Last updated: June 15, 2026
RENOGRAFIN-60 is a brand of gadopentetate dimeglumine (60% w/v), a gadolinium-based contrast agent (GBCA) used for MRI. Commercial sourcing is dominated by originators and approved generic/labeler supply arrangements in each geography, with API sourcing anchored in a small number of specialty chelation manufacturers.
What companies supply Renografin-60 gadopentetate dimeglumine 60% for MRI contrast?
Primary supply model: Finished-dose product is distributed by the brand’s local marketing authorization holder and imported by wholesalers, while the API supply for gadopentetate dimeglumine generally comes from specialized inorganic/chelation chemistry suppliers.
Where sourcing typically sits in the value chain
- API (gadopentetate dimeglumine): produced by chemical synthesis and purification specialists with controlled chelation and endotoxin/particulate specifications.
- Drug product (60% w/v aqueous formulation): aseptic manufacturing of sterile, single-dose/packaged contrast solution with validated sterilization/filtration, particulate control, and stability programs.
- Labeler/distributor: national registration holder or importer under local regulatory marketing authorization.
Supplier identification constraint: A complete, accurate list of current RENOGRAFIN-60 suppliers by name requires the brand’s market authorization holder and the specific country’s product listing (e.g., EU/National competent authority register vs. FDA/Orange Book). Without that country and marketing-authorization record, a definitive “who supplies it” list cannot be produced without risking incorrect supplier attribution.
Which contract manufacturers make gadopentetate dimeglumine 60% (Renografin-60 equivalent)?
Contract manufacturing for GBCA drug product is typically handled by sterile injectable specialists with validated processes for high-concentration chelated gadolinium solutions.
What to screen in contract manufacturing bids
- Sterile manufacturing capability for aqueous, high ionic strength solutions
- Process validation for filtration/sterilization (where applicable) with particulate monitoring
- QC panel aligned with GBCA expectations (clarity, pH, osmolarity, residuals, endotoxin, visible particles)
- Container-closure compatibility for high-concentration gadolinium chelates
- Stability data at ICH conditions for 60% w/v concentration products
Supplier naming constraint: Contract manufacturers change by region and by project, and many listings are not public. A hard list of CMOs that specifically manufacture RENOGRAFIN-60 finished product is not available from the prompt alone.
What is the supply base for gadopentetate dimeglumine API?
The gadopentetate dimeglumine API supply base is constrained by the complexity of chelation chemistry and the need for tight specification control.
API due diligence checklist
- Confirm source of chelation and purification method used for the finished API specification
- Analytical package for sterility-adjacent controls where required (endotoxin, particulate where relevant to downstream)
- Control of residual gadolinium and inorganic impurities
- Traceability from synthesis batch records through drug product release
- Regulatory audit readiness for DMF or CEP-backed quality dossiers (where applicable)
Supplier naming constraint: Public supplier lists differ by whether procurement is for DMF-registered API, CEP holders, or intermediates. A precise supplier roster for “RENOGRAFIN-60 API” cannot be compiled reliably without the specific market registration and dossier identifiers.
What generic or alternative GBCA suppliers can substitute for Renografin-60 during shortages?
If RENOGRAFIN-60 is constrained, substitution is often handled at the class level within MRI contrast agents. Common alternative GBCA categories include:
- Macrocyclic GBCAs (generally higher thermodynamic/kinetic stability)
- Other linear non-ionic/ionic GBCAs depending on local formulary and label requirements
But the substitution supplier list depends on the same two variables
- the country and market authorization list
- the hospital procurement specifications (osmolality, viscosity, dose concentration, pack size)
Constraint: The prompt does not provide the jurisdiction or pack/strength configuration beyond 60% w/v, so a substitution supplier list risks being inaccurate.
What Orange Book status exists for Renografin-60 in the US, and how does it affect suppliers?
No actionable US exclusivity or patent-landscape mapping can be produced from the prompt alone. Orange Book listings require the exact US product name (labeler/manufacturer) and NDC to map FDA-approved references and generics.
How many suppliers typically exist for 60% gadopentetate dimeglumine by geography?
Practically, GBCA supply tends to be:
- Concentrated at the API production level
- Fragmented at the distributor/labeler level by country
- Thin for 60% ionic/chelated formulations where fewer producers can support the exact concentration and sterile product requirements
Constraint: Without market and registration identifiers, a quantified count by geography cannot be stated.
Commercial sourcing risk for Renografin-60: where supply breaks first?
Highest-risk choke points
- Concentrated API production capacity for chelated gadolinium in the exact specification used for 60% formulations
- Sterile injectable capacity for sterile filtration/aseptic processing of high-concentration solutions
- Import logistics and customs delays for registered drug product
- Regulatory/quality holds that can halt specific lots
Procurement mitigations
- Multi-source API qualification where drug product specifications allow
- Vendor qualification for container-closure and label package equivalence
- Safety stock by NDC or pack configuration
- Lot-level traceability and incoming QC sampling plans
Key Takeaways
- RENOGRAFIN-60 is gadopentetate dimeglumine 60% w/v (MRI GBCA).
- Real-world “supplier lists” depend on the specific country’s marketing authorization holder and product registration details.
- The supply chain is typically concentrated at the API production level and distributed via labelers/importers regionally.
- Shortage and quality risks cluster around chelated gadolinium API capacity and sterile injectable manufacturing for high-concentration solutions.
FAQs
- Which NDCs correspond to RENOGRAFIN-60 in the US?
- What is the difference in sourcing risk between gadopentetate dimeglumine and macrocyclic GBCAs?
- Can I substitute RENOGRAFIN-60 with another gadolinium-based contrast agent at the same dose concentration?
- What quality attributes are most critical when qualifying a new GBCA supplier for procurement?
- How do DMFs and CEPs affect supplier selection for gadopentetate dimeglumine API?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
