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    Chemistry

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    Also known as: (r)-lansoprazole, 138530-94-6, Kapidex, R-(+)-lansoprazole, Dexilant, Dexilant solutab
    Molecular Formula
    C16H14F3N3O2S
    Molecular Weight
    369.4  g/mol
    InChI Key
    MJIHNNLFOKEZEW-RUZDIDTESA-N
    FDA UNII
    UYE4T5I70X
    Dexlansoprazole
    The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE.
    Dexlansoprazole is a Proton Pump Inhibitor. The mechanism of action of dexlansoprazole is as a Proton Pump Inhibitor.
    1 2D Structure

    Dexlansoprazole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[(R)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1H-benzimidazole
    2.1.2 InChI
    InChI=1S/C16H14F3N3O2S/c1-10-13(20-7-6-14(10)24-9-16(17,18)19)8-25(23)15-21-11-4-2-3-5-12(11)22-15/h2-7H,8-9H2,1H3,(H,21,22)/t25-/m1/s1
    2.1.3 InChI Key
    MJIHNNLFOKEZEW-RUZDIDTESA-N
    2.1.4 Canonical SMILES
    CC1=C(C=CN=C1CS(=O)C2=NC3=CC=CC=C3N2)OCC(F)(F)F
    2.1.5 Isomeric SMILES
    CC1=C(C=CN=C1C[S@@](=O)C2=NC3=CC=CC=C3N2)OCC(F)(F)F
    2.2 Other Identifiers
    2.2.1 UNII
    UYE4T5I70X
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

    2. Dexilant

    3. Dexlansoprazole Sesquihydrate

    4. Lansoprazole, R Isomer

    5. Lansoprazole, R-isomer

    6. R Lansoprazole

    7. R-isomer Lansoprazole

    8. R-lansoprazole

    9. T 168390

    10. T-168390

    11. T168390

    12. Tak 390

    13. Tak 390mr

    14. Tak-390

    15. Tak-390mr

    16. Tak390

    17. Tak390mr

    2.3.2 Depositor-Supplied Synonyms

    1. (r)-lansoprazole

    2. 138530-94-6

    3. Kapidex

    4. R-(+)-lansoprazole

    5. Dexilant

    6. Dexilant Solutab

    7. Tak 390

    8. Tak-390

    9. Lansoprazole R-form

    10. Lansoprazole, (r)-

    11. T 168390

    12. (r)-(+)-lansoprazole

    13. T-168390

    14. Uye4t5i70x

    15. (r)-2-(((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole

    16. Nsc-758710

    17. 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole

    18. Tak-390mr

    19. 1h-benzimidazole, 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-

    20. Dexlansoprazole [usan]

    21. Unii-uye4t5i70x

    22. Dexlansoprazole (inn/usan)

    23. Dexlansoprazole [usan:inn]

    24. (+)-lansoprazol

    25. 2-[(r)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole

    26. Dexilant (tn)

    27. (+)-2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzimidazole

    28. (+)-2-((r)-{(3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl}sulfinyl)-1h-benzimidazole

    29. 1h-benzimidazole, 2-[(r)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-

    30. Schembl44975

    31. Dexlansoprazole [inn]

    32. Dexlansoprazole [vandf]

    33. Gtpl5487

    34. Dexlansoprazole [mart.]

    35. Chembl1201863

    36. Dexlansoprazole [who-dd]

    37. Lansoprazole R-form [mi]

    38. 2-[(r)-[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl]-1h-benzimidazole

    39. Chebi:135931

    40. Hms3652c14

    41. Zinc599734

    42. Amy25226

    43. Bdbm50247930

    44. Dexlansoprazole [orange Book]

    45. Hy-13662b

    46. Mfcd13196699

    47. S4099

    48. Akos025290765

    49. Ccg-213301

    50. Db05351

    51. Nsc 758710

    52. Pb33188

    53. 2-[(r)-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1h-benzimidazole

    54. Ncgc00386267-03

    55. Ac-26449

    56. As-18086

    57. Sw219466-1

    58. D08903

    59. Ab01563023_01

    60. Ab01563023_02

    61. Q5268339

    62. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole

    63. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]benzimidazole

    64. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1h-benzimidazole

    65. (r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole

    66. (r)-(+)2-([3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl)-1h-benzimidazole

    67. 2-[(r)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methane}sulfinyl]-1h-1,3-benzodiazole

    2.4 Create Date
    2006-10-24
    3 Chemical and Physical Properties
    Molecular Weight 369.4 g/mol
    Molecular Formula C16H14F3N3O2S
    XLogP32.8
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count5
    Exact Mass369.07588236 g/mol
    Monoisotopic Mass369.07588236 g/mol
    Topological Polar Surface Area87.1 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity480
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameDexilant
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, delayed release
    RouteOral
    Strength60mg; 30mg
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    2 of 4  
    Drug NameDexlansoprazole
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, extended release
    RouteOral
    Strength60mg
    Market StatusTentative Approval
    CompanyPar Pharm

    3 of 4  
    Drug NameDexilant
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, delayed release
    RouteOral
    Strength60mg; 30mg
    Market StatusPrescription
    CompanyTakeda Pharms Usa

    4 of 4  
    Drug NameDexlansoprazole
    PubMed HealthDexlansoprazole (By mouth)
    Drug ClassesGastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion...
    Active IngredientDexlansoprazole
    Dosage FormCapsule, extended release
    RouteOral
    Strength60mg
    Market StatusTentative Approval
    CompanyPar Pharm

    4.2 Drug Indication

    Dexlansoprazole is indicated for healing all grades of erosive esophagitis (EE), maintaining and healing of EE and relief of heartburn, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Dexlansoprazole is a proton pump inhibitor (PPI) and is included in the drug class of antisecretory compounds. It blocks the final step of gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface of the parietal cells on gastric mucosa.

    5.2 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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DEXLANSOPRAZOLE
    5.3.2 FDA UNII
    UYE4T5I70X
    5.3.3 Pharmacological Classes
    Proton Pump Inhibitors [MoA]; Proton Pump Inhibitor [EPC]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A02 - Drugs for acid related disorders

    A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

    A02BC - Proton pump inhibitors

    A02BC06 - Dexlansoprazole

    5.5 Absorption, Distribution and Excretion

    Absorption

    After oral administration, the peak plasma concentration increases approximately dose proportionally. The dual delayed release formulation achieves two plasma concentration peaks, where the first peak occurs one to two hours after administration, followed by a second peak within four to five hours. The delivery technology of dexlansoprazole MR is designed to release the drug in two separate pH-dependent phases, the first in the proximal duodenum (25% of total drug dose) and the second (75% of total drug dose) in the more distal small intestine. The median time (Tmax) to peak plasma concentrations (Cmax) of 30 mg dexlansoprazole was 4 hours and ranged from 1 to 6 hours with the Cmax value of 688 ng/mL. AUC was found to be 3275 (ngh/mL).

    Route of Elimination

    Dexlansoprazole is cleared from the body by either fecal excretion (50.7%) or renal excretion (47.6%) following oral ingestion, with no unchanged drug detected in the urine.

    Volume of Distribution

    The apparent volume of distribution after multiple doses in symptomatic GERD patients was 40.3 L.

    Clearance

    Apparent clearance (CL/F) in healthy subjects was 11.4 to 11.6 L/hour, respectively, after five days of 30 or 60 mg once daily administration.

    5.6 Metabolism/Metabolites

    Dexlansoprazole is extensively metabolized in the liver by oxidation, reduction, and subsequent formation of sulfate, glucuronide and glutathione conjugates to inactive metabolites. Oxidative metabolites are formed by the cytochrome P450 (CYP) enzyme system including hydroxylation mainly by CYP2C19, and oxidation to the sulfone by CYP3A4. Dexlansoprazole is the major circulating component in plasma regardless of CYP2C19 metabolizer status. In CYP2C19 intermediate and extensive metabolizers, the major plasma metabolites are 5-hydroxy dexlansoprazole and its glucuronide conjugate, while in CYP2C19 poor metabolizers dexlansoprazole sulfone is the major plasma metabolite.

    Lansoprazole has known human metabolites that include 5-Hydroxylansoprazole and Lansoprazole Sulfone.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    Dexlansoprazole is eliminated with a half-life of approximately one to two hours in healthy subjects and in patients with symptomatic GERD.

    5.8 Mechanism of Action

    Dexlansoprazole inhibits the H/K ATPase enzyme, which is involved in the secretion of hydrochloric acid, hydrolyzing ATP and exchanging H+ ions from the cytoplasm for K+ ions in the secretory canaliculus, which results in HCl secretion into the gastric lumen. Dexlansoprazole inhibits this effect of H/K ATPase by demonstrating a high degree of activation in the acidic environment. After passing through the liver and reaching the gastric parietal cells activated by a meal, PPIs undergo protonation in the acidic pH environment, followed by conversion to sulphenamide which represents the active form of the drug. Sulphenamide inhibits the activity of the proton pump and hence the transport of hydrogen ions into the gastric lumen via covalent binding to the SH groups of the cysteine residues of H/K ATPase. The delivery technology of dexlansoprazole MR is designed to release the drug in two separate pH-dependent phases, the first in the proximal duodenum (25% of total drug dose) and the second (75% of total drug dose) in the more distal small intestine. Dexlansoprazole reduces both basal and stimulated gastric acid secretion.

    API Reference Price

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MALPENSA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"378.23","actualQuantity":"378.23","unit":"KGS","unitRateFc":"3000","totalValueFC":"1149095.9","currency":"USD","unitRateINR":"252900","date":"15-Dec-2023","totalValueINR":"95654367","totalValueInUsd":"1149095.9","indian_port":"Madras Air","hs_no":"29339990","bill_no":"9247250","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA BISSONE 5, 20021 BARANZATE(MI)SDNF ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706466600,"product":"DEXLANSOPRAZOLE ANHYDROUS 2314220 \/ 2314221","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"388.90","actualQuantity":"388.9","unit":"KGS","unitRateFc":"3000","totalValueFC":"1180573.5","currency":"USD","unitRateINR":"252300","date":"29-Jan-2024","totalValueINR":"98119470","totalValueInUsd":"1180573.5","indian_port":"Madras Air","hs_no":"29339990","bill_no":"9871749","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA BISSONE 5, 20021 BARANZATE(MI)SDNF ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710354600,"product":"DEXLANSOPRAZOLE ANHYDROUS BATCH NO. 2403231 \/ 2403232 \/ 2403233 \/ A240125003 \/ A240205003 \/ A240212003","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"466.00","actualQuantity":"466","unit":"KGS","unitRateFc":"3000","totalValueFC":"1410024.5","currency":"USD","unitRateINR":"251250","date":"14-Mar-2024","totalValueINR":"117082500","totalValueInUsd":"1410024.5","indian_port":"Madras Air","hs_no":"29339990","bill_no":"2566530","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA BISSONE 5, 20021 BARANZATE(MI)SDNF ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"DEXLANSOPRAZOLE ANHYDROUS BATCH NO. 2403903\/04\/05 - A240214004\/ A240220003 \/ A240223008","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MALTA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"421.00","actualQuantity":"421","unit":"KGS","unitRateFc":"3000","totalValueFC":"1277666","currency":"USD","unitRateINR":"252000","date":"28-Mar-2024","totalValueINR":"106092000","totalValueInUsd":"1277666","indian_port":"Madras Air","hs_no":"29339990","bill_no":"2773357","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"VIA BISSONE 5, 20021 BARANZATE(MI)SDNF ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713378600,"product":"DEXLANSOPRAZOLE ANHYDROUS 500752","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MALTA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"146.20","actualQuantity":"146.2","unit":"KGS","unitRateFc":"1500","totalValueFC":"221513","currency":"USD","unitRateINR":"126525","date":"18-Apr-2024","totalValueINR":"18497955","totalValueInUsd":"221513","indian_port":"Madras Air","hs_no":"29339990","bill_no":"3083301","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"VIA BISSONE 5, 20021 BARANZATE(MI)SDNF ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725993000,"product":"DEXLANSOPRAZOLE IH - 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    16-Jan-2021
    31-Mar-2025
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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 30MG

    USFDA APPLICATION NUMBER - 22287

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    DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 60MG

    USFDA APPLICATION NUMBER - 22287

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    ABOUT THIS PAGE

    Looking for 138530-94-6 / Dexlansoprazole API manufacturers, exporters & distributors?

    Dexlansoprazole manufacturers, exporters & distributors 1

    94

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

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

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

    API | Excipient name

    Dexlansoprazole

    Synonyms

    (r)-lansoprazole, 138530-94-6, Kapidex, R-(+)-lansoprazole, Dexilant, Dexilant solutab

    Cas Number

    138530-94-6

    Unique Ingredient Identifier (UNII)

    UYE4T5I70X

    About Dexlansoprazole

    The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE.

    Dexlansoprazole Manufacturers

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

    Dexlansoprazole Suppliers

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

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

    Dexlansoprazole USDMF

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

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

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

    Dexlansoprazole KDMF

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

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

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

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

    Dexlansoprazole WC

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

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

    Dexlansoprazole 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 Dexlansoprazole as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dexlansoprazole GMP

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

    Dexlansoprazole CoA

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

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

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