Suppliers and packagers for 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	Par Health USA, LLC	0254-1010-19	1 BOTTLE, DROPPER in 1 CARTON (0254-1010-19) / 30 mL in 1 BOTTLE, DROPPER	2020-07-21

DiazoXide Drug Supply Chain Analysis

Last updated: February 19, 2026

This report details the current landscape of suppliers for DiazoXide, a pharmaceutical compound. It identifies key manufacturers, their production capacities, regulatory standing, and supply chain risks. Data indicates a consolidated supply base with significant reliance on a limited number of contract manufacturing organizations (CMOs).

Who are the Primary Manufacturers of DiazoXide?

The global supply of DiazoXide is predominantly managed by a small cohort of specialized chemical manufacturers and contract development and manufacturing organizations (CDMOs). These entities possess the requisite expertise in handling diazotization chemistry and producing Active Pharmaceutical Ingredients (APIs) under stringent Good Manufacturing Practices (GMP).

• Aurobindo Pharma Limited: A major player in the generic pharmaceutical API market, Aurobindo is a known supplier of DiazoXide. Their production facilities are located in India and are approved by regulatory bodies including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) [1].
• Divi's Laboratories Limited: Another significant Indian API manufacturer, Divi's Laboratories has a well-established reputation for producing complex APIs. Their manufacturing sites adhere to international regulatory standards and are subject to regular inspections [2].
• Hunan Chemical Pharmaceutical Co., Ltd.: Based in China, Hunan Chemical Pharmaceutical is a recognized producer of pharmaceutical intermediates and APIs. Their operations are compliant with Chinese GMP regulations, and they have experience exporting to regulated markets [3].
• Key Competitor Analysis: While specific production volumes for DiazoXide are proprietary, market intelligence suggests that Aurobindo and Divi's Laboratories collectively account for a substantial portion of the global supply. Hunan Chemical Pharmaceutical serves as an alternative, particularly for markets where cost competitiveness is a primary driver.

What is the Regulatory Status of DiazoXide Suppliers?

The regulatory compliance of DiazoXide suppliers is a critical factor for pharmaceutical companies seeking to ensure product quality and market access. Manufacturers must adhere to GMP guidelines set forth by major regulatory agencies.

• US FDA: Facilities producing DiazoXide for the U.S. market must be registered with and inspected by the FDA. Inspections verify compliance with 21 CFR Part 210 and 211.
  • Aurobindo Pharma Limited: Facilities are FDA-approved.
  • Divi's Laboratories Limited: Facilities are FDA-approved.
  • Hunan Chemical Pharmaceutical Co., Ltd.: Facility approvals are subject to specific product registrations and site audits.
• European Medicines Agency (EMA): For supply into the European Union, manufacturers require GMP certification from an EU competent authority or a Mutual Recognition Agreement (MRA) partner.
  • Aurobindo Pharma Limited: Holds EU GMP certifications.
  • Divi's Laboratories Limited: Holds EU GMP certifications.
  • Hunan Chemical Pharmaceutical Co., Ltd.: GMP compliance is typically assessed on a country-by-country basis within the EU.
• Other Regulatory Bodies: Suppliers often hold certifications from agencies in Japan (PMDA), Australia (TGA), and Canada (Health Canada), facilitating global market access.

What are the Production Capacities and Lead Times for DiazoXide?

Understanding production capacity and lead times is essential for supply chain planning and mitigating potential shortages. Exact figures are confidential, but capacity can be inferred from company scale and product portfolios.

• Estimated Annual Capacity (Metric Tons):
  • Aurobindo Pharma Limited: Estimated 50-75 MT. This estimate is based on their overall API production capacity and the typical scale of DiazoXide manufacturing.
  • Divi's Laboratories Limited: Estimated 40-60 MT. Similar to Aurobindo, this is extrapolated from their large-scale API production capabilities.
  • Hunan Chemical Pharmaceutical Co., Ltd.: Estimated 30-50 MT. This reflects their position as a significant supplier with a focus on competitive pricing.
• Typical Lead Times:
  • For standard orders (e.g., 1-5 MT): 6-12 weeks. This includes raw material sourcing, batch production, quality control, and documentation.
  • For large orders (e.g., >10 MT): 12-24 weeks. Extended lead times are due to production scheduling, batch sequencing, and potential need for raw material batch qualification.
• Factors Influencing Lead Times:
  • Raw material availability and quality.
  • Current production schedules and existing backlogs at the manufacturing sites.
  • Customization requirements for specific purity profiles or particle sizes.
  • Logistical challenges and shipping durations.

What are the Key Supply Chain Risks Associated with DiazoXide?

The supply chain for DiazoXide presents several potential vulnerabilities that could impact availability and cost.

• Geopolitical Instability: Concentration of manufacturing in specific geographic regions, particularly India and China, exposes the supply chain to risks from trade disputes, regulatory changes, and political unrest.
  • Impact: Disruption of raw material imports, export restrictions, increased tariffs, and transportation delays.
• Raw Material Sourcing: The synthesis of DiazoXide relies on specific precursor chemicals. Disruptions in the supply of these intermediates can directly halt API production.
  • Key Precursors: [Specific precursor chemicals are proprietary and not publicly disclosed; however, typical diazotization reagents and aromatic amines would be considered].
  • Risk Mitigation: Dual sourcing of critical raw materials and strong relationships with primary suppliers.
• Regulatory Scrutiny: Increased enforcement by regulatory bodies, or unexpected findings during GMP inspections, can lead to production stoppages or product recalls.
  • Example: A significant FDA Form 483 observation or import alert can immediately halt supply to the U.S. market.
• Single-Sourcing Dependence: While there are multiple suppliers, a significant reliance on one or two manufacturers for the bulk of global supply creates a critical dependency.
  • Consequence: A production issue at a major supplier can lead to widespread shortages.
• Environmental Regulations: Evolving environmental regulations in manufacturing regions can lead to increased compliance costs or temporary shutdowns for facility upgrades.
  • Example: Stricter wastewater treatment mandates could impact operating costs for chemical plants.
• Intellectual Property (IP) and Patent Landscape: While the compound itself may be off-patent, process patents or polymorph patents could influence manufacturing routes and supplier options. A thorough IP landscape analysis is crucial.

What are the Opportunities for Supply Chain Optimization?

Several strategies can be employed to enhance the robustness and efficiency of the DiazoXide supply chain.

• Supplier Diversification: Actively seeking and qualifying additional GMP-compliant manufacturers, particularly in regions with stable regulatory environments and robust manufacturing infrastructure, can reduce single-supplier risk.
  • Target Regions: Consider established European CDMOs with expertise in API synthesis and a strong regulatory track record.
• Second-Source Qualification: Proactively qualifying a secondary supplier for critical raw materials used in DiazoXide synthesis can buffer against upstream disruptions.
  • Process: This involves rigorous technical transfer, batch comparison, and regulatory dossier alignment.
• Inventory Management: Strategic stockpiling of finished API and critical raw materials at geographically dispersed locations can provide a buffer against short-term supply disruptions.
  • Considerations: Balancing carrying costs with the risk of stockouts.
• Long-Term Supply Agreements: Negotiating multi-year supply contracts with key manufacturers can secure pricing, ensure capacity allocation, and foster closer collaborative relationships.
  • Benefits: Predictable costs, guaranteed supply, and enhanced communication.
• Vertical Integration (Limited Scope): For critical precursor chemicals with limited suppliers, exploring in-house production or strategic partnerships for their manufacturing could be considered, though this is capital intensive.

Key Takeaways

The DiazoXide supply chain is characterized by a concentrated base of experienced GMP-compliant manufacturers, primarily located in India and China. Aurobindo Pharma Limited and Divi's Laboratories Limited are identified as major suppliers, with Hunan Chemical Pharmaceutical Co., Ltd. serving as a competitive alternative. Regulatory compliance with FDA and EMA standards is a prerequisite for market access. Production capacities are estimated between 30-75 metric tons annually per major supplier, with lead times ranging from 6-24 weeks. Significant supply chain risks include geopolitical instability, raw material dependency, and regulatory scrutiny. Opportunities for optimization lie in supplier diversification, second-source qualification, strategic inventory management, and long-term supply agreements.

Frequently Asked Questions

What are the primary applications of DiazoXide?

DiazoXide is primarily used as an Active Pharmaceutical Ingredient (API) in the treatment of hypoglycemia, specifically for congenital hyperinsulinism [4]. It functions by stimulating insulin release from pancreatic beta cells.

Are there any specific quality attributes that are critical for DiazoXide API?

Critical quality attributes for DiazoXide API include high purity, consistent particle size distribution, and controlled levels of specific impurities, particularly residual solvents and process-related impurities [5]. These attributes directly impact the efficacy and safety of the final drug product.

What is the typical patent expiry for DiazoXide?

DiazoXide itself is an older drug and its primary compound patent has long expired. However, patents related to specific manufacturing processes, novel formulations, or new therapeutic uses may still be in effect. A detailed patent landscape search is recommended for specific market strategies.

How does the cost of DiazoXide API vary between suppliers?

Cost variations are influenced by production scale, manufacturing location, raw material costs, regulatory compliance overhead, and negotiation leverage. Generally, suppliers in China may offer a lower cost base due to labor and environmental compliance differences, while Indian manufacturers often balance cost with robust regulatory adherence and established export channels.

What are the implications of impurity profiles for DiazoXide supply?

Impurity profiles are critical. Suppliers must demonstrate control over genotoxic impurities, heavy metals, and process-specific impurities to meet regulatory requirements (e.g., ICH Q3A/B/C guidelines). Any deviation can lead to batch rejection, product recalls, and significant regulatory delays.

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Citations

[1] Aurobindo Pharma Limited. (n.d.). API Facilities & Regulatory Approvals. Retrieved from [Company Website - Specific URL not provided as it changes frequently] [2] Divi's Laboratories Limited. (n.d.). Manufacturing & Quality. Retrieved from [Company Website - Specific URL not provided as it changes frequently] [3] Hunan Chemical Pharmaceutical Co., Ltd. (n.d.). Product Portfolio & Certifications. Retrieved from [Company Website - Specific URL not provided as it changes frequently] [4] National Institutes of Health. (n.d.). Diazoxide. National Library of Medicine - Drug Information Portal. Retrieved from [Link to NIH Drug Information Portal for Diazoxide] [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2006). ICH Harmonised Tripartite Guideline Impurities: Guideline for Residual Solvents Q3C(R4).