DIPRIVAN: Pharmaceutical manufacturers, suppliers, and packagers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Diprivan, the brand name for propofol, is a potent intravenous anesthetic agent widely used in surgical procedures, intensive care units, and sedation settings. Its rapid onset and short duration of action make it a preferred choice among anesthesiologists globally. Given its critical role in anesthesia and sedation, understanding the landscape of suppliers for Diprivan is essential for healthcare providers, pharmaceutical distributors, and regulatory agencies striving to ensure drug availability, quality, and supply chain security.

Overview of Diprivan (Propofol) Supply Chain

Propofol’s production involves complex chemical synthesis, stringent quality control, and adherence to regulatory standards. The supply chain encompasses raw material suppliers, active pharmaceutical ingredient (API) manufacturers, formulation plants, and finished product distributors. Major pharmaceutical companies and generic manufacturers are key players supplying Diprivan worldwide.

Major Suppliers and Manufacturers of Diprivan

1. AstraZeneca (Formerly affiliated with Diprivan Production)

Initially, AstraZeneca was the commercializer of Diprivan; however, production was later transitioned to other manufacturers. AstraZeneca’s involvement historically set the benchmark for production quality, regulatory standards, and global distribution.

2.ijing Jichun Pharmaceutical Co., Ltd.

Jichun Pharmaceutical, based in China, is a prominent producer of generic propofol. They supply both raw API and finished injectable solutions to regional markets, particularly within Asia. Their adherence to Good Manufacturing Practices (GMP) has facilitated entry into several international markets.

3. Fuji Pharma Co., Ltd.

A Japanese pharmaceutical company, Fuji Pharma manufactures proprietary formulations of propofol for domestic use. Their quality standards align with Japanese and international regulatory frameworks, contributing to regional stability in supply.

4. Jiangsu Hengrui Medicine Co., Ltd. (Hengrui Pharma)

This Chinese company produces both API and finished injectable formulations of propofol. Hengrui has expanded its global footprint through robust quality assurance and competitive pricing, making it a key regional supplier.

5. Sandoz (Novartis)

Sandoz, a Novartis division, is recognized for manufacturing high-quality generic injectables, including propofol. They serve global markets with API, along with finished dosage forms, maintaining GMP compliance and rigorous quality standards.

6. Fresenius Kabi

A global leader in infusion therapy and clinical nutrition, Fresenius Kabi supplies Diprivan in various markets. Their products meet international regulatory standards, with a focus on sterile manufacturing processes.

7. West-Ward Pharmaceuticals (Part of Teva Pharmaceutical Industries)

Teva, through West-Ward, offers generic propofol in multiple regions. Their scalable manufacturing operations ensure supply resilience.

Regional and Market-Specific Suppliers

India: Companies like Neon Laboratories and Dr. Reddy’s Laboratories are notable suppliers of generic propofol, catering primarily to the Indian subcontinent and neighboring markets.
Europe: Sandoz, Fresenius Kabi, and Teva are major suppliers with EU-GMP-compliant manufacturing sites.
United States: Masimo Corporation and West-Ward also supply Propofol, often sourced via importers due to regional regulatory frameworks.
Asia-Pacific: Multiple regional manufacturers facilitate supply, including Chinese and Japanese firms, addressing local demand with varying API quality levels.

Regulatory and Quality Considerations

Supply chain security for Diprivan hinges on stringent regulatory oversight. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent national agencies oversee manufacturing compliance with GMP standards. Suppliers with approved drug master files (DMFs) and product registrations in key markets ensure regulatory adherence.

Quality concerns, especially regarding counterfeit or substandard products, necessitate due diligence from healthcare providers and distributors. Certifications from bodies like the World Health Organization (WHO) and adherence to ICH guidelines are markers of quality assurance for suppliers.

Supply Challenges and Risks

The global demand for Diprivan remains high, especially in the context of elective surgeries and ICU admissions. Supply disruptions can arise from:

Raw Material Shortages: Price fluctuations or regulatory issues affecting key ingredients.
Manufacturing Capacity Constraints: Especially during global crises like the COVID-19 pandemic, which strained supply chains.
Regulatory Restrictions: Stringent approval requirements can delay entry or re-entry into markets.
Counterfeit and Substandard Products: Highlighting the need for verified suppliers and secure distribution.

To mitigate these risks, healthcare providers often diversify supplier bases and engage with multiple approved manufacturers.

Emerging Trends and Future Outlook

Recent trends indicate increasing procurement from emerging markets, with Chinese and Indian manufacturers expanding their global footprint. There is also a growing emphasis on biotechnological approaches to produce safer, more sustainable formulations of propofol.

Furthermore, regulatory agencies are enhancing surveillance for counterfeit drugs, pushing suppliers to innovate in serialization and tracking systems.

Innovation in alternative formulations and biosimilar versions could influence the supply landscape, potentially increasing options and competition in the future.

Key Takeaways

The supply of Diprivan (propofol) is dominated by a combination of global pharmaceutical giants and regional manufacturers, primarily based in China, India, Japan, and Europe.
Ensuring supply security hinges on adherence to regulatory standards, quality assurance, and diversification of supplier sources.
Emerging markets are expanding their manufacturing capabilities, contributing to increased global supply and competitive pricing.
Vigilance against counterfeit and substandard products remains critical, emphasizing the importance of verified suppliers with transparent regulatory compliance.
Supply chain resilience can be enhanced by strategic procurement, regulatory engagement, and investing in supply chain transparency initiatives.

FAQs

1. Who are the leading global suppliers of Diprivan (propofol)?
Key international suppliers include Sandoz (Novartis), Fresenius Kabi, West-Ward (Teva), and regional manufacturers from China and India such as Jiangsu Hengrui Medicine and Neon Laboratories.

2. How do regulatory agencies impact Diprivan’s supply?
Regulatory approval ensures manufacturing quality and safety, and agencies like the FDA and EMA enforce compliance. Delays or restrictions can disrupt supply, emphasizing the importance of suppliers with approved drug master files.

3. Are there risks associated with sourcing propofol from emerging markets?
Risks include variable quality standards and counterfeit products. Selecting suppliers with GMP certification and regulatory approval mitigates these risks.

4. How has the COVID-19 pandemic affected Diprivan supply chains?
The pandemic caused increased demand and logistical challenges, leading to supply shortages in some regions, prompting increased reliance on multiple suppliers and local manufacturers.

5. What future trends could influence Diprivan suppliers?
Growth of biosimilars, innovations in drug formulations, stricter regulatory oversight, and supply chain digitalization are expected to shape future supplier landscapes.

References

[1] World Health Organization. (2021). Guidelines on the quality, safety, and efficacy of locally manufactured medicines.
[2] U.S. Food & Drug Administration. (FDA Drug Approvals and Manufacturing Regulations)
[3] European Medicines Agency. (EMA Guidelines for Injectable Products)
[4] Industry Reports. (2022). Global Propofol Market Analysis.
[5] Company Websites. (Fresenius Kabi, Sandoz, West-Ward/Teva, Jiangsu Hengrui)

Suppliers and packagers for DIPRIVAN

DIPRIVAN

Suppliers for the Pharmaceutical Drug: Diprivan (Propofol)