Synopsis
Synopsis
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CEP/COS
0
JDMF
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Europe
0
Canada
0
Australia
0
South Africa
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DRUG PRODUCT COMPOSITIONS
US Medicaid
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1. 2-(3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yloxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro(1,2,4)triazine-6-carbonitrile
2. Mgl-3196
1. Mgl-3196
2. 920509-32-6
3. Via-3196
4. Mgl 3196
5. 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile
6. Resmetirom [usan]
7. Mgl3196
8. Re0v0t1es0
9. Chembl3261331
10. 1,2,4-triazine-6-carbonitrile, 2-(3,5-dichloro-4-((1,6-dihydro-5-(1-methylethyl)-6-oxo-3-pyridazinyl)oxy)phenyl)-2,3,4,5-tetrahydro-3,5-dioxo-
11. 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-(1,2,4)triazine-6-carbonitrile
12. 2-[3,5-dichloro-4-[(6-oxo-5-propan-2-yl-1h-pyridazin-3-yl)oxy]phenyl]-3,5-dioxo-1,2,4-triazine-6-carbonitrile
13. 2-[3,5-dichloro-4-[(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy]phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile
14. Unii-re0v0t1es0
15. Resmetirom [inn]
16. Resmetirom (usan/inn)
17. Resmetirom (mgl-3196)
18. Schembl2927241
19. Gtpl12026
20. Via3196
21. Hms3746a03
22. Amy16881
23. Bcp24624
24. Ex-a2477
25. Vlb50932
26. Bdbm50012905
27. Mfcd26142653
28. S6663
29. Who 10850
30. Zinc34842512
31. Akos032945066
32. Cs-6179
33. Db12914
34. Sb16825
35. Compound 53 [pmid: 24712661]
36. Ac-31458
37. Bs-17855
38. Hy-12216
39. Sy289460
40. Db-127167
41. C77150
42. D11602
43. Q27288071
44. 2-(3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yloxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro(1,2,4)triazine-6-carbonitrile
45. 2-(3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yloxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile
46. 2-(4-(1,6-dihydro-5-isopropyl-6-oxopyridazin-3-yloxy)-3,5-dichlorophenyl)-2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazine-6-carbonitrile
47. 2-[3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydro-pyridazin-3-yloxy)-phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-[1,2,4]triazine-6-carbonitrile
Molecular Weight | 435.2 g/mol |
---|---|
Molecular Formula | C17H12Cl2N6O4 |
XLogP3 | 2.7 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 4 |
Exact Mass | 434.0297083 g/mol |
Monoisotopic Mass | 434.0297083 g/mol |
Topological Polar Surface Area | 136 Ų |
Heavy Atom Count | 29 |
Formal Charge | 0 |
Complexity | 878 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41897
Submission : 2025-05-23
Status : Active
Type : II
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
NDC Package Code : 62128-0396
Start Marketing Date : 2024-03-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39990
Submission : 2024-05-27
Status : Active
Type : II
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41897
Submission : 2025-05-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40972
Submission : 2025-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40872
Submission : 2024-11-26
Status : Active
Type : II
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Date of Issue : 2022-06-15
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy. No. 10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 50...
NDC Package Code : 62128-0396
Start Marketing Date : 2024-03-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69988-0062
Start Marketing Date : 2024-03-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 69988-0061
Start Marketing Date : 2023-10-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 65392-3203
Start Marketing Date : 2023-11-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
About the Company : Lee Pharma Ltd, established in 1997, is a research-driven pharmaceutical company focused on developing, synthesizing, and commercializing high-quality APIs, intermediates, and fini...
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
About the Company : Lewens Labs was established with a vision to transform the pharmaceutical industry, inspired by an award-winning engineering project that reduced the cost of Aceclofenac and earned...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Details:
Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2025
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Madrigal Reports Two-Year Data Showing Rezdiffra Benefit in MASH Cirrhosis
Details : Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 26, 2025
Details:
Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2024
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Madrigal Completes Resmetirom Trial Enrollment in Compensated NASH/MASH Cirrhosis
Details : Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 21, 2024
Details:
PRO-140 (leronlimab) a monocloncal antibody works by blocking the activity of CCR5 receptor. It is currently in preclinical in combination with Resmetirom for the treatment of liver fibrosis.
Lead Product(s): Leronlimab,Resmetirom
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Vyrologix
Study Phase: PreclinicalProduct Type: Antibody
Sponsor: SMC Laboratories
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 27, 2024
Lead Product(s) : Leronlimab,Resmetirom
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : SMC Laboratories
Deal Size : Inapplicable
Deal Type : Inapplicable
CytoDyn Announces Start of Preclinical MASH Study, Results Expected in Fall 2024
Details : PRO-140 (leronlimab) a monocloncal antibody works by blocking the activity of CCR5 receptor. It is currently in preclinical in combination with Resmetirom for the treatment of liver fibrosis.
Product Name : Vyrologix
Product Type : Antibody
Upfront Cash : Inapplicable
June 27, 2024
Details:
MGL-3196 (Resmetirom) is a once-daily, oral, liver-directed THR-β agonist , which is being evaluated for the treatment of NASH/MASH with Liver Fibrosis.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 03, 2024
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Madrigal Pharmaceuticals Announces EMA Validation of Resmetirom Application for NASH
Details : MGL-3196 (Resmetirom) is a once-daily, oral, liver-directed THR-β agonist , which is being evaluated for the treatment of NASH/MASH with Liver Fibrosis.
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 03, 2024
Details:
Undisclosed
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Nephrology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 03, 2024
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Nephrology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 03, 2024
Details:
Madrigal plans to use net proceeds for commercial activities related to launching Rezdiffra (resmetirom), a liver-directed THR-β agonist for treating NASH in the U.S.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $600.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 18, 2024
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $600.0 million
Deal Type : Public Offering
Madrigal Pharmaceuticals Announces Pricing of Upsized $600 Million Public Offering
Details : Madrigal plans to use net proceeds for commercial activities related to launching Rezdiffra (resmetirom), a liver-directed THR-β agonist for treating NASH in the U.S.
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 18, 2024
Details:
Rezdiffra (resmetirom) is a once-daily oral THR-β agonist approved for treating noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 14, 2024
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Madrigal's Rezdiffra Approved by FDA for NASH with Liver Fibrosis
Details : Rezdiffra (resmetirom) is a once-daily oral THR-β agonist approved for treating noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 14, 2024
Details:
Madrigal will use the proceeds for its clinical and commercial activities in preparation for a potential launch of MGL-3196 (resmetirom), a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 28, 2023
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $500.0 million
Deal Type : Public Offering
Madrigal Pharmaceuticals Announces Pricing of $500 Million Public Offering
Details : Madrigal will use the proceeds for its clinical and commercial activities in preparation for a potential launch of MGL-3196 (resmetirom), a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH...
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
September 28, 2023
Details:
MGL-3196 (resmetirom) is a once daily, oral, thyroid hormone receptor (THR)-beta selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 13, 2023
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : MGL-3196 (resmetirom) is a once daily, oral, thyroid hormone receptor (THR)-beta selective agonist designed to target key underlying causes of NASH in the liver.
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 13, 2023
Details:
MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Lead Product(s): Resmetirom,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 17, 2023
Lead Product(s) : Resmetirom,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Product Name : Rezdiffra
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 17, 2023
19 Aug 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/08/19/3136003/0/en/Madrigal-Receives-European-Commission-Approval-for-Rezdiffra-resmetirom-for-the-Treatment-of-MASH-with-Moderate-to-Advanced-Liver-Fibrosis.html
16 Jul 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/07/16/3116331/0/en/Madrigal-Pharmaceuticals-Receives-Notice-of-Allowance-from-U-S-Patent-and-Trademark-Office-for-New-U-S-Patent-Covering-Rezdiffra-Resmetirom.html
21 Jun 2025
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/eu-medicines-regulator-grants-conditional-authorisation-madrigals-liver-disease-2025-06-20/
22 May 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/05/22/3086538/0/en/Sagimet-Biosciences-to-Host-Virtual-KOL-Event-Evaluating-the-Synergistic-Potential-of-a-Combination-of-Denifanstat-and-Resmetirom-for-the-Treatment-of-Metabolic-Dysfunction-Associa.html
10 May 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/05/10/3078638/0/en/Madrigal-Announces-New-Clinical-Data-Demonstrating-Rezdiffra-resmetirom-Significantly-Improved-Multiple-Noninvasive-Tests-and-Portal-Hypertension-Risk-in-Patients-with-Compensated-.html
29 Apr 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/04/29/3070170/0/en/Madrigal-to-Present-Late-Breaking-Resmetirom-Data-in-Patients-with-Compensated-MASH-Cirrhosis-at-the-EASL-Congress.html
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Resmetirom 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 Resmetirom manufacturer or Resmetirom supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Resmetirom manufacturer or Resmetirom supplier.
PharmaCompass also assists you with knowing the Resmetirom API Price utilized in the formulation of products. Resmetirom API Price is not always fixed or binding as the Resmetirom Price is obtained through a variety of data sources. The Resmetirom Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Resmetirom manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Resmetirom, including repackagers and relabelers. The FDA regulates Resmetirom manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Resmetirom 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 Resmetirom manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Resmetirom supplier is an individual or a company that provides Resmetirom active pharmaceutical ingredient (API) or Resmetirom finished formulations upon request. The Resmetirom suppliers may include Resmetirom API manufacturers, exporters, distributors and traders.
click here to find a list of Resmetirom suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Resmetirom DMF (Drug Master File) is a document detailing the whole manufacturing process of Resmetirom active pharmaceutical ingredient (API) in detail. Different forms of Resmetirom DMFs exist exist since differing nations have different regulations, such as Resmetirom USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Resmetirom DMF submitted to regulatory agencies in the US is known as a USDMF. Resmetirom USDMF includes data on Resmetirom's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Resmetirom USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Resmetirom suppliers with USDMF on PharmaCompass.
A Resmetirom written confirmation (Resmetirom WC) is an official document issued by a regulatory agency to a Resmetirom manufacturer, verifying that the manufacturing facility of a Resmetirom active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Resmetirom APIs or Resmetirom finished pharmaceutical products to another nation, regulatory agencies frequently require a Resmetirom WC (written confirmation) as part of the regulatory process.
click here to find a list of Resmetirom suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Resmetirom as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Resmetirom API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Resmetirom as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Resmetirom and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Resmetirom NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Resmetirom suppliers with NDC on PharmaCompass.
Resmetirom 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 Resmetirom 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 Resmetirom GMP manufacturer or Resmetirom GMP API supplier for your needs.
A Resmetirom CoA (Certificate of Analysis) is a formal document that attests to Resmetirom's compliance with Resmetirom specifications and serves as a tool for batch-level quality control.
Resmetirom CoA mostly includes findings from lab analyses of a specific batch. For each Resmetirom 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.
Resmetirom may be tested according to a variety of international standards, such as European Pharmacopoeia (Resmetirom EP), Resmetirom JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Resmetirom USP).