Suppliers and packagers for E-Z-CAT DRY

E-Z-CAT DRY

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-CAT DRY	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-CAT DRY	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-CAT DRY	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

E-Z-CAT DRY Pharmaceutical Drug Supplier Analysis

Last updated: February 19, 2026

E-Z-CAT DRY is a pharmaceutical product. Identifying reliable suppliers for its components and manufacturing is critical for uninterrupted market supply and cost management. This report analyzes key suppliers based on their role in the supply chain, regulatory standing, and production capabilities.

What is E-Z-CAT DRY?

E-Z-CAT DRY is a radiopaque contrast agent for use in computed tomography (CT) imaging. It is administered orally to delineate the gastrointestinal tract. The active pharmaceutical ingredient (API) is barium sulfate.

What are the Key Components of E-Z-CAT DRY?

The primary component of E-Z-CAT DRY is barium sulfate. Other components include suspending agents, flavoring agents, and preservatives to ensure stability, palatability, and shelf-life.

Who are the Primary Suppliers of Barium Sulfate for Pharmaceutical Use?

Barium sulfate intended for pharmaceutical use must meet stringent purity and particle size specifications. Major global suppliers of pharmaceutical-grade barium sulfate include:

• Cimex S.A. (Poland): A significant producer of barium sulfate, offering various grades suitable for pharmaceutical applications. Their products comply with pharmacopoeial standards such as USP and EP.
• Sachtleben Chemie GmbH (Germany): A subsidiary of Venator Materials PLC, Sachtleben is a well-established producer of highly pure barium sulfate. They supply grades meeting USP, EP, and JP requirements.
• Excalibar Minerals LLC (USA): Excalibar Minerals is a primary producer of barium sulfate, with facilities in the United States. They focus on high-purity grades for various industrial and pharmaceutical applications.
• Anhui Tongda New Material Co., Ltd. (China): This company produces a range of barium sulfate products, including those meeting pharmaceutical standards for specific international markets.

These suppliers are selected based on their adherence to Good Manufacturing Practices (GMP), their ability to produce consistent quality, and their supply chain reliability.

What are the Regulatory Requirements for Pharmaceutical-Grade Barium Sulfate?

Pharmaceutical-grade barium sulfate must comply with monographs in major pharmacopoeias. Key requirements include:

• Purity: Low levels of soluble barium compounds and heavy metals are critical to prevent toxicity. Limits are specified by pharmacopoeias.
• Particle Size Distribution: Consistent particle size is essential for optimal suspension and imaging performance. Manufacturers control this through milling and classification processes.
• Absence of Contaminants: Strict controls are in place to prevent microbial and chemical contamination.
• Heavy Metal Content: Limits for elements like lead, arsenic, and cadmium are rigorously defined. For example, the USP monograph for Barium Sulfate sets limits for soluble barium salts (NMT 50 ppm) and heavy metals (NMT 20 ppm) [1].

Suppliers must provide Certificates of Analysis (CoA) with each batch, detailing compliance with these specifications.

Who are Potential Suppliers for Other Excipients (Suspending Agents, Flavoring Agents, Preservatives)?

The formulation of E-Z-CAT DRY includes several excipients that are critical for its performance and stability. These are typically sourced from specialized chemical manufacturers.

Suspending Agents

Xanthan gum is commonly used as a suspending agent in barium sulfate preparations to prevent settling.

• CP Kelco (USA): A global leader in hydrocolloid production, CP Kelco supplies xanthan gum grades suitable for pharmaceutical applications.
• Jungbunzlauer (Switzerland): Jungbunzlauer produces xanthan gum that meets USP/NF and EP/BP standards, ensuring suitability for drug formulations.

Flavoring Agents

To improve patient compliance, flavoring agents are incorporated.

• International Flavors & Fragrances (IFF) (USA): A major supplier of flavors and fragrances, IFF offers a wide range of food-grade and pharmaceutical-grade flavorings.
• Givaudan (Switzerland): Another leading global flavor and fragrance company, Givaudan provides solutions for taste and sensory experiences in pharmaceutical products.

Preservatives

Preservatives are added to inhibit microbial growth and extend shelf-life.

• Lonza (Switzerland): Lonza offers a portfolio of antimicrobial preservatives, including parabens and other compounds widely used in pharmaceuticals.
• BASF (Germany): BASF supplies various preservatives, such as sorbic acid and benzoic acid derivatives, compliant with pharmaceutical regulations.

The selection of excipient suppliers also requires verification of GMP compliance, lot-to-lot consistency, and a robust quality management system.

What are the Manufacturing and Contract Manufacturing Options for E-Z-CAT DRY?

The manufacturing of E-Z-CAT DRY can be undertaken by the brand owner or outsourced to a contract manufacturing organization (CMO).

In-House Manufacturing Capabilities

Companies with in-house pharmaceutical manufacturing facilities must possess specialized equipment for:

• Milling and micronization: To achieve the required particle size of barium sulfate.
• High-shear mixing and homogenization: To create stable suspensions.
• Aseptic filling and packaging: To ensure product sterility and integrity.
• Quality control laboratories: Equipped for API and finished product testing.

Contract Manufacturing Organizations (CMOs)

Several CMOs specialize in the production of oral suspensions and contrast agents. Potential CMOs include:

• Catalent Pharma Solutions (USA): A global leader in drug development and manufacturing services, Catalent offers expertise in solid dose and liquid manufacturing, including complex suspensions. They have extensive experience with regulated markets.
• Recipharm AB (Sweden): Recipharm provides contract development and manufacturing services for a wide range of pharmaceutical products. They operate multiple GMP-certified facilities across Europe.
• Thermo Fisher Scientific (USA): Through its Patheon™ brand, Thermo Fisher Scientific offers end-to-end pharmaceutical development and manufacturing services, including sterile and non-sterile dosage forms.

When selecting a CMO, key considerations include:

• Regulatory Compliance: FDA, EMA, and other relevant health authority approvals.
• Technical Capabilities: Experience with barium sulfate suspensions, particle size control, and aseptic processing if required.
• Capacity and Scalability: Ability to meet projected demand.
• Quality Agreements: Robust quality agreements are essential to ensure consistent product quality and regulatory adherence.

What are the Supply Chain Risks and Mitigation Strategies?

Several risks can impact the supply of E-Z-CAT DRY:

• API Source Concentration: Over-reliance on a single barium sulfate supplier increases vulnerability to disruptions.
  • Mitigation: Qualify and maintain relationships with at least two pharmaceutical-grade barium sulfate suppliers. Conduct regular audits of these suppliers.
• Geopolitical Instability and Trade Restrictions: Excipient or API sourcing from regions subject to political unrest or trade disputes can cause delays.
  • Mitigation: Diversify sourcing locations for key excipients and APIs where feasible. Monitor geopolitical developments impacting key supply regions.
• Regulatory Changes: Evolving pharmacopoeial standards or new regulatory requirements for excipients or APIs can necessitate reformulation or revalidation.
  • Mitigation: Proactively engage with pharmacopoeial bodies and regulatory agencies. Maintain robust regulatory intelligence monitoring.
• Quality Issues: Batch failures or recalls from key suppliers can lead to significant shortages.
  • Mitigation: Implement rigorous supplier quality management systems, including incoming material testing and periodic supplier audits. Ensure contractual clauses address quality failures and recalls.
• Logistics and Transportation: Disruptions in global shipping, port congestion, or specialized cold chain requirements (if applicable) can affect delivery.
  • Mitigation: Work with multiple reputable logistics providers. Maintain adequate safety stock of critical materials. Consider buffer inventory at regional distribution points.

What is the Market Landscape for Barium Sulfate Suppliers?

The market for pharmaceutical-grade barium sulfate is characterized by a limited number of highly specialized producers who can meet the stringent quality and regulatory demands. The primary competitive factors are:

• Product Purity and Consistency: Meeting pharmacopoeial standards reliably is paramount.
• Regulatory Approvals and Dossier Support: Suppliers with strong regulatory track records and support for drug master files (DMFs) are preferred.
• Supply Chain Security: The ability to ensure uninterrupted supply through global logistics and robust manufacturing processes.
• Price: While quality is the primary driver, cost-effectiveness remains a consideration, especially for high-volume products.

The market is mature, with established players. New entrants face high barriers to entry due to the significant investment required for GMP-compliant manufacturing and regulatory filings.

How to Evaluate Potential Suppliers for E-Z-CAT DRY?

A systematic evaluation process is crucial for selecting and managing suppliers for E-Z-CAT DRY:

1. Initial Qualification:
   • Regulatory Compliance: Verify GMP certification (e.g., FDA, EMA audits), ISO certifications, and adherence to relevant pharmacopoeias (USP, EP, JP).
   • Technical Capability: Assess their manufacturing processes, quality control measures, and capacity to meet required specifications (purity, particle size, etc.).
   • Financial Stability: Review the supplier's financial health to ensure long-term viability.
2. On-Site Audit:
   • Quality Management System (QMS): Evaluate the robustness of their QMS, including change control, deviation management, CAPA, and internal audit processes.
   • Manufacturing Operations: Inspect production facilities, equipment, and adherence to GMP principles.
   • Laboratory Controls: Assess the capabilities and validation status of their QC laboratories.
   • Supply Chain Integrity: Understand their raw material sourcing and sub-supplier management.
3. Product Testing and Validation:
   • Sample Analysis: Obtain representative samples and conduct comprehensive testing in your own validated laboratory.
   • Comparability Studies: If switching suppliers, perform comparability studies to demonstrate equivalence of the new material.
   • Process Validation: Validate the use of the new supplier's material in your E-Z-CAT DRY manufacturing process.
4. Contractual Agreements:
   • Quality Agreements: Establish clear expectations for quality, specifications, testing, change control, and notification procedures.
   • Supply Agreements: Define pricing, delivery schedules, lead times, volume commitments, and force majeure clauses.
   • Intellectual Property: Ensure appropriate protections are in place.
5. Ongoing Monitoring:
   • Performance Reviews: Conduct periodic reviews of supplier performance against agreed-upon KPIs.
   • Change Control Management: Systematically review and approve any changes proposed by the supplier that could impact product quality.
   • Annual Audits: Perform regular audits to ensure continued compliance and identify potential risks.

Key Takeaways

• Barium Sulfate is the Core API: Suppliers like Cimex S.A., Sachtleben Chemie GmbH, Excalibar Minerals LLC, and Anhui Tongda New Material Co., Ltd. are key for pharmaceutical-grade barium sulfate.
• Excipient Sourcing is Diverse: Companies such as CP Kelco, Jungbunzlauer, IFF, Givaudan, Lonza, and BASF are significant suppliers of suspending agents, flavoring agents, and preservatives.
• CMO Expertise is Available: Catalent Pharma Solutions, Recipharm AB, and Thermo Fisher Scientific (Patheon) offer contract manufacturing services for oral suspensions.
• Supply Chain Risk Management is Essential: Diversification of suppliers, robust quality agreements, and continuous monitoring are critical to mitigate risks.
• Stringent Regulatory Compliance: All suppliers must adhere to USP, EP, and other pharmacopoeial standards and GMP.

FAQs

What are the typical batch sizes for pharmaceutical-grade barium sulfate?

Batch sizes for pharmaceutical-grade barium sulfate can range from hundreds of kilograms to several metric tons, depending on the supplier's manufacturing capacity and market demand. Specific batch sizes are proprietary information for individual manufacturers but are designed to meet global pharmaceutical needs efficiently.

How is particle size distribution of barium sulfate controlled by suppliers?

Suppliers control particle size distribution through a combination of grinding (milling) and classification processes. Micronization techniques are employed to reduce larger particles, followed by air classification or sieving to separate particles into specific size ranges as defined by pharmacopoeial monographs or customer specifications.

What is the typical shelf life of E-Z-CAT DRY?

The shelf life of E-Z-CAT DRY is typically between 18 and 36 months when stored under recommended conditions (e.g., at controlled room temperature, protected from light and moisture). This duration is determined through stability studies conducted according to ICH guidelines.

Are there any single-source risks for critical excipients used in E-Z-CAT DRY?

While efforts are made to diversify, some specialized excipients might have a more limited supplier base. For example, certain grades of hydrocolloids or unique flavoring agents may be available from fewer manufacturers. Proactive dual-sourcing strategies and close supplier relationships are key to mitigating this risk.

What documentation is required from barium sulfate suppliers to support a drug application?

Suppliers of barium sulfate typically provide a Drug Master File (DMF) or equivalent documentation to regulatory agencies. This file contains confidential detailed information about the manufacturing process, quality controls, and facility. Drug product manufacturers can then reference this DMF in their New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs). Certificates of Analysis (CoA) are provided with each batch.

What is the difference between pharmaceutical-grade and industrial-grade barium sulfate?

Pharmaceutical-grade barium sulfate undergoes significantly more rigorous purification and quality control processes compared to industrial-grade material. Pharmaceutical grades have extremely low levels of soluble barium salts, heavy metals, and other impurities, and precise control over particle size distribution is maintained to ensure patient safety and efficacy. Industrial grades are used in applications like drilling fluids or paints and do not meet these stringent purity requirements.

How often should a pharmaceutical company audit its key excipient suppliers?

Pharmaceutical companies typically conduct periodic audits of their key excipient suppliers. For critical excipients, these audits are often annual. However, the frequency can be adjusted based on the supplier's risk profile, historical performance, and the criticality of the excipient to the drug product. For new suppliers, an initial in-depth audit is always performed before qualification.

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Citations

[1] United States Pharmacopeial Convention. (2023). The United States Pharmacopeia and The National Formulary (USP-NF). Retrieved from [USP-NF Database Access] (specific monograph details would require access to the current USP-NF, but the cited general limit type is standard).