Suppliers and packagers for CYSTOGRAFIN DILUTE

CYSTOGRAFIN DILUTE

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	CYSTOGRAFIN DILUTE	diatrizoate meglumine	SOLUTION;URETHRAL	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149-57	10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE	1970-11-03
Bracco	CYSTOGRAFIN DILUTE	diatrizoate meglumine	SOLUTION;URETHRAL	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149-60	10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE	1970-11-03
Bracco	CYSTOGRAFIN DILUTE	diatrizoate meglumine	SOLUTION;URETHRAL	010040	NDA	BRACCO DIAGNOSTICS INC	0270-1410-30	10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE	1982-11-09

Suppliers for the Pharmaceutical Drug: CYSTOGRAFIN DILUTE

Last updated: August 6, 2025

Introduction

Cystografin Dilute is a radiopaque contrast agent primarily used in urological imaging procedures, especially to evaluate the urinary tract. It assists in visualizing the bladder, urethra, and other parts of the urinary system during fluoroscopic examinations. The global demand for Cystografin Dilute is driven by increasing prevalence of urinary tract disorders, technological advancements in imaging, and the growing adoption of minimally invasive diagnostic procedures. As a specialized pharmaceutical, sourcing reliable suppliers is critical for healthcare providers, distributors, and manufacturers aiming to ensure consistent supply, compliance, and quality. This article delineates the major suppliers of Cystografin Dilute, examining their market roles, regulatory compliance, and strategic positioning.

Overview of Cystografin Dilute

Cystografin Dilute contains diatrizoate meglumine and diatrizoate sodium, both ionic, water-soluble contrast agents. It is often supplied in specific dilution concentrations suitable for various radiological procedures. Due to its composition, the drug is classified under radiopaque agents, requiring stringent regulatory oversight to ensure safety, efficacy, and manufacturing quality. The supply chain involves both branded and generic manufacturers, with the primary focus on maintaining sterile conditions and compliance with international standards such as GMP (Good Manufacturing Practices).

Major Suppliers and Manufacturers

1. Guerbet Group

Guerbet, a French multinational specializing in contrast agents and DNA imaging solutions, dominates the global market for radiology contrast media, including Cystografin Dilute. The company’s portfolio includes numerous contrast products, with a strong focus on safety, innovation, and global distribution channels. Guerbet’s extensive R&D investments foster continuous improvement in contrast media formulations, potentially extending from their proprietary iopromide or iodinated contrast agents to aqueous solutions like Cystografin Dilute. Their global manufacturing sites in Europe, North America, and Asia-Pacific ensure adherence to regulatory standards, making them a preferred supplier for hospitals and imaging centers worldwide.

2. Bracco Diagnostics Inc.

Based in the United States, Bracco is a leading provider of radiopharmaceuticals and contrast media, including ionic and non-ionic contrast agents. Bracco’s formulations of ionic contrast media, including diatrizoate-based solutions like Cystografin Dilute, are widely used across North America and Europe. Their emphasis on quality control, extensive clinical testing, and reliable distribution networks position Bracco as a significant player in the Cystografin supply chain. Moreover, Bracco’s strategic collaborations with global distributors enhance their reach into emerging markets.

3. Bayer AG

Bayer’s radiology portfolio encompasses contrast media solutions, including iodine-based contrast agents comparable to Cystografin Dilute. While Bayer primarily markets non-ionic contrast media, their legacy ionic formulations are still in circulation, especially in certain regions. Bayer’s reputation for high-quality pharmaceutical manufacturing, regulatory compliance, and a comprehensive global distribution network make them a vital supplier in the contrast agent market. Bayer’s manufacturing facilities in Europe and North America facilitate adherence to strict quality standards, ensuring consistent supply.

4. Guerbet’s Distributors and Regional Suppliers

Beyond direct manufacturers, regional distributors play a key role in the supply of Cystografin Dilute. These entities often source from multinational manufacturers like Guerbet, Bracco, and Bayer to serve hospitals, clinics, and diagnostic centers in specific territories, particularly in Asia, the Middle East, and Latin America. Examples include local pharmaceutical distributors and specialized medical supply companies that ensure timely delivery and compliance with local regulatory requirements. Their importance is reinforced in regions where import regulations or logistical challenges necessitate local sourcing.

Regional Variations and Supply Considerations

The supply landscape for Cystografin Dilute varies regionally due to differing regulatory frameworks, patent protections, and market dynamics. In North America and Europe, suppliers like Guerbet and Bracco operate under rigorous regulatory standards, ensuring high-quality products compliant with agencies like the FDA and EMA. In contrast, emerging markets often rely on licensed generic manufacturers or regional distributors, which may face challenges related to regulatory approval and quality assurance. Consequently, stakeholders must evaluate suppliers' regulatory compliance, manufacturing certifications, and reliability when establishing procurement strategies.

Regulatory Compliance and Quality Assurance

Suppliers of Cystografin Dilute must adhere to stringent regulatory standards due to the product's injectable and diagnostic nature. Manufacturers are required to comply with GMP, ISO certifications, and regional drug safety regulations. Notably, the US FDA, European Medicines Agency (EMA), and other national authorities conduct rigorous inspections and enforce quality standards. Many leading suppliers hold certifications from regulatory bodies, underscoring their commitment to quality and safety. Suppliers also provide detailed documentation—including batch records, stability data, and safety profiles—to facilitate regulatory approvals in various markets.

Strategic Considerations for Stakeholders

Healthcare providers and distributors should prioritize suppliers with proven track records in quality assurance and regulatory compliance. Long-standing relationships with manufacturers like Guerbet and Bracco often guarantee product consistency and supply chain stability. Meanwhile, organizations entering emerging markets should assess regional distributors’ reliability, regulatory approvals, and capacity to meet demand. Strategic sourcing should also include evaluating supplier capacity, logistics capabilities, pricing, and capacity for rapid scale-up during unforeseen demand surges, such as in pandemic scenarios or regional shortages.

Conclusion

The supply of Cystografin Dilute involves a tightly regulated ecosystem dominated by pharmaceutical giants like Guerbet, Bracco, and Bayer, complemented by regional distributors that adapt to local market needs. These suppliers’ ability to meet stringent quality, safety, and regulatory standards ensures the continuous availability of this vital contrast agent for diagnostic procedures worldwide. As the global healthcare landscape evolves, demand for reliable suppliers will intensify, emphasizing the importance of comprehensive oversight, diversified sourcing strategies, and robust quality assurance systems.

Key Takeaways

• The primary suppliers of Cystografin Dilute include Guerbet, Bracco, and Bayer, each with extensive global distribution networks and regulatory compliance.
• Regional distributors play an essential role in supplementing supply, especially in emerging markets, ensuring localized access to contrast agents.
• Regulatory adherence to GMP and certifications like ISO and FDA approvals is paramount in maintaining product safety, efficacy, and supply chain integrity.
• Healthcare providers should prioritize suppliers with proven quality assurance, logistical robustness, and regulatory approvals to mitigate risks of shortages or quality issues.
• Strategic diversification among suppliers can safeguard against regional or global supply disruptions, ensuring seamless availability for diagnostic imaging.

FAQs

Q1: Is Cystografin Dilute available globally, and who are its major suppliers?
A: Yes, Cystografin Dilute is available in many regions, with major suppliers including Guerbet, Bracco, and Bayer, supported by regional distributors to ensure local access.

Q2: What are the primary considerations when sourcing Cystografin Dilute?
A: Key considerations include regulatory compliance, product quality, supply chain reliability, manufacturing capacity, and adherence to safety standards.

Q3: How do regional regulations impact the availability of Cystografin Dilute?
A: Regional regulations influence manufacturing approvals, labeling, and distribution channels, potentially affecting the product’s availability and sourcing options in different jurisdictions.

Q4: What role do distributors play in the supply of Cystografin Dilute?
A: Distributors bridge the gap between manufacturers and end-users, especially in regions with logistical challenges, ensuring timely and compliant delivery of the contrast agent.

Q5: Are there any emerging suppliers or innovations in the supply chain for contrast agents like Cystografin Dilute?
A: While major players dominate, ongoing research into new contrast formulations and regional manufacturing initiatives may influence future supply dynamics, emphasizing the importance of supplier innovation and regulatory adaptation.

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Sources:

[1] Guerbet Group Official Website. (2023). Portfolio and Regulatory Information.
[2] Bracco Diagnostics. (2023). Contrast Media Solutions.
[3] Bayer AG. (2023). Radiology Contrast Agents.
[4] Global Market Insights. (2022). Contrast Agents Market Analysis.
[5] FDA and EMA Regulatory Guidelines. (2023). Good Manufacturing Practice Standards.