nexterone: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325	NDA	Baxter Healthcare Company	43066-150-10	100 mL in 1 BAG (43066-150-10)	2010-11-16
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325	NDA	Baxter Healthcare Company	43066-360-20	200 mL in 1 BAG (43066-360-20)	2010-11-16
Baxter Hlthcare	NEXTERONE	amiodarone hydrochloride	INJECTABLE;INJECTION	022325	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1480-1	1 BAG in 1 CARTON (51662-1480-1) / 100 mL in 1 BAG	2020-01-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

NEXTERONE (amiodarone hydrochloride injection) is a critical antiarrhythmic medication primarily used to treat various life-threatening cardiac arrhythmias, including ventricular fibrillation and hemodynamically unstable ventricular tachycardia. Given its complex manufacturing process and strict regulatory standards, the landscape of NEXTERONE suppliers plays a crucial role for healthcare providers, pharmaceutical distributors, and hospital pharmacies seeking reliable procurement channels. This report provides a comprehensive overview of the key suppliers for NEXTERONE, analyzing their market positioning, manufacturing capabilities, regulatory compliance, and strategic significance.

Overview of NEXTERONE Supply Chain Dynamics

Manufactured by Baxter International Inc., NEXTERONE is approved by the U.S. Food and Drug Administration (FDA) and other regulatory authorities worldwide. The supply chain involves multiple stakeholders, including raw material providers, contract manufacturing organizations (CMOs), and distribution networks.

The high complexity of amiodarone synthesis, which involves multiple chemical intermediates and stringent quality controls, results in centralized manufacturing with limited supplier options. Consequently, Baxter, as the primary manufacturer, sources raw materials globally, with discontinuities potentially impacting availability.

Primary Manufacturer and Key Suppliers

1. Baxter International Inc.

Baxter is the sole FDA-approved manufacturer of NEXTERONE, leveraging decades of experience in sterile injectable drugs. Their manufacturing facilities in the United States and Europe are subject to rigorous FDA and European Medicines Agency (EMA) inspections, aligning with Good Manufacturing Practices (GMP). Their control over the entire production process emphasizes quality assurance and supply stability.

Baxter’s vertical integration minimizes dependency on external suppliers; however, it does not eliminate risks tied to raw material procurement, especially for critical excipients and active pharmaceutical ingredients (APIs).

2. Raw Material and API Suppliers

Amiodarone hydrochloride's production requires high-purity APIs sourced globally. Major suppliers of AMIODARONE APIs include:

Chugai Pharmaceutical Co., Ltd. (Japan): A leading supplier for pharmaceutical-grade amiodarone. Chugai’s robust GMP compliance and supply chain stability make it a vital raw material source for Baxter and other intermediaries.
Hikma Pharmaceuticals (UK): As a notable API producer, Hikma supplies pharmaceutical ingredients for various injectable drugs, including amiodarone.
Hubei Madera Pharmaceutical Co., Ltd. (China): An emerging supplier providing affordable API options, though its supply stability and regulatory compliance require ongoing validation.
Boehringer Ingelheim (Germany): Historically involved in the production of pharmaceutical chemicals, including amiodarone APIs, aligning with strict European standards.

The sourcing of API raw materials is highly strategic, with potential dependencies on geographic regions vulnerable to supply disruptions.

3. Excipients and Other Raw Materials

In addition to APIs, excipients such as sodium chloride, sodium hydroxide, and sterile water are sourced from multiple suppliers globally. Reputable companies include:

Fresenius Kabi (Germany): Known for sterile water and saline solutions.
BASF SE (Germany): Supplies high-quality excipients and stabilizers.

Secondary suppliers may be regional, depending on regulatory requirements and logistics.

Contract Manufacturing Organizations (CMOs) and Distribution Networks

While Baxter directly produces NEXTERONE, some regional markets or generic equivalents rely on CMOs or third-party distributors. Major distributors include:

McKesson Corporation
Cardinal Health
AmerisourceBergen

These entities ensure global distribution with adherence to regulatory standards, maintaining supply chain integrity.

Regulatory and Geopolitical Influences on Supply

Regulatory scrutiny, trade policies, and geopolitical factors influence supplier stability. The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting Baxter and other pharmaceutical firms to diversify sourcing strategies and maintain strategic inventories.

In particular, dependence on API imports from China and India has become a focal point for supply security efforts. Stricter regulations, quality standards, and tariffs can impact procurement timelines and costs.

Emerging Trends and Future Outlook

Supply chain diversification: Baxter may seek to diversify API suppliers to reduce reliance on singular sources, especially from regions with geopolitical uncertainties.
Vertical integration: Increased investment in in-house API manufacturing could enhance supply security.
Strategic stockpiling: Hospitals and governments are emphasizing stockpiling to buffer potential supply disruptions.
Regulatory harmonization: Increased international regulatory cooperation aims to streamline approvals for APIs and excipients, facilitating smoother supply pathways.

Conclusion

The supply ecosystem for NEXTERONE remains concentrated, primarily revolving around Baxter International Inc., with raw material procurement from global API suppliers such as Chugai Pharmaceutical and Hikma Pharmaceuticals. External influences, including geopolitical factors and regulatory shifts, significantly impact supply stability. Stakeholders must monitor these dynamics and consider diversification strategies to safeguard against potential shortages.

Key Takeaways

Baxter International Inc. is the sole FDA-approved producer of NEXTERONE, controlling end-to-end manufacturing processes.
API sourcing involves key global players like Chugai, Hikma, and emerging suppliers from China and India.
Supply chain risks stem from geopolitical tensions, trade restrictions, and reliance on specific geographic regions for raw materials.
Industry trends focus on diversification, vertical integration, and strategic stockpiling to enhance supply resilience.
Regulatory compliance and quality assurance remain crucial in maintaining supplier credibility and product integrity.

FAQs

1. Are there any generic versions of NEXTERONE available in the market?
Currently, NEXTERONE remains a branded product produced exclusively by Baxter. However, several generic formulations of amiodarone injectable exist, subject to regulatory approvals in different jurisdictions.

2. How does Baxter ensure supply chain stability for NEXTERONE?
Baxter maintains multiple manufacturing sites, diverse raw material sourcing, strict quality controls, and strategic inventory management to mitigate supply disruptions.

3. What are the key challenges in sourcing API components for NEXTERONE?
Challenges include geopolitical tensions, supply chain disruptions from high-demand regions like China and India, regulatory compliance for foreign suppliers, and price fluctuations.

4. How might new regulations impact NEXTERONE suppliers?
Enhanced GMP standards and stricter import-export controls can influence supplier eligibility, lead times, and costs, necessitating adaptation by manufacturers.

5. What strategic steps are companies taking to mitigate supply risks for critical drugs like NEXTERONE?
Companies are diversifying supplier bases, increasing local production capacity, investing in inventory buffers, and collaborating with regulatory agencies to streamline approvals and supply chain oversight.

Sources

[1] Baxter International Inc. – NEXTERONE product information.
[2] FDA Drug Approvals and Safety Communications.
[3] Pharmaceutical supply chain reports by IQVIA and McKinsey.
[4] API supplier profiles from public industry dossiers.
[5] Regulatory guidelines from EMA and other authorities.

Suppliers and packagers for nexterone

nexterone

Suppliers for the Pharmaceutical Drug: NEXTERONE