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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
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
| Molecular Weight | 369.4 g/mol |
|---|---|
| Molecular Formula | C16H14F3N3O2S |
| XLogP3 | 2.8 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 5 |
| Exact Mass | 369.07588236 g/mol |
| Monoisotopic Mass | 369.07588236 g/mol |
| Topological Polar Surface Area | 87.1 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 480 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Dexilant |
| PubMed Health | Dexlansoprazole (By mouth) |
| Drug Classes | Gastric Acid Secretion Inhibitor |
| Drug Label | The 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 Ingredient | Dexlansoprazole |
| Dosage Form | Capsule, delayed release |
| Route | Oral |
| Strength | 60mg; 30mg |
| Market Status | Prescription |
| Company | Takeda Pharms Usa |
| 2 of 4 | |
|---|---|
| Drug Name | Dexlansoprazole |
| PubMed Health | Dexlansoprazole (By mouth) |
| Drug Classes | Gastric Acid Secretion Inhibitor |
| Drug Label | The 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 Ingredient | Dexlansoprazole |
| Dosage Form | Capsule, extended release |
| Route | Oral |
| Strength | 60mg |
| Market Status | Tentative Approval |
| Company | Par Pharm |
| 3 of 4 | |
|---|---|
| Drug Name | Dexilant |
| PubMed Health | Dexlansoprazole (By mouth) |
| Drug Classes | Gastric Acid Secretion Inhibitor |
| Drug Label | The 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 Ingredient | Dexlansoprazole |
| Dosage Form | Capsule, delayed release |
| Route | Oral |
| Strength | 60mg; 30mg |
| Market Status | Prescription |
| Company | Takeda Pharms Usa |
| 4 of 4 | |
|---|---|
| Drug Name | Dexlansoprazole |
| PubMed Health | Dexlansoprazole (By mouth) |
| Drug Classes | Gastric Acid Secretion Inhibitor |
| Drug Label | The 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 Ingredient | Dexlansoprazole |
| Dosage Form | Capsule, extended release |
| Route | Oral |
| Strength | 60mg |
| Market Status | Tentative Approval |
| Company | Par Pharm |
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
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.
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.)
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
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.
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
Dexlansoprazole is eliminated with a half-life of approximately one to two hours in healthy subjects and in patients with symptomatic GERD.
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.
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DMF Number : 33685
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Rev. Date : 2021-03-26
Pay. Date : 2021-02-11
DMF Number : 35135
Submission : 2020-12-30
Status : Active
Type : II
NDC Package Code : 59285-038
Start Marketing Date : 2020-12-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Dexlansoprazole API and other APIs are published in this directory by the FDA.
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.
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 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.
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).
