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Suppliers and packagers for GASTROGRAFIN
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GASTROGRAFIN
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 | GASTROGRAFIN | diatrizoate meglumine; diatrizoate sodium | SOLUTION;ORAL, RECTAL | 011245 | NDA | Bracco Diagnostics Inc | 0270-0445-35 | 24 BOTTLE in 1 BOX (0270-0445-35) / 30 mL in 1 BOTTLE | 1958-02-26 |
| Bracco | GASTROGRAFIN | diatrizoate meglumine; diatrizoate sodium | SOLUTION;ORAL, RECTAL | 011245 | NDA | Bracco Diagnostics Inc | 0270-0445-40 | 12 BOTTLE in 1 BOX (0270-0445-40) / 120 mL in 1 BOTTLE | 1958-02-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Gastrografin
Introduction
Gastrografin, a water-soluble iodinated contrast agent primarily used in diagnostic imaging procedures like computed tomography (CT) and gastrointestinal (GI) studies, is a critical product within the pharmaceutical and medical device markets. Its unique formulation, comprising diatrizoate meglumine and diatrizoate sodium, enables effective visualization of the gastrointestinal tract, making it indispensable for clinicians worldwide. As demand for accurate diagnostic tools increases, understanding the landscape of suppliers for Gastrografin is vital for pharmaceutical companies, healthcare providers, and procurement specialists. This report provides a comprehensive overview of the key suppliers, market dynamics, and strategic considerations surrounding Gastrografin procurement.
Global Market Overview
The global market for GI contrast agents, including Gastrografin, is projected to grow steadily driven by rising incidences of gastrointestinal diseases, expanding imaging applications, and technological advancements in diagnostic techniques. According to industry reports, the global contrast media market is expected to reach USD 2.4 billion by 2027, with Gastrografin enjoying significant share due to its preferred properties in specific diagnostic scenarios[1].
Key Suppliers of Gastrografin
Several multinational pharmaceutical companies and specialized medical instrument manufacturers serve as suppliers, either through direct manufacturing or authorized distribution channels. The following delineates the primary suppliers, their geographic presence, and strategic positioning.
1. Bracco Diagnostics
Overview:
Bracco Diagnostics Inc., a subsidiary of the Italian pharmaceutical giant Bracco Group, is the primary manufacturer of Gastrografin. It is considered the original and most prominent supplier globally[2].
Product Portfolio:
Gastrografin (diatrizoate meglumine and sodium solutions) is part of Bracco’s extensive contrast agent portfolio used in imaging diagnostics.
Market Presence:
Bracco maintains a dominant position due to its extensive manufacturing facilities in North America, Europe, and Asia. The company supplies through direct channels and authorized distributors, ensuring widespread availability.
Strategic Significance:
Bracco’s longstanding reputation, extensive R&D investments, and compliance with international regulatory standards position it as the central supplier for Gastrografin globally.
2. Guerbet Group
Overview:
Guerbet, headquartered in France, is a prominent player in the contrast media market, providing a range of contrast agents, including formulations similar to Gastrografin, often used as substitutes or complementary products.
Product Portfolio & Role:
While Guerbet develops various iodine-based contrast agents (e.g., Lipiodol, Meglumine Diatrizoate), it does not directly manufacture Gastrografin but operates as a regional supplier or distributor in certain markets.
Regional Focus & Distribution:
Guerbet’s strong presence in Europe and Asia allows it to serve as a regional distributor, particularly in markets where Bracco’s direct presence is limited.
3. Sedico Medical
Overview:
Sedico Medical, based in India, specializes in manufacturing generic and over-the-counter contrast media, including diatrizoate-based solutions.
Role & Market Adoption:
While primarily focusing on regional markets, Sedico Medical supplies generic versions of diatrizoate solutions, which might serve as alternative options, albeit with different branding and minor formulation variations.
4. Contract Manufacturing Organizations (CMOs) and Distributors
In addition to major branded manufacturers, several third-party contract manufacturing organizations produce generic or branded contrast agents under licensing or contractual agreements. Major global distributors, such as Medline, Cardinal Health, and McKesson, facilitate the distribution of Gastrografin and similar products across healthcare facilities.
Regulatory and Patent Landscape
The original patent for Gastrografin has long expired, facilitating generic manufacturing in various regions. Regulatory approvals are essential for market entry; products must demonstrate bioequivalence, safety, and efficacy per regional health authorities like the FDA (USA), EMA (Europe), and CDSCO (India).
Bracco maintains exclusivity in certain jurisdictions through patents guarding manufacturing processes or formulations, but generic competitors have gained momentum in regions with patent expiries.
Market Entry and Procurement Considerations
Quality Assurance:
Suppliers must comply with cGMP (current Good Manufacturing Practices) standards and possess valid regulatory approvals to ensure product safety and efficacy.
Pricing and Supply Chain:
Pricing negotiations generally favor established suppliers like Bracco, but regional manufacturers may offer cost-effective alternatives with comparable quality, especially in emerging markets.
Distribution Channels:
Procurement strategies should evaluate distributor reliability, inventory management, and regional regulatory compliance to prevent supply disruptions.
Impact of Geopolitical Factors:
Trade policies, tariffs, and import restrictions influence supplier selection, especially for multinational organizations.
Emerging Trends and Strategic Outlook
-
Generic & Biosimilar Competition:
Patent expiries have paved the way for generic manufacturers, intensifying competitive pressure on branded suppliers. -
Regional Market Variability:
In regions like Asia, India, and Latin America, local manufacturers and distributors dominate, providing cost advantages but necessitating rigorous quality assessments. -
Supply Chain Resilience:
COVID-19 underscored vulnerabilities in global supply chains. Diversifying supplier bases and maintaining strategic inventories are critical tactics.
Key Takeaways
- Bracco remains the dominant global supplier, holding the original patent and extensive manufacturing infrastructure.
- Regional suppliers, including Guerbet, Sedico Medical, and various distributors, provide alternative options, especially in emerging markets.
- Regulatory compliance, quality assurance, and supply chain reliability are essential considerations for procurement decisions.
- The expiration of patents has increased the availability of generic alternatives, intensifying market competition.
- Strategic diversification and supplier evaluation are critical to maintaining a resilient supply of Gastrografin.
FAQs
1. Who is the primary manufacturer of Gastrografin globally?
Bracco Diagnostics is the primary and original manufacturer of Gastrografin worldwide, holding the original patent and manufacturing rights.
2. Are there generic alternatives to Gastrografin?
Yes. Patent expiries have enabled various regional manufacturers and generic producers to develop diatrizoate-based contrast agents that serve as alternatives.
3. What are key factors to consider when sourcing Gastrografin?
Quality assurance, regulatory compliance, supply chain reliability, pricing, and regional availability are critical procurement considerations.
4. How does regional market regulation affect supplier choice?
Different regions have varying approval processes, quality standards, and patent protections, influencing the eligibility and preference for certain suppliers.
5. What trends are expected to influence future supply of Gastrografin?
Increased competition from generics, technological advances, supply chain resilience initiatives, and regional regulation dynamics are shaping future supply strategies.
Sources
[1] MarketsandMarkets, “Contrast Agents Market by Type, Application, and Region - Global Forecast to 2027.”
[2] Bracco Group Official Website.
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