Suppliers and packagers for AMIDATE

AMIDATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	AMIDATE	etomidate	INJECTABLE;INJECTION	018227	NDA	Henry Schein, Inc.	0404-9811-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9811-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-01-06
Hospira	AMIDATE	etomidate	INJECTABLE;INJECTION	018227	NDA	Hospira, Inc.	0409-6695-01	10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-6695-11)	2005-07-26
Hospira	AMIDATE	etomidate	INJECTABLE;INJECTION	018227	NDA	Hospira, Inc.	0409-6695-02	10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6695-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-6695-12)	2005-07-26
Hospira	AMIDATE	etomidate	INJECTABLE;INJECTION	018227	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1459-1	10 mL in 1 VIAL, SINGLE-USE (51662-1459-1)	2020-03-31

Suppliers for the Pharmaceutical Drug: Amidate (Etomidate)

Last updated: August 1, 2025

Introduction

Amidate, the trade name for Etomidate, is an intravenous anesthetic agent primarily used for induction of general anesthesia and sedation in medical procedures. Its unique pharmacological profile, characterized by rapid onset and short duration, makes it a vital drug in anesthesia practices worldwide. The availability of Amidate hinges on the global supplier network, encompassing generic manufacturers, proprietary pharmaceutical firms, and specialty chemical producers.

This article examines the leading suppliers for Amidate (Etomidate), explores their market dominance, manufacturing capacities, regulatory landscapes, and future supply chain dynamics. A comprehensive understanding of these suppliers is fundamental amid fluctuating healthcare demands and supply chain disruptions.

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Global Market Overview of Amidate (Etomidate)

Etomidate was first introduced in the 1970s by Janssen Pharmaceuticals, which held exclusive rights for some time. Currently, the drug is available both as a branded product (Amidate) and as a generic formulation supplied by various manufacturers worldwide. The global demand for Etomidate remains steady, driven by its pivotal role in anesthesia, intensive care, and emergency medicine.

Key regions of supply include North America, Europe, Asia-Pacific, and emerging markets in Latin America and Africa. Supply stability and manufacturing quality are paramount, given the drug’s critical care applications and regulatory scrutiny.

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Leading Suppliers of Amidate (Etomidate)

1. Pharmaceutica Products Corporation (Janssen Pharmaceuticals)

Overview:
Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was the original developer of Etomidate. Although its exclusive marketing rights have expired post-patent, Janssen continues to supply branded Amidate in certain markets. The company maintains high standards for manufacturing and regulatory compliance, ensuring product reliability.

Market Position & Supply:
Janssen’s production facilities in the United States and Europe ensure consistent supply for branded Amidate. While competition introduces generics, Janssen remains a key supplier for hospitals and clinics preferring branded formulations for assured quality.

Regulatory Environment:
Janssen’s products are FDA-approved and compliant with EMA standards, facilitating distribution across major markets.

2. Hospira (Pfizer Inc.)

Overview:
Hospira, now part of Pfizer, was among the first to commercialize generic Etomidate. The company’s focus on infusion and anesthetic drugs has resulted in significant manufacturing capacity for generic Amidate.

Manufacturing Capacity & Quality:
Hospira’s manufacturing facilities in the US, Ireland, and Italy meet stringent cGMP standards, enabling large-scale production vital for global hospital supply chains.

Market Impact:
Pfizer’s extensive distribution network ensures broad availability of generic Etomidate, often more cost-competitive than branded versions.

3. Fresenius Kabi

Overview:
Fresenius Kabi is a major player in sterile injectable pharmaceuticals, including anesthetic agents like Etomidate. Their focus on infusion therapies positions them as a leading generic supplier.

Supply Chain & Distribution:
Fresenius Kabi operates manufacturing sites across Europe, Asia, and the Americas, allowing flexibility and rapid response to market demands. The company emphasizes high quality and regulatory compliance, facilitating their products’ trustworthiness.

4. Hikma Pharmaceuticals

Overview:
Hikma, a UK-based global pharmaceutical company, supplies sterile injectables including Etomidate. They maintain production sites in the Middle East, Europe, and the US.

Competitive Edge:
Hikma’s strategic investments in manufacturing capacity and quality management enable a reliable supply of Etomidate to markets in Europe, the Middle East, and North Africa.

5. Dipharma Group

Overview:
Dipharma, an Italian pharmaceutical manufacturer, produces generic anesthetic agents, including Etomidate. The company emphasizes cleanroom manufacturing and stringent quality standards.

Market Dynamics:
While smaller than global giants, Dipharma's niche capabilities position it as a key regional supplier, particularly for European and certain Asian markets.

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Emerging and Regional Suppliers

Beyond these established players, several regional manufacturers are expanding their portfolios to include Amidate, especially as demand increases in emerging markets. India and China are notable hubs for generic API (Active Pharmaceutical Ingredient) synthesis, with companies like Sun Pharmaceutical, Ajanta Pharma, and Liuzhou Pharmaceutical producing both APIs and finished formulations.

API Suppliers:
Many suppliers manufacture Etomidate API, which is then packaged and marketed by regional pharmaceutical firms. The quality of API production greatly impacts the safety and efficacy of final products.

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Regulatory and Quality Considerations

All suppliers must adhere to Good Manufacturing Practices (GMP) and obtain approvals from regulatory agencies such as the FDA, EMA, TGA, and others. Regulatory compliance is critical for international supply, particularly for parenteral drugs like Etomidate, where contamination risks are high.

Manufacturers often navigate complex approval procedures and need to maintain rigorous quality assurance protocols to ensure product consistency and safety.

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Supply Chain Challenges and Future Outlook

Global supply chains face disruptions driven by geopolitical issues, raw material shortages, and the COVID-19 pandemic. These disruptions strain the availability of raw materials (API synthesis), packaging, and distribution channels.

Several manufacturers are investing in API manufacturing capacity expansion to reduce dependency on external suppliers. Additionally, the trend toward regionalized production aims to mitigate logistical risks and meet local demand more efficiently.

Innovation in formulation technology, including sustained-release formulations and alternative administration routes, could reshape the supplier landscape, driving new entrants and alliances.

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Key Takeaways

• Dominance of Global Major Players: Janssen Pharmaceuticals, Hospira (Pfizer), Fresenius Kabi, and Hikma are primary suppliers, offering both branded and generic Etomidate globally.
• API Production Is Critical: Quality API manufacturers in India and China supply the core raw materials, influencing overall supply stability.
• Regulatory Compliance Is Crucial: Suppliers’ ability to navigate diverse regulatory landscapes ensures market access, especially in stringent markets like the US and Europe.
• Supply Chain Vulnerabilities: Disruptions reinforce the need for diversified suppliers and regional manufacturing capabilities.
• Future Trends: Expansion of API capacity, regulatory harmonization, and technological innovations will influence supplier dynamics.

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FAQs

1. Who are the top global suppliers of Amidate (Etomidate)?
The leading suppliers include Janssen Pharmaceuticals (branded Amidate), Hospira (Pfizer), Fresenius Kabi, and Hikma Pharmaceuticals. These companies ensure broad availability in global markets through manufacturing capacity, regulatory compliance, and distribution networks.

2. How does the API (Active Pharmaceutical Ingredient) market impact Amidate supply?
API quality and availability are fundamental to the stability of Amidate supply. Major API producers in India and China supply the raw materials, with their capacity and quality directly influencing the final product’s availability and safety.

3. Are there regional differences in the supply of Amidate?
Yes. In North America and Europe, regulatory approvals and high-quality manufacturing favor large multinational companies. Developing markets rely more on regional manufacturers and generic API suppliers, which may sometimes influence pricing and availability.

4. What are the main challenges facing Amidate supply chains?
Disruptions stem from raw material shortages, geopolitical issues, regulatory delays, and pandemic-related logistical problems. These factors necessitate strategic planning, diversification, and investments in local manufacturing.

5. How might future regulations affect Amidate suppliers?
Regulatory standards are becoming more stringent globally, demanding higher quality assurance, stability data, and compliance. Suppliers investing in GMP enhancements, regulatory harmonization, and digital quality management systems are better positioned for future growth.

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References

[1] Food and Drug Administration (FDA). "Approved Drug Products with Therapeutic Equivalence Evaluations."
[2] EMA. "European Medicines Agency – List of Authorized Medicinal Products."
[3] Johnson & Johnson. "Janssen Pharmaceuticals – Product Portfolio."
[4] Pfizer Inc. "Pfizer’s Injectable Portfolio."
[5] Fresenius Kabi. "Global Pharmaceutical Manufacturing Capabilities."

(Note: The references listed are indicative; specific source verification is recommended for detailed due diligence.)