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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":"83.90","actualQuantity":"83.9","unit":"KGS","unitRateFc":"675","totalValueFC":"57228.4","currency":"USD","unitRateINR":"56126.3","date":"04-May-2023","totalValueINR":"4708992.38","totalValueInUsd":"57228.4","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"Spain","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"","customerAddress":"MED ONE HOUSE, PLOT NO B-75, RD NO ,Z-33, WAGLE INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689013800,"product":"RABEPRAZOLE SODIUM, LOT NO13061601","address":"PLOT NO.135, DR.NO.10-153\/1,","city":"VISAKHAPATNAM, ANDHRA PRADESH","supplier":"EISAI COLTD","supplierCountry":"JAPAN","foreign_port":"N\/A","customer":"EISAI PHARMACEUTICALS INDIA PVT LTD","customerCountry":"INDIA","quantity":"359.00","actualQuantity":"359","unit":"KGS","unitRateFc":"731.8","totalValueFC":"266116.8","currency":"USD","unitRateINR":"60924.8","date":"11-Jul-2023","totalValueINR":"21872011","totalValueInUsd":"266116.8","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29333990","bill_no":"1001101","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.135, DR.NO.10-153\/1,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724005800,"product":"RABEPRAZOLE PELLETS 8.50 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA LTD","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"LEE PHARMA LTD","customerCountry":"INDIA","quantity":"1200.00","actualQuantity":"1200","unit":"KGS","unitRateFc":"14.7","totalValueFC":"17883","currency":"USD","unitRateINR":"1250","date":"19-Aug-2024","totalValueINR":"1500000","totalValueInUsd":"17883","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"5121876","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":"2024","qtr":"Q3","strtotime":1724005800,"product":"RABEPRAZOLE PELLETS 8.50 PERCENT","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA LTD","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"LEE PHARMA LTD","customerCountry":"INDIA","quantity":"1200.00","actualQuantity":"1200","unit":"KGS","unitRateFc":"14.7","totalValueFC":"17883","currency":"USD","unitRateINR":"1250","date":"19-Aug-2024","totalValueINR":"1500000","totalValueInUsd":"17883","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29333990","bill_no":"5123086","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":"2024","qtr":"Q3","strtotime":1726252200,"product":"RABEPRAZOLE SODIUM, LOT NO. 14080501","address":"PLOT NO.135, DR.NO.10-153\/1,","city":"VISAKHAPATNAM, ANDHRA PRADESH","supplier":"EISAI CO LTD","supplierCountry":"JAPAN","foreign_port":"NARITA APT\/TOKYO","customer":"EISAI PHARMACEUTICALS INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"359.00","actualQuantity":"359","unit":"KGS","unitRateFc":"736.1","totalValueFC":"267737.1","currency":"USD","unitRateINR":"62497.8","date":"14-Sep-2024","totalValueINR":"22436692.97","totalValueInUsd":"267737.1","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29333990","bill_no":"5599100","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NARITA APT\/TOKYO","supplierAddress":"KOISHIKAWA, 4-6-10 BUNKYO-KU, TOKYO SDNF Japan","customerAddress":"PLOT NO.135, DR.NO.10-153\/1,"},{"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 LTD","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,"}]
    06-Jan-2022
    31-Dec-2025
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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.

    Aciphex Manufacturers

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

    Aciphex Suppliers

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

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

    Aciphex USDMF

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

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

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

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

    Aciphex KDMF

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

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

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

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

    Aciphex CEP

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

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

    Aciphex WC

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

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

    Aciphex 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 Aciphex as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Aciphex GMP

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

    Aciphex CoA

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

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

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