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    Chemistry

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    Also known as: 61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox
    Molecular Formula
    C16H25N3O8S
    Molecular Weight
    419.5  g/mol
    InChI Key
    MQXQVCLAUDMCEF-CWLIKTDRSA-N
    FDA UNII
    804826J2HU
    Amoxicillin Trihydrate
    A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.
    1 2D Structure

    Amoxicillin Trihydrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S,5R,6R)-6-[[(2R)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid;trihydrate
    2.1.2 InChI
    InChI=1S/C16H19N3O5S.3H2O/c1-16(2)11(15(23)24)19-13(22)10(14(19)25-16)18-12(21)9(17)7-3-5-8(20)6-4-7;;;/h3-6,9-11,14,20H,17H2,1-2H3,(H,18,21)(H,23,24);3*1H2/t9-,10-,11+,14-;;;/m1.../s1
    2.1.3 InChI Key
    MQXQVCLAUDMCEF-CWLIKTDRSA-N
    2.1.4 Canonical SMILES
    CC1(C(N2C(S1)C(C2=O)NC(=O)C(C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O
    2.1.5 Isomeric SMILES
    CC1([C@@H](N2[C@H](S1)[C@@H](C2=O)NC(=O)[C@@H](C3=CC=C(C=C3)O)N)C(=O)O)C.O.O.O
    2.2 Other Identifiers
    2.2.1 UNII
    804826J2HU
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Actimoxi

    2. Amoxicillin

    3. Amoxicillin Anhydrous

    4. Amoxicillin Monopotassium Salt

    5. Amoxicillin Monosodium Salt

    6. Amoxicillin Sodium

    7. Amoxicillin, (r*)-isomer

    8. Amoxicilline

    9. Amoxil

    10. Amoxycillin

    11. Brl 2333

    12. Brl-2333

    13. Brl2333

    14. Clamoxyl

    15. Clamoxyl G.a.

    16. Clamoxyl Parenteral

    17. Hydroxyampicillin

    18. Penamox

    19. Polymox

    20. Trimox

    21. Wymox

    2.3.2 Depositor-Supplied Synonyms

    1. 61336-70-7

    2. Larotid

    3. Polymox

    4. Trimox

    5. Utimox

    6. Wymox

    7. Clamoxyl

    8. Amoxil

    9. Amoxipen

    10. Moxaline

    11. Amodex

    12. Zimox

    13. Robamox

    14. Dispermox

    15. Novabritine

    16. Hiconcil

    17. Imacillin

    18. Amoxycillin Trihydrate

    19. Brl 2333

    20. Moxatag

    21. 61336-70-7 (hydrate)

    22. Topramoxin

    23. Amoxyke

    24. Atoksilin

    25. Demoksil

    26. Largopen

    27. Moksilin

    28. Promoxil

    29. Remoxil

    30. Damoxy

    31. 804826j2hu

    32. (2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

    33. Amoksicillin

    34. Kentrocyllin

    35. Zamocilline

    36. Alfamox

    37. Amophar

    38. Amoxidal

    39. Amoxillat

    40. Amoxina

    41. Amoxine

    42. Flemoxine

    43. Galenamox

    44. Gramidil

    45. Himinomax

    46. Izoltil

    47. Matasedrin

    48. Metifarma

    49. Pacetocin

    50. Pamocil

    51. Paradroxil

    52. Siganopen

    53. Simplamox

    54. Sintopen

    55. Velamox

    56. Zamocillin

    57. Amoran

    58. Ciblor

    59. Amoxicillin Hydrate

    60. Amoxi-wolff

    61. Uro-clamoxyl

    62. Brl-2333

    63. Amoxi-diolan

    64. Amox

    65. Amoksicillin Forte

    66. A-gram

    67. Dura Ax

    68. Amoxicillin [usan]

    69. Amoxicillin-ratiopharm

    70. Drg-0075

    71. Amoxicillin (as Trihydrate)

    72. (2s,5r,6r)-6-((r)-2-amino-2-(4-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

    73. (2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid;trihydrate

    74. Amoxicillin Hydrate (1:3)

    75. Neotetranase

    76. Sawacillin

    77. Pasetocin

    78. Eupen

    79. Amoxil Trihydrate

    80. Unii-804826j2hu

    81. Alpha-amino-p-hydroxybenzylpenicillin Trihydrate

    82. Amoxipen Trihydrate

    83. Dispermox (tn)

    84. Moxaline Trihydrate

    85. Pasetocin (tn)

    86. (2s,5r,6r)-6-{[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

    87. Amoxicillin (usp)

    88. Amoxicillin Pulsys

    89. Amoxicillin-trihydrat

    90. Amoxicilline (inn)

    91. Amoxil (tn)

    92. Amoxicillin [usan:usp:inn:ban:jan]

    93. (2s,5r,6r)-6-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid

    94. Amoxicillin [vandf]

    95. Amoxicillin Hydrate (jp17)

    96. Amoxicillin [usp-rs]

    97. (2s,5r,6r)-6-((r)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid Trihydrate

    98. Dtxsid2022599

    99. Chebi:51254

    100. Amoxicillin [orange Book]

    101. Amoxicillin Hydrate [jan]

    102. Apc-111

    103. Amoxicillin [usp Impurity]

    104. Amoxicillin [usp Monograph]

    105. Amoxicillin Trihydrate [mi]

    106. Prevpac Component Amoxicillin

    107. Talicia Component Amoxicillin

    108. Mfcd00072029

    109. S5298

    110. Amoxicillin Trihydrate [vandf]

    111. Augmentin Component Amoxicillin

    112. Akos015896673

    113. Amoxicillin Trihydrate [mart.]

    114. Amoxicillin Component Of Prevpac

    115. Amoxicillin Component Of Talicia

    116. Amoxicillin Trihydrate [who-dd]

    117. Amoxicillin Trihydrate [who-ip]

    118. Ccg-268878

    119. Ks-5338

    120. Amoxicillin Component Of Augmentin

    121. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate (2s-(2alpha,5alpha,6beta(s*)))-

    122. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2alpha,5alpha,6beta(s*)))-

    123. Amoxicillin Trihydrate [green Book]

    124. Amoxicillin Trihydrate [ep Monograph]

    125. Clavulox Component Amoxicillin Trihydrate

    126. D00229

    127. Amoxicillinum Trihydricum [who-ip Latin]

    128. A833170

    129. Amoxicillin Trihydrate Component Of Clavulox

    130. Q27122483

    131. Amoxil Trihydrate;amoxipen Trihydrate;moxaline Trihydrate

    132. Amoxicillin Trihydrate, Vetranal(tm), Analytical Standard

    133. Amoxicillin, United States Pharmacopeia (usp) Reference Standard

    134. Amoxicillin Trihydrate, British Pharmacopoeia (bp) Reference Standard

    135. Amoxicillin Trihydrate, European Pharmacopoeia (ep) Reference Standard

    136. Amoxicillin Trihydrate, Pharmaceutical Secondary Standard; Certified Reference Material

    137. (2s,5r)-6-[[2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Trihydrate

    138. (2s,5r,6r)-6-((r)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicycl(3.2.0)heptane-2-carboxylic Acid Trihydrate

    139. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-(((2r)-amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate, (2s,5r,6r)-

    140. 4-thia-1-azabicyclo(3.2.0)heptane-2-carboxylic Acid, 6-((amino(4-hydroxyphenyl)acetyl)amino)-3,3-dimethyl-7-oxo-, Trihydrate(2s-(2.alpha.,5.alpha.,6.beta.(s*)))-

    141. 6beta-[(2r)-2-amino-2-(4-hydroxyphenyl)acetamido]-2,2-dimethylpenam-3alpha-carboxylic Acid Trihydrate

    142. Amoxicillin Trihydrate For Performance Verification, European Pharmacopoeia (ep) Reference Standard

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 419.5 g/mol
    Molecular Formula C16H25N3O8S
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count4
    Exact Mass419.13623594 g/mol
    Monoisotopic Mass419.13623594 g/mol
    Topological Polar Surface Area161 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity590
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count4
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameAmoxil
    Active IngredientAmoxicillin
    Dosage FormTablet; Capsule; Tablet, chewable; For suspension
    RouteOral
    Strength875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
    Market StatusPrescription
    CompanyDr Reddys Labs

    2 of 6  
    Drug NameLarotid
    PubMed HealthAmoxicillin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelMOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi...
    Active IngredientAmoxicillin
    Dosage FormFor suspension
    RouteOral
    Strength250mg/5ml; 125mg/5ml
    Market StatusPrescription
    CompanyDr Reddys Labs

    3 of 6  
    Drug NameMoxatag
    Active IngredientAmoxicillin
    Dosage FormTablet, extended release
    RouteOral
    Strength775mg
    Market StatusPrescription
    CompanyPragma Pharms

    4 of 6  
    Drug NameAmoxil
    Active IngredientAmoxicillin
    Dosage FormTablet; Capsule; Tablet, chewable; For suspension
    RouteOral
    Strength875mg; 50mg/ml; 200mg/5ml; 250mg; 125mg/5ml; 400mg/5ml; 125mg; 500mg; 250mg/5ml
    Market StatusPrescription
    CompanyDr Reddys Labs

    5 of 6  
    Drug NameLarotid
    PubMed HealthAmoxicillin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelMOXATAG (amoxicillin extended-release) tablets for oral administration are provided as blue film-coated, oval shaped tablets that contain 775 mg of amoxicillin as the trihydrate and are printed with MB-111 on one side in black edible ink. Amoxi...
    Active IngredientAmoxicillin
    Dosage FormFor suspension
    RouteOral
    Strength250mg/5ml; 125mg/5ml
    Market StatusPrescription
    CompanyDr Reddys Labs

    6 of 6  
    Drug NameMoxatag
    Active IngredientAmoxicillin
    Dosage FormTablet, extended release
    RouteOral
    Strength775mg
    Market StatusPrescription
    CompanyPragma Pharms

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

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FLEMINGLAAN 1, 2613 AX DELFT P.O.BOX 425, 2600 AK DELFT NL","customerAddress":"PARIJAT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"AMOXICILLIN TRIHYDRATE AMOXICILLIN TRIHYDRATE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"TEAM CROWN TRADING LIMITED","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"MEDREICH LIMITED","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"30","totalValueFC":"60699.7","currency":"USD","unitRateINR":"2598","date":"15-Apr-2025","totalValueINR":"5196000","totalValueInUsd":"60699.7","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"9494824","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"6 FUK WANG STREET YUEN LONG INDUSTRIAL ESTATE YUEN LONG HONGKONG SDNF","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744914600,"product":"AMOXICILLIN TRIHYDRATE BP\/USP (AMOXICILLIN TRIHYDRATE COMPACTED BP\/EP)AMOXICILLIN TRIHYDRATE COMPACTED BP","address":"25, PULIYUR II MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"NORTH CHINA PHARMACEUTICAL GROUP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MEDOPHARM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"7000.00","actualQuantity":"7000","unit":"KGS","unitRateFc":"26","totalValueFC":"183697.1","currency":"USD","unitRateINR":"2246.4","date":"18-Apr-2025","totalValueINR":"15724800","totalValueInUsd":"183697.1","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"9559026","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"SEMISYNTECH CO LTD NO.20 YANGZI RD,E AND T DEVELOPMENT ZONE SHIJIAZHUANG,PRC HEBEI CHINA","customerAddress":"25, PULIYUR II MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745519400,"product":"AMOXICILLIN TRIHYDRATE (POWDER)USP (USDMF) RA05A AMOXICILLIN TRIHYDRATE (POWDER)USP (USDMF) RA05A","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SANDOZ GMBH","supplierCountry":"SPAIN","foreign_port":"VIENNA","customer":"CIPLA LIMITED","customerCountry":"INDIA","quantity":"1196.70","actualQuantity":"1196.7","unit":"KGS","unitRateFc":"61.6","totalValueFC":"74446.9","currency":"USD","unitRateINR":"5325.3","date":"25-Apr-2025","totalValueINR":"6372786.51","totalValueInUsd":"74446.9","indian_port":"Bombay Air","hs_no":"29411030","bill_no":"9700064","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"VIENNA","supplierAddress":"BIOCHEMIESTRASSE 10 6250 KUNDL SDNF AUSTRIA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745519400,"product":"AMOXICILLIN TRIHYDRATE (POWDER)USP (USDMF) RA05A AMOXICILLIN TRIHYDRATE (POWDER)USP (USDMF) RA05A","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SANDOZ GMBH","supplierCountry":"SPAIN","foreign_port":"VIENNA","customer":"CIPLA LIMITED","customerCountry":"INDIA","quantity":"1206.40","actualQuantity":"1206.4","unit":"KGS","unitRateFc":"61.6","totalValueFC":"75050.3","currency":"USD","unitRateINR":"5325.3","date":"25-Apr-2025","totalValueINR":"6424441.92","totalValueInUsd":"75050.3","indian_port":"Bombay Air","hs_no":"29411030","bill_no":"9700064","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"VIENNA","supplierAddress":"BIOCHEMIESTRASSE 10 6250 KUNDL SDNF AUSTRIA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745865000,"product":"AMOXICILLIN TRIHYDRATE IP\/EP (POWDER) AMOXICILLIN TRIHYDRATE IP\/EP (POWDER)","address":"NO.27,RACE COURSE ROAD,","city":"KARNATAKA","supplier":"ZHUHAI UNITED LABORATORIES TRADING COMPANY LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO PT","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"30.8","totalValueFC":"310367.4","currency":"USD","unitRateINR":"2656.8","date":"29-Apr-2025","totalValueINR":"26568000","totalValueInUsd":"310367.4","indian_port":"Madras Sea","hs_no":"29411030","bill_no":"9774292","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO PT","supplierAddress":"7-8 FL, NO. 2428 ANJI ROAD, SANZAO TOWN, JINWAN DISTRICT, ZHUHAI, GUANGDONG, CHINA","customerAddress":"NO.27,RACE COURSE ROAD,"}]
    01-Jan-2022
    29-Apr-2025
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    API Imports and Exports

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50564

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    DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **...DOSAGE - TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50564

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    DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 3...DOSAGE - FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML

    USFDA APPLICATION NUMBER - 50575

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    DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 6...DOSAGE - FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML

    USFDA APPLICATION NUMBER - 50575

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    DOSAGE - TABLET;ORAL - 875MG;EQ 125MG BASE

    USFDA APPLICATION NUMBER - 50720

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    DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 2...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML

    USFDA APPLICATION NUMBER - 50725

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    DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 5...DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML

    USFDA APPLICATION NUMBER - 50725

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    DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50754

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    DOSAGE - TABLET;ORAL - 875MG **Federal Regist...DOSAGE - TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50754

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    DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 4...DOSAGE - FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML

    USFDA APPLICATION NUMBER - 50755

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    DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50757

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    DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Fe...DOSAGE - FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50760

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    DOSAGE - FOR SUSPENSION;ORAL - 400MG/5ML

    USFDA APPLICATION NUMBER - 50760

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50785

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 775MG

    USFDA APPLICATION NUMBER - 50813

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    DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RE...DOSAGE - CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50824

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    ABOUT THIS PAGE

    Looking for 61336-70-7 / Amoxicillin Trihydrate API manufacturers, exporters & distributors?

    Amoxicillin Trihydrate manufacturers, exporters & distributors 1

    47

    PharmaCompass offers a list of Amoxicillin Trihydrate 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 Amoxicillin Trihydrate manufacturer or Amoxicillin Trihydrate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amoxicillin Trihydrate manufacturer or Amoxicillin Trihydrate supplier.

    PharmaCompass also assists you with knowing the Amoxicillin Trihydrate API Price utilized in the formulation of products. Amoxicillin Trihydrate API Price is not always fixed or binding as the Amoxicillin Trihydrate Price is obtained through a variety of data sources. The Amoxicillin Trihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Amoxicillin Trihydrate

    Synonyms

    61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox

    Cas Number

    61336-70-7

    Unique Ingredient Identifier (UNII)

    804826J2HU

    About Amoxicillin Trihydrate

    A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

    Amoxine Manufacturers

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

    Amoxine Suppliers

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

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

    Amoxine USDMF

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

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

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

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

    Amoxine KDMF

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

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

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

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

    Amoxine CEP

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

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

    Amoxine WC

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

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

    Amoxine 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 Amoxine as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Amoxine 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 Amoxine 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 Amoxine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxine NDC to their finished compounded human drug products, they may choose to do so.

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

    Amoxine GMP

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

    Amoxine CoA

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

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

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