Find Gadopiclenol manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

US DMFs Filed

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

KDMF

KDMF

0

NDC API

NDC API

0

VMF

NDC API

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

Health Canada Patents

API REF. PRICE (USD/KG)

$
$ 0

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

0

API

0

FDF

DIGITAL CONTENT

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: Unii-s276568koy, Gadopiclenol [usan], S276568koy, Elucirem, P03277, Who 10744
Molecular Formula
C35H54GdN7O15
Molecular Weight
970.1  g/mol
InChI Key
GNRQMLROZPOLDG-UHFFFAOYSA-K
FDA UNII
S276568KOY

Gadopiclenol
Gadopiclenol is a gadolinium-based paramagnetic contrast agent, with potential imaging enhancing activity upon magnetic resonance imaging (MRI). Upon administration of gadopiclenol and placement in a magnetic field, this agent produces a large magnetic moment and creates a large local magnetic field, which can enhance the relaxation rate of nearby protons. This change in proton relaxation dynamics, increases the MRI signal intensity of tissues in which this agent has accumulated; therefore, contrast and visualization of those tissues is enhanced compared to unenhanced MRI.
1 2D Structure

Gadopiclenol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[3,9-bis[1-carboxylato-4-(2,3-dihydroxypropylamino)-4-oxobutyl]-3,6,9,15-tetrazabicyclo[9.3.1]pentadeca-1(15),11,13-trien-6-yl]-5-(2,3-dihydroxypropylamino)-5-oxopentanoate;gadolinium(3+)
2.1.2 InChI
InChI=1S/C35H57N7O15.Gd/c43-19-24(46)14-36-30(49)7-4-27(33(52)53)40-10-12-41(28(34(54)55)5-8-31(50)37-15-25(47)20-44)17-22-2-1-3-23(39-22)18-42(13-11-40)29(35(56)57)6-9-32(51)38-16-26(48)21-45;/h1-3,24-29,43-48H,4-21H2,(H,36,49)(H,37,50)(H,38,51)(H,52,53)(H,54,55)(H,56,57);/q;+3/p-3
2.1.3 InChI Key
GNRQMLROZPOLDG-UHFFFAOYSA-K
2.1.4 Canonical SMILES
C1CN(CC2=NC(=CC=C2)CN(CCN1C(CCC(=O)NCC(CO)O)C(=O)[O-])C(CCC(=O)NCC(CO)O)C(=O)[O-])C(CCC(=O)NCC(CO)O)C(=O)[O-].[Gd+3]
2.2 Other Identifiers
2.2.1 UNII
S276568KOY
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetic Acid, Alpha, Alpha', Alpha''-tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-, Gadolinium Salt (1:1)

2. Gadolinium 2,2',2''-(3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triyl)tris(5-((2,3-dihydroxypropyl)amino)-5-oxopentanoate)

2.3.2 Depositor-Supplied Synonyms

1. Unii-s276568koy

2. Gadopiclenol [usan]

3. S276568koy

4. Elucirem

5. P03277

6. Who 10744

7. 933983-75-6

8. P-03277

9. (alpha3,alpha6,alpha9-tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-kappan3,kappan6,kappan9,kappan15,kappao3,kappao6,kappao9)gadolinium

10. 2-[3,9-bis[1-carboxylato-4-(2,3-dihydroxypropylamino)-4-oxobutyl]-3,6,9,15-tetrazabicyclo[9.3.1]pentadeca-1(15),11,13-trien-6-yl]-5-(2,3-dihydroxypropylamino)-5-oxopentanoate;gadolinium(3+)

11. Gadopiclenolum

12. Vueway

13. Gadopiclenol [inn]

14. Schembl21682611

15. Gbca P03277

16. P 03277

17. Gadolinium-based Magnetic Resonance Contrast Agent P03277

18. (.alpha.3,.alpha.6,.alpha.9-tris(3-((2,3-dihydroxypropyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-.kappa.n3,.kappa.n6,.kappa.n9,.kappa.n15,.kappa.o3,.kappa.o6,.kappa.o9)gadolinium

19. Gadolinium, (.alpha.3, .alpha.6, .alpha.9-tris(3-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-.kappa.n3, .kappa.n6, .kappa.n9, .kappa.n15, .kappa.o3, .kappa.o6, .kappa.o9)

20. Gadolinium, (alpha3, Alpha6, Alpha9-tris(3-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-3-oxopropyl)-3,6,9,15-tetraazabicyclo(9.3.1)pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-kappan3, Kappan6, Kappan9, Kappan15, Kappao3, Kappao6, Kappao9)

2.4 Create Date
2007-07-23
3 Chemical and Physical Properties
Molecular Weight 970.1 g/mol
Molecular Formula C35H54GdN7O15
Hydrogen Bond Donor Count9
Hydrogen Bond Acceptor Count19
Rotatable Bond Count21
Exact Mass g/mol
Monoisotopic Mass g/mol
Topological Polar Surface Area352
Heavy Atom Count58
Formal Charge0
Complexity1200
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count6
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Gadopiclenol is indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).


Detection and visualization of disorders or lesions with suspected abnormal vascularity in various body regions for diagnostic purposes


Detection and visualisation of areas with disruption of the blood brain barrier and/or abnormal vascularity for diagnostic purposes


5 Pharmacology and Biochemistry
5.1 ATC Code

V - Various

V08 - Contrast media

V08C - Magnetic resonance imaging contrast media

V08CA - Paramagnetic contrast media

V08CA12 - Gadopiclenol


5.2 Absorption, Distribution and Excretion

Absorption

At a dose range between 0.025 mmol/kg and 0.3 mmol/kg (0.5 times to 6 times the recommended dosage), the Cmax and AUCinf of gadopiclenol increases in a dose-proportional manner. At the recommended dose, gadopiclenol has a Cmax of 525 g/mL and an AUCinf of 569 gh/mL. A study that evaluated the pharmacokinetic parameters of gadopiclenol in healthy subjects and patients with brain lesions did not detect significant differences between the two groups.


Route of Elimination

Gadopiclenol is mainly excreted in urine by glomerular filtration. Within 48 hours after administration, approximately 98% of the gadopiclenol dose was recovered in urine.


Volume of Distribution

At steady state, the mean volume of distribution of gadopiclenol is 13 L.


Clearance

Gadopiclenol has a total body clearance of 100 mL/min and a renal clearance of 81 mL/min.


5.3 Metabolism/Metabolites

Gadopiclenol is not metabolized and is eliminated unchanged.


5.4 Biological Half-Life

Gadopiclenol has a mean elimination half-life of is 1.5 hours.


5.5 Mechanism of Action

Gadopiclenol is a macrocyclic non-ionic complex of gadolinium and a 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 gadopiclenol accumulates.


API SUPPLIERS

read-more
read-more

01

Supriya Lifescience

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Supriya

02

GUERBET

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

ChemOutsourcing
Not Confirmed
arrow

GUERBET

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

arrow
ChemOutsourcing
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

read-more
read-more

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Gadopiclenol

About the Company : Supriya Lifescience Limited is a globally recognized, technology-driven manufacturer of APIs , CDMO & formulations, established in 1987. Headquartered in Mumbai, India, we operate ...

Supriya Lifescience Limited is a globally recognized, technology-driven manufacturer of APIs , CDMO & formulations, established in 1987. Headquartered in Mumbai, India, we operate a 3 times USFDA, 2 times EUGMP, Health Canada & numerous other regulatory approved API facility in Lote & a state-of-the-art formulation site in Ambernath. Founded by Dr. Satish Wagh, we are global leaders in therapeutic segments like antihistamines, antiallergics, vitamins, anesthetics, & anti-asthmatics. With a presence in over 86 countries and serving 1500+ customers, we are your trusted partner with 15+ USDMFs, 10+ CEPs, & a manufacturing capacity of 1050 KL.
Supriya

02

GUERBET

France
Coatings Trends
Not Confirmed
arrow

GUERBET

France
arrow
Coatings Trends
Not Confirmed

Gadopiclenol

About the Company : As an international pharmaceutical group, Guerbet is directly present in 18 countries by way of its affiliates. From Research & Development to distribution, we exert full control o...

As an international pharmaceutical group, Guerbet is directly present in 18 countries by way of its affiliates. From Research & Development to distribution, we exert full control over the entire range of our processes.The Group is headquartered in Villepinte (12 km from Paris) near the Charles de Gaulle airport. Most of the company's support services can be found here (Quality, Human Resources, Information Systems, Purchasing, Communications, Marketing, Finance, Strategic projects, Medical and Regulatory Affairs etc.).
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

read-more
read-more
  • Development Update

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 26, 2025

blank

01

UConn Health

Country
arrow
ChemOutsourcing
Not Confirmed

UConn Health

Country
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 26, 2025

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Bracco

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 09, 2024

blank

02

University of California, San Diego

Country
arrow
ChemOutsourcing
Not Confirmed

University of California, San Diego

Country
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 09, 2024

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Other Small Molecule

Sponsor: GUERBET

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 26, 2024

blank

03

University of Massachusetts, Worcester

Country
arrow
ChemOutsourcing
Not Confirmed

University of Massachusetts, Worcester

Country
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 26, 2024

blank

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Inapplicable

Therapeutic Area: Oncology Brand Name: Elucirem

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 28, 2023

blank

04

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Elucirem

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 28, 2023

blank

05

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 24, 2023

blank
  • Development Update

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Elucirem

Study Phase: Phase IVProduct Type: Other Small Molecule

Sponsor: GUERBET

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 20, 2023

blank

06

Johns Hopkins University

Country
arrow
ChemOutsourcing
Not Confirmed

Johns Hopkins University

Country
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Elucirem

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 20, 2023

blank

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 21, 2022

blank

07

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 21, 2022

blank

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 28, 2021

blank

08

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 28, 2021

blank

09

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 24, 2019

blank

Details:

Undisclosed


Lead Product(s): Gadopiclenol,Gadobutrol

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 14, 2019

blank

10

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 14, 2019

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATE SUPPLIERS

read-more
read-more

01

ChemOutsourcing
Not Confirmed
arrow
ChemOutsourcing
Not Confirmed
arrow

CAS Number : 99-32-1

End Use API : Gadopiclenol

About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...

blank

02

ChemOutsourcing
Not Confirmed
arrow
ChemOutsourcing
Not Confirmed
arrow

CAS Number : 138-60-3

End Use API : Gadopiclenol

About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

read-more
read-more

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Gadopiclenol

Brand Name :

Dosage Form : Injection

Dosage Strength : 48.51G/100ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

02

Bracco

Italy
ChemOutsourcing
Not Confirmed
arrow

Bracco

Italy
arrow
ChemOutsourcing
Not Confirmed

Gadopiclenol

Brand Name : Vueway

Dosage Form : Injection

Dosage Strength : 0.5 MMOL/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

03

Bracco

Italy
ChemOutsourcing
Not Confirmed
arrow

Bracco

Italy
arrow
ChemOutsourcing
Not Confirmed

Gadopiklenol

Brand Name : Vueway

Dosage Form : Solution for injection

Dosage Strength : 0.5 mmol/ml

Packaging : Vials 7.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

04

Bracco

Italy
ChemOutsourcing
Not Confirmed
arrow

Bracco

Italy
arrow
ChemOutsourcing
Not Confirmed

Gadopiklenol

Brand Name : Vueway

Dosage Form : Solution for injection

Dosage Strength : 0.5 mmol/ml

Packaging : Vials 10ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

05

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1.4553GM/3ML (485.1MG/ML)

Packaging :

Approval Date : 2022-09-21

Application Number : 216986

Regulatory Info : RX

Registration Country : USA

blank

06

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 3.63825GM/7.5ML (485.1MG/ML)

Packaging :

Approval Date : 2022-09-21

Application Number : 216986

Regulatory Info : RX

Registration Country : USA

blank

07

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 4.851GM/10ML (485.1MG/ML)

Packaging :

Approval Date : 2022-09-21

Application Number : 216986

Regulatory Info : RX

Registration Country : USA

blank

08

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 14.553GM/30ML (485.1MG/ML)

Packaging :

Approval Date : 2022-09-21

Application Number : 216986

Regulatory Info : RX

Registration Country : USA

blank

09

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 24.255GM/50ML (485.1MG/ML)

Packaging :

Approval Date : 2022-09-21

Application Number : 216986

Regulatory Info : RX

Registration Country : USA

blank

10

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 48.51GM/100ML (485.1MG/ML)

Packaging :

Approval Date : 2022-09-21

Application Number : 216986

Regulatory Info : RX

Registration Country : USA

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

read-more
read-more

01

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1.4553GM/3ML (485.1MG/ML)

Approval Date : 2022-09-21

Application Number : 216986

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

02

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 3.63825GM/7.5ML (485.1MG/ML)

Approval Date : 2022-09-21

Application Number : 216986

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

03

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 4.851GM/10ML (485.1MG/ML)

Approval Date : 2022-09-21

Application Number : 216986

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

04

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 7.2765GM/15ML (485.1MG/ML)

Approval Date : 2022-09-21

Application Number : 216986

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

05

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 14.553GM/30ML (485.1MG/ML)

Approval Date : 2022-09-21

Application Number : 216986

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

06

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 24.255GM/50ML (485.1MG/ML)

Approval Date : 2022-09-21

Application Number : 216986

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

07

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

Brand Name : ELUCIREM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 48.51GM/100ML (485.1MG/ML)

Approval Date : 2022-09-21

Application Number : 216986

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Europe

read-more
read-more

01

ChemOutsourcing
Not Confirmed
arrow
arrow
ChemOutsourcing
Not Confirmed

Gadopiklenol

Brand Name : Vueway

Dosage Form : Solution for injection

Dosage Strength : 0.5 mmol/ml

Packaging : Vials 7.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

02

ChemOutsourcing
Not Confirmed
arrow
arrow
ChemOutsourcing
Not Confirmed

Gadopiklenol

Brand Name : Vueway

Dosage Form : Solution for injection

Dosage Strength : 0.5 mmol/ml

Packaging : Vials 30ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

03

ChemOutsourcing
Not Confirmed
arrow
arrow
ChemOutsourcing
Not Confirmed

Gadopiklenol

Brand Name : Vueway

Dosage Form : Solution for injection

Dosage Strength : 0.5 mmol/ml

Packaging : Vials 10ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Dossiers

read-more
read-more

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Gadopiclenol

Brand Name :

Dosage Form : Injection

Dosage Strength : 48.51G/100ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Gadopiclenol

Dosage : Injection

Dosage Strength : 48.51G/100ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

02

Bracco

Italy
ChemOutsourcing
Not Confirmed
arrow

Bracco

Italy
arrow
ChemOutsourcing
Not Confirmed

Gadopiclenol

Brand Name : Vueway

Dosage Form : Injection

Dosage Strength : 0.5 MMOL/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

02

Bracco

Italy
ChemOutsourcing
Not Confirmed
arrow

Bracco

Italy
arrow
ChemOutsourcing
Not Confirmed

Gadopiclenol

Dosage : Injection

Dosage Strength : 0.5 MMOL/ML

Brand Name : Vueway

Approval Date :

Application Number :

Registration Country : Italy

blank

03

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Gadopiclenol

Brand Name : Elucirem

Dosage Form : Injection

Dosage Strength : 0.5 MMOL/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

blank

03

GUERBET

France
ChemOutsourcing
Not Confirmed
arrow

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

Gadopiclenol

Dosage : Injection

Dosage Strength : 0.5 MMOL/ML

Brand Name : Elucirem

Approval Date :

Application Number :

Registration Country : France

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more

NEWS #PharmaBuzz

read-more
read-more

https://www.prnewswire.com/news-releases/bracco-diagnostics-inc-obtains-hallmark-achievement-of-one-million-injections-with-its-mri-agent-vueway-gadopiclenol-solution-for-injection-302300316.html

PR NEWSWIRE
11 Nov 2024

Global Sales Information

Do you need Business Intel? Ask us

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

read-more
read-more

01

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 10973934

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-08-06

blank

02

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 10973934

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-08-06

blank

03

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 11590246

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-01-17

blank

04

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 11590246

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-01-17

blank

05

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 8114863

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-09-19

blank

06

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 11590246

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-01-17

blank

07

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 8114863

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-09-19

blank

08

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 11590246

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-01-17

blank

09

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 8114863

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-09-19

blank

10

arrow
ChemOutsourcing
Not Confirmed

GUERBET

France
arrow
ChemOutsourcing
Not Confirmed

GADOPICLENOL

US Patent Number : 11590246

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 216986

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-01-17

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

Looking for 933983-75-6 / Gadopiclenol API manufacturers, exporters & distributors?

Gadopiclenol manufacturers, exporters & distributors 1

96

PharmaCompass offers a list of Gadopiclenol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gadopiclenol manufacturer or Gadopiclenol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadopiclenol manufacturer or Gadopiclenol supplier.

PharmaCompass also assists you with knowing the Gadopiclenol API Price utilized in the formulation of products. Gadopiclenol API Price is not always fixed or binding as the Gadopiclenol Price is obtained through a variety of data sources. The Gadopiclenol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gadopiclenol

Synonyms

Unii-s276568koy, Gadopiclenol [usan], S276568koy, Elucirem, P03277, Who 10744

Cas Number

933983-75-6

Unique Ingredient Identifier (UNII)

S276568KOY

About Gadopiclenol

Gadopiclenol is a gadolinium-based paramagnetic contrast agent, with potential imaging enhancing activity upon magnetic resonance imaging (MRI). Upon administration of gadopiclenol and placement in a magnetic field, this agent produces a large magnetic moment and creates a large local magnetic field, which can enhance the relaxation rate of nearby protons. This change in proton relaxation dynamics, increases the MRI signal intensity of tissues in which this agent has accumulated; therefore, contrast and visualization of those tissues is enhanced compared to unenhanced MRI.

Gadopiclenol Manufacturers

A Gadopiclenol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadopiclenol, including repackagers and relabelers. The FDA regulates Gadopiclenol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadopiclenol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Gadopiclenol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Gadopiclenol Suppliers

A Gadopiclenol supplier is an individual or a company that provides Gadopiclenol active pharmaceutical ingredient (API) or Gadopiclenol finished formulations upon request. The Gadopiclenol suppliers may include Gadopiclenol API manufacturers, exporters, distributors and traders.

click here to find a list of Gadopiclenol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Gadopiclenol GMP

Gadopiclenol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Gadopiclenol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Gadopiclenol GMP manufacturer or Gadopiclenol GMP API supplier for your needs.

Gadopiclenol CoA

A Gadopiclenol CoA (Certificate of Analysis) is a formal document that attests to Gadopiclenol's compliance with Gadopiclenol specifications and serves as a tool for batch-level quality control.

Gadopiclenol CoA mostly includes findings from lab analyses of a specific batch. For each Gadopiclenol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Gadopiclenol may be tested according to a variety of international standards, such as European Pharmacopoeia (Gadopiclenol EP), Gadopiclenol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gadopiclenol USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty