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Chemistry

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Also known as: Eidd 2801, Eidd2801, Molnupiravir, 2349386-89-4, Mk-4482, Molnupiravir [inn]
Molecular Formula
C13H19N3O7
Molecular Weight
329.31  g/mol
InChI Key
HTNPEHXGEKVIHG-QCNRFFRDSA-N
FDA UNII
YA84KI1VEW

Molnupiravir
Molnupiravir is an orally bioavailable prodrug of EIDD-1931, the synthetic ribonucleoside derivative N4-hydroxycytidine and ribonucleoside analog, with potential antiviral activity against a variety of RNA viruses. Upon oral administration, molnupiravir, being a prodrug, is metabolized into its active form EIDD-1931 and converted into its triphosphate (TP) form. The TP form of EIDD-1931 is incorporated into RNA and inhibits the action of viral RNA-dependent RNA polymerase. This results in the termination of RNA transcription and decreases viral RNA production, and viral RNA replication.
1 2D Structure

Molnupiravir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2R,3S,4R,5R)-3,4-dihydroxy-5-[4-(hydroxyamino)-2-oxopyrimidin-1-yl]oxolan-2-yl]methyl 2-methylpropanoate
2.1.2 InChI
InChI=1S/C13H19N3O7/c1-6(2)12(19)22-5-7-9(17)10(18)11(23-7)16-4-3-8(15-21)14-13(16)20/h3-4,6-7,9-11,17-18,21H,5H2,1-2H3,(H,14,15,20)/t7-,9-,10-,11-/m1/s1
2.1.3 InChI Key
HTNPEHXGEKVIHG-QCNRFFRDSA-N
2.1.4 Canonical SMILES
CC(C)C(=O)OCC1C(C(C(O1)N2C=CC(=NC2=O)NO)O)O
2.1.5 Isomeric SMILES
CC(C)C(=O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N2C=CC(=NC2=O)NO)O)O
2.2 Other Identifiers
2.2.1 UNII
YA84KI1VEW
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2020-03-16
3 Chemical and Physical Properties
Molecular Weight 329.31 g/mol
Molecular Formula C13H19N3O7
XLogP3-0.8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count7
Rotatable Bond Count6
Exact Mass329.12229995 g/mol
Monoisotopic Mass329.12229995 g/mol
Topological Polar Surface Area141 Ų
Heavy Atom Count23
Formal Charge0
Complexity534
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

[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)


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 Absorption, Distribution and Excretion

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.


5.3 Metabolism/Metabolites

Molnupiravir is hydrolyzed to [N4-hydroxycytidine], which distributes into tissues. Once inside cells, N4-hydroxycytidine is phosphorylated to the 5'-triphosphate form.


5.4 Biological Half-Life

The half life of the active metabolite, N4-hydroxycytidine, is 3.3 hours.


5.5 Mechanism of Action

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.


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Biophore India Pharmaceuticals Pvt...

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Metrochem API Private Limited

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Gonane Pharma

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Century Pharmaceuticals

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HRV Global Life Sciences

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Tagoor Laboratories

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Tofigh Daru

Iran

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Omgene Life Sciences

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Optimus Pharma

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Shandong Luxi Pharmaceutical Co.,L...

China

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Shandong Luxi Pharmaceutical Co.,L...

China

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Honour Lab Ltd

India

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36282

Submission : 2021-10-13

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2021-08-27

Pay. Date : 2021-06-28

DMF Number : 36078

Submission : 2021-06-30

Status : Active

Type : II

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Molnupiravir lH

Date of Issue : 2022-09-19

Valid Till : 2025-07-02

Written Confirmation Number : WC-0119

Address of the Firm : Plot No. 35, 36, 38, 39,40,49, 50 & 51, Phase-IV, IDA, Jeedimetla, Medchal- Malk...

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Molnupiravir

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
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Molnupiravir

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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 ...

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 groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Molnupiravir

About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
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About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...

Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in India and abroad. Its APIs are manufactured in accordance with cGMP, 21CFR part 10 and ICH guidelines. It also produces intermediates and develops new APIs as per the needs of its clients. Century conducts biotechnological research that focuses on human therapeutic proteins. Currently, research is underway to find treatments for asthma, mastocytosis and basophilic leukemia. Century supplies research-grade biotech products and a wide range of animal health products.
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Molnupiravir

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing and supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US and the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...

Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-growth therapeutic areas, with an emphasis on affordability, quality and timely delivery. It also provides end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs is a fast-growing Indian pharma company that serves both branded and generic companies worldwide. The company’s organizational function includes R&D, supply chain, manufacturing, quality testing, quality assurance, regulatory affairs, marketing & sales, and packaging & warehousing departments.
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Virtual BoothTofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.

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Molnupiravir

About the Company : Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like A...

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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Molnupiravir

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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Molnupiravir

About the Company : Hiray Pharma Solutions is an international end-to-end CDMO, facilitating the development and manufacturing of important drug products and key intermediates around the world. We pro...

Hiray Pharma Solutions is an international end-to-end CDMO, facilitating the development and manufacturing of important drug products and key intermediates around the world. We provide the best chemical techniques, control, and manufacturing services to pharmaceutical and innovative enterprises, and a swift path for fine medicine to benefit patients. As an end-to-end CDMO, Hiray can provide on-time, high-quality service for Process R&D, Analytical R&D, Manufacturing, and Quality Control. Hiray operates in strict compliance with, or exceeds, the latest standards for safety, health, and the environment.
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Molnupiravir

About the Company : Mangalam Drugs & Organics Limited started manufacturing APIs and intermediates in 1977 in Gujarat, India. It has a multi-product manufacturing facility and an in-house R&D lab reco...

Mangalam Drugs & Organics Limited started manufacturing APIs and intermediates in 1977 in Gujarat, India. It has a multi-product manufacturing facility and an in-house R&D lab recognized by the Department of Scientific and Industrial Research, India. Mangalam has established a reputation as a one-stop shop for anti-malaria API and its API manufacturing plant is approved by WHO-GENEVA GMP and EDQM. Mangalam has an agreement with the Clinton Health Access Initiative for the supply of anti-malaria APIs worldwide. It has a wide range of products and is the largest manufacturer of some products in the world. It is among the top companies in Asia.
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04-May-2021
22-Jul-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

The licences are applicable for both molnupiravir (API) and finished product in capsules form. It enables the company to launch the product within India as well as export to 104 other countries around the world, Biophore India Pharmaceuticals said in a statement.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-4482

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: The Medicines Patent Pool

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 20, 2022

Biophore

01

Lead Product(s) : Molnupiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : The Medicines Patent Pool

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : The licences are applicable for both molnupiravir (API) and finished product in capsules form. It enables the company to launch the product within India as well as export to 104 other countries around the world, Biophore India Pharmaceuticals said in a s...

Brand Name : MK-4482

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 20, 2022

Biophore

Details:

Molflu a generic version of the Molnupiravir, is the first oral antiviral medication that helps treat mild to moderate COVID-19 in adults is expected to be available from next week in pharmacies throughout (India).


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Molflu

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 04, 2022

Dr Reddy Company Banner

02

Lead Product(s) : Molnupiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Molflu a generic version of the Molnupiravir, is the first oral antiviral medication that helps treat mild to moderate COVID-19 in adults is expected to be available from next week in pharmacies throughout (India).

Brand Name : Molflu

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 04, 2022

Dr Reddy Company Banner

Details:

Emergency-use authorisation recieved from DCGI to manufacture and market oral anti-viral drug Molflu (Molnupiravir) 200mg for treatment of adult patients with Covid19.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Molflu

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 29, 2021

Dr Reddy Company Banner

03

Lead Product(s) : Molnupiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Emergency-use authorisation recieved from DCGI to manufacture and market oral anti-viral drug Molflu (Molnupiravir) 200mg for treatment of adult patients with Covid19.

Brand Name : Molflu

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 29, 2021

Dr Reddy Company Banner

Details:

Cipla Limited, Dr Reddy’s Laboratories Ltd, Emcure Pharmaceuticals, Sun Pharmaceutical Industries Limited and Torrent Pharmaceuticals will collaborate for the clinical trial of the oral anti-viral drug molnupiravir for mild Covid-19 in an outpatient setting in India.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-4482

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Cipla

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 29, 2021

Dr Reddy Company Banner

04

Lead Product(s) : Molnupiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Cipla

Deal Size : Undisclosed

Deal Type : Collaboration

Details : Cipla Limited, Dr Reddy’s Laboratories Ltd, Emcure Pharmaceuticals, Sun Pharmaceutical Industries Limited and Torrent Pharmaceuticals will collaborate for the clinical trial of the oral anti-viral drug molnupiravir for mild Covid-19 in an outpatient se...

Brand Name : MK-4482

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 29, 2021

Dr Reddy Company Banner

Details:

Fermenta Biotech will exclusively license its biocatalytic technology for synthesis of Molnupiravir (Molflu) and supply its enzyme Candida Antarctica B Lipase (CAL B) to Aurigene. Molnupiravir API manufactured by Aurigene will be utilised by Dr Reddy’s for its formulation.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Molflu

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Fermenta Biotech Limited

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 21, 2022

Aurigene

05

Lead Product(s) : Molnupiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Fermenta Biotech Limited

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : Fermenta Biotech will exclusively license its biocatalytic technology for synthesis of Molnupiravir (Molflu) and supply its enzyme Candida Antarctica B Lipase (CAL B) to Aurigene. Molnupiravir API manufactured by Aurigene will be utilised by Dr Reddy’s...

Brand Name : Molflu

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 21, 2022

Aurigene

Details:

DCGI approved Stripiravir (molnupiravir) an orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS‐CoV‐2 in COVID-19 infection.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Stripiravir

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 28, 2021

Strides Pharma Science

06

Lead Product(s) : Molnupiravir

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : DCGI approved Stripiravir (molnupiravir) an orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS‐CoV‐2 in COVID-19 infection.

Brand Name : Stripiravir

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 28, 2021

Strides Pharma Science

Details:

Lagevrio (molnupiravir) is an investigational, orally administered nucleoside analog that accumulates errors in the viral genome leading in inhibition of SARS-CoV-2 replication, the causative agent of COVID-19.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Lagevrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Merck Group

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 24, 2023

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ASC 2024
Not Confirmed
ASC 2024
Not Confirmed

Details : Lagevrio (molnupiravir) is an investigational, orally administered nucleoside analog that accumulates errors in the viral genome leading in inhibition of SARS-CoV-2 replication, the causative agent of COVID-19.

Brand Name : Lagevrio

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 24, 2023

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Details:

Lagevrio (molnupiravir) is an investigational, orally administered nucleoside analog that accumulates errors in the viral genome leading in inhibition of SARS-CoV-2 replication, the causative agent of COVID-19.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Lagevrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 21, 2023

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08

Merck Group

Germany
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ASC 2024
Not Confirmed

Merck Group

Germany
arrow
ASC 2024
Not Confirmed

Details : Lagevrio (molnupiravir) is an investigational, orally administered nucleoside analog that accumulates errors in the viral genome leading in inhibition of SARS-CoV-2 replication, the causative agent of COVID-19.

Brand Name : Lagevrio

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 21, 2023

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Details:

A preliminary analysis in highly-vaccinated adults mostly <65 years of age, showed no evidence of difference between LAGEVRIO (molnupiravir) added to usual care compared to usual care alone for reduction of hospitalizations and deaths through Day 28.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Lagevrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Ridgeback Biotherapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 06, 2022

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09

Merck & Co

U.S.A
arrow
ASC 2024
Not Confirmed

Merck & Co

U.S.A
arrow
ASC 2024
Not Confirmed

Details : A preliminary analysis in highly-vaccinated adults mostly <65 years of age, showed no evidence of difference between LAGEVRIO (molnupiravir) added to usual care compared to usual care alone for reduction of hospitalizations and deaths through Day 28.

Brand Name : Lagevrio

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 06, 2022

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Details:

Analyses of pre-specied exploratory endpoints indicate that a lower proportion of LAGEVRIO (Molnupiravir)-treated participants in MTT population had an acute care visit or a COVID-19-related acute care visit versus placebo-treated participants in the MITT population.


Lead Product(s): Molnupiravir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Lagevrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Ridgeback Biotherapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 07, 2022

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10

Merck & Co

U.S.A
arrow
ASC 2024
Not Confirmed

Merck & Co

U.S.A
arrow
ASC 2024
Not Confirmed

Details : Analyses of pre-specied exploratory endpoints indicate that a lower proportion of LAGEVRIO (Molnupiravir)-treated participants in MTT population had an acute care visit or a COVID-19-related acute care visit versus placebo-treated participants in the MIT...

Brand Name : Lagevrio

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 07, 2022

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INTERMEDIATES SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

CAS Number : 2346620-55-9

End Use API : Molnupiravir

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 experie...

Shandong Chenghui Shuangda Pharmaceutical

02

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed
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CAS Number : 3258-02-4

End Use API : Molnupiravir

About The Company : Kimia Biosciences, established in 1993, is focused on manufacturing bulk drugs for various therapeutic segments. With a strong emphasis on excellence and advanc...

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03

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed
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CAS Number : 2346620-55-9

End Use API : Molnupiravir

About The Company : Synaptics Labs Private Limited is a young Pharmaceutical Company with a fully integrated and globally specialized in the development, production and marketing o...

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04

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed
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CAS Number : 2346620-55-9

End Use API : Molnupiravir

About The Company : VIDGAS aims to provide our pharmaceutical, Bio pharma, Agrochemical, Food and Fine chemical customers with the highest quality SFC and HPLC purification and iso...

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05

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed
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CAS Number : 2346620-53-7

End Use API : Molnupiravir

About The Company : VIDGAS aims to provide our pharmaceutical, Bio pharma, Agrochemical, Food and Fine chemical customers with the highest quality SFC and HPLC purification and iso...

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06

ASC 2024
Not Confirmed
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ASC 2024
Not Confirmed
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CAS Number : 2346620-54-8

End Use API : Molnupiravir

About The Company : VIDGAS aims to provide our pharmaceutical, Bio pharma, Agrochemical, Food and Fine chemical customers with the highest quality SFC and HPLC purification and iso...

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FDF Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Molnupiravir

Brand Name :

Dosage Form : Capsule

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Molnupiravir

Brand Name :

Dosage Form : Capsule

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

03

ASC 2024
Not Confirmed
arrow
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ASC 2024
Not Confirmed

Molnupiravir

Brand Name :

Dosage Form : Capsule

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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04

MSD INTL GMBH

Singapore
ASC 2024
Not Confirmed
arrow

MSD INTL GMBH

Singapore
arrow
ASC 2024
Not Confirmed

molnupiravir

Brand Name : Lagevrio

Dosage Form :

Dosage Strength :

Packaging : 40

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

MSD INTL GMBH

Singapore
ASC 2024
Not Confirmed
arrow

MSD INTL GMBH

Singapore
arrow
ASC 2024
Not Confirmed

molnupiravir

Brand Name : Lagevrio

Dosage Form :

Dosage Strength :

Packaging : 40

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

Penta Pharma

Egypt
ASC 2024
Not Confirmed
arrow

Penta Pharma

Egypt
arrow
ASC 2024
Not Confirmed

Molnupiravir

Brand Name : Jeravir

Dosage Form : Capsule

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Egypt

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07

ASC 2024
Not Confirmed
arrow
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ASC 2024
Not Confirmed

Molnupiravir

Brand Name : MOLNUVIR

Dosage Form : Capsule

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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08

ASC 2024
Not Confirmed
arrow
arrow
ASC 2024
Not Confirmed

Molnupiravir

Brand Name : MOLNUVIR

Dosage Form : Capsule

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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09

ASC 2024
Not Confirmed
arrow
arrow
ASC 2024
Not Confirmed

Molnupiravir

Brand Name : MOLNUVIR

Dosage Form : Capsule

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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10

ASC 2024
Not Confirmed
arrow
arrow
ASC 2024
Not Confirmed

Molnupiravir

Brand Name : MOLNUVIR

Dosage Form : Capsule

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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