Last updated: April 25, 2026
Who supplies CYSTOGRAFIN (iothalamate meglumine) and who manufactures it?
What is CYSTOGRAFIN?
CYSTOGRAFIN is a urinary tract contrast agent containing iothalamate meglumine (radiographic contrast used for cystography and related urinary imaging). The market supply chain is split between:
- Brand/marketers (sell under the CYSTOGRAFIN name in specific geographies)
- Manufacturers (produce iothalamate meglumine drug substance and/or the finished sterile injectable product)
Which companies supply or manufacture CYSTOGRAFIN?
CYSTOGRAFIN is supplied by different entities by country and pack/label configuration. The consistent pattern across regulatory and commercial footprints is that Sterling/Bracco-era historical brands and major European generic/sterile injectables supply chains commonly appear for iothalamate meglumine contrast products. However, a definitive “supplier list” for CYSTOGRAFIN requires product-specific regulatory documents (SmPC/labeling and marketing authorization holder in each country) tied to the exact strength and pack.
Country-by-country supply is not uniform
For contrast agents, the same active ingredient often has:
- Multiple brand names
- Multiple marketing authorizations
- Multiple sterile manufacturing sites
As a result, “suppliers for CYSTOGRAFIN” must be interpreted as “who is the marketing authorization holder and who is listed as manufacturer on the product label in each market.”
What do regulatory labels typically identify for CYSTOGRAFIN supply?
On the EU side (for centrally authorized and many national authorizations), the supply chain is typically described as:
- Marketing Authorization Holder (MAH): the entity responsible for regulatory submissions for that product/strength/pack.
- Manufacturer: the entity (or entities) responsible for:
- Manufacturing of the active ingredient (less common to list in full detail on consumer labels)
- Manufacturing of the finished medicinal product (sterile filling)
- Batch release (often the same entity or a contract testing site)
On the US side, the product is tied to:
- NDC-labeled manufacturer/labeler (the entity appearing on the NDC directory and label)
- Potential CDMO manufacturing sites for sterile injectables
Who are the known iothalamate meglumine brand suppliers historically associated with CYSTOGRAFIN?
CYSTOGRAFIN is historically associated with Bracco-linked contrast portfolios in many markets for iothalamate meglumine products. In practice, brands in this class often shift manufacturing over time via CDMO arrangements, so the “current” finished-product manufacturer can change even when the brand owner stays the same.
Because you asked for “Suppliers for CYSTOGRAFIN” (not “the active ingredient iothalamate meglumine”), the supplier list must be sourced from:
- The exact CYSTOGRAFIN product label (manufacturer + MAH)
- The exact country authorization (where the label is used)
- The exact strength and pack (for instance, different presentations can list different manufacturers)
What is the actionable way to map CYSTOGRAFIN suppliers?
Use a two-field mapping that decision-makers can operationalize fast:
- MAH (marketing authorization holder / labeler)
- Listed manufacturer(s) (site-level if named)
This produces a supplier roster that is directly usable for:
- R&D partner selection
- Supply-chain risk review
- Contract manufacturing outreach
- Regulatory gap assessment for reformulation or supply continuity
Supplier mapping template (use for each country/pack)
| Field |
What to extract from CYSTOGRAFIN label/regulatory text |
Why it matters |
| Marketing/Labeler |
Company name appearing as MAH or labeler |
Determines who controls regulatory ownership and supply allocation |
| Finished product manufacturer |
Company and address/site for manufacturing and/or batch release |
Determines the real sterile injectable supply capability |
| Drug substance manufacturer (if listed) |
Company for iothalamate meglumine substance |
Determines sourcing continuity and cost base |
Key Takeaways
- “Suppliers for CYSTOGRAFIN” varies by geography, strength, and pack because marketing authorization holders and sterile manufacturing sites change by market.
- The only defensible supplier roster is the one extracted from the CYSTOGRAFIN label/regulatory listing for each market presentation.
- The fastest operational mapping is to capture MAH/labeler and listed finished-product manufacturer(s) per country and pack.
FAQs
1) Is CYSTOGRAFIN supplied by one global manufacturer?
No. Sterile injectable manufacturing and label/regulatory ownership vary by country and presentation.
2) Does the iothalamate meglumine supplier equal the CYSTOGRAFIN supplier?
Not necessarily. The drug substance maker can differ from the finished sterile product manufacturer.
3) Where do you find the finished-product manufacturer for CYSTOGRAFIN?
On the product label and regulatory documentation for that specific market/strength/pack.
4) Can CYSTOGRAFIN’s manufacturer change while the brand remains?
Yes. Contract manufacturing and batch release arrangements can shift over time.
5) What is the minimum supplier data required for sourcing decisions?
Marketing/labeler plus the finished-product manufacturer listed for the exact CYSTOGRAFIN presentation.
References
[1] FDA. “NDC Directory.” U.S. Food and Drug Administration, accessed 2026-04-26.
[2] European Commission. “Union Register of medicinal products.” European Commission, accessed 2026-04-26.
[3] DailyMed. “CYSTOGRAFIN (iothalamate meglumine) injection label information.” U.S. National Library of Medicine, accessed 2026-04-26.
