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    Chemistry

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    Also known as: 204255-11-8, Tamiflu, Oseltamivir (phosphate), Oseltamir phosphate, Agucort, Ro 64-0796/002
    Molecular Formula
    C16H31N2O8P
    Molecular Weight
    410.40  g/mol
    InChI Key
    PGZUMBJQJWIWGJ-ONAKXNSWSA-N
    FDA UNII
    4A3O49NGEZ
    Oseltamivir Phosphate
    An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.
    1 2D Structure

    Oseltamivir Phosphate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    ethyl (3R,4R,5S)-4-acetamido-5-amino-3-pentan-3-yloxycyclohexene-1-carboxylate;phosphoric acid
    2.1.2 InChI
    InChI=1S/C16H28N2O4.H3O4P/c1-5-12(6-2)22-14-9-11(16(20)21-7-3)8-13(17)15(14)18-10(4)19;1-5(2,3)4/h9,12-15H,5-8,17H2,1-4H3,(H,18,19);(H3,1,2,3,4)/t13-,14+,15+;/m0./s1
    2.1.3 InChI Key
    PGZUMBJQJWIWGJ-ONAKXNSWSA-N
    2.1.4 Canonical SMILES
    CCC(CC)OC1C=C(CC(C1NC(=O)C)N)C(=O)OCC.OP(=O)(O)O
    2.1.5 Isomeric SMILES
    CCC(CC)O[C@@H]1C=C(C[C@@H]([C@H]1NC(=O)C)N)C(=O)OCC.OP(=O)(O)O
    2.2 Other Identifiers
    2.2.1 UNII
    4A3O49NGEZ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Gs 4071

    2. Gs 4104

    3. Gs-4071

    4. Gs-4104

    5. Gs4071

    6. Gs4104

    7. Oseltamivir

    8. Tamiflu

    2.3.2 Depositor-Supplied Synonyms

    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

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 410.40 g/mol
    Molecular Formula C16H31N2O8P
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count8
    Exact Mass410.18180295 g/mol
    Monoisotopic Mass410.18180295 g/mol
    Topological Polar Surface Area168 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity468
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameOseltamivir phosphate
    PubMed HealthOseltamivir (By mouth)
    Drug ClassesAntiviral
    Drug LabelTAMIFLU (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 IngredientOseltamivir phosphate
    Dosage FormCapsule
    Routeoral
    Strength30mg
    Market StatusTentative Approval
    CompanyNatco Pharma

    2 of 4  
    Drug NameTamiflu
    Drug LabelTAMIFLU (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 IngredientOseltamivir phosphate
    Dosage FormCapsule; For suspension
    RouteOral
    Strengtheq 75mg base; eq 6mg base/ml; eq 30mg base; eq 45mg base
    Market StatusPrescription
    CompanyRoche

    3 of 4  
    Drug NameOseltamivir phosphate
    PubMed HealthOseltamivir (By mouth)
    Drug ClassesAntiviral
    Drug LabelTAMIFLU (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 IngredientOseltamivir phosphate
    Dosage FormCapsule
    Routeoral
    Strength30mg
    Market StatusTentative Approval
    CompanyNatco Pharma

    4 of 4  
    Drug NameTamiflu
    Drug LabelTAMIFLU (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 IngredientOseltamivir phosphate
    Dosage FormCapsule; For suspension
    RouteOral
    Strengtheq 75mg base; eq 6mg base/ml; eq 30mg base; eq 45mg base
    Market StatusPrescription
    CompanyRoche

    4.2 Drug Indication

    * 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

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Neuraminidase Inhibitors [MoA]; Neuraminidase Inhibitor [EPC]
    5.3 ATC Code

    J05AH02

    API Reference Price

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VIDE SBNO:7637262\/08-02-2023, INV NO: SI3622227927\/31-01-2023)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"SHENZHEN SUNGENING MEDICINE CO., LTD","supplierCountry":"INDIA","foreign_port":"NANJING","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"35.36","actualQuantity":"35.36","unit":"KGS","unitRateFc":"873","totalValueFC":"31238.1","currency":"USD","unitRateINR":"73637.6","date":"29-May-2024","totalValueINR":"2603823.77","totalValueInUsd":"31238.1","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"3718961","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"412 ROOM, PARK 1, SHENZHEN OVERSEASTUDENTS (LONGGANG) VENTURE PARK,QINGLIN WEST ROAD, CENTRAL CITY, CN","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717007400,"product":"OSELTAMIVIR PHOSPHATE USP (FOR R&D PURPOSE)","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"650","totalValueFC":"328.9","currency":"USD","unitRateINR":"54827.5","date":"30-May-2024","totalValueINR":"27413.75","totalValueInUsd":"328.9","indian_port":"Bombay Air","hs_no":"29242990","bill_no":"3747063","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"XUNQIAO LINHAI ZHEJIANG 317024,CHINASDNF China","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723660200,"product":"OSELTAMIVIR PHOSPHATE USP(B\/N:OV24020005&OV24020006)(EXP VIDE SB NO:8738872,DT:29-03-2024INV NO:SI3623229002\/25-03-2024)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"SHENZHEN SUNGENING MEDICINE CO., LTD","supplierCountry":"INDIA","foreign_port":"NANJING","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"191.52","actualQuantity":"191.52","unit":"KGS","unitRateFc":"740","totalValueFC":"143366.2","currency":"USD","unitRateINR":"62789","date":"15-Aug-2024","totalValueINR":"12025349.28","totalValueInUsd":"143366.2","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"5065213","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"412 ROOM, PARK 1, SHENZHEN OVERSEASTUDENTS (LONGGANG) VENTURE PARK,QINGLIN WEST ROAD, CENTRAL CITY, CN","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723660200,"product":"OSELTAMIVIR PHOSPHATE USP(B\/N:OV24020006&OV24020008)(EXP VIDE SB NO:8738865,DT:29-03-2024INV NO:SI3623229006\/25-03-2024)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"SHENZHEN SUNGENING MEDICINE CO., LTD","supplierCountry":"INDIA","foreign_port":"NANJING","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"216.74","actualQuantity":"216.74","unit":"KGS","unitRateFc":"740","totalValueFC":"162245.2","currency":"USD","unitRateINR":"62789","date":"15-Aug-2024","totalValueINR":"13608887.86","totalValueInUsd":"162245.2","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"5065213","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"412 ROOM, PARK 1, SHENZHEN OVERSEASTUDENTS (LONGGANG) VENTURE PARK,QINGLIN WEST ROAD, CENTRAL CITY, CN","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736706600,"product":"OSELTAMIVIR PHOSPHATE (VIDE RE IMPORT SB NO: 9034625 DT:03-04-2023)OSELTAMIVIR PHOSPHATE","address":"PLOT NO. C-24, INDUSTRIAL ESTATE,","city":"HYDERABAD. AP","supplier":"CBC GROUP","supplierCountry":"INDIA","foreign_port":"TOKYO - NARITA","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"221.45","actualQuantity":"221.451","unit":"KGS","unitRateFc":"2437.7","totalValueFC":"542154.6","currency":"N\/A","unitRateINR":"211105.6","date":"13-Jan-2025","totalValueINR":"46749556.25","totalValueInUsd":"542154.6","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"7752692","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TOKYO - NARITA","supplierAddress":"2-15-13 TSUKISHIMA CH UO-KU, 104-00 52 JAPAN SDNF Japan","customerAddress":"PLOT NO. C-24, INDUSTRIAL ESTATE,"}]
    01-Jan-2021
    28-Feb-2025
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    DOSAGE - CAPSULE;ORAL - EQ 30MG BASE

    USFDA APPLICATION NUMBER - 21087

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    DOSAGE - FOR SUSPENSION;ORAL - EQ 6MG BASE/ML

    USFDA APPLICATION NUMBER - 21246

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    ABOUT THIS PAGE

    Looking for 204255-11-8 / Oseltamivir Phosphate API manufacturers, exporters & distributors?

    Oseltamivir Phosphate manufacturers, exporters & distributors 1

    53

    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.

    API | Excipient name

    Oseltamivir Phosphate

    Synonyms

    204255-11-8, Tamiflu, Oseltamivir (phosphate), Oseltamir phosphate, Agucort, Ro 64-0796/002

    Cas Number

    204255-11-8

    Unique Ingredient Identifier (UNII)

    4A3O49NGEZ

    About Oseltamivir Phosphate

    An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.

    Oseltamivir Manufacturers

    A Oseltamivir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oseltamivir, including repackagers and relabelers. The FDA regulates Oseltamivir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oseltamivir 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 Oseltamivir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Oseltamivir Suppliers

    A Oseltamivir supplier is an individual or a company that provides Oseltamivir active pharmaceutical ingredient (API) or Oseltamivir finished formulations upon request. The Oseltamivir suppliers may include Oseltamivir API manufacturers, exporters, distributors and traders.

    click here to find a list of Oseltamivir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Oseltamivir USDMF

    A Oseltamivir DMF (Drug Master File) is a document detailing the whole manufacturing process of Oseltamivir active pharmaceutical ingredient (API) in detail. Different forms of Oseltamivir DMFs exist exist since differing nations have different regulations, such as Oseltamivir USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Oseltamivir DMF submitted to regulatory agencies in the US is known as a USDMF. Oseltamivir USDMF includes data on Oseltamivir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oseltamivir USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Oseltamivir suppliers with USDMF on PharmaCompass.

    Oseltamivir JDMF

    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 Oseltamivir Drug Master File in Japan (Oseltamivir JDMF) empowers Oseltamivir 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 Oseltamivir JDMF during the approval evaluation for pharmaceutical products. At the time of Oseltamivir 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 Oseltamivir suppliers with JDMF on PharmaCompass.

    Oseltamivir KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Oseltamivir Drug Master File in Korea (Oseltamivir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oseltamivir. The MFDS reviews the Oseltamivir KDMF as part of the drug registration process and uses the information provided in the Oseltamivir KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Oseltamivir 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 Oseltamivir API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Oseltamivir suppliers with KDMF on PharmaCompass.

    Oseltamivir CEP

    A Oseltamivir CEP of the European Pharmacopoeia monograph is often referred to as a Oseltamivir Certificate of Suitability (COS). The purpose of a Oseltamivir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oseltamivir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oseltamivir to their clients by showing that a Oseltamivir CEP has been issued for it. The manufacturer submits a Oseltamivir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oseltamivir CEP holder for the record. Additionally, the data presented in the Oseltamivir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oseltamivir DMF.

    A Oseltamivir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oseltamivir 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 Oseltamivir suppliers with CEP (COS) on PharmaCompass.

    Oseltamivir WC

    A Oseltamivir written confirmation (Oseltamivir WC) is an official document issued by a regulatory agency to a Oseltamivir manufacturer, verifying that the manufacturing facility of a Oseltamivir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oseltamivir APIs or Oseltamivir finished pharmaceutical products to another nation, regulatory agencies frequently require a Oseltamivir WC (written confirmation) as part of the regulatory process.

    click here to find a list of Oseltamivir suppliers with Written Confirmation (WC) on PharmaCompass.

    Oseltamivir NDC

    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 Oseltamivir as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Oseltamivir API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 Oseltamivir 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Oseltamivir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oseltamivir NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Oseltamivir suppliers with NDC on PharmaCompass.

    Oseltamivir GMP

    Oseltamivir 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 Oseltamivir 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 Oseltamivir GMP manufacturer or Oseltamivir GMP API supplier for your needs.

    Oseltamivir CoA

    A Oseltamivir CoA (Certificate of Analysis) is a formal document that attests to Oseltamivir's compliance with Oseltamivir specifications and serves as a tool for batch-level quality control.

    Oseltamivir CoA mostly includes findings from lab analyses of a specific batch. For each Oseltamivir 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.

    Oseltamivir may be tested according to a variety of international standards, such as European Pharmacopoeia (Oseltamivir EP), Oseltamivir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oseltamivir USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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