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    Chemistry

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    Also known as: Omeprazole magnesium, 161973-10-0, Prilosec otc, H 168/68 magnesium, 95382-33-5, Omeprazole (as magnesium)
    Molecular Formula
    C34H36MgN6O6S2
    Molecular Weight
    713.1  g/mol
    InChI Key
    KWORUUGOSLYAGD-UHFFFAOYSA-N
    FDA UNII
    426QFE7XLK
    Esomeprazole Magnesium
    The S-isomer of omeprazole.
    1 2D Structure

    Esomeprazole Magnesium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    magnesium;5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
    2.1.2 InChI
    InChI=1S/2C17H18N3O3S.Mg/c2*1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17;/h2*5-8H,9H2,1-4H3;/q2*-1;+2
    2.1.3 InChI Key
    KWORUUGOSLYAGD-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC.CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC.[Mg+2]
    2.2 Other Identifiers
    2.2.1 UNII
    426QFE7XLK
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Esomeprazole

    2. Esomeprazole Potassium

    3. Esomeprazole Sodium

    4. Esomeprazole Strontium

    5. Esomeprazole Strontium Anhydrous

    6. Nexium

    7. Strontium, Esomeprazole

    2.3.2 Depositor-Supplied Synonyms

    1. Omeprazole Magnesium

    2. 161973-10-0

    3. Prilosec Otc

    4. H 168/68 Magnesium

    5. 95382-33-5

    6. Omeprazole (as Magnesium)

    7. 426qfe7xlk

    8. Magnesium;5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

    9. Esomeprazole Magnesium Salt

    10. Unii-426qfe7xlk

    11. Omeprazole Magnesium [usan]

    12. Omeprazole Magnesium [usan:usp]

    13. Prilosec Otc (tn)

    14. Esomeprazole(magnesium)

    15. Omeprazole Magnesium Salt

    16. Omeprazole Magnesium (usp)

    17. Mls001165732

    18. Schembl722792

    19. Esomeprazole Magnesium (nexium)

    20. Chembl1567328

    21. Chebi:94401

    22. H-168/68 Magnesium

    23. Hms2878h13

    24. Omeprazole Magnesium [vandf]

    25. Mfcd06798050

    26. Omeprazole Magnesium [mart.]

    27. Omeprazole Magnesium [usp-rs]

    28. Omeprazole Magnesium [who-dd]

    29. Akos015896379

    30. Akos025402081

    31. Omeprazole Magnesium Salt [mi]

    32. As-75082

    33. Omeprazole Magnesium [orange Book]

    34. Smr000550477

    35. Omeprazole Magnesium [ep Monograph]

    36. Omeprazole Magnesium [usp Impurity]

    37. Omeprazole Magnesium [usp Monograph]

    38. Ft-0657297

    39. Sw220306-1

    40. Talicia Component Omeprazole Magnesium

    41. D05259

    42. Omeprazole Magnesium Component Of Talicia

    43. A810316

    44. J-014249

    45. Q-100195

    46. Q27166253

    47. 5-methoxy-1h-1,3-benzimidazol-2-yl (4-methoxy-3,5-dimethyl-2-pyridinyl)methyl Sulfoxide

    48. (rs)-5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole, Magnesium Salt (2:1)

    49. 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole, Magnesium Salt

    50. 5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, Magnesium Salt (2:1)

    51. Magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide;esomeprazole Magnesium(random Configuration)

    52. Magnesium(2+) 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1h-1,3-benzodiazol-1-ide 6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1h-1,3-benzodiazol-1-ide

    53. Magnesium, Bis(6-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl-.kappa.o)-1h-benzimidazolato-.kappa.n3)-, (t-4)-

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 713.1 g/mol
    Molecular Formula C34H36MgN6O6S2
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count10
    Exact Mass712.1988169 g/mol
    Monoisotopic Mass712.1988169 g/mol
    Topological Polar Surface Area163 Ų
    Heavy Atom Count49
    Formal Charge0
    Complexity453
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameEsomeprazole magnesium
    PubMed HealthEsomeprazole
    Drug ClassesGastric Acid Secretion Inhibitor, Gastrointestinal Agent
    Drug LabelThe active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
    Active IngredientEsomeprazole magnesium
    Dosage FormCapsule, delayed release
    Routeoral
    Strength40mg; 20mg
    Market StatusTentative Approval
    CompanyRanbaxy

    2 of 6  
    Drug NameNexium
    Drug LabelThe active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
    Active IngredientEsomeprazole magnesium
    Dosage FormCapsule, delayed rel pellets; For suspension, delayed release
    RouteOral
    Strengtheq 5mg base/packet; eq 20mg base/packet; eq 20mg base; eq 40mg base; eq 10mg base/packet; eq 40mg base/packet; eq 2.5mg base/packet
    Market StatusPrescription
    CompanyAstrazeneca

    3 of 6  
    Drug NameOmeprazole magnesium
    Drug LabelThe active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
    Active IngredientOmeprazole magnesium
    Dosage FormCapsule, delayed release
    RouteOral
    Strengtheq 20mg base
    Market StatusOver the Counter
    CompanyDr Reddys Labs

    4 of 6  
    Drug NameEsomeprazole magnesium
    PubMed HealthEsomeprazole
    Drug ClassesGastric Acid Secretion Inhibitor, Gastrointestinal Agent
    Drug LabelThe active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
    Active IngredientEsomeprazole magnesium
    Dosage FormCapsule, delayed release
    Routeoral
    Strength40mg; 20mg
    Market StatusTentative Approval
    CompanyRanbaxy

    5 of 6  
    Drug NameNexium
    Drug LabelThe active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
    Active IngredientEsomeprazole magnesium
    Dosage FormCapsule, delayed rel pellets; For suspension, delayed release
    RouteOral
    Strengtheq 5mg base/packet; eq 20mg base/packet; eq 20mg base; eq 40mg base; eq 10mg base/packet; eq 40mg base/packet; eq 2.5mg base/packet
    Market StatusPrescription
    CompanyAstrazeneca

    6 of 6  
    Drug NameOmeprazole magnesium
    Drug LabelThe active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole...
    Active IngredientOmeprazole magnesium
    Dosage FormCapsule, delayed release
    RouteOral
    Strengtheq 20mg base
    Market StatusOver the Counter
    CompanyDr Reddys Labs

    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 Inhibitor [EPC]; Proton Pump Inhibitors [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]

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Turkey","customerAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738866600,"product":"ESOMEPRAZOLE MEGNESIUM DIHYDRATE(REJECTED AND REIMPORTED MATERIAL,EXPORTED VIDE SB NO-3451932DT-25-AUG-2023,B-EMD0250723ESOMEPRAZOLE MEGNESIUM DIHYDRATE(REJECTED AND RE-IMPORTED MA","address":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY","city":"HYDERABAD.AP","supplier":"ULKAR HOLDING","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"NOSCH LABS PVT","customerCountry":"INDIA","quantity":"223.51","actualQuantity":"223.51","unit":"KGS","unitRateFc":"234.3","totalValueFC":"53239.5","currency":"N\/A","unitRateINR":"20714.6","date":"07-Feb-2025","totalValueINR":"4629926.5","totalValueInUsd":"53239.5","indian_port":"Hyderabad Air","hs_no":"29331999","bill_no":"8239138","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"SARAY MAHALLESI DR.ADNAN BUYUKDENIZ CADDESI NO.14(34768) UMRANIYE\/ISTA NBUL\/TURKEY Istanbul, , Turkey Tel. Turkey","customerAddress":"FLAT NO.404 TO 406,4TH FLOOR,VIJAY"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740940200,"product":"ESOMEPRAZOLE MAGNESIUM TRIHYDRATE PH.EUR","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"IPCA LABORATORIES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"172.4","totalValueFC":"349.2","currency":"USD","unitRateINR":"15125","date":"03-Mar-2025","totalValueINR":"30250","totalValueInUsd":"349.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8656916","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"48, KANDIVLI INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP","address":"NO.8-2-248\/1\/7\/64, PLOT NO.64,","city":"PUNJAGUTTA, HYDERABAD, AP.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"GRAVITI PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1020.01","actualQuantity":"1020.01","unit":"KGS","unitRateFc":"142.7","totalValueFC":"147494.6","currency":"USD","unitRateINR":"12525","date":"07-Mar-2025","totalValueINR":"12775625.25","totalValueInUsd":"147494.6","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8748656","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"NO.8-2-248\/1\/7\/64, PLOT NO.64,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"ESOMEPRAZOLE MAGNESIUM TRIHYDRATE WS","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"98.8","totalValueFC":"500.8","currency":"USD","unitRateINR":"8676.4","date":"07-Mar-2025","totalValueINR":"43382.05","totalValueInUsd":"500.8","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"8744818","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT NO 1 HETERO INFRASTRUCTURE SEZ N.NARASAPURAM (V), NAKKAPALLY SDNF India","customerAddress":"7-2-A2, HETERO CORPORATE,"}]
    01-Jan-2021
    31-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 2...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 20MG BASE

    USFDA APPLICATION NUMBER - 204655

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    DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

    USFDA APPLICATION NUMBER - 21153

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    DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 40MG BASE

    USFDA APPLICATION NUMBER - 21153

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    DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 2.5MG BASE/PACKET

    USFDA APPLICATION NUMBER - 21957

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    DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 20MG BASE/PACKET

    USFDA APPLICATION NUMBER - 21957

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    DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 40MG BASE/PACKET

    USFDA APPLICATION NUMBER - 21957

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    DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL...DOSAGE - FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET

    USFDA APPLICATION NUMBER - 21957

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22511

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22511

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    ABOUT THIS PAGE

    Looking for 95382-33-5 / Esomeprazole Magnesium API manufacturers, exporters & distributors?

    Esomeprazole Magnesium manufacturers, exporters & distributors 1

    15

    PharmaCompass offers a list of Esomeprazole Magnesium 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 Esomeprazole Magnesium manufacturer or Esomeprazole Magnesium supplier for your needs.

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

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

    API | Excipient name

    Esomeprazole Magnesium

    Synonyms

    Omeprazole magnesium, 161973-10-0, Prilosec otc, H 168/68 magnesium, 95382-33-5, Omeprazole (as magnesium)

    Cas Number

    95382-33-5

    Unique Ingredient Identifier (UNII)

    426QFE7XLK

    About Esomeprazole Magnesium

    The S-isomer of omeprazole.

    Esomeprazole Magnesium Trihydrate Manufacturers

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

    Esomeprazole Magnesium Trihydrate Suppliers

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

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

    Esomeprazole Magnesium Trihydrate USDMF

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

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

    click here to find a list of Esomeprazole Magnesium Trihydrate suppliers with USDMF on PharmaCompass.

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

    Esomeprazole Magnesium Trihydrate KDMF

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

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

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

    click here to find a list of Esomeprazole Magnesium Trihydrate suppliers with KDMF on PharmaCompass.

    Esomeprazole Magnesium Trihydrate CEP

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

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

    Esomeprazole Magnesium Trihydrate WC

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

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

    Esomeprazole Magnesium Trihydrate 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 Esomeprazole Magnesium Trihydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Esomeprazole Magnesium Trihydrate suppliers with NDC on PharmaCompass.

    Esomeprazole Magnesium Trihydrate GMP

    Esomeprazole Magnesium Trihydrate 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 Esomeprazole Magnesium Trihydrate 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 Esomeprazole Magnesium Trihydrate GMP manufacturer or Esomeprazole Magnesium Trihydrate GMP API supplier for your needs.

    Esomeprazole Magnesium Trihydrate CoA

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

    Esomeprazole Magnesium Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Esomeprazole Magnesium Trihydrate 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.

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