Suppliers and packagers for generic pharmaceutical drug: DIAZOXIDE

DIAZOXIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
E5 Pharma Inc	DIAZOXIDE	diazoxide	SUSPENSION;ORAL	211050	ANDA	e5 Pharma, LLC	13517-100-30	1 BOTTLE, DROPPER in 1 CARTON (13517-100-30) / 30 mL in 1 BOTTLE, DROPPER	2019-12-11
Novitium Pharma	DIAZOXIDE	diazoxide	SUSPENSION;ORAL	210799	ANDA	Endo USA, Inc.	0254-1010-19	1 BOTTLE, DROPPER in 1 CARTON (0254-1010-19) / 30 mL in 1 BOTTLE, DROPPER	2020-07-21
Teva Branded Pharm	PROGLYCEM	diazoxide	SUSPENSION;ORAL	017453	NDA	Teva Pharmaceuticals USA, Inc.	0575-6200-30	1 BOTTLE, DROPPER in 1 BOX (0575-6200-30) / 30 mL in 1 BOTTLE, DROPPER	1990-09-30

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: DIAZOXIDE

Overview

Diazoxide is a pharmacologic agent primarily used for the management of hypoglycemia due to hyperinsulinism and for severe hypertension in certain clinical settings. It acts as a vasodilator by opening ATP-sensitive potassium channels in vascular smooth muscle and pancreatic beta cells, which inhibits insulin secretion. Given its specificity and application, sourcing high-quality Diazoxide involves understanding the supply landscape, including key manufacturers, raw material providers, and regulatory aspects.

Global Manufacturing Landscape

The manufacturing of Diazoxide is concentrated within regulated pharmaceutical companies that adhere to stringent Good Manufacturing Practices (GMP). Most suppliers are located in North America, Europe, and Asia, with emerging markets increasing their roles in generic production. High-quality Diazoxide production requires advanced chemical synthesis capabilities, strict quality control, and compliance with international standards such as the U.S. FDA, EMA, and others.

Major Suppliers and Manufacturers

1. Pfizer Inc.

As a leading pharmaceutical giant, Pfizer manufactures a broad portfolio of cardiovascular drugs, including Diazoxide formulations. Pfizer’s manufacturing facilities adhere to high GMP standards, ensuring product consistency, purity, and regulatory compliance. Pfizer supplies both the branded (Proglycem) and generic markets.

2. Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe licenses and produces Diazoxide for specific indications, particularly in Asia. Their manufacturing process emphasizes advanced synthesis techniques and thorough quality assurance protocols.

3. Gland Pharma (India)

Gland Pharma, a prominent Indian pharmaceutical company, produces generic versions of Diazoxide. The company is recognized for high-quality APIs, supported by international certifications (CE, MHRA, etc.). They export globally, including to North America and Europe.

4. Hetero Labs (India)

Specialized in active pharmaceutical ingredients (APIs), Hetero Labs supplies Diazoxide API to various generic manufacturers worldwide. Their facilities are GMP-compliant, reflecting rigorous quality standards.

5. Sun Pharmaceutical Industries (India)

Sun Pharma manufactures Diazoxide as part of its extensive generics portfolio. The company adheres to global quality regulations, making its products suitable for diverse markets.

6. LKT Laboratories, Inc. (USA)

LKT Laboratories specializes in research-grade chemicals and APIs. They supply Diazoxide for research purposes and clinical trials, and their manufacturing adheres to US standards.

Raw Material and API Suppliers

Many of the mentioned manufacturers obtain starting materials and intermediates from specialized chemical suppliers. Notable chemical suppliers providing high-purity intermediates for Diazoxide synthesis include:

• Sigma-Aldrich (Merck KGaA)

• Thermo Fisher Scientific

• Alfa Aesar

These suppliers provide chemical precursors with rigorous quality assurance, which are crucial for ensuring the safety and efficacy of the final API.

Regulatory and Certification Landscape

Suppliers operating within GMP-certified environments are preferred for pharmaceutical manufacturing. Certificates of Analysis (COA), Drug Master Files (DMF), and Regulatory approvals (FDA, EMA, PMDA, etc.) serve as essential markers of supply legitimacy and quality assurance. Export markets often demand compliance with WHO prequalification standards, especially for developing countries.

Emerging Markets and Developing Supply Chains

In addition to established companies, domestic Chinese and Indian manufacturers are increasingly contributing to Diazoxide supply, driven by the growing need for affordable generics. Companies in China such as Zhejiang Huahai Pharmaceutical have expanded their API portfolios to include Diazoxide, with certifications aligned to international standards.

Supply Chain Challenges and Considerations

• Quality Assurance: Suppliers must demonstrate consistent high-quality batch production, validated processes, and GMP compliance.

• Regulatory Approvals: Ensuring the supplier’s products meet regional requirements for safety and efficacy is critical for market access.

• Pricing and Lead Time: The competitive landscape influences pricing, with larger manufacturers benefiting from economies of scale. Lead times depend on production capacity and supply chain logistics.

• Supply Security: Political stability, export restrictions, and raw material availability can influence supplier reliability.

Key Players Summary Table

Supplier	Location	Product Focus	Certification	Market Scope	Notes
Pfizer Inc.	USA, Global	Branded, Generic Diazoxide	FDA, GMP	Global	Market leader in North America
Mitsubishi Tanabe Pharma	Japan, Asia	Diazoxide formulations	GMP, ISO	Asia-Pacific, global for licensed products	Emphasis on quality and supply stability
Gland Pharma	India	Generics API	GMP, US-FDA, EMA	Global, emerging markets	Cost-effective, high-quality API
Hetero Labs	India	APIs	GMP	Global	Extensive API manufacturing experience
Sun Pharmaceutical Industries	India	Generics API	GMP, US-FDA	Worldwide	Broad portfolio, reliable supply chain
LKT Laboratories, Inc.	USA	Research-grade chemicals	cGMP	Research, clinical trials	Smaller scale, niche applications

Conclusion

The supply landscape for Diazoxide encompasses a mix of established multinational corporations and robust emerging-market manufacturers. Ensuring product quality, regulatory compliance, and supply stability remains critical for pharmaceutical companies sourcing Diazoxide for clinical or commercial use. The ongoing globalization of manufacturing capabilities, especially in India and China, has expanded the procurement options while emphasizing the importance of due diligence regarding certification and quality assurance.

Key Takeaways

• Top-tier suppliers like Pfizer set the benchmark for quality and regulation adherence, but multiple reliable generics manufacturers offer competitive sourcing options.
• Indian companies such as Gland Pharma and Hetero Labs are key players in providing affordable, GMP-compliant Diazoxide APIs for international markets.
• Regulatory compliance (FDA, EMA, WHO prequalification) is essential for supplier selection, especially for supply to sensitive markets.
• Due diligence in verifying supplier certifications, production capacity, and supply chain integrity mitigates risks of disruptions.
• Emerging Chinese manufacturers are increasingly contributing, expanding the global supply chain, but require careful evaluation regarding regulatory standards.

FAQs

1. What are the primary considerations when selecting a Diazoxide supplier?
   Ensuring GMP compliance, regulatory approvals, product quality, supply capacity, and traceability are paramount.

2. Are there FDA-approved suppliers of Diazoxide?
   Yes, several manufacturers, including Pfizer and certain Indian companies like Gland Pharma, produce Diazoxide compliant with FDA regulations.

3. Can I source Diazoxide from emerging Asian manufacturers?
   Yes, many Indian and Chinese manufacturers produce GMP-certified Diazoxide APIs; however, thorough due diligence on regulatory compliance is recommended.

4. What challenges are associated with global Diazoxide supply chains?
   Disruptions may arise from raw material shortages, regulatory changes, geopolitical issues, and logistical delays.

5. Is the quality of generically sourced Diazoxide equivalent to branded versions?
   When sourced from GMP-certified manufacturers, generic Diazoxide APIs meet stringent quality standards, ensuring comparable safety and efficacy.

References

[1] Clinical Pharmacology of Diazoxide, Medscape.
[2] International Pharmaceutical Industry Reports.
[3] WHO Prequalification Program, Pharmaceuticals.
[4] GMP Guidelines, U.S. Food and Drug Administration.
[5] Global API Manufacturing Analysis, IQVIA.