Last updated: June 8, 2026
ISOVUE-M 200 suppliers: who manufactures, kits, and supplies iopamidol injection (200 mg I/mL) for US distribution
Executive summary: ISOVUE-M 200 (iopamidol injection, 200 mg iodine/mL) is supplied in the US market by Bristol Myers Squibb (BMS) through its commercial and distribution structure, with iopamidol and finished-dose manufacturing supply tied to BMS’s contract manufacturing network for sterile injectable products. The precise upstream supplier names (API/iopamidol producer, sterile-fill/finish plants, vial/closure packaging suppliers) are typically not listed publicly at the granularity needed for a definitive “named supplier” roster because US prescribing and distributor materials generally do not disclose component-level sourcing. Public disclosures that would identify named upstream suppliers are usually limited to confidential CMO/CMO-to-CMO arrangements, FDA facility registrations not mapped to finished-goods identities, or Orange Book/BLA-level documents that do not enumerate ingredient suppliers.
Result: A complete, auditable supplier list that identifies named upstream manufacturers for ISOVUE-M 200 components cannot be produced from publicly available sourcing in a way that is both complete and accurate.
Who is the supplier/manufacturer of ISOVUE-M 200 in the US market?
Answer (public-facing): ISOVUE-M 200 is distributed under the BMS commercial umbrella. The market-facing “supplier/manufacturer” on labeling materials for ISOVUE-M 200 is Bristol Myers Squibb (company responsible for the marketed product under its label).
What does “supplier” mean for ISOVUE-M 200?
- Labeler/sponsor: typically the marketing authorization holder responsible for product lot release.
- Finished-dose manufacturer (drug product): the sterile fill-finish site used for injection manufacturing.
- API supplier (iopamidol): producer of iopamidol active ingredient.
- Packaging component suppliers: vial type, rubber closures, seals, and cartons, often sourced from industrial component suppliers.
Publicly accessible sources usually identify the first category (labeler) but not the remaining categories for this product.
What manufacturing sites (CMOs) produce ISOVUE-M 200 sterile injection?
Answer: Named CMO/sterile fill-finish site(s) for ISOVUE-M 200 cannot be stated with completeness and accuracy from public sources alone. FDA facility registration data can show manufacturing establishments that may be associated with iopamidol-containing sterile injectables, but it does not provide a clean, product-specific mapping that ties a specific facility to ISOVUE-M 200 lots.
Which FDA listings help locate facilities?
- Drug establishment registration and listing (DERL): identifies facilities registered for drug products, but mapping to a single NDC and strength may require cross-referencing multiple datasets and is not always sufficient for a definitive “CMO for ISOVUE-M 200” identification.
- BLA/ANDA-type references: ISOVUE-M 200 is an older, marketed iodinated contrast product; public documents that enumerate manufacturing sites may not exist at the level needed for a strict supplier roster.
What suppliers provide the iopamidol active ingredient used in ISOVUE-M 200?
Answer: A named list of iopamidol API producers used specifically for ISOVUE-M 200 cannot be produced with a complete, accurate “supplier roster” from public sources. While iopamidol is manufactured by multiple chemical producers globally, the specific API supply chain used for a particular branded product is typically not disclosed publicly.
Why is API supplier disclosure limited?
- Contract manufacturing and supply chain arrangements are commonly confidential.
- FDA public datasets generally identify facility registrations and product classes, not which API producer feeds which branded label at the lot level.
How do labeling and Orange Book entries affect supplier identification for ISOVUE-M 200?
Answer: Orange Book coverage and patent listings generally do not enumerate component-level suppliers for branded injectables. Even when patent and exclusivity information exists, it does not provide iopamidol API or sterile fill-finish supplier names.
What Orange Book typically does and does not provide
- Does provide: drug identifiers, active ingredient, dosage form, route, and relevant exclusivity/patent data.
- Does not provide: named upstream API suppliers, vial/closure suppliers, or specific CMO plant names mapped to the branded product.
What packaging suppliers are used for ISOVUE-M 200 (vials, closures, cartons)?
Answer: Named packaging component suppliers for ISOVUE-M 200 are not publicly identified in a way that supports a definitive supplier list.
What can be inferred vs. what can be proven
- Many sterile injectable vials and closures are sourced from global packaging manufacturers.
- However, product labels and standard public documentation do not reliably disclose the exact packaging supplier tied to each NDC presentation of ISOVUE-M 200.
Which companies supply ISOVUE-M 200 under distribution or private label channels?
Answer: ISOVUE-M 200 is marketed under its branded label with BMS as the labeler/sponsor. Private-label channel suppliers are not typically listed for this product in public materials in a way that supports a confident named roster.
How many suppliers are in the ISOVUE-M 200 supply chain and where are the bottlenecks?
Answer (structural): The supply chain has at least four supplier layers:
- iopamidol API producers
- sterile drug product manufacturers (sterile fill-finish)
- packaging component suppliers (vials, closures, seals)
- logistics and distribution networks (wholesale distributors under BMS label governance)
Bottlenecks typically occur at:
- sterile fill-finish capacity for high-volume iodinated contrast sterile injectables
- availability of qualified packaging components
- API supply continuity for iopamidol
What generic or biosimilar competition implies about alternative suppliers?
Answer: For iodinated contrast media injectables, generic competition often exists for iopamidol strengths and formats, but supplier substitution does not automatically mean substitution into ISOVUE-M 200’s supply chain. The branded label’s supply chain is controlled through BMS procurement and CMO/contract arrangements.
Does competition change ISOVUE-M 200’s supplier roster?
- It can change the supplier ecosystem for the molecule overall.
- It does not automatically change the branded product’s internal sourcing unless BMS changes its contract manufacturing or procurement.
Key takeaways
- The public, auditable “supplier” for ISOVUE-M 200 at the product level is Bristol Myers Squibb (labeler/distributor role).
- A complete named roster of upstream suppliers (iopamidol API producers, sterile fill-finish CMO sites, vial/closure packaging suppliers) cannot be produced accurately from publicly available sources at the granularity required.
- The most material supply-chain nodes for continuity risk are iopamidol API supply and sterile fill-finish capacity.
FAQs
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What is the active ingredient in ISOVUE-M 200?
ISOVUE-M 200 contains iopamidol injection, 200 mg iodine/mL.
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Who is listed as the manufacturer/sponsor on ISOVUE-M 200 labeling?
Bristol Myers Squibb is the labeler/sponsor on the marketed product materials.
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Are iopamidol API suppliers publicly listed for ISOVUE-M 200?
Public sources generally do not disclose named iopamidol API suppliers specific to ISOVUE-M 200.
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Can FDA facility registration data identify the exact CMO for ISOVUE-M 200?
FDA registration data can list facilities registered for relevant drug manufacturing categories, but it does not reliably map to the exact ISOVUE-M 200 finished-goods manufacturer without additional product-lot linkage.
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What parts of the supply chain are most likely to cause ISOVUE-M 200 shortages?
Sterile fill-finish capacity, iopamidol API availability, and qualified packaging component supply are the dominant risk areas for sterile iodinated contrast injectables.
References (APA)
- U.S. Food and Drug Administration. Drug Establishment Registration and Drug Listing (DERP/DESI) databases. FDA.
- U.S. FDA Orange Book database. Therapeutic Equivalence Evaluations and patent/exclusivity listings (where applicable). FDA.
- ISOVUE-M 200 prescribing information and US label materials (Bristol Myers Squibb). FDA labeling repository.
