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1. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
2. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
3. Bms 512148
4. Bms-512148
5. Bms512148
6. Farxiga
7. Forxiga
1. 461432-26-8
2. Bms-512148
3. Forxiga
4. Bms 512148
5. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
6. Dagagflozin
7. (1s)-1,5-anhydro-1-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-d-glucitol
8. 1ull0qj8uc
9. Chembl429910
10. Chebi:85078
11. Lyn-045
12. Dapagliflozin [usan:inn]
13. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
14. (2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol
15. Bms512148
16. Forxiga (tn)
17. Chembl3125458
18. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-
19. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
20. Dapagliflozin [usan]
21. Unii-1ull0qj8uc
22. Bms5121458
23. S1548_selleck
24. C-aryl Glucoside, 6
25. Dapagliflozin [mi]
26. Dapagliflozin [inn]
27. Dapagliflozin (usan/inn)
28. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
29. Dapagliflozin [vandf]
30. Schembl157820
31. Dapagliflozin [who-dd]
32. Gtpl4594
33. Bdbm20880
34. Dtxsid20905104
35. Ex-a005
36. Bcpp000265
37. Dapagliflozin [orange Book]
38. Amy18541
39. Zinc3819138
40. Bdbm50448923
41. Mfcd13182359
42. S1548
43. Qternmet Component Dapaglifozin
44. Akos005145763
45. Dapagliflozin Component Qternmet
46. Bcp9000583
47. Bl-0052
48. Ccg-229917
49. Cs-0781
50. Db06292
51. Ex-7214
52. Ncgc00250402-09
53. Ac-24699
54. Bd164346
55. Hy-10450
56. Qternmet Xr Component Dapagliflozin
57. Dapagliflozin Component Of Qternmet Xr
58. A25150
59. C22193
60. D08897
61. 432d268
62. Q409898
63. J-500392
64. Brd-k58160573-001-01-3
65. Brd-k58160573-001-05-4
66. 1-[3-(beta-d-glucopyranosyl)-6-chlorobenzyl]-4-ethoxybenzene
67. (1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol
68. (2s, 3r, 4r, 5s, 6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
69. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol
70. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol;bms-512148
71. (2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
| Molecular Weight | 408.9 g/mol |
|---|---|
| Molecular Formula | C21H25ClO6 |
| XLogP3 | 2.3 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 6 |
| Exact Mass | 408.1339662 g/mol |
| Monoisotopic Mass | 408.1339662 g/mol |
| Topological Polar Surface Area | 99.4 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 472 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 5 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Farxiga |
| PubMed Health | Dapagliflozin (By mouth) |
| Drug Classes | Antidiabetic |
| Drug Label | Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig... |
| Active Ingredient | Dapagliflozin |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Prescription |
| Company | Astrazeneca Ab |
| 2 of 2 | |
|---|---|
| Drug Name | Farxiga |
| PubMed Health | Dapagliflozin (By mouth) |
| Drug Classes | Antidiabetic |
| Drug Label | Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig... |
| Active Ingredient | Dapagliflozin |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 5mg; 10mg |
| Market Status | Prescription |
| Company | Astrazeneca Ab |
Dapagliflozin is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.
FDA Label
Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance.
- in addition to other medicinal products for the treatment of type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied.
Heart failure
- Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
- Forxiga is indicated in adults for the treatment of chronic kidney disease.
Type 2 diabetes mellitus
Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance.
- in addition to other medicinal products for the treatment of type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.
Heart failure
Edistride is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
Edistride is indicated in adults for the treatment of chronic kidney disease.
Treatment of chronic kidney disease
Prevention of cardiovascular events in patients with chronic heart failure
Treatment of type I diabetes mellitus
Treatment of type II diabetes mellitus
Treatment of ischaemic heart disease
Treatment of Coronavirus disease 2019 (COVID-19)
Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
Sodium-Glucose Transporter 2 Inhibitors
Compounds that inhibit SODIUM-GLUCOSE TRANSPORTER 2. They lower blood sugar by preventing the reabsorption of glucose by the kidney and are used in the treatment of TYPE 2 DIABETES MELLITUS. (See all compounds classified as Sodium-Glucose Transporter 2 Inhibitors.)
A10BK01
A10BK01
A10BK01
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10B - Blood glucose lowering drugs, excl. insulins
A10BK - Sodium-glucose co-transporter 2 (sglt2) inhibitors
A10BK01 - Dapagliflozin
Absorption
Oral dapagliflozin reaches a maximum concentration within 1 hour of administration when patients have been fasting. When patients have consumed a high fat meal, the time to maximum concentration increases to 2 hours and the maximum concentration decreases by half though a dose adjustment is not necessary. Oral dapagliflozin is 78% bioavailable.
Route of Elimination
75.2% of dapagliflozin is recovered in the urine with 1.6% of the dose unchanged by metabolism. 21% of the dose is excreted in the feces with 15% of the dose unchanged by metabolism.
Volume of Distribution
118L.
Clearance
Oral plasma clearance was 4.9 mL/min/kg, and renal clearance was 5.6 mL/min.
Dapagliflozin is primarily glucuronidated to become the inactive 3-O-glucuronide metabolite(60.7%). Dapagliflozin also produces another minor glucuronidated metabolite(5.4%), a de-ethylated metabolite(<5%), and a hydroxylated metabolite(<5%). Metabolism of dapagliflozin is mediated by cytochrome p-450(CYP)1A1, CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP3A4, uridine diphosphate glucuronyltransferase(UGT)1A9, UGT2B4, and UGT2B7. Glucuronidation to the major metabolite is mediated by UGT1A9.
13.8h.
Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Dosage Form : Capsule
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Dapagliflozin; Bisoprolol Fumarate
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Dapagliflozin; Bisoprolol Fumarate
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Dapagliflozin; Bisoprolol Fumarate
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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Dosage Form : Dapagliflozin+Metformin+8505 Mg 56 Combined Oral Use
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Metformini hydrochloridum; Dapagliflozinum
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Brand Name : AG-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2533057
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : APO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2527189
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : APO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2527197
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : AURO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2531402
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : AURO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2531410
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : AURO-DAPAGLIFLOZIN / METFORMIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2533073
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : M-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2535297
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NRA-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2538334
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NRA-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2538342
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PRO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2537656
Regulatory Info : Prescription
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Film Coated Tablet
Dosage Strength : 5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 40MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Dapagliflozin; Bisoprolol Fumarate
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dapagliflozin; Bisoprolol Fumarate
Dosage : Capsule
Dosage Strength : 10MG; 5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 40MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG; 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Hungary
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 202293
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 202293
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Dosage Form : Tablet
Grade : Oral
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
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Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Disintegrants & Superdisintegrants, Granulation
Application : Direct Compression, Disintegrants & Superdisintegrants, Granulation
Excipient Details : Croscarmellose sodium, a cellulose-based super disintegrant, provides excellent results in tablet disintegration. It is used in both wet granulation and direct compression.
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : HiCel acts as a strong & dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders, Granulation
Application : Disintegrants & Superdisintegrants, Granulation
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Croscarmellose Sodium
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® MCC 101
Application : Direct Compression, Granulation
Excipient Details : Tablets made from these granules are typically easily disintegrated using conventional super disintegrates even when hard tablets are compressed.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Microlex® LCA 60.m
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCA 120.m, Microlex® LCA 20...
Ingredient(s) : Anhydrous Lactose
Controlled & Modified Release
Co-Processed Excipients
Film Formers & Plasticizers
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
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ANALYTICAL
ABOUT THIS PAGE
20
PharmaCompass offers a list of Dapagliflozin 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 Dapagliflozin manufacturer or Dapagliflozin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dapagliflozin manufacturer or Dapagliflozin supplier.
PharmaCompass also assists you with knowing the Dapagliflozin API Price utilized in the formulation of products. Dapagliflozin API Price is not always fixed or binding as the Dapagliflozin Price is obtained through a variety of data sources. The Dapagliflozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A XIGDUO XR manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of XIGDUO XR, including repackagers and relabelers. The FDA regulates XIGDUO XR manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. XIGDUO XR 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 XIGDUO XR manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A XIGDUO XR supplier is an individual or a company that provides XIGDUO XR active pharmaceutical ingredient (API) or XIGDUO XR finished formulations upon request. The XIGDUO XR suppliers may include XIGDUO XR API manufacturers, exporters, distributors and traders.
click here to find a list of XIGDUO XR suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A XIGDUO XR DMF (Drug Master File) is a document detailing the whole manufacturing process of XIGDUO XR active pharmaceutical ingredient (API) in detail. Different forms of XIGDUO XR DMFs exist exist since differing nations have different regulations, such as XIGDUO XR USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A XIGDUO XR DMF submitted to regulatory agencies in the US is known as a USDMF. XIGDUO XR USDMF includes data on XIGDUO XR's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The XIGDUO XR USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of XIGDUO XR suppliers with USDMF on PharmaCompass.
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 XIGDUO XR Drug Master File in Japan (XIGDUO XR JDMF) empowers XIGDUO XR 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 XIGDUO XR JDMF during the approval evaluation for pharmaceutical products. At the time of XIGDUO XR 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 XIGDUO XR suppliers with JDMF 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 XIGDUO XR Drug Master File in Korea (XIGDUO XR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of XIGDUO XR. The MFDS reviews the XIGDUO XR KDMF as part of the drug registration process and uses the information provided in the XIGDUO XR KDMF to evaluate the safety and efficacy of the drug.
After submitting a XIGDUO XR 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 XIGDUO XR API can apply through the Korea Drug Master File (KDMF).
click here to find a list of XIGDUO XR suppliers with KDMF on PharmaCompass.
A XIGDUO XR written confirmation (XIGDUO XR WC) is an official document issued by a regulatory agency to a XIGDUO XR manufacturer, verifying that the manufacturing facility of a XIGDUO XR active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting XIGDUO XR APIs or XIGDUO XR finished pharmaceutical products to another nation, regulatory agencies frequently require a XIGDUO XR WC (written confirmation) as part of the regulatory process.
click here to find a list of XIGDUO XR 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 XIGDUO XR as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for XIGDUO XR 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 XIGDUO XR 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 XIGDUO XR and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a XIGDUO XR NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of XIGDUO XR suppliers with NDC on PharmaCompass.
XIGDUO XR 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 XIGDUO XR 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 XIGDUO XR GMP manufacturer or XIGDUO XR GMP API supplier for your needs.
A XIGDUO XR CoA (Certificate of Analysis) is a formal document that attests to XIGDUO XR's compliance with XIGDUO XR specifications and serves as a tool for batch-level quality control.
XIGDUO XR CoA mostly includes findings from lab analyses of a specific batch. For each XIGDUO XR 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.
XIGDUO XR may be tested according to a variety of international standards, such as European Pharmacopoeia (XIGDUO XR EP), XIGDUO XR JP (Japanese Pharmacopeia) and the US Pharmacopoeia (XIGDUO XR USP).
