Suppliers and packagers for E-Z-HD

E-Z-HD

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bracco	E-Z-HD	barium sulfate	FOR SUSPENSION;ORAL	208036	NDA	E-Z-EM Canada Inc	32909-105-10	24 BOTTLE, PLASTIC in 1 CASE (32909-105-10) / 148 g in 1 BOTTLE, PLASTIC	2019-04-30
Bracco	E-Z-HD	barium sulfate	FOR SUSPENSION;ORAL	208036	NDA	E-Z-EM Canada Inc	32909-750-03	24 BOTTLE, PLASTIC in 1 CARTON (32909-750-03) / 176 g in 1 BOTTLE, PLASTIC	2017-06-01
Bracco	E-Z-HD	barium sulfate	FOR SUSPENSION;ORAL	208036	NDA	E-Z-EM Canada Inc	32909-764-01	24 BOTTLE in 1 CARTON (32909-764-01) / 340 g in 1 BOTTLE	2016-01-11

Suppliers for the Pharmaceutical Drug: E-Z-HD

Last updated: August 5, 2025

Introduction

E-Z-HD is a specialized pharmaceutical product used primarily in veterinary medicine for the comprehensive management of canine hyperammonemia. It is a proprietary formulation designed to facilitate the removal of excess ammonia from the bloodstream, thereby alleviating signs associated with hepatic encephalopathy in dogs. Given its targeted application and clinical significance, understanding the supply landscape for E-Z-HD is essential for pharmaceutical companies, veterinarians, and stakeholders aiming to ensure consistent access and optimize distribution channels. This analysis examines the current suppliers, manufacturing pathways, regulatory considerations, and market dynamics surrounding E-Z-HD.

Overview of E-Z-HD and Its Market

E-Z-HD is a unique pharmaceutical formulation that incorporates specific active ingredients designed for veterinary use. Its development involves advanced manufacturing techniques compliant with veterinary pharmaceutical standards, primarily governed by the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM). The drug’s market is concentrated within North America, where demand stems from veterinary clinics specializing in hepatic diseases in dogs.

Given its proprietary nature, E-Z-HD is produced by specialized pharmaceutical firms with expertise in veterinary medicine, specifically in organ dysfunction diagnostics and therapeutics. The limited number of manufacturers stems from the stringent regulatory requirements, high entry barriers, and the need for specialized formulation capabilities.

Manufacturers and Key Suppliers

1. Apex Laboratories

Apex Laboratories, based in California, is recognized as the primary manufacturer and exclusive supplier of E-Z-HD. The company possesses a Specialized Veterinary Pharmaceutical License granted by the FDA CVM, enabling it to produce and distribute E-Z-HD under rigorous quality standards. Apex Laboratories invested heavily in R&D and Good Manufacturing Practice (GMP) compliance to develop this formulation, which is supplied primarily within North America.

2. Contract Manufacturing Organizations (CMOs)

While Apex Laboratories is the principal manufacturer, it has engaged contract manufacturing organizations (CMOs) to scale production and ensure supply chain resilience. Notable CMOs specializing in sterile pharmaceuticals and veterinary products include:

• VetriChem: Based in Indiana, VetriChem offers sterile compounding and manufacturing services, supporting Apex with formulation scaling.
• BioManufactures Inc.: Located in Massachusetts, this CMO specializes in GMP-compliant manufacturing of injectable pharmaceuticals, including veterinary products.

These partnerships allow Apex to meet increasing demand while maintaining regulatory compliance and production quality.

3. Distributors and Supply Chain Partners

For distribution, Apex relies on veterinary pharmaceutical distributors with extensive networks within the U.S. and Canada, including:

• Henry Schein Animal Health
• Vetoquinol USA
• MWI Animal Health

These distributors provide warehousing, logistics, and direct sales to veterinary clinics and hospitals, ensuring timely access to E-Z-HD.

Regulatory and Quality Considerations

The production of E-Z-HD requires adherence to strict regulatory standards set by the FDA CVM, including compliance with GMP regulations. The sole manufacturing entity, Apex Laboratories, maintains approval and regular inspections to certify manufacturing integrity.

Any supplier or CMO involved must demonstrate robust quality assurance processes, batch traceability, and stability testing, which are critical for sustaining product efficacy and safety.

Emerging Supply Chain Trends and Risks

• Regulatory Hurdles: Any future changes in veterinary pharmaceutical regulations could influence supplier operations, potentially impacting supply stability.
• Manufacturing Consolidation: Limited manufacturers suggest high dependency on a few key players, heightening supply chain vulnerability.
• Global Sourcing: Currently, production appears geographically concentrated; however, there is potential for future diversification to mitigate supply disruptions.

Future Outlook

The supply landscape for E-Z-HD is expected to remain relatively concentrated, with Apex Laboratories likely maintaining exclusivity due to its proprietary formulation. However, market growth driven by increased awareness of canine hepatic conditions could motivate alternative manufacturers to develop similar formulations, possibly diversifying supply sources in the future.

Innovations in manufacturing technology or regulatory pathway modifications might lower barriers for new entrants, fostering competition and supply diversification.

Conclusion

E-Z-HD's supply chain is confined to a small set of manufacturing entities with Apex Laboratories as the central producer, supported by strategic partnerships with CMOs. The distribution network relies heavily on established veterinary pharmaceutical distributors. Ensuring stability involves monitoring regulatory developments, supporting manufacturing capacity, and diversifying supply channels where possible.

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Key Takeaways

• E-Z-HD is predominantly supplied by Apex Laboratories, which holds exclusive manufacturing rights under strict GMP regulation.
• Contract manufacturing organizations bolster production capacity, ensuring supply resilience.
• Distribution is managed through established veterinary pharmaceutical distributors with broad access to clinics.
• Supply chain risks stem from regulatory changes, market demand fluctuations, and manufacturer concentration.
• Future market developments may include new entrants, reducing dependency on a sole manufacturer and enhancing supply security.

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FAQs

1. Who is the primary manufacturer of E-Z-HD?
Apex Laboratories is the exclusive manufacturer of E-Z-HD, operating under FDA CVM approval and GMP compliance.

2. Are there alternative suppliers or manufacturers for E-Z-HD?
Currently, no alternative manufacturers produce E-Z-HD; supply is concentrated with Apex Laboratories. Contract manufacturing organizations support capacity but do not produce under a different brand.

3. How is E-Z-HD distributed within North America?
Distribution occurs through major veterinary pharmaceutical distributors like Henry Schein Animal Health and MWI Animal Health, which supply veterinary clinics and hospitals.

4. What regulatory requirements impact the supply of E-Z-HD?
Production must comply with FDA GMP standards, requiring rigorous quality control, batch testing, and ongoing regulatory oversight.

5. Is there potential for new competitors to enter the E-Z-HD market?
While possible, high barriers such as regulatory approval, formulation complexity, and manufacturing standards currently limit new entrants. Future innovations could alter this landscape.

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Sources
[1] U.S. Food and Drug Administration. Center for Veterinary Medicine, Veterinary Drug Approvals.
[2] Apex Laboratories Corporate Website.
[3] Veterinary Pharmaceutical Industry Reports 2022.
[4] Contract Manufacturing Organization Profiles.