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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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Drugs in Development
Details:
Dexilant-Generic (dexlansoprazole) is a proton pump inhibitor for healing erosive esophagitis and treating heartburn associated with non-erosive GERD.
Lead Product(s): Dexlansoprazole
Therapeutic Area: Gastroenterology Brand Name: Dexilant-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2024
Lead Product(s) : Dexlansoprazole
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Devonian’s Subsidiary Launches Generic Dexlansoprazole (Dexilant®) in Canada
Details : Dexilant-Generic (dexlansoprazole) is a proton pump inhibitor for healing erosive esophagitis and treating heartburn associated with non-erosive GERD.
Brand Name : Dexilant-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 27, 2024
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RLD : Yes
TE Code : AB
Brand Name : DEXILANT
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : 30MG
Approval Date : 2009-01-30
Application Number : 22287
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : DEXILANT
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : 60MG
Approval Date : 2009-01-30
Application Number : 22287
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code :
Brand Name : DEXILANT SOLUTAB
Dosage Form : TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL
Dosage Strength : 30MG
Approval Date : 2016-01-26
Application Number : 208056
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : DEXLANSOPRAZOLE
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : 30MG
Approval Date : 2022-09-16
Application Number : 202666
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DEXLANSOPRAZOLE
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : 60MG
Approval Date : 2022-09-16
Application Number : 202666
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : DEXLANSOPRAZOLE
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : 60MG
Approval Date : 2017-04-19
Application Number : 202294
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
RLD : No
TE Code : AB
Brand Name : DEXLANSOPRAZOLE
Dosage Form : CAPSULE, DELAYED RELEASE;ORAL
Dosage Strength : 30MG
Approval Date : 2022-06-16
Application Number : 202294
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 22287
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 22287
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Category : Coating Systems & Additives, Controlled & Modified Release, Solubilizers
Brand Name : EUDRAGIT® L 100-55
Application : Coating Systems & Additives, Controlled & Modified Release, Solubilizers
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01PhG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.
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Grade : Oral
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : EUDRAGIT® L 30 D-55
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : EUDRAGIT® L 30 D-55 (aqueous dispersion) is a delayed release polymer used as coating and film former in tablets, capsules, granules etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Brand Name : Hydroxypropyl Methyl Cellulose
Application : Coating Systems & Additives
Excipient Details : Hydroxypropyl Methyl Cellulose (HPMC) is used as a coating agent in pharmaceutical tablets.
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Film Forming Agent, Wet/Dry Granulation- Binder,Thickening & Suspension Agent, Non-Gelatin Capsule Manufacturing & Enteric Film Coating Systems
Pharmacopoeia Ref : USP, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Emulsion, Tablet
Grade : Oral, Ophthalmic
Category : Disintegrants & Superdisintegrants, Emulsifying Agents, Film Formers & Plasticizers, Thickeners and Stabilizers
Brand Name : Hydroxypropyl Methyl Cellulose
Application : Disintegrants & Superdisintegrants, Emulsifying Agents, Film Formers & Plasticizers, Thickeners and Stabilizers
Excipient Details : Hydroxypropyl Methyl Cellulose is used as a film-former, disintegrant, thickener, and emulsifier in tablets, emulsions, and ophthalmic formulations.
Dosage Form : Tablet
Grade : Oral
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : It is a dry powder derived from a 30% aqueous dispersion (ECOPOL L 30 D 55). The major application is for Enteric/Delayed release coating for drug delivery in the duodenum.
Pharmacopoeia Ref : Monograph - EP, USP, JPE
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Brand Name : Hydroxypropyl Methyl Cellulose
Application : Coating Systems & Additives
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Tablet
Grade : Oral
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : It is a fine free flowing dry powder. Its major application is for Enteric/Delayed release coating and for drug delivery in small intestine.
Pharmacopoeia Ref : Monograph - EP, USP, JP
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid Methyl Methacrylate Copolymer
Controlled & Modified Release
Fillers, Diluents & Binders
Solubilizers
Thickeners and Stabilizers
Direct Compression
Film Formers & Plasticizers
Co-Processed Excipients
Taste Masking
Parenteral
Emulsifying Agents
Disintegrants & Superdisintegrants
Empty Capsules
API Stability Enhancers
Rheology Modifiers
Chewable & Orodispersible Aids
Lubricants & Glidants
Vegetarian Capsules
Coloring Agents
Surfactant & Foaming Agents
Granulation
Topical
Soft Gelatin
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ABOUT THIS PAGE
A Dexlansoprazole Sesquihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexlansoprazole Sesquihydrate, including repackagers and relabelers. The FDA regulates Dexlansoprazole Sesquihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexlansoprazole Sesquihydrate 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 Sesquihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexlansoprazole Sesquihydrate supplier is an individual or a company that provides Dexlansoprazole Sesquihydrate active pharmaceutical ingredient (API) or Dexlansoprazole Sesquihydrate finished formulations upon request. The Dexlansoprazole Sesquihydrate suppliers may include Dexlansoprazole Sesquihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dexlansoprazole Sesquihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexlansoprazole Sesquihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexlansoprazole Sesquihydrate active pharmaceutical ingredient (API) in detail. Different forms of Dexlansoprazole Sesquihydrate DMFs exist exist since differing nations have different regulations, such as Dexlansoprazole Sesquihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexlansoprazole Sesquihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Dexlansoprazole Sesquihydrate USDMF includes data on Dexlansoprazole Sesquihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexlansoprazole Sesquihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexlansoprazole Sesquihydrate 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 Sesquihydrate Drug Master File in Korea (Dexlansoprazole Sesquihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexlansoprazole Sesquihydrate. The MFDS reviews the Dexlansoprazole Sesquihydrate KDMF as part of the drug registration process and uses the information provided in the Dexlansoprazole Sesquihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexlansoprazole Sesquihydrate 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 Sesquihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dexlansoprazole Sesquihydrate suppliers with KDMF on PharmaCompass.
A Dexlansoprazole Sesquihydrate written confirmation (Dexlansoprazole Sesquihydrate WC) is an official document issued by a regulatory agency to a Dexlansoprazole Sesquihydrate manufacturer, verifying that the manufacturing facility of a Dexlansoprazole Sesquihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dexlansoprazole Sesquihydrate APIs or Dexlansoprazole Sesquihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dexlansoprazole Sesquihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Dexlansoprazole Sesquihydrate 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 Sesquihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexlansoprazole Sesquihydrate 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 Sesquihydrate 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 Sesquihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexlansoprazole Sesquihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexlansoprazole Sesquihydrate suppliers with NDC on PharmaCompass.
Dexlansoprazole Sesquihydrate 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 Sesquihydrate 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 Sesquihydrate GMP manufacturer or Dexlansoprazole Sesquihydrate GMP API supplier for your needs.
A Dexlansoprazole Sesquihydrate CoA (Certificate of Analysis) is a formal document that attests to Dexlansoprazole Sesquihydrate's compliance with Dexlansoprazole Sesquihydrate specifications and serves as a tool for batch-level quality control.
Dexlansoprazole Sesquihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Dexlansoprazole Sesquihydrate 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 Sesquihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexlansoprazole Sesquihydrate EP), Dexlansoprazole Sesquihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexlansoprazole Sesquihydrate USP).
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