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    Chemistry

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    Also known as: 117976-90-6, Rebeprazole sodium, Pariet, Aciphex, Rabeprazole sodium salt, Dexrabeprazole sodium
    Molecular Formula
    C18H20N3NaO3S
    Molecular Weight
    381.4  g/mol
    InChI Key
    KRCQSTCYZUOBHN-UHFFFAOYSA-N
    FDA UNII
    3L36P16U4R
    Rabeprazole Sodium
    A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
    1 2D Structure

    Rabeprazole Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]benzimidazol-1-ide
    2.1.2 InChI
    InChI=1S/C18H20N3O3S.Na/c1-13-16(19-9-8-17(13)24-11-5-10-23-2)12-25(22)18-20-14-6-3-4-7-15(14)21-18;/h3-4,6-9H,5,10-12H2,1-2H3;/q-1;+1
    2.1.3 InChI Key
    KRCQSTCYZUOBHN-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C=CN=C1CS(=O)C2=NC3=CC=CC=C3[N-]2)OCCCOC.[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    3L36P16U4R
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1h-benzimidazole, 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt

    2. 2-((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methylsulfinyl)-1h-benzimidazole

    3. Aciphex

    4. Dexrabeprazole

    5. E 3810

    6. E3810

    7. Ly 307640

    8. Ly-307640

    9. Ly307640

    10. Pariet

    11. Rabeprazole

    12. Sodium, Rabeprazole

    2.3.2 Depositor-Supplied Synonyms

    1. 117976-90-6

    2. Rebeprazole Sodium

    3. Pariet

    4. Aciphex

    5. Rabeprazole Sodium Salt

    6. Dexrabeprazole Sodium

    7. Rabeprazole (sodium)

    8. (s)-rabeprazole Sodium Salt

    9. Aciphex Sprinkle

    10. Ly307640 Sodium

    11. Sodium Rabeprazole

    12. Rabeprazole Sodium [usan]

    13. Idiazole

    14. Rabeprazole Na

    15. Chebi:8769

    16. 171440-19-0

    17. Ly-307640

    18. E3810

    19. E-3810 Sodium

    20. Sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]benzimidazol-1-ide

    21. Ly-307640 Sodium

    22. 3l36p16u4r

    23. 1h-benzimidazole, 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt

    24. 2-(((4-(3-methoxypropoxy)-3-methyl-2-pyridyl)methyl)sulfinyl)benzimidazole Sodium Salt

    25. Nsc-759270

    26. Dsstox_cid_24205

    27. Dsstox_rid_80118

    28. Dsstox_gsid_44205

    29. 1h-benzimidazole, 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-, Sodium Salt (1:1)

    30. Rabicip

    31. Pepcia

    32. Aciphex Sodium

    33. Ly 307640 Sodium

    34. Habeprazole Sodium

    35. Sodium 2-((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methylsulfinyl)benzo[d]imidazol-1-ide

    36. Sodium 2-({[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methyl}sulfinyl)benzimidazol-1-ide

    37. Smr000550493

    38. Cas-117976-90-6

    39. Ncgc00159518-02

    40. E 3810

    41. Pariete

    42. Unii-3l36p16u4r

    43. Pariprazole Sodium

    44. Dexrabeprazolesodium

    45. Rebeprazole Sodium;

    46. Aciphex (tn)

    47. Pariet (tn)

    48. Rebeprazole Sodium Salt

    49. Rabeprazole Sodium- Bio-x

    50. Mls001165734

    51. Mls006010621

    52. Schembl140494

    53. Rabeprazole Na [vandf]

    54. Chembl1200930

    55. Dtxsid3044205

    56. Rabeprazole Sodium [jan]

    57. Hy-b0656a

    58. Rabeprazole Sodium (jp17/usp)

    59. Ex-a176

    60. Hms2093h10

    61. Hms2231e04

    62. Hms3373b05

    63. Rabeprazole Sodium [mart.]

    64. Bcp06639

    65. Rabeprazole Sodium [usp-rs]

    66. Rabeprazole Sodium [who-dd]

    67. Tox21_111736

    68. Tox21_302317

    69. Ac-715

    70. Bdbm50247881

    71. Mfcd02092688

    72. Rabeprazole Sodium Salt [mi]

    73. S4665

    74. Rabeprazole Sodium, >=98% (hplc)

    75. Akos015895734

    76. Akos015962116

    77. Akos025310160

    78. Tox21_111736_1

    79. Am81231

    80. Ccg-213574

    81. Ccg-268423

    82. Nsc 759270

    83. Rabeprazole Sodium [orange Book]

    84. Ncgc00159518-05

    85. Ncgc00255838-01

    86. Rabeprazole Sodium [ep Monograph]

    87. As-13338

    88. Br167318

    89. Rabeprazole Sodium [usp Monograph]

    90. Ft-0631090

    91. Ft-0689461

    92. R0115

    93. C07865

    94. D00724

    95. F17418

    96. 976r906

    97. Sr-01000799133

    98. J-010726

    99. Q-201655

    100. Sr-01000799133-2

    101. Q27108142

    102. [2-[[4-(3-methoxypropoxy)-3-methyl-2-pyridyl]methylsulfinyl]benzimidazol-1-yl]sodium

    103. Sodium;2-[[4-(3-methoxypropoxy)-3-methylpyridin-2-yl]methylsulfinyl]-1h-benzimidazole

    104. 1h-benzimidazole,2-[[[4-(3-methoxypropoxy)- 3-methyl-2-pyridinyl]methyl]sulfinyl]-,sodium Salt

    105. 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole, Sodium Salt

    106. Sodium 2-(((4-(3-methoxypropoxy)-3-methylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide

    2.4 Create Date
    2007-02-09
    3 Chemical and Physical Properties
    Molecular Weight 381.4 g/mol
    Molecular Formula C18H20N3NaO3S
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count8
    Exact Mass381.11230696 g/mol
    Monoisotopic Mass381.11230696 g/mol
    Topological Polar Surface Area81.5 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity446
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    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 NameAciphex
    PubMed HealthRabeprazole (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
    Active IngredientRabeprazole sodium
    Dosage FormTablet, delayed release
    Routeoral; Oral
    Strength20mg
    Market StatusPrescription
    CompanyEisai; Eisai Medcl Res

    2 of 4  
    Drug NameRabeprazole sodium
    Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
    Active IngredientRabeprazole sodium
    Dosage FormTablet, delayed release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyMylan Pharms; Kremers Urban Dev; Teva Pharms Usa; Torrent Pharms; Lupin; Dr Reddys Labs

    3 of 4  
    Drug NameAciphex
    PubMed HealthRabeprazole (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
    Active IngredientRabeprazole sodium
    Dosage FormTablet, delayed release
    Routeoral; Oral
    Strength20mg
    Market StatusPrescription
    CompanyEisai; Eisai Medcl Res

    4 of 4  
    Drug NameRabeprazole sodium
    Drug LabelThe active ingredient in ACIPHEX Delayed-Release Tablets is rabeprazole sodium, a substituted benzimidazole that inhibits gastric acid secretion. Rabeprazole sodium is known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfiny...
    Active IngredientRabeprazole sodium
    Dosage FormTablet, delayed release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyMylan Pharms; Kremers Urban Dev; Teva Pharms Usa; Torrent Pharms; Lupin; Dr Reddys Labs

    4.2 Drug Indication

    Treatment of duodenal ulcer, Treatment of gastric ulcer, Treatment of gastro-oesophageal reflux disease, Treatment of Helicobacter pylori in patients with peptic ulcer disease, Treatment of Zollinger-Ellison syndrome

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    Proton Pump Inhibitors

    Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Proton Pump Inhibitors [MoA]; Proton Pump Inhibitor [EPC]

    API Reference Price

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LTD","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"335","totalValueFC":"102908.3","currency":"USD","unitRateINR":"28131","date":"02-Aug-2023","totalValueINR":"8524547.372","totalValueInUsd":"102908.3","indian_port":"JNPT\/ NHAVA SHEVA SEA","hs_no":"29333990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SOUTH KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1701 B-WING,LOTUS CORPORATE PARK,W ,ESTERN EXPRESS HIGHWAY, GOREGAON ,EAST ,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708885800,"product":"RABEPRAZOLE SODIUM (QTY : 1 X 250 MG,VALUE USD: 451)(FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNDISCLOSED","supplierCountry":"ITALY","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"1804000","totalValueFC":"476.2","currency":"USD","unitRateINR":"158043720","date":"26-Feb-2024","totalValueINR":"39510.93","totalValueInUsd":"476.2","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"2306449","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD 21704 USA Frederick, , United States United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718217000,"product":"RABEPRAZOLE SODIUM (QTY: 1 X 250 MG, VALUE: USD 451)(FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"HUNGARY","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"1804000","totalValueFC":"480.6","currency":"USD","unitRateINR":"160476920","date":"13-Jun-2024","totalValueINR":"40119.23","totalValueInUsd":"480.6","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"3975560","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD,US UNITED STATESSDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"RABEPRAZOLE SODIUM PELLETS 8.5 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"MM FARMACHEM D O O","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"274.13","actualQuantity":"274.13","unit":"KGS","unitRateFc":"69","totalValueFC":"19151.7","currency":"USD","unitRateINR":"5854.7","date":"03-Sep-2024","totalValueINR":"1604935.2","totalValueInUsd":"19151.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"5397758","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pellets","supplierPort":"ZAGREB","supplierAddress":"RADNICKA CESTA 54 R3 5TH FLOOR 10000 ZAGREB SDNF Croatia","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"RABEPRAZOLE SODIUM PELLETS 8.5 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"MM FARMACHEM DOO","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"4.49","actualQuantity":"4.49","unit":"KGS","unitRateFc":"69","totalValueFC":"313.2","currency":"USD","unitRateINR":"5861.6","date":"25-Oct-2024","totalValueINR":"26318.36","totalValueInUsd":"313.2","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"6319641","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pellets","supplierPort":"ZAGREB","supplierAddress":"RADNICKA CESTA 54, R3\/5TH FLOOR 1000 ZAGREB, HRVATSKA SDNF Croatia","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"RABEPRAZOLE SODIUM (QTY : 1 X 250 MG, VALUE USD:450) (FOC) SAMPLES FOR IN HOUSE R&D\/TESTING PURPOSE","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNDISCLOSED","supplierCountry":"SPAIN","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIAINDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"1828092","totalValueFC":"461.6","currency":"USD","unitRateINR":"159226720","date":"17-Jan-2025","totalValueINR":"39806.68","totalValueInUsd":"461.6","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7834431","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,M D 21704 USA Frederick, , United Sta tes United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749666600,"product":"RABEPRAZOLE PELLETS 8.50 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"14.4","totalValueFC":"21821.3","currency":"USD","unitRateINR":"1250","date":"12-Jun-2025","totalValueINR":"1875000","totalValueInUsd":"21821.3","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"2600943","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pellets","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"PLOT NO.5, PHASE-2, VSEZ, DUVVADA, VISAKHAPATNAM SDNF India","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758220200,"product":"RABEPRAZOLE SODIUM BP(B\/N:RB24100016,17,18,19,20,21&22)(SB NO: 5764719,DT:20-11-2024-INV NO:SI3624103748,DT:16-11-2024)RABEPRAZOLE SODIUM BP(B\/NRB24100016,17,18,19,20,21&22)(SB NO","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"ARISTO PHARMA GMBH","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"124.3","totalValueFC":"125117.8","currency":"USD","unitRateINR":"11044","date":"19-Sep-2025","totalValueINR":"11044030.24","totalValueInUsd":"125117.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4611768","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DHAKA","supplierAddress":"PLOT NO:14-22, ROAD NO. 11 & 12 SHAMPUT - KADAMTALI, I\/A DHAKA-1204 BD","customerAddress":"7-2-A2, HETERO CORPORATE,"}]
    03-Jan-2022
    27-Feb-2026
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 204736

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 5MG

    USFDA APPLICATION NUMBER - 204736

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG ...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20973

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - 20MG

    USFDA APPLICATION NUMBER - 20973

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    ABOUT THIS PAGE

    Looking for 117976-90-6 / Rabeprazole Sodium API manufacturers, exporters & distributors?

    Rabeprazole Sodium manufacturers, exporters & distributors 1

    27

    PharmaCompass offers a list of Rabeprazole Sodium 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 Rabeprazole Sodium manufacturer or Rabeprazole Sodium supplier for your needs.

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

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

    API | Excipient name

    Rabeprazole Sodium

    Synonyms

    117976-90-6, Rebeprazole sodium, Pariet, Aciphex, Rabeprazole sodium salt, Dexrabeprazole sodium

    Cas Number

    117976-90-6

    Unique Ingredient Identifier (UNII)

    3L36P16U4R

    About Rabeprazole Sodium

    A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.

    AC-715 Manufacturers

    A AC-715 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AC-715, including repackagers and relabelers. The FDA regulates AC-715 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AC-715 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 AC-715 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    AC-715 Suppliers

    A AC-715 supplier is an individual or a company that provides AC-715 active pharmaceutical ingredient (API) or AC-715 finished formulations upon request. The AC-715 suppliers may include AC-715 API manufacturers, exporters, distributors and traders.

    click here to find a list of AC-715 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    AC-715 USDMF

    A AC-715 DMF (Drug Master File) is a document detailing the whole manufacturing process of AC-715 active pharmaceutical ingredient (API) in detail. Different forms of AC-715 DMFs exist exist since differing nations have different regulations, such as AC-715 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A AC-715 DMF submitted to regulatory agencies in the US is known as a USDMF. AC-715 USDMF includes data on AC-715's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AC-715 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of AC-715 suppliers with USDMF on PharmaCompass.

    AC-715 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 AC-715 Drug Master File in Japan (AC-715 JDMF) empowers AC-715 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 AC-715 JDMF during the approval evaluation for pharmaceutical products. At the time of AC-715 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 AC-715 suppliers with JDMF on PharmaCompass.

    AC-715 KDMF

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

    Pharmaceutical companies submit a AC-715 Drug Master File in Korea (AC-715 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AC-715. The MFDS reviews the AC-715 KDMF as part of the drug registration process and uses the information provided in the AC-715 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a AC-715 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 AC-715 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of AC-715 suppliers with KDMF on PharmaCompass.

    AC-715 CEP

    A AC-715 CEP of the European Pharmacopoeia monograph is often referred to as a AC-715 Certificate of Suitability (COS). The purpose of a AC-715 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AC-715 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AC-715 to their clients by showing that a AC-715 CEP has been issued for it. The manufacturer submits a AC-715 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AC-715 CEP holder for the record. Additionally, the data presented in the AC-715 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AC-715 DMF.

    A AC-715 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AC-715 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 AC-715 suppliers with CEP (COS) on PharmaCompass.

    AC-715 WC

    A AC-715 written confirmation (AC-715 WC) is an official document issued by a regulatory agency to a AC-715 manufacturer, verifying that the manufacturing facility of a AC-715 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AC-715 APIs or AC-715 finished pharmaceutical products to another nation, regulatory agencies frequently require a AC-715 WC (written confirmation) as part of the regulatory process.

    click here to find a list of AC-715 suppliers with Written Confirmation (WC) on PharmaCompass.

    AC-715 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 AC-715 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for AC-715 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 AC-715 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 AC-715 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AC-715 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of AC-715 suppliers with NDC on PharmaCompass.

    AC-715 GMP

    AC-715 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 AC-715 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 AC-715 GMP manufacturer or AC-715 GMP API supplier for your needs.

    AC-715 CoA

    A AC-715 CoA (Certificate of Analysis) is a formal document that attests to AC-715's compliance with AC-715 specifications and serves as a tool for batch-level quality control.

    AC-715 CoA mostly includes findings from lab analyses of a specific batch. For each AC-715 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.

    AC-715 may be tested according to a variety of international standards, such as European Pharmacopoeia (AC-715 EP), AC-715 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AC-715 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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