality assurance.

Emerging Suppliers and Market Entry Barriers

While the market is concentrated among a few established players, emerging pharmaceutical companies in Asia and Eastern Europe are attempting market entry through licensing agreements or joint ventures. However, entering the supply chain for a high-risk, sterile injectable like propofol involves overcoming significant regulatory hurdles, achieving GMP certification, and establishing distribution infrastructure. Consequently, market entry barriers remain high, favoring established multinational corporations.

Strategic Implications for Procurement

Healthcare providers and procurement agencies should prioritize reliable suppliers with extensive regulatory approvals and proven quality records. Establishing strategic partnerships and diversifying sources can mitigate risks associated with supply shortages or regulatory delays. Additionally, proactive engagement with manufacturers regarding capacity expansion and supply forecasts enhances preparedness to meet fluctuating demand.

Conclusion

The supply of propofol is predominantly controlled by a handful of leading pharmaceutical companies renowned for their manufacturing expertise and regulatory compliance. Fresenius Kabi, AbbVie (Hospira), Hikma Pharmaceuticals, Teva, and Sandoz stand out as key global suppliers, ensuring widespread availability across critical healthcare markets. Given the complex nature of sterile injectable manufacturing and regulatory barriers, new entrants remain limited, reinforcing the importance of established relationships in procurement strategies. Careful monitoring of regional supply stability, capacity investments, and compliance provisions is crucial for healthcare providers to secure a continuous supply of this vital anesthetic.

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Key Takeaways

• Market Concentration: The global propofol supply is concentrated among a few key players, making supply chain reliability critical for healthcare providers.
• Leading Suppliers: Major manufacturers include Fresenius Kabi, AbbVie (Hospira), Hikma, Teva, and Sandoz, each with extensive manufacturing and distribution networks.
• Regulatory Compliance: Suppliers must adhere to stringent GMP standards and maintain multiple regulatory approvals to ensure product safety and efficacy.
• Supply Chain Risks: Geopolitical issues, natural disasters, and pandemics can disrupt supply; diversification and strategic partnerships are essential.
• Market Entry Barriers: High regulatory and manufacturing entry barriers limit competition, favoring established producers, although emerging players are attempting to penetrate the market.

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FAQs

1. Who are the leading global suppliers of propofol?
Fresenius Kabi, AbbVie (Hospira), Hikma Pharmaceuticals, Teva, and Sandoz are the primary suppliers, each with significant manufacturing capabilities and distribution reach.

2. What are the primary regulatory considerations for propofol suppliers?
Manufacturers must comply with GMP standards set by agencies like the FDA and EMA, maintaining high-quality manufacturing practices, sterility, potency, and stability of the injectable formulations.

3. How has the COVID-19 pandemic affected propofol supply?
The pandemic exposed vulnerabilities in the global supply chain, leading to shortages and prompting healthcare providers to diversify sources and increase inventory buffers.

4. Are there emerging markets or new entrants in the propofol manufacturing sector?
While some Asian and Eastern European companies aim to enter the market, high regulatory and manufacturing barriers limit new entrants, preserving supply chain concentration.

5. How can healthcare providers mitigate propofol supply risks?
Building relationships with multiple trusted suppliers, maintaining adequate stockpiles, and monitoring regulatory and geopolitical developments are key strategies.

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References

[1] U.S. Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. 21 CFR Part 211.

[2] European Medicines Agency. Guidelines on Good Manufacturing Practices for Medicinal Products for Human Use. EMA/INS/GMP/642112/2013.

[3] World Health Organization. Good Manufacturing Practices (GMP) for Pharmaceutical Products. WHO Technical Report Series.

[4] MarketResearch.com. Global Propofol Market Report. 2022.

[5] PharmaManufacturing.com. Supply Chain Lessons from COVID-19: Focus on Anesthetic Drugs. 2021.