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Suppliers and packagers for generic pharmaceutical drug: barium sulfate
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barium sulfate
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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Barium Sulfate
Introduction
Barium sulfate is a vital inorganic compound predominantly used as a contrast agent in radiographic imaging and diagnostic procedures. Its high radiopacity makes it ideal for enhancing X-ray images of the gastrointestinal tract. As demand for diagnostic imaging surges, the supply chain for barium sulfate is critical for hospitals, diagnostic labs, pharmaceutical companies, and medical device manufacturers. This report examines the leading suppliers, global production trends, quality standards, and strategic considerations for stakeholders engaged in sourcing barium sulfate.
Global Market Overview and Demand Drivers
The global demand for barium sulfate is driven by the expanding healthcare sector, increased prevalence of gastrointestinal diseases, and technological advances in medical imaging. According to industry estimates, the market size for barium sulfate was valued at over USD 1.2 billion in 2021, with a Compound Annual Growth Rate (CAGR) of approximately 4% from 2022 to 2028 [1].
North America and Europe dominate the market, attributed to advanced healthcare infrastructure and stringent regulatory standards. Asia-Pacific nations, notably China and India, are rapidly increasing production capacity to meet domestic and international demands. The increasing adoption of minimally invasive diagnostic procedures further fuels the demand.
Leading Suppliers of Barium Sulfate
1. E. I. du Pont de Nemours and Company (DuPont)
DuPont is a pioneer in barium sulfate manufacturing, with a longstanding reputation for high-purity products used in medical imaging. Their E-Z-EM brand is highly regarded, supplying pharmaceutical-grade barium sulfate compliant with pharmacopeias such as USP and EP [2].
Product Focus: Pharmaceutical and diagnostic-grade barium sulfate, with specifications tailored for oral and rectal contrast agents.
Strengths: Consistent product quality, strong regulatory compliance, and extensive global distribution network.
2. Gioiello Corp.
An Italy-based specialty chemical supplier, Gioiello provides pharmaceutical-grade barium sulfate with high purity and tailored particle sizes. They prioritize product consistency and regulatory adherence, serving European markets and beyond [3].
Product Focus: Both standard and custom-formulated barium sulfate preparations for diagnostic imaging.
Strengths: Regulatory expertise within the European Union, customizable formulations.
3. Jiangsu Weihua Pharmaceutical Co., Ltd.
A prominent Chinese manufacturer recognized for large-scale production of pharmacopeia-grade barium sulfate. They supply globally, especially to emerging markets, with competitive pricing and efficient logistics.
Product Focus: Pharmaceutical-grade barium sulfate with high whiteness, high density, and stable particle size distribution.
Strengths: Cost competitiveness, large production capacity, compliance with international standards.
4. Solvay (a division of Solvay S.A.)
As a leader in specialty chemicals, Solvay produces high-quality barium sulfate used across multiple industries, including pharmaceuticals. Their offerings emphasize purity and particle control for precise diagnostic applications [4].
Product Focus: Pharmaceutical and technological grade barium sulfate.
Strengths: Innovation in particle size control, extensive R&D capabilities, and global reach.
5. Sakai Chemical Industry Co., Ltd.
A Japan-based chemical company specializing in high-purity inorganic compounds, Sakai supplies pharmaceutical-grade barium sulfate catering to Asian and global markets.
Product Focus: Purity and particle size-specific barium sulfate powders.
Strengths: High manufacturing standards, technological innovation, and robust quality assurance.
Quality and Regulatory Standards
Suppliers must comply with pharmacopeial standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). These standards specify parameters including purity, particle size, density, and bio-compatibility. Suppliers often obtain certifications such as ISO 9001, ISO 13485 (medical devices), and Good Manufacturing Practice (GMP) accreditation to assure quality.
Both pharmaceutical and medical device manufacturers prioritize suppliers with proven compliance history and transparent quality control protocols. The trend towards high-density, fine-particle barium sulfate demands suppliers maintain advanced milling and quality assurance technology.
Emerging Trends and Strategic Considerations
a. Global Supply Chain Resilience
Recent supply disruptions, exacerbated by the COVID-19 pandemic, underscore the importance of diversified sourcing strategies. Companies increasingly seek multiple suppliers across geographies to mitigate risks related to geopolitical tensions, natural disasters, or regulatory hurdles [5].
b. Sustainability and Environmental Considerations
Suppliers implementing eco-friendly practices—reducing waste, improving energy efficiency, and adhering to environmental regulations—are gaining favor. The production process's environmental footprint impacts procurement decisions, especially for large-volume buyers.
c. Customization and Particle Engineering
Innovations in particle size control, surface modification, and formulation customization enable suppliers to tailor products for specific imaging modalities, improving diagnostic clarity. Stakeholders require suppliers capable of delivering consistent particle morphology and density.
d. Regulatory Shifts
Stringent global regulations on pharmaceuticals and medical diagnostics necessitate suppliers' active engagement with evolving standards. Suppliers with robust regulatory affairs teams to manage submissions and compliance documentation are preferred.
Strategic Advice for Buyers
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Prioritize suppliers with proven compliance to international pharmacopeial standards (USP, EP, JP).
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Assess suppliers' capacity for customization, especially particle size and density control, to optimize imaging outcomes.
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Consider logistical capabilities and certifications for global distribution, particularly in emerging markets.
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Evaluate sustainability and environmental compliance as part of supplier due diligence.
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Maintain supplier diversification to enhance supply chain resilience amid unforeseen disruptions.
Key Takeaways
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The global barium sulfate market is dominated by established manufacturers such as DuPont, Solvay, and Jiangsu Weihua, with emerging regional players increasing capacity.
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Quality standards aligned with pharmacopeial specifications and regulatory compliance are non-negotiable for pharmaceutical and diagnostic applications.
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Supply chain resilience, innovation in particle engineering, and sustainable manufacturing practices are key differentiators for sourcing decisions.
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Strategic diversification of suppliers and proactive regulatory engagement can mitigate risks and ensure uninterrupted supply.
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Emerging markets present opportunities for cost-effective procurement but require rigorous quality oversight.
FAQs
1. What are the primary quality standards for pharmaceutical-grade barium sulfate?
Pharmaceutical-grade barium sulfate must meet criteria outlined by pharmacopeias such as USP, EP, or JP. Standards specify purity levels, particle size distribution, density, and biocompatibility. Suppliers with ISO 9001 or GMP certification typically adhere to these standards.
2. How does particle size impact the performance of barium sulfate as a contrast agent?
Smaller, uniformly sized particles enhance coating and suspension stability, providing clearer imaging with fewer artifacts. Custom particle engineering improves diagnostic accuracy and patient safety.
3. Are there environmental concerns associated with the production of barium sulfate?
Yes. The mining and processing of barium sulfate can generate waste and emissions. Leading suppliers adopt environmentally friendly practices, including waste management, energy-efficient processes, and regulatory compliance.
4. What role does geographic diversification play in supply chain management?
Diversification mitigates risks from regional disruptions, regulatory changes, or political instability in specific countries. Multiple sourcing ensures consistent supply and price stability.
5. How do regulatory changes influence supplier selection?
Evolving regulations require suppliers to demonstrate compliance with updated standards, documentation practices, and safety protocols. Buyers should select suppliers with proactive regulatory engagement and up-to-date certifications.
References
[1] MarketResearch.com, “Global Barium Sulfate Market Analysis,” 2022.
[2] DuPont, “E-Z-EM Barium Sulfate Product Portfolio,” 2023.
[3] Gioiello Corp., “Product Specifications and Regulatory Compliance,” 2022.
[4] Solvay, “High-Purity Barium Sulfate for Medical Imaging,” 2023.
[5] McKinsey & Company, “Supply Chain Resilience in Pharma,” 2022.
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