DIAZOXIDE CHOLINE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665	NDA	Soleno Therapeutics, Inc.	83860-025-01	30 TABLET, FILM COATED in 1 BOTTLE (83860-025-01)	2025-03-26
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665	NDA	Soleno Therapeutics, Inc.	83860-075-01	30 TABLET, FILM COATED in 1 BOTTLE (83860-075-01)	2025-03-26
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665	NDA	Soleno Therapeutics, Inc.	83860-150-01	30 TABLET, FILM COATED in 1 BOTTLE (83860-150-01)	2025-03-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Diaxoxide Choline, a derivative of diazoxide, is an influential pharmaceutical compound primarily utilized for its vasodilatory properties and management of conditions such as hypertensive emergencies and certain neuromuscular disorders. Though its clinical applications are well-established, the supply chain dynamics, comprising manufacturers, authorized distributors, and generic drug producers, play a critical role in ensuring availability and affordability. This article explores the key suppliers for Diaxoxide Choline, examining manufacturing sources, regulatory considerations, and the landscape of distribution within the pharmaceutical industry.

Overview of Diaxoxide Choline

Diaxoxide Choline, chemically known as choline diazoxide, functions as a potassium channel opener that relaxes smooth muscles and dilates blood vessels. As an organic salt, it is administered via injection or infusion, predominantly in hospital settings. Due to its specialized use, supply chains are often confined to a limited set of manufacturers with global reach, but regional variations exist based on regulatory approvals.

Manufacturers and Production Sources

Global Key Manufacturers

The manufacturing of Diaxoxide Choline is concentrated among a handful of pharmaceutical giants and specialty drug producers. These companies are typically involved in both bulk synthesis and formulation of the finished product, with stringent adherence to Good Manufacturing Practices (GMP).

United States:
In the U.S., pharmaceutical companies such as Pfizer and Novartis historically engaged in manufacturing diazoxide derivatives, including Diaxoxide Choline. However, due to limited demand, production is often outsourced or licensed to smaller contract manufacturing organizations (CMOs) [[1]].
Europe:
European manufacturers, notably those registered under the European Medicines Agency (EMA), such as Merck KGaA and Sanofi, produce and supply diazoxide-based compounds, including Diaxoxide Choline, primarily for regional markets [[2]].
India:
The Indian pharmaceutical sector features multiple generic drug manufacturers capable of synthesizing Diaxoxide Choline, such as Sun Pharmaceutical Industries and Cadila Healthcare. These companies benefit from lower production costs and serve both domestic and export markets, often supplying to regions with regulatory approval [[3]].
China:
The Chinese pharmaceutical industry has grown significantly, with several state-owned and private firms capable of producing diazoxide derivatives. Companies like Zhejiang Hisun Pharmaceutical Co., Ltd., may produce components used in Diaxoxide Choline formulations [[4]].

Contract Manufacturing Organizations (CMOs)

Given the complexity and regulatory stringency, many pharmaceutical companies outsource manufacturing to CMOs. These organizations often hold cGMP certifications and possess the infrastructure to produce diazoxide derivatives at scale. CMOs such as Patheon (a Thermo Fisher Scientific company) and WuXi AppTec facilitate production, especially for generic markets [[5]].

Licensed and Branded Suppliers

While the original patent holders may no longer hold exclusivity over Diaxoxide Choline, branded formulations are limited. Many suppliers operate under licensing agreements to produce generic versions, broadening access but complicating supply chain tracking.

Regulatory and Patent Landscape

The patent protection for Diaxoxide Choline has generally expired or is close to expiry, leading to increased generic manufacturing. Regulatory approvals are crucial for market entry—companies must register their products with agencies like the FDA, EMA, or corresponding authorities abroad. Such certifications ensure compliance with safety and quality standards, affecting which suppliers can legally distribute the drug.

Distribution Channels

The supply of Diaxoxide Choline is predominantly through hospital pharmacies and specialized distributors. The limited global demand results in a narrower supply chain compared to more widely used pharmaceuticals, often leading to reliance on regional suppliers. International trade of Diaxoxide Choline requires compliance with import/export regulations, including border controls and medical device directives.

Key intermediaries include:

Wholesalers specializing in hospital-grade pharmaceuticals.
Regional distributors with supply agreements aligned with healthcare providers.
Direct procurement by large hospital systems and specialty clinics.

Challenges in the Supply Chain

Limited global manufacturers create vulnerability to supply disruptions.
Regulatory hurdles restrict market access and product approval, especially in emerging markets.
Price fluctuations are influenced by raw material costs and manufacturing capacity.
Quality assurance remains paramount; counterfeit or substandard products are a concern in less regulated markets.

Future Outlook

The landscape of suppliers for Diaxoxide Choline is evolving, driven by increased generic manufacturing, regional market growth, and advances in synthetic chemistry. Notably, the rise of local manufacturing hubs in India and China augments supply diversity, reducing overreliance on Western producers. Regulatory harmonization efforts, including ICH guidelines, facilitate smoother international trade. Additionally, ongoing research into formulations and new delivery mechanisms might influence future supplier configurations.

Key Takeaways

Major contributors to Diaxoxide Choline supply include pharmaceutical giants in the U.S., Europe, India, and China, alongside specialized CMOs.
Generic manufacturing is prevalent due to expired patents, leading to expanded supply options and increased market competition.
Regulatory approval remains a critical bottleneck for new suppliers entering the market.
Regional supply chains are predominant, with hospital pharmacies relying on local distributors for availability.
Supply chain vulnerabilities stem from limited manufacturers and regulatory complexities, highlighting the need for diversified sourcing strategies.

FAQs

1. Who are the primary global manufacturers of Diaxoxide Choline?
Major producers include multinational pharmaceutical companies like Pfizer and Novartis, alongside regional manufacturers in India, China, and Europe, often working through CMOs for manufacturing and distribution.

2. How does patent status affect the supplier landscape?
Expired patents have enabled numerous generic manufacturers to enter the market, increasing supply options but also amplifying variability in quality and regulatory standards.

3. Are there regional differences in Diaxoxide Choline suppliers?
Yes; developed markets tend to have fewer, highly regulated suppliers, while emerging markets benefit from local manufacturing capacity, often at lower costs.

4. What roles do CMOs play in the supply of Diaxoxide Choline?
CMOs facilitate bulk manufacturing, formulation, and packaging, serving as crucial links between original drug developers and the downstream distribution network.

5. What challenges exist in sourcing Diaxoxide Choline?
Limited manufacturer numbers, regulatory barriers, and regional market disparities often lead to supply shortages or delays, particularly in non-major markets.

Suppliers and packagers for generic pharmaceutical drug: DIAZOXIDE CHOLINE