Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
FDA Orange Book
0
Canada
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Weekly News Recap #Phispers
1. ((2r,3s,4r,5r)-3,4-dihydroxy-5-((4z)-4-(hydroxyimino)-2-oxo-3,4- Dihydropyrimidin-1(2h)-yl)oxolan-2-yl)methyl 2-methylpropanoate
2. Lagevrio
3. Mk-4482
4. Molnupiravir
1. Eidd 2801
2. Eidd2801
3. Molnupiravir
4. 2349386-89-4
5. Mk-4482
6. Molnupiravir [inn]
7. 2492423-29-5
8. Molnupiravir [usan]
9. Molnupiravir [who-dd]
10. Ya84ki1vew
11. Eidd 1931-isopropyl Ester
12. Uridine, 4-oxime, 5'-(2-methylpropanoate), (4z)-
13. N4-hydroxycytidine, 5'-isopropyl Ester
14. ((2r,3s,4r,5r)-3,4-dihydroxy-5-((4z)-4-(hydroxyimino)-2-oxo-3,4- Dihydropyrimidin-1(2h)-yl)oxolan-2-yl)methyl 2-methylpropanoate
15. ((2r,3s,4r,5r)-3,4-dihydroxy-5-(4-(hydroxyamino)-2-oxopyrimidin-1(2h)-yl)tetrahydrofuran-2-yl)methyl Isobutyrate
16. [(2r,3s,4r,5r)-3,4-dihydroxy-5-[4-(hydroxyamino)-2-oxopyrimidin-1-yl]oxolan-2-yl]methyl 2-methylpropanoate
17. Lagevrio
18. Who 11853
19. ((2r,3s,4r,5r)-3,4-dihydroxy-5-(4-(hydroxyimino)-2-oxo-3,4-dihydropyrimidin-1(2h)-yl)tetrahydrofuran-2-yl)methyl Isobutyrate
20. Molnupiravirum
21. Unii-ya84ki1vew
22. Pro-eidd-1931
23. Molnupiravir [jan]
24. Eidd-2801(molnupiravir)
25. Chembl4650320
26. Eidd 1931 5'-isopropylester
27. Gtpl10737
28. Med.21724, Compound 182
29. Chebi:180653
30. Bdbm429508
31. Dtxsid501028058
32. Bcp32744
33. Eidd-1931 Isopropyl Ester
34. Ex-a3432
35. Mfcd32663515
36. Mk4482
37. S8969
38. At13078
39. N(4)-hydroxycytidine 5'-isopropylester
40. Ac-35171
41. As-84465
42. Beta-d-n4 Hydroxycytidine-5'-isopropyl Ester
43. Beta-d-n(4)-hydroxycytidine-5'-isopropyl Ester
44. A936190
45. .beta.-d-n4 Hydroxycytidine-5'-isopropyl Ester
46. N-hydroxy-5'-o-(2-methylpropanoyl)-3,4-dihydrocytidine
47. Eidd 2801; Eidd2801; Uridine, 4-oxime, 5'-(2-methylpropanoate
48. ((2r,3s,4r,5r)-3,4-dihydroxy-5-((e)-4-(hydroxyimino)-2-oxo-3,4-dihydropyrimidin-1(2h)-yl)tetrahydrofuran-2-yl)methyl Isobutyrate
49. ((2r,3s,4r,5r)-3,4-dihydroxy-5-((z)-4-(hydroxyimino)-2-oxo-3,4-dihydropyrimidin-1(2h)-yl)tetrahydrofuran-2-yl)methyl Isobutyrate
50. [(2r,3s,4r,5r)-3,4-dihydroxy-5-[(4e)-4-(hydroxyimino)-2-oxo-1,2,3,4-tetrahydropyrimidin-1-yl]oxolan-2-yl]methyl 2-methylpropanoate
51. {(2r,3s,4r,5r)-3,4-dihydroxy-5-[4-(hydroxyimino)-2-oxo-3,4-dihydropyrimidin-1(2h)-yl]tetrahydrofuran-2-yl}methyl 2-methylpropanoate
| Molecular Weight | 329.31 g/mol |
|---|---|
| Molecular Formula | C13H19N3O7 |
| XLogP3 | -0.8 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 6 |
| Exact Mass | 329.12229995 g/mol |
| Monoisotopic Mass | 329.12229995 g/mol |
| Topological Polar Surface Area | 141 Ų |
| Heavy Atom Count | 23 |
| Formal Charge | 0 |
| Complexity | 534 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
[N4-hydroxycytidine] and its prodrug molnupiravir are being studied for its activity against a number of viral infections including influenza, MERS-CoV, and SARS-CoV-2. Molnupiravir is approved in the UK for reducing the risk of hospitalization and death in mild to moderate COVID-19 cases for patients at increased risk of severe disease (eg. with obesity, diabetes mellitus, heart disease, or are over 60 years old).
Treatment of Coronavirus disease 2019 (COVID-19)
Antiviral Agents
Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)
Absorption
After an 800 mg oral dose of molnupiravir every 12 hours, the active compound (N4-hydroxycytidine) reaches a Cmax of 2970 ng/mL, with a Tmax of 1.5 hours, and an AUC0-12h of 8360 h\*ng/mL.
Route of Elimination
3% of an oral molnupiravir dose is eliminated in the urine as the active metabolite N4-hydroxycytidine.
Molnupiravir is hydrolyzed to [N4-hydroxycytidine], which distributes into tissues. Once inside cells, N4-hydroxycytidine is phosphorylated to the 5'-triphosphate form.
The half life of the active metabolite, N4-hydroxycytidine, is 3.3 hours.
Molnupiravir is hydrolyzed _in vivo_ to N4-hydroxycytidine, which is phosphorylated in tissue to the active 5-triphosphate form, and incorporated into the genome of new virions, resulting in the accumulation of inactivating mutations, known as viral error catastrophe. A [remdesivir] resistant mutant mouse hepatitis virus has also been shown to have increased sensitivity to N4-hydroxycytidine.
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Turkey
Brand Name : MOLNUVIR
Dosage Form : Capsule
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Turkey
Brand Name : MOLNUVIR
Dosage Form : Capsule
Dosage Strength : 400MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Molnupiravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Molnupiravir, including repackagers and relabelers. The FDA regulates Molnupiravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Molnupiravir 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 Molnupiravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Molnupiravir supplier is an individual or a company that provides Molnupiravir active pharmaceutical ingredient (API) or Molnupiravir finished formulations upon request. The Molnupiravir suppliers may include Molnupiravir API manufacturers, exporters, distributors and traders.
click here to find a list of Molnupiravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Molnupiravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Molnupiravir active pharmaceutical ingredient (API) in detail. Different forms of Molnupiravir DMFs exist exist since differing nations have different regulations, such as Molnupiravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Molnupiravir DMF submitted to regulatory agencies in the US is known as a USDMF. Molnupiravir USDMF includes data on Molnupiravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Molnupiravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Molnupiravir suppliers with USDMF on PharmaCompass.
A Molnupiravir written confirmation (Molnupiravir WC) is an official document issued by a regulatory agency to a Molnupiravir manufacturer, verifying that the manufacturing facility of a Molnupiravir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Molnupiravir APIs or Molnupiravir finished pharmaceutical products to another nation, regulatory agencies frequently require a Molnupiravir WC (written confirmation) as part of the regulatory process.
click here to find a list of Molnupiravir 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 Molnupiravir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Molnupiravir 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 Molnupiravir 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 Molnupiravir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Molnupiravir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Molnupiravir suppliers with NDC on PharmaCompass.
Molnupiravir 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 Molnupiravir 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 Molnupiravir GMP manufacturer or Molnupiravir GMP API supplier for your needs.
A Molnupiravir CoA (Certificate of Analysis) is a formal document that attests to Molnupiravir's compliance with Molnupiravir specifications and serves as a tool for batch-level quality control.
Molnupiravir CoA mostly includes findings from lab analyses of a specific batch. For each Molnupiravir 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.
Molnupiravir may be tested according to a variety of international standards, such as European Pharmacopoeia (Molnupiravir EP), Molnupiravir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Molnupiravir USP).
LOOKING FOR A SUPPLIER?
