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Iopamidol API Manufacturers & Suppliers

13 verified results
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Commercial-scale Suppliers

Distributor
Produced in  India
|

Employees: 25

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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MSDS
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BSE/TSE
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ISO9001

All certificates

GMP
FDA
MSDS
BSE/TSE
ISO9001
CoA
Distributor
Produced in  United States
|

Employees: 50+

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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MSDS
|
BSE/TSE
|
ISO9001
|
CoA

All certificates

GMP
MSDS
BSE/TSE
ISO9001
CoA
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Distributor
Produced in  China
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
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MSDS
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BSE/TSE
|
ISO9001

All certificates

GMP
CEP
MSDS
BSE/TSE
ISO9001
WC
CoA
Producer
Produced in  India
|

Employees: 19

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
CoA

All certificates

GMP
FDA
CoA
Producer
Produced in  China
|

Employees: 10+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
USDMF
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MSDS
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CoA

All certificates

GMP
USDMF
MSDS
CoA
Producer
Produced in  Italy
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
USDMF
|
CoA

All certificates

GMP
USDMF
CoA
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Producer
Produced in  South Korea
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: CEP
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coa

All certificates

CEP
coa
Producer
Produced in  Portugal
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
JDMF
|
CoA

All certificates

GMP
JDMF
CoA
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Producer
Produced in  South Korea
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
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CEP
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WC
|
coa

All certificates

GMP
FDA
CEP
WC
coa
Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Not active
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Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
USDMF
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ISO
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coa

All certificates

GMP
FDA
USDMF
ISO
coa
ISO 9001
WC
KDMF
Not active
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Iopamidol | CAS No: 60166-93-0 | GMP-certified suppliers

A medication that supports diagnostic imaging by enhancing visualization of vascular and anatomical structures in CT and angiographic procedures across key clinical settings.

Therapeutic categories

Acids, CarbocyclicBenzene DerivativesBenzoatesCompounds used in a research, industrial, or household settingContrast MediaDiagnostic Uses of Chemicals
Generic name
Iopamidol
Molecule type
small molecule
CAS number
60166-93-0
DrugBank ID
DB08947
Approval status
Approved drug
ATC code
V08AB04

Product Snapshot

  • Iopamidol is a nonionic, water‑soluble contrast agent supplied as an injectable solution for intravascular, intrathecal, and related imaging routes
  • It is used for diagnostic radiographic procedures requiring iodinated contrast, including CT and angiographic applications
  • It holds approved status in the US and Canada

Clinical Overview

Iopamidol (CAS 60166-93-0) is a nonionic, low‑osmolar iodinated contrast agent widely used to enhance visualization during diagnostic imaging procedures. Its primary clinical applications include intravascular administration for computed tomography and angiography, as well as intrathecal and cavity administration when appropriate formulations are used. The compound is an iodobenzene derivative containing three iodine atoms on a benzoic acid core, contributing to its radiodensity.

Pharmacologically, iopamidol acts as a passive radiographic marker. Following administration, the tri‑iodinated aromatic structure absorbs X‑rays, increasing contrast between vascular or anatomical structures and surrounding tissues. The molecule does not undergo receptor-mediated interactions and exhibits minimal protein binding.

Absorption is route dependent. After intravenous administration, distribution is largely confined to the extracellular fluid compartment. Iopamidol is not metabolized and is eliminated almost entirely through renal excretion via glomerular filtration, with a plasma half‑life of approximately two hours in individuals with normal renal function. Clearance is significantly prolonged in renal impairment, necessitating careful risk assessment.

Safety considerations focus on the potential for contrast‑induced nephrotoxicity, hypersensitivity reactions, and adverse events associated with intrathecal use. Low osmolarity reduces but does not eliminate the risk of renal stress or neurotoxicity. Adequate hydration, screening for renal dysfunction, and avoidance of excessive cumulative iodine load are standard precautions. Adverse reactions may include nausea, warmth, headache, or transient hemodynamic changes, with rare but serious anaphylactoid responses.

Iopamidol is marketed in multiple concentration‑specific formulations for imaging applications and is used globally in hospital and diagnostic center settings. Product selection depends on route of administration and required iodine concentration.

For API procurement, suppliers should provide verifiable data on assay purity, iodine content uniformity, osmolality profile, and residual solvent levels. Compliance with major pharmacopeial monographs and validated control of iodinated impurity profiles are essential to ensure consistent performance in finished contrast media products.

Identification & chemistry

Generic name Iopamidol
Molecule type Small molecule
CAS 60166-93-0
UNII JR13W81H44
DrugBank ID DB08947

Formulation & handling

  • Highly water‑soluble, nonlipophilic small‑molecule contrast agent formulated as high‑strength aqueous solutions for intravascular, intrathecal, and other parenteral uses.
  • Formulations require control of viscosity and osmolality; solutions are typically supplied ready‑to‑use with attention to thermal handling to maintain appropriate flow characteristics.
  • Oral and rectal solutions are used diagnostically and generally require no specialized food‑related considerations beyond standard contrast‑medium administration.

Regulatory status

LifecyclePatent protections in the US and Canada appear to be at or near expiry, indicating that the API is transitioning into a mature stage of its lifecycle. Market conditions are consistent with increasing generic availability and a stable, established therapeutic role.
MarketsUS, Canada
Supply Chain
Supply chain summaryIopamidol was originally developed by a single innovator manufacturer, after which production expanded to multiple firms supplying finished formulations and API. Branded and unbranded presentations are well established in the US and Canada, indicating mature global commercial availability. Core patents have long expired, supporting the presence of existing generic competition in these markets.

Iopamidol is a type of Diagnostic agents


Diagnostic agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the field of medical diagnostics. These agents play a vital role in diagnosing various diseases and conditions by aiding in the visualization and identification of specific biomarkers or structures within the body.

Diagnostic agents encompass a wide range of substances, including contrast agents, radiopharmaceuticals, and imaging agents. Contrast agents are commonly used in medical imaging techniques such as X-rays, magnetic resonance imaging (MRI), and computed tomography (CT) scans. They enhance the visibility of certain tissues or organs, allowing healthcare professionals to detect abnormalities more accurately.

Radiopharmaceuticals are another type of diagnostic agent that combines a radioactive component with a pharmaceutical compound. These agents emit radiation that can be detected by specialized imaging equipment, enabling the visualization of metabolic processes and the identification of abnormal cellular activity.

Imaging agents are designed to target specific molecular structures or biomarkers within the body. They can be used to detect and visualize specific proteins, enzymes, or receptors associated with certain diseases or conditions. By targeting these specific biomarkers, imaging agents provide valuable information about the presence, location, and extent of a disease, aiding in diagnosis and treatment planning.

Overall, diagnostic agents are essential tools in modern medicine, facilitating accurate and timely diagnoses. These pharmaceutical APIs enable healthcare professionals to identify and monitor diseases at an early stage, leading to better patient outcomes and improved treatment strategies.

Iopamidol API manufacturers & distributors

Compare qualified Iopamidol API suppliers worldwide. We currently have 13 companies offering Iopamidol API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
China China CoA, GMP, MSDS, USDMF229 products
Distributor
China China BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC250 products
Producer
Italy Italy CoA, GMP, USDMF3 products
Producer
India India CoA, FDA, GMP, ISO9001, Other, KDMF, USDMF, WC47 products
Producer
South Korea South Korea CEP, CoA4 products
Producer
South Korea South Korea CoA, JDMF6 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products
Producer
Portugal Portugal CoA, GMP, JDMF16 products
Distributor
United States United States BSE/TSE, CoA, GMP, ISO9001, MSDS144 products
Producer
India India CoA, FDA, GMP515 products
Distributor
China China CoA162 products
Producer
China China CEP, CoA, FDA, GMP, WC3 products
Producer
China China CoA, USDMF4 products

When sending a request, specify which Iopamidol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Iopamidol API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

Frequently asked questions about Iopamidol API


Sourcing

What matters most when sourcing GMP-grade Iopamidol?
When sourcing GMP‑grade Iopamidol, confirm that the API is manufactured under GMP standards appropriate for the US and Canada. Given mature commercial availability and generic competition, verify supplier regulatory compliance and traceability across the supply chain. It is also important to ensure consistent documentation to support regional quality and registration requirements.
Which documents are typically required when sourcing Iopamidol API?
Request the core API documentation set: CoA (13 companies), GMP (9 companies), ISO9001 (4 companies), USDMF (4 companies), FDA (4 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Iopamidol API?
Known or reported manufacturers for Iopamidol: Aurora Industry Co., Ltd, Apino Pharma Co., Ltd., Global Pharma Tek, SETV Global, Rochem International, Inc.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Iopamidol API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Iopamidol manufacturers?
Audit reports may be requested for Iopamidol: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Iopamidol API on Pharmaoffer?
Reported supplier count for Iopamidol: 13 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Iopamidol API?
Production countries reported for Iopamidol: China (5 producers), India (3 producers), South Korea (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Iopamidol usually hold?
Common certifications for Iopamidol suppliers: CoA (13 companies), GMP (9 companies), ISO9001 (4 companies), USDMF (4 companies), FDA (4 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Iopamidol (CAS 60166-93-0) used for?
Iopamidol is used as a nonionic, low‑osmolar iodinated contrast agent to enhance visualization during diagnostic imaging. It is administered intravascularly for computed tomography and angiography, and may also be used intrathecally or in body cavities when appropriate formulations are selected. Its tri‑iodinated structure increases X‑ray absorption, improving contrast between anatomical structures.
Which therapeutic class does Iopamidol fall into?
Iopamidol belongs to the following therapeutic categories: Acids, Carbocyclic, Benzene Derivatives, Benzoates, Compounds used in a research, industrial, or household setting, Contrast Media. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What should someone know about the safety or toxicity profile of Iopamidol?
Iopamidol has a generally predictable safety profile, but its use carries risks of contrast‑induced nephrotoxicity, hypersensitivity reactions, and neurotoxicity with intrathecal administration. Renal impairment increases systemic exposure, so hydration and renal screening are important precautions. Common reactions include transient warmth, nausea, headache, or hemodynamic changes, while severe anaphylactoid responses are rare. Low osmolarity reduces but does not eliminate these risks.
What are important formulation and handling considerations for Iopamidol as an API?
Iopamidol is formulated as high‑strength, aqueous solutions; its high water solubility and nonlipophilic nature guide the use of simple, water‑based systems for parenteral and enteric administration. Formulations require controlled viscosity and osmolality to ensure appropriate injectability and diagnostic performance. Solutions are typically supplied ready to use, with thermal handling important to maintain flow characteristics. Oral and rectal preparations follow standard contrast‑medium administration without special dietary requirements.
Is Iopamidol a small molecule?
Iopamidol is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Iopamidol?
Oral Iopamidol is supplied as a ready‑to‑use aqueous solution and does not have unique stability issues beyond those typical for contrast‑medium handling. It should be stored and handled according to standard thermal recommendations to maintain viscosity and flow characteristics. No special food‑related or additional stability precautions are noted for the oral preparation.

Regulatory

Where is Iopamidol approved or in use globally?
Iopamidol is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Iopamidol right now?
Iopamidol is regulated for medical use in the United States and Canada, where it is approved as a contrast agent under established national frameworks. Patent status differs by jurisdiction and is not addressed in this overview, so only regulatory positioning in these two markets is described here.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Iopamidol procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Iopamidol. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Iopamidol included in the PRO Data Insights coverage?
PRO Data Insights coverage for Iopamidol: 466 verified transactions across 70 suppliers and 60 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Iopamidol?
Market report availability for Iopamidol: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.