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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)
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)
Molecular Weight | 970.1 g/mol |
---|---|
Molecular Formula | C35H54GdN7O15 |
Hydrogen Bond Donor Count | 9 |
Hydrogen Bond Acceptor Count | 19 |
Rotatable Bond Count | 21 |
Exact Mass | g/mol |
Monoisotopic Mass | g/mol |
Topological Polar Surface Area | 352 |
Heavy Atom Count | 58 |
Formal Charge | 0 |
Complexity | 1200 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 6 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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
V - Various
V08 - Contrast media
V08C - Magnetic resonance imaging contrast media
V08CA - Paramagnetic contrast media
V08CA12 - Gadopiclenol
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.
Gadopiclenol is not metabolized and is eliminated unchanged.
Gadopiclenol has a mean elimination half-life of is 1.5 hours.
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.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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 ...
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...
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
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 26, 2025
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
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bracco
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 09, 2024
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
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : GUERBET
Deal Size : Inapplicable
Deal Type : Inapplicable
Gadopiclenol in Contrast Enhanced MRI of the Prostate
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 26, 2024
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
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
Details : Undisclosed
Product Name : Elucirem
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 28, 2023
Details:
Undisclosed
Lead Product(s): Gadopiclenol,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Bracco
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2023
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bracco
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 24, 2023
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
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : GUERBET
Deal Size : Inapplicable
Deal Type : Inapplicable
High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment
Details : Undisclosed
Product Name : Elucirem
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 20, 2023
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
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 21, 2022
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
Lead Product(s) : Gadopiclenol,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 28, 2021
Details:
Undisclosed
Lead Product(s): Gadopiclenol,Gadobutrol
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 24, 2019
Lead Product(s) : Gadopiclenol,Gadobutrol
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 24, 2019
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
Lead Product(s) : Gadopiclenol,Gadobutrol
Therapeutic Area : Undisclosed
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 14, 2019
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...
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...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 48.51G/100ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Italy
Brand Name : Vueway
Dosage Form : Injection
Dosage Strength : 0.5 MMOL/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 48.51G/100ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 48.51G/100ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Italy
Brand Name : Vueway
Dosage Form : Injection
Dosage Strength : 0.5 MMOL/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 0.5 MMOL/ML
Brand Name : Vueway
Approval Date :
Application Number :
Registration Country : Italy
Regulatory Info :
Registration Country : France
Brand Name : Elucirem
Dosage Form : Injection
Dosage Strength : 0.5 MMOL/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 0.5 MMOL/ML
Brand Name : Elucirem
Approval Date :
Application Number :
Registration Country : France
11 Nov 2024
// PR NEWSWIRE
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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.
A ELUCIREM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ELUCIREM, including repackagers and relabelers. The FDA regulates ELUCIREM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ELUCIREM 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 ELUCIREM manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ELUCIREM supplier is an individual or a company that provides ELUCIREM active pharmaceutical ingredient (API) or ELUCIREM finished formulations upon request. The ELUCIREM suppliers may include ELUCIREM API manufacturers, exporters, distributors and traders.
click here to find a list of ELUCIREM suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
ELUCIREM 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 ELUCIREM 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 ELUCIREM GMP manufacturer or ELUCIREM GMP API supplier for your needs.
A ELUCIREM CoA (Certificate of Analysis) is a formal document that attests to ELUCIREM's compliance with ELUCIREM specifications and serves as a tool for batch-level quality control.
ELUCIREM CoA mostly includes findings from lab analyses of a specific batch. For each ELUCIREM 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.
ELUCIREM may be tested according to a variety of international standards, such as European Pharmacopoeia (ELUCIREM EP), ELUCIREM JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ELUCIREM USP).