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1. Gs 4071
2. Gs 4104
3. Gs-4071
4. Gs-4104
5. Gs4071
6. Gs4104
7. Oseltamivir
8. Tamiflu
1. 204255-11-8
2. Tamiflu
3. Oseltamivir (phosphate)
4. Oseltamir Phosphate
5. Agucort
6. Ro 64-0796/002
7. Aseltamivir Phosphate
8. Gs 4104
9. Oseltamivir (as Phosphate)
10. 4a3o49ngez
11. Ethyl (3r,4r,5s)-4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate Phosphate
12. Chebi:7799
13. Ethyl (3r,4r,5s)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate Phosphate (1:1)
14. (3r,4r,5s)-ethyl 4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate Phosphate
15. (3r-(3alpha,4beta,5alpha))-ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate Phosphate (1:1)
16. Ro-64-0796-002
17. Ro-64-0796/002
18. 1-cyclohexene-1-carboxylic Acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, Ethyl Ester, (3r,4r,5s)-, Phosphate (1:1)
19. Phosphoric Acid Ethyl (3r,4r,5s)-5-amino-4-acetamido-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate
20. Oseltamivir Phosphate [usan]
21. Unii-4a3o49ngez
22. Sr-05000001499
23. Mfcd08059548
24. Ebilfumin (tn)
25. Oseltamivir Phosphate [usan:usp]
26. Ethyl (3r,4r,5s)-4-acetamido-5-amino-3-pentan-3-yloxycyclohexene-1-carboxylate;phosphoric Acid
27. Tamiflu (tn)
28. Oseltamiviri Phosphas
29. Gs 4104 Phosphate
30. Schembl8730
31. (3r-(3alpha,4beta,5alpha)-ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate Phosphate (1:1)
32. Mls006011559
33. Amy583
34. Chembl1200340
35. Dtxsid0044230
36. Oseltamivir Phosphate (jan/usp)
37. Bcpp000138
38. Oseltamivir Phosphate [mi]
39. Oseltamivir Phosphate [jan]
40. Act03369
41. Oseltamivir Phosphate [vandf]
42. S2597
43. Oseltamivir Phosphate [mart.]
44. Akos015896056
45. Oseltamivir Phosphate [usp-rs]
46. Oseltamivir Phosphate [who-dd]
47. Oseltamivir Phosphate [who-ip]
48. Bcp9001033
49. Ccg-230250
50. Cs-0871
51. Ks-1184
52. Nsc 758897
53. Oseltamivir Phosphate, >=98% (hplc)
54. 1-cyclohexene-1-carboxylic Acid, 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-, Ethyl Ester, (3r-(3alpha,4beta,5alpha)-, Phosphate (1:1)
55. Ac-25911
56. Bo164181
57. Ethyl (3r,4r,5s)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate, Phosphate (1:1)
58. Hy-17016
59. Smr004703323
60. Oseltamivir Phosphate [orange Book]
61. Oseltamivir Phosphate [ep Monograph]
62. Oseltamivir Phosphate [usp Impurity]
63. Oseltamivir Phosphate [usp Monograph]
64. Oseltamiviri Phosphas [who-ip Latin]
65. Gs-4104/002
66. C08093
67. D00900
68. 255o118
69. Sr-05000001960
70. J-013302
71. J-523838
72. Sr-05000001499-2
73. Sr-05000001960-1
74. Q27107588
75. Z1550675456
76. Benzofuran-3-yl-(3-boc-amino-azetidin-1-yl)-aceticacid
77. Oseltamivir Phosphate, United States Pharmacopeia (usp) Reference Standard
78. Oseltamivir Phosphate (impurity B Free), European Pharmacopoeia (ep) Reference Standard
79. Oseltamivir Phosphate, Pharmaceutical Secondary Standard; Certified Reference Material
80. (3r,4r,5s)-4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic Acid Ethyl Ester Phosphate
81. (3r,4r,5s)-4-acetylamino-5-amino-3-(1-ethyl-propoxy)-cyclohex-1-enecarboxylic Acid Ethyl Ester Phosphate
82. (3r,4r,5s)-4-acetylamino-5-amino-3-(1-ethyl-propoxy)-cyclohex-1-enecarboxylic Acid Ethyl Ester Phosphoric Acid Salt
83. (3r,5s)-ethyl 4-acetamido-5-amino-3-(pentan-3-yloxy)cyclohex-1-enecarboxylate Phosphate;osteltamivir Phosphate
84. (3r-(3.alpha.,4.beta.,5.alpha.))-ethyl 4-(acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate Phosphate (1:1)
85. Ethyl (3r,4r,5s)-5-amino-4-acetamido-3-(pentan-3-yloxy)cyclohex-1-ene-1-carboxylate; Phosphoric Acid
86. Ethyl-(3r,4r,5s)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate Phosphate
| Molecular Weight | 410.40 g/mol |
|---|---|
| Molecular Formula | C16H31N2O8P |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 8 |
| Exact Mass | 410.18180295 g/mol |
| Monoisotopic Mass | 410.18180295 g/mol |
| Topological Polar Surface Area | 168 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 468 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 3 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Oseltamivir phosphate |
| PubMed Health | Oseltamivir (By mouth) |
| Drug Classes | Antiviral |
| Drug Label | TAMIFLU (oseltamivir phosphate) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 6 m... |
| Active Ingredient | Oseltamivir phosphate |
| Dosage Form | Capsule |
| Route | oral |
| Strength | 30mg |
| Market Status | Tentative Approval |
| Company | Natco Pharma |
| 2 of 4 | |
|---|---|
| Drug Name | Tamiflu |
| Drug Label | TAMIFLU (oseltamivir phosphate) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 6 m... |
| Active Ingredient | Oseltamivir phosphate |
| Dosage Form | Capsule; For suspension |
| Route | Oral |
| Strength | eq 75mg base; eq 6mg base/ml; eq 30mg base; eq 45mg base |
| Market Status | Prescription |
| Company | Roche |
| 3 of 4 | |
|---|---|
| Drug Name | Oseltamivir phosphate |
| PubMed Health | Oseltamivir (By mouth) |
| Drug Classes | Antiviral |
| Drug Label | TAMIFLU (oseltamivir phosphate) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 6 m... |
| Active Ingredient | Oseltamivir phosphate |
| Dosage Form | Capsule |
| Route | oral |
| Strength | 30mg |
| Market Status | Tentative Approval |
| Company | Natco Pharma |
| 4 of 4 | |
|---|---|
| Drug Name | Tamiflu |
| Drug Label | TAMIFLU (oseltamivir phosphate) is available as capsules containing 30 mg, 45 mg, or 75 mg oseltamivir for oral use, in the form of oseltamivir phosphate, and as a powder for oral suspension, which when constituted with water as directed contains 6 m... |
| Active Ingredient | Oseltamivir phosphate |
| Dosage Form | Capsule; For suspension |
| Route | Oral |
| Strength | eq 75mg base; eq 6mg base/ml; eq 30mg base; eq 45mg base |
| Market Status | Prescription |
| Company | Roche |
* Treatment of influenza:
Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. Prevention of influenza
- Post-exposure prevention in individuals one year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case-by-case basis by the circumstances and the population requiring protection. In exceptional situations (e. g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
- Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic-influenza outbreak.
Tamiflu is not a substitute for influenza vaccination.
The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations.
Treatment and prevention of influenza
Enzyme Inhibitors
Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)
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.)
J05AH02
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Type : II

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DMF Number : 33767
Submission : 2020-01-10
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Pay. Date : 2016-04-08
DMF Number : 30253
Submission : 2016-04-13
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GDUFA
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DMF Number : 22926
Submission : 2009-07-08
Status : Active
Type : II

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Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
Oseltamivir Phosphate BP/IP/USP/Ph. Eur.
Date of Issue : 2024-05-22
Valid Till : 2027-02-07
Written Confirmation Number : WC-0301
Address of the Firm : Plot No. 60A, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District...
Date of Issue : 2024-07-18
Valid Till : 2027-06-07
Written Confirmation Number : WC-0317
Address of the Firm : Plot No. 43 & 44, IDA Phase-ll, Pashamylaram, Pashamylaram(V), Patancheru (M), S...

Oseltamivir Phosphate BP/USP/PH. Eur
Date of Issue : 2025-06-20
Valid Till : 2028-07-02
Written Confirmation Number : WC-0140
Address of the Firm : D-22, M.I.D.C, Industrial Area,Kurkumbh, Taluka

Date of Issue : 2024-02-19
Valid Till : 2027-02-18
Written Confirmation Number : WC-0578
Address of the Firm : Sy.No.405 & 408, Veliminedu (Village), Chityal (Mandal), Nalgonda District - 508...

Oseltamivir Phosphate USP/Ph.Eur.
Date of Issue : 2025-09-03
Valid Till : 2028-08-08
Written Confirmation Number : WC-0041
Address of the Firm : Unit-I, Sy. No. 10, I.D.A, Gaddapotharam (V), Jinnaram (M), Sangareddy District,...

Oseltamivir Phosphate USP/Ph.Eur
Date of Issue : 2023-10-25
Valid Till : 2026-01-07
Written Confirmation Number : WC-471
Address of the Firm : Plot no.23A & 23B, Atchutapuram, Lalam Koduru (Village), Rambilli (Mandal), Visa...

Oseltamivir Phosphate USP/Ph. Eur
Date of Issue : 2023-10-25
Valid Till : 2023-12-18
Written Confirmation Number : WC-0471
Address of the Firm : Plotno.23A&23B,Atchutapuram, LalamKoduru(Village), Rambilli (Mandal), Visakhapat...

Date of Issue : 2024-08-04
Valid Till : 2026-03-22
Written Confirmation Number : WC-0395
Address of the Firm : Plot No. 18, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District ...

Oseltamivir Phosphate USP/Ph. Eur
Date of Issue : 2025-09-08
Valid Till : 2028-08-15
Written Confirmation Number : WC-0022
Address of the Firm : Plot No. 182 to 186, 192-A and 193 to 197 & 212/A,B,C,D Phase-ll, IDA, Pashamyla...

Date of Issue : 2025-09-24
Valid Till : 2028-08-08
Written Confirmation Number : WC-0383
Address of the Firm : Unit-ll, Sy No * Parts of 454,455,457,458 & 459 Chandampet-Village, Shankarampet...

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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
JKN2301 is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of respiratory tract infections.
Lead Product(s): JKN2301,Oseltamivir Phosphate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 21, 2026

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Lead Product(s) : JKN2301,Oseltamivir Phosphate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : JKN2301 is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of respiratory tract infections.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 21, 2026

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ZX-7101A is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): ZX-7101A,Oseltamivir Phosphate
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 28, 2023

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Lead Product(s) : ZX-7101A,Oseltamivir Phosphate
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ZX-7101A is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 28, 2023

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Details:
GP681 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): GP681,Rosuvastatin Calcium,Digoxin,Itraconazole,Oseltamivir Phosphate
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 29, 2023

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Lead Product(s) : GP681,Rosuvastatin Calcium,Digoxin,Itraconazole,Oseltamivir Phosphate
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : GP681 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
March 29, 2023

Details:
Baloxavir Marboxil is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Influenza, Human.
Lead Product(s): Baloxavir Marboxil,Oseltamivir Phosphate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Genentech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 27, 2021

Lead Product(s) : Baloxavir Marboxil,Oseltamivir Phosphate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Genentech
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Baloxavir Marboxil is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Influenza, Human.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 27, 2021

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ZSP1273 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): ZSP1273,Oseltamivir Phosphate
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 04, 2021

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Lead Product(s) : ZSP1273,Oseltamivir Phosphate
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Investigate the Potential Drug-Drug Interaction Between ZSP1273 and Oseltamivir
Details : ZSP1273 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
November 04, 2021

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Oseltamivir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Oseltamivir Phosphate,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2021

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Lead Product(s) : Oseltamivir Phosphate,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product
Details : Oseltamivir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 19, 2021

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The venture loan is intended to support Immunic’s ongoing phase 2 CALVID-1 trial of its lead asset, IMU-838, in patients with moderate coronavirus disease 2019 (COVID-19).
Lead Product(s): Vidofludimus Calcium,Oseltamivir Phosphate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: European Investment Bank
Deal Size: $28.6 million Upfront Cash: Undisclosed
Deal Type: Funding October 20, 2020

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Lead Product(s) : Vidofludimus Calcium,Oseltamivir Phosphate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : European Investment Bank
Deal Size : $28.6 million
Deal Type : Funding
EIB Provides Immunic With up to €24.5 Million to Support Ongoing Development of a Potential COVI...
Details : The venture loan is intended to support Immunic’s ongoing phase 2 CALVID-1 trial of its lead asset, IMU-838, in patients with moderate coronavirus disease 2019 (COVID-19).
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
October 20, 2020

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Oseltamivir Phosphate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Lead Product(s): Oseltamivir Phosphate,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 02, 2020

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Lead Product(s) : Oseltamivir Phosphate,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Oseltamivir Phosphate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 02, 2020

Details:
IMU-838 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of COVID-19.
Lead Product(s): IMU-838,Oseltamivir Phosphate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Immunic Therapeutics | University of Warwick | MODEPHARMA
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 18, 2020

Lead Product(s) : IMU-838,Oseltamivir Phosphate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Immunic Therapeutics | University of Warwick | MODEPHARMA
Deal Size : Inapplicable
Deal Type : Inapplicable
IMU-838 and Oseltamivir in the Treatment of COVID-19
Details : IMU-838 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of COVID-19.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 18, 2020

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Details:
The IONIC trial is a prospective, randomized, parallel-group, open-label phase 2b study, designed to evaluate efficacy & safety of IMU-838 in combination with the neuraminidase inhibitor, Oseltamivir, in approximately 120 adult COVID-19 patients.
Lead Product(s): Vidofludimus Calcium,Oseltamivir Phosphate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2020

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Lead Product(s) : Vidofludimus Calcium,Oseltamivir Phosphate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The IONIC trial is a prospective, randomized, parallel-group, open-label phase 2b study, designed to evaluate efficacy & safety of IMU-838 in combination with the neuraminidase inhibitor, Oseltamivir, in approximately 120 adult COVID-19 patients.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 27, 2020

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PharmaCompass offers a list of Oseltamivir Phosphate 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 Oseltamivir Phosphate manufacturer or Oseltamivir Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oseltamivir Phosphate manufacturer or Oseltamivir Phosphate supplier.
PharmaCompass also assists you with knowing the Oseltamivir Phosphate API Price utilized in the formulation of products. Oseltamivir Phosphate API Price is not always fixed or binding as the Oseltamivir Phosphate Price is obtained through a variety of data sources. The Oseltamivir Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ebilfumin (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ebilfumin (TN), including repackagers and relabelers. The FDA regulates Ebilfumin (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ebilfumin (TN) 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 Ebilfumin (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ebilfumin (TN) supplier is an individual or a company that provides Ebilfumin (TN) active pharmaceutical ingredient (API) or Ebilfumin (TN) finished formulations upon request. The Ebilfumin (TN) suppliers may include Ebilfumin (TN) API manufacturers, exporters, distributors and traders.
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A Ebilfumin (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Ebilfumin (TN) active pharmaceutical ingredient (API) in detail. Different forms of Ebilfumin (TN) DMFs exist exist since differing nations have different regulations, such as Ebilfumin (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ebilfumin (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Ebilfumin (TN) USDMF includes data on Ebilfumin (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ebilfumin (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Ebilfumin (TN) Drug Master File in Japan (Ebilfumin (TN) JDMF) empowers Ebilfumin (TN) API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Ebilfumin (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Ebilfumin (TN) JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ebilfumin (TN) Drug Master File in Korea (Ebilfumin (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ebilfumin (TN). The MFDS reviews the Ebilfumin (TN) KDMF as part of the drug registration process and uses the information provided in the Ebilfumin (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ebilfumin (TN) KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ebilfumin (TN) API can apply through the Korea Drug Master File (KDMF).
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A Ebilfumin (TN) CEP of the European Pharmacopoeia monograph is often referred to as a Ebilfumin (TN) Certificate of Suitability (COS). The purpose of a Ebilfumin (TN) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ebilfumin (TN) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ebilfumin (TN) to their clients by showing that a Ebilfumin (TN) CEP has been issued for it. The manufacturer submits a Ebilfumin (TN) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ebilfumin (TN) CEP holder for the record. Additionally, the data presented in the Ebilfumin (TN) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ebilfumin (TN) DMF.
A Ebilfumin (TN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ebilfumin (TN) CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Ebilfumin (TN) written confirmation (Ebilfumin (TN) WC) is an official document issued by a regulatory agency to a Ebilfumin (TN) manufacturer, verifying that the manufacturing facility of a Ebilfumin (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ebilfumin (TN) APIs or Ebilfumin (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Ebilfumin (TN) WC (written confirmation) as part of the regulatory process.
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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 Ebilfumin (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ebilfumin (TN) 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 Ebilfumin (TN) 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 Ebilfumin (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ebilfumin (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ebilfumin (TN) suppliers with NDC on PharmaCompass.
Ebilfumin (TN) 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 Ebilfumin (TN) 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 Ebilfumin (TN) GMP manufacturer or Ebilfumin (TN) GMP API supplier for your needs.
A Ebilfumin (TN) CoA (Certificate of Analysis) is a formal document that attests to Ebilfumin (TN)'s compliance with Ebilfumin (TN) specifications and serves as a tool for batch-level quality control.
Ebilfumin (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Ebilfumin (TN) 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.
Ebilfumin (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Ebilfumin (TN) EP), Ebilfumin (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ebilfumin (TN) USP).