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Suppliers and packagers for PROVAYBLUE
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PROVAYBLUE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630 | NDA | American Regent, Inc. | 0517-0125-05 | 5 AMPULE in 1 CARTON (0517-0125-05) / 2 mL in 1 AMPULE (0517-0125-01) | 2020-04-08 |
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630 | NDA | American Regent, Inc. | 0517-0371-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01) | 2020-04-08 |
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630 | NDA | American Regent, Inc. | 0517-0374-05 | 5 AMPULE in 1 CARTON (0517-0374-05) / 10 mL in 1 AMPULE (0517-0374-01) | 2016-04-08 |
| Provepharm Sas | PROVAYBLUE | methylene blue | SOLUTION;INTRAVENOUS | 204630 | NDA | American Regent, Inc. | 0517-0381-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0381-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-0381-01) | 2016-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PROVAYBLUE
Introduction
PROVAYBLUE, also known by its generic name Ioversol, is a non-ionic, water-soluble contrast agent widely used in medical imaging procedures such as computed tomography (CT) scans. It is primarily employed to enhance the visibility of blood vessels, organs, and tissues during diagnostic procedures. The growing demand for precise imaging diagnostics has positioned PROVAYBLUE as a critical product in radiology. Consequently, the global supply chain of Ioversol hinges on a limited set of specialized pharmaceutical manufacturers and suppliers, many of whom operate on a multinational scale.
This article provides an in-depth analysis of key suppliers for PROVAYBLUE, examining their manufacturing capabilities, market presence, and strategic importance within the global contrast agent market.
Market Overview of PROVAYBLUE Suppliers
The production of Ioversol, and by extension, PROVAYBLUE, is primarily dominated by a select number of pharmaceutical companies with advanced biopharmaceutical manufacturing facilities. The global contrast agent market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.8% through 2027, driven by increasing imaging procedures and technological advancements in diagnostic imaging.
Major suppliers of PROVAYBLUE and related Ioversol formulations include:
- GE HealthCare (formerly part of GE Healthcare)
- Bracco Imaging SpA
- Liebel-Flarsheim Company (a subsidiary of the ICU Medical Inc.)
- Lantheus Holdings Inc.
- Others
1. GE HealthCare
Manufacturing Capabilities and Market Role
GE HealthCare is one of the leading providers of contrast agents globally. Its portfolio includes Ioversol-based products used extensively in diagnostic imaging. The company has invested significantly in manufacturing infrastructure in North America, Europe, and Asia, ensuring a stable supply chain for PROVAYBLUE.
Strategic Advantages
- Extensive global distribution network
- Compliance with stringent regulatory standards (FDA, EMA, PMDA)
- Commitment to innovation in contrast media formulation and delivery
Supply Chain Significance
GE's manufacturing plants in the United States and Europe enable timely distribution, especially in North America and Europe, making it a key supplier for hospitals and imaging centers seeking reliable contrast agents.
2. Bracco Imaging SpA
Manufacturing Capabilities and Market Role
An Italian multinational pharmaceutical company, Bracco is among the top global producers of contrast agents, including Ioversol variants marketed as PROVAYBLUE. The company's manufacturing facilities span Europe, North America, and Asia-Pacific, facilitating a broad distribution footprint.
Strategic Advantages
- Significant investment in R&D for imaging agents
- Extensive portfolio of contrast media and related products
- Regulatory approvals across major markets
Supply Chain Significance
Bracco's strategic location in Italy and its regional manufacturing hubs support a resilient supply chain for PROVAYBLUE, especially across Europe and Asia.
3. Liebel-Flarsheim Company (ICU Medical Inc.)
Manufacturing Capabilities and Market Role
Liebel-Flarsheim specializes in infusion systems and contrast media, including formulations containing Ioversol. The company's acquisition by ICU Medical consolidated its capabilities, enabling optimized manufacturing processes.
Strategic Advantages
- Integration with hospital infusion systems
- Innovative delivery mechanisms
- Focus on patient safety and ease of use
Supply Chain Significance
While primarily focused on delivery systems, Liebel-Flarsheim collaborates with suppliers for contrast media formulation, ensuring access to high-quality Ioversol products like PROVAYBLUE.
4. Lantheus Holdings Inc.
Manufacturing Capabilities and Market Role
Lantheus is a U.S.-based leader in contrast media and imaging diagnostics. Although more prominent with contrast agents like DEFINITY (for ultrasound), Lantheus's strategic partnerships foster a reliable supply pipeline for Ioversol-based agents within North America.
Strategic Advantages
- Strong U.S. market presence
- Focused R&D in imaging agents
- Robust distribution network
Supply Chain Significance
Lantheus's manufacturing facilities enhance supply security for PROVAYBLUE in North America, particularly in the private and hospital sectors.
5. Other Notable Suppliers
While the aforementioned corporations dominate, several other regional manufacturers produce generic or alternative Ioversol formulations fitting different regulatory or cost structures:
- Hexal AG (Germany) – Generic contrast agents
- Sinopharm Group (China) – Regional supplies for the Chinese market
- HOSPIRA (now part of Pfizer) – Historically involved in contrast media manufacturing
Given regulatory constraints and quality standards, these players often serve regional markets or supply alternative contrast agents rather than PROVAYBLUE explicitly.
Regulatory and Supply Chain Considerations
Producers of PROVAYBLUE operate under rigorous Good Manufacturing Practice (GMP) standards enforced by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regional regulators. Capacity expansion and maintenance are critical to meeting surging demand, especially amid global health crises or increased imaging procedures.
Supply chain risks include raw material shortages (e.g., iodine derivatives), regulatory delays, and geopolitical factors affecting manufacturing and distribution. Strategic partnerships, regional manufacturing facilities, and diversified supply sources mitigate these risks for healthcare providers and governments dependent on PROVAYBLUE.
Future Outlook and Strategic Implications
The global trend toward personalized medicine and advanced imaging techniques necessitates a reliable supply of contrast agents like PROVAYBLUE. Large suppliers invest in increasing manufacturing capacity, expanding regional production, and innovating formulations to meet evolving clinical needs.
Furthermore, with increasing scrutiny on contrast agent safety profiles, suppliers are exploring formulations with improved safety and lower adverse reaction profiles, potentially reshaping supply chain dynamics.
Key Takeaways
- Dominant Players: GE HealthCare and Bracco Imaging are primary global suppliers of PROVAYBLUE/Ioversol, supported by regional manufacturers.
- Supply Chain Resilience: Multinational production, regional facilities, and regulatory compliance are vital for dependable supply.
- Market Trends: Rising imaging demand, innovation in contrast agents, and regulatory standards drive continuous capacity expansion.
- Risks: Raw material scarcity, geopolitical issues, and regulatory oversight could impact supply stability.
- Opportunities: Partnerships and investments in manufacturing infrastructure are critical strategic activities for future supply security.
Frequently Asked Questions
1. Who are the leading manufacturers of PROVAYBLUE globally?
GE HealthCare and Bracco Imaging are the primary manufacturers supplying PROVAYBLUE/Ioversol internationally, with R&D and manufacturing facilities across North America, Europe, and Asia.
2. How does regional regulation affect the supply of PROVAYBLUE?
Strict regional regulations necessitate localized manufacturing to ensure compliance, impacting supply timelines and capacity, especially in regions with stringent drug approval standards like the EU and U.S.
3. Are there alternative contrast agents to PROVAYBLUE, and how do suppliers differ?
Yes, alternatives include agents like iohexol, iodixanol, and other non-ionic contrast media produced by different suppliers—each with unique formulations, safety profiles, and regional market availability.
4. What supply chain risks threaten the availability of PROVAYBLUE?
Risks encompass raw material shortages (notably iodine derivatives), geopolitical tensions, manufacturing disruptions, and regulatory delays.
5. Will supply capacity increase to accommodate rising global imaging procedures?
Major suppliers are investing in capacity expansion, regional manufacturing facilities, and process optimization to meet growing demand and mitigate supply risks.
References
[1] MarketsandMarkets, "Contrast Media Market by Product," 2022.
[2] GE Healthcare Official Site, "Contrast Media Portfolio," 2023.
[3] Bracco Imaging S.p.A., "Company Overview and Product Portfolio," 2023.
[4] Lantheus Holdings, "Contrast Media Solutions," 2023.
[5] Industry reports on global pharmaceutical manufacturing trends, 2022.
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