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Weekly News Recap #Phispers
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.)
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Drugs in Development
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Suanfarma, at the Core of a Better Life.
CAS Number : 1493-13-6
End Use API : Oseltamivir Phosphate
About The Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
(1S,5R,6S)-Ethyl 5-(pentan-3-yl-oxy)-7-oxa-bicyclo...
CAS Number : 204254-96-6
End Use API : Oseltamivir Phosphate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
(3R,4R,5S)-4-N-Acetyl(1,1-dimethylethyl)amino-5-N,...
CAS Number : 651324-08-2
End Use API : Oseltamivir Phosphate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Ethyl (1S,5R,6S)-5-(pentan-3- yloxy)- 7-oxabicyclo...
CAS Number : 204254-96-6
End Use API : Oseltamivir Phosphate
About The Company : Alkaloids is a family company established in 1967. Starting with production of natural Caffeine, quite a number of speciality products have been added to our p...
Ethyl (3R,4R,5S)-4-(acetylamino)-5- azido-3-(penta...
CAS Number : 204255-06-1
End Use API : Oseltamivir Phosphate
About The Company : Alkaloids is a family company established in 1967. Starting with production of natural Caffeine, quite a number of speciality products have been added to our p...
CAS Number : 769-42-6
End Use API : Oseltamivir Phosphate
About The Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (AP...
Ethyl (3R, 4S, 5S)- 4,5-epoxy-3-(1-ethyl-propoxy) ...
CAS Number : 204254-96-6
End Use API : Oseltamivir Phosphate
About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...
Ethyl (3R,4R,5S)-4-acetamido-5-azido-3-(1- ethylpr...
CAS Number : 204255-06-1
End Use API : Oseltamivir Phosphate
About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...
Ethyl (3R, 4S, 5S)-4, N-acetyl (1,1-dimethyl ethyl...
CAS Number : 651324-08-2
End Use API : Oseltamivir Phosphate
About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...
Trimethylsilyltrifluoromethanesulfonate (Tmst )
CAS Number : 27607-77-8
End Use API : Oseltamivir Phosphate
About The Company : We are a top producer of Pharmaceutical Intermediates, Specialty Chemicals, and More, with origins dating back to 1998. Globally renowned for its Organic Compou...
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DOSAGE - CAPSULE;ORAL - EQ 30MG BASE
USFDA APPLICATION NUMBER - 21087
DOSAGE - CAPSULE;ORAL - EQ 45MG BASE
USFDA APPLICATION NUMBER - 21087
DOSAGE - CAPSULE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 21087
DOSAGE - FOR SUSPENSION;ORAL - EQ 6MG BASE/ML
USFDA APPLICATION NUMBER - 21246
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ABOUT THIS PAGE
A Tamiflu manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tamiflu, including repackagers and relabelers. The FDA regulates Tamiflu manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tamiflu 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 Tamiflu manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tamiflu supplier is an individual or a company that provides Tamiflu active pharmaceutical ingredient (API) or Tamiflu finished formulations upon request. The Tamiflu suppliers may include Tamiflu API manufacturers, exporters, distributors and traders.
click here to find a list of Tamiflu suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tamiflu DMF (Drug Master File) is a document detailing the whole manufacturing process of Tamiflu active pharmaceutical ingredient (API) in detail. Different forms of Tamiflu DMFs exist exist since differing nations have different regulations, such as Tamiflu USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tamiflu DMF submitted to regulatory agencies in the US is known as a USDMF. Tamiflu USDMF includes data on Tamiflu's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tamiflu USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tamiflu suppliers with USDMF on PharmaCompass.
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 Tamiflu Drug Master File in Japan (Tamiflu JDMF) empowers Tamiflu 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 Tamiflu JDMF during the approval evaluation for pharmaceutical products. At the time of Tamiflu JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Tamiflu suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tamiflu Drug Master File in Korea (Tamiflu KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tamiflu. The MFDS reviews the Tamiflu KDMF as part of the drug registration process and uses the information provided in the Tamiflu KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tamiflu 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 Tamiflu API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tamiflu suppliers with KDMF on PharmaCompass.
A Tamiflu CEP of the European Pharmacopoeia monograph is often referred to as a Tamiflu Certificate of Suitability (COS). The purpose of a Tamiflu CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tamiflu EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tamiflu to their clients by showing that a Tamiflu CEP has been issued for it. The manufacturer submits a Tamiflu CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tamiflu CEP holder for the record. Additionally, the data presented in the Tamiflu CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tamiflu DMF.
A Tamiflu CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tamiflu CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Tamiflu suppliers with CEP (COS) on PharmaCompass.
A Tamiflu written confirmation (Tamiflu WC) is an official document issued by a regulatory agency to a Tamiflu manufacturer, verifying that the manufacturing facility of a Tamiflu active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tamiflu APIs or Tamiflu finished pharmaceutical products to another nation, regulatory agencies frequently require a Tamiflu WC (written confirmation) as part of the regulatory process.
click here to find a list of Tamiflu 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 Tamiflu as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tamiflu 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 Tamiflu 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 Tamiflu and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tamiflu NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tamiflu suppliers with NDC on PharmaCompass.
Tamiflu 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 Tamiflu 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 Tamiflu GMP manufacturer or Tamiflu GMP API supplier for your needs.
A Tamiflu CoA (Certificate of Analysis) is a formal document that attests to Tamiflu's compliance with Tamiflu specifications and serves as a tool for batch-level quality control.
Tamiflu CoA mostly includes findings from lab analyses of a specific batch. For each Tamiflu 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.
Tamiflu may be tested according to a variety of international standards, such as European Pharmacopoeia (Tamiflu EP), Tamiflu JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tamiflu USP).
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