- Raw materials
- Diagnostic agents
- Gadodiamide
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Gadodiamide API Manufacturers & Suppliers
4 verified results
All Gadodiamide data. Full access. Full negotiation power
Commercial-scale Suppliers
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Gadodiamide | CAS No: 131410-48-5 | GMP-certified suppliers
A medication that enhances MRI visualization of vascular lesions in the brain, spine, and body cavities, and aids in detecting arterial stenosis via magnetic resonance angiography.
Therapeutic categories
Primary indications
- Gadodiamide is indicated for the visualization of lesions with abnormal vascularity in the brain (intracranial lesions), spine, and associated tissues and the body (including the thoracic (noncardiac), abdominal, pelvic cavities, and retroperitoneal space) by the FDA and Health Canada
- Additionally, gadoliamide is approved by Health Canada to detect and localize tenosis in renal arteries and aorto-iliac arteries in magnetic resonance angiography (MRA)
Product Snapshot
- Gadodiamide is an intravenous injectable solution used as a contrast agent
- It is primarily indicated for visualization of abnormal vascular lesions in the brain, spine, and body tissues, including use in magnetic resonance angiography for renal and aorto-iliac arteries
- Gadodiamide is approved by the FDA in the US and Health Canada for clinical imaging applications
Clinical Overview
Pharmacodynamically, gadodiamide acts by influencing proton relaxation times in tissues. As a paramagnetic compound containing unpaired electrons, gadodiamide generates local magnetic fields that accelerate the reorientation of water protons within an external magnetic field. This mechanism decreases both T1 and T2 relaxation times; however, at clinically relevant doses, enhancement predominantly arises from the shortening of T1 relaxation times, which increases signal intensity on MR images. The agent's accumulation occurs preferentially in areas with disrupted blood-brain barriers or abnormal vascularity, including neoplasms, abscesses, and subacute infarcts. Precise pharmacokinetic parameters within pathological lesions remain undetermined.
The mechanism of action rests on gadodiamide's magnetic moment induced upon exposure to the MRI’s external magnetic field, which modifies relaxation rates of proximate water protons, thereby selectively increasing contrast in affected tissues.
Key safety considerations are linked to gadodiamide’s linear, non-ionic structure, which is less stable than macrocyclic or ionic GBCAs. This lower stability can contribute to increased gadolinium retention in the brain, raising concerns regarding potential toxicity and side effects. The drug’s elimination primarily occurs via renal excretion, necessitating caution in patients with impaired renal function to mitigate risks such as nephrogenic systemic fibrosis (NSF).
For sourcing or procurement of gadodiamide API, suppliers should ensure compliance with stringent quality control parameters, including gadolinium content, chelate stability, purity, and absence of free gadolinium ions. Adherence to pharmacopeial standards and regulatory guidelines is essential to maintain product consistency and patient safety in pharmaceutical formulations.
Identification & chemistry
| Generic name | Gadodiamide |
|---|---|
| Molecule type | Small molecule |
| CAS | 131410-48-5 |
| UNII | 84F6U3J2R6 |
| DrugBank ID | DB00225 |
Pharmacology
| Summary | Gadodiamide is a paramagnetic contrast agent used to enhance magnetic resonance imaging (MRI) by shortening the T1 and T2 relaxation times of water protons in tissues. It selectively accumulates in areas with abnormal vascularity or disrupted blood-brain barriers, altering local magnetic environments to increase signal intensity on MRI scans. Its primary application includes visualization of intracranial and body lesions, as well as vascular abnormalities in magnetic resonance angiography. |
|---|---|
| Mechanism of action | Gadodiamide paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body. Its use in magnetic resonance imaging (MRI) allows to selectively increase contrast in tissues where gadodiamide accumulates. |
| Pharmacodynamics | In magnetic resonance imaging, visualization of normal and pathologic tissue depends in part on variations in the radiofrequency signal intensity. These variations occur due to: changes in proton density; alteration of the spin-lattice or longitudinal relaxation time (T1); and variation of the spin-spin or transverse relaxation time (T2). Gadodiamide is a paramagnetic agent with unpaired electron spins which generate a local magnetic field. As water protons move through this local magnetic field, the changes in the magnetic field experienced by the protons reorient them with the main magnetic field more quickly than in the absence of a paramagnetic agent. By increasing the relaxation rate, gadodiamide decreases both the T1 and T2 relaxation times in tissues where it is distributed. At clinical doses, the effect is primarily on the T1 relaxation time and produces an increase in signal intensity. Disruption of the blood-brain barrier or abnormal vascularity allows the accumulation of gadodiamide in lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetic parameters of gadodiamide in various lesions are not known. |
ADME / PK
| Absorption | The pharmacokinetics of intravenously administered gadodiamide in normal subjects conforms to an open, two-compartment model. |
|---|---|
| Half-life | The mean distribution and elimination half-lives (reported as mean ± SD) were calculated to be of 3.7 ± 2.7 minutes and 77.8 ± 16 minutes, respectively. |
| Protein binding | Gadodiamide does not bind to human serum proteins in vitro. |
| Metabolism | There is no detectable biotransformation or decomposition of gadodiamide. |
| Route of elimination | Gadodiamide is eliminated primarily in the urine with 95.4 ± 5.5% (mean ± SD) of the administered dose eliminated by 24 hours. |
| Volume of distribution | The volume of distribution of gadodiamide (200 ± 61 mL/kg) is equivalent to that of extracellular water. Following GBCA administration, gadolinium is present for months or years in the brain, bone, skin, and other organs. |
| Clearance | The renal and plasma clearance rates of gadodiamide are nearly identical (1.7 and 1.8 mL/min/kg, respectively), and are similar to that of substances excreted primarily by glomerular filtration. |
Formulation & handling
- Gadodiamide is formulated exclusively for intravenous injection as a sterile aqueous solution.
- As a small molecule with high water solubility and negative LogP, it requires consideration of solvent compatibility during formulation.
- Handling should ensure maintenance of solution stability, avoiding exposure to conditions that may compromise the integrity of the liquid form.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's key patents expired between 2011 and 2013 in the United States and Canada, indicating it is in a mature market phase with potential generic competition in these regions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Gadodiamide is primarily manufactured and packaged by a single originator company with products marketed in the US and Canada under the brand name Omniscan. Existing patent expirations in the US and Canada indicate that generic competition may already be present or forthcoming in these markets. There is no indication of branded product presence outside North America. |
|---|
Safety
| Toxicity | GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. In animal reproduction studies, no adverse fetal effects were observed with the administration of gadodiamide to pregnant rats during organogenesis at doses 1.3 times the maximum human dose based on body surface area. Because of the potential risks of gadolinium to the fetus, use gadodiamide only if imaging is essential during pregnancy and cannot be delayed. Clinical consequences of overdose with gadodiamide have not been reported. The minimum lethal dose of intravenously administered gadodiamide in rats and mice is greater than 20 mmol/kg (200 times the recommended human dose of 0.1 mmol/kg; 67 times the cumulative 0.3 mmol/kg dose). Gadodiamide is dialyzable. Long-term animal studies have not been performed to evaluate the carcinogenic potential of gadodiamide. The results of the following genotoxicity assays were negative: in vitro bacterial reverse mutation assay, in vitro Chinese Hamster Ovary (CHO)/Hypoxanthine Guanine Phosphoribosyl Transferase (HGPT) forward mutation assay, in vitro CHO chromosome aberration assay, and the in vivo mouse micronucleus assay at intravenous doses of 27 mmol/kg (approximately 7 times the maximum human dose based on a body surface area comparison). Impairment of male or female fertility was not observed in rats after intravenous administration three times per week at the maximum dose tested of 1.0 mmol/kg (approximately 0.5 times the maximum human dose based on a body surface area comparison). |
|---|
- Gadodiamide crosses the placenta, resulting in fetal exposure and gadolinium retention
- Animal studies show no adverse fetal effects at doses up to 1
- 3 times the human dose, but potential fetal risks warrant restricted use during pregnancy
Gadodiamide 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.
Gadodiamide API manufacturers & distributors
Compare qualified Gadodiamide API suppliers worldwide. We currently have 4 companies offering Gadodiamide API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Dongkook Pharma | Producer | South Korea | South Korea | CoA, JDMF | 6 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, JDMF | 36 products |
| GE Healthcare | Producer | New Zealand | Unknown | CoA, JDMF | 4 products |
| kiama research labs | Producer | India | India | BSE/TSE, CoA, FDA, GDP, GMP, ISO9001, MSDS, USDMF, WC | 1 products |
When sending a request, specify which Gadodiamide 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 Gadodiamide 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.
