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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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USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
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DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2016-12-08
DMF Number : 30555
Submission : 2016-05-12
Status : Active
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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DMF Review : Complete
Rev. Date : 2017-04-17
Pay. Date : 2017-03-20
DMF Number : 30729
Submission : 2016-12-30
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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DMF Review : N/A
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DMF Number : 36608
Submission : 2022-02-10
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AMI Lifesciences is Driven by Chemistry. Powered by People.
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DMF Number : 38009
Submission : 2023-02-23
Status : Active
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-21
Pay. Date : 2024-01-08
DMF Number : 39120
Submission : 2023-12-30
Status : Active
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-19
Pay. Date : 2017-01-27
DMF Number : 31235
Submission : 2017-03-23
Status : Active
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GDUFA
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DMF Number : 31284
Submission : 2017-01-31
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DMF Number : 31841
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DMF Number : 31762
Submission : 2017-07-03
Status : Active
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DMF Number : 31867
Submission : 2017-08-31
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Dapagliflozin Propylene Glycol Monohydrate
Certificate Number : CEP 2025-043 - Rev 00
Status : Valid
Issue Date : 2025-08-06
Type : Chemical
Substance Number : 3137
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Drugs in Development
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
(5-bromo-2-chlorophenyl)(4- ethoxyphenyl)methanone
CAS Number : 461432-22-4
End Use API : Dapagliflozin
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
5-bromo-2-chloro-4’- ethoxydiphenylmethane
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
[(2R,3R,4R,5S,6S)-3,4,5- triacetyloxy-6-[4-chloro-...
CAS Number : 461432-25-7
End Use API : Dapagliflozin
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer ...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
(5-Bromo-2-chlorophenyl)(4-ethoxyphenyl)methanone
CAS Number : 461432-22-4
End Use API : Dapagliflozin
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
5-Bromo-2-chloro-4'-ethoxydiphenylmethane
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
With Virupaksha, you get a quality product with on-time delivery.
5-Bromo-2-chloro-4-ethoxydiphenylmethane
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of les...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
4-(5-bromo-2-chlorobenzyl) phenyl ethyl ether
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
(2S)-2-(8-amino-1-bromoimidazo[1,5-a] pyrazin-3-yl...
CAS Number : 461432-25-7
End Use API : Dapagliflozin
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
4-(5-Bromo-2- chlorobenzyl)phenyl ethyl ether
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...
(5-Bromo-2-chlorophenyl)(4- ethoxyphenyl)methanone
CAS Number : 461432-22-4
End Use API : Dapagliflozin
About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...
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RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date :
Application Number : 216119
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date :
Application Number : 216119
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date :
Application Number : 211478
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN AND METFORMIN
Dosage Form : TABLET
Dosage Strength : 5MG
Approval Date :
Application Number : 218091
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN AND METFORMIN
Dosage Form : TABLET
Dosage Strength : 10MG
Approval Date :
Application Number : 218091
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN AND METFORMIN
Dosage Form : TABLET
Dosage Strength : 500MG
Approval Date :
Application Number : 218091
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN AND METFORMIN
Dosage Form : TABLET
Dosage Strength : 1000MG
Approval Date :
Application Number : 218091
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : DAPAGLIFLOZIN
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date :
Application Number : 211582
RX/OTC/DISCN :
RLD :
TE Code :
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Regulatory Info :
Registration Country : Italy
Brand Name : Xigduo
Dosage Form : Dapagliflozin+Metformin+10005 Mg 56 Combined Oral Use
Dosage Strength : 56 cpr riv 5 mg + 1,000 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Qtern
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 05MG; 10MG
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Xigduo
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5MG; 1000MG
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Allowed
Registration Country : Switzerland
Metformini Hydrochloridum; Dapagliflozinum
Brand Name : Xigduo XR
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg;500mg
Packaging :
Approval Date : 16/07/2015
Application Number : 65377
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Metformin Hydrochloride; Dapagliflozin
Brand Name : Ebymect
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG; 850 MG
Packaging :
Approval Date : 2015-12-09
Application Number : 1151051003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Qtern
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG; 10 MG
Packaging :
Approval Date : 2016-08-01
Application Number : 1161108002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dapagliflozina Macleods
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2022-05-26
Application Number : 87468
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dapagliflozine Teva
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date : 2022-09-09
Application Number : 88074
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : DIAGLYCO 10 mg
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 202293
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 202293
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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 Dapagliflozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapagliflozin, including repackagers and relabelers. The FDA regulates Dapagliflozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapagliflozin 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 Dapagliflozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapagliflozin supplier is an individual or a company that provides Dapagliflozin active pharmaceutical ingredient (API) or Dapagliflozin finished formulations upon request. The Dapagliflozin suppliers may include Dapagliflozin API manufacturers, exporters, distributors and traders.
click here to find a list of Dapagliflozin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dapagliflozin DMF (Drug Master File) is a document detailing the whole manufacturing process of Dapagliflozin active pharmaceutical ingredient (API) in detail. Different forms of Dapagliflozin DMFs exist exist since differing nations have different regulations, such as Dapagliflozin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dapagliflozin DMF submitted to regulatory agencies in the US is known as a USDMF. Dapagliflozin USDMF includes data on Dapagliflozin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dapagliflozin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dapagliflozin 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 Dapagliflozin Drug Master File in Japan (Dapagliflozin JDMF) empowers Dapagliflozin 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 Dapagliflozin JDMF during the approval evaluation for pharmaceutical products. At the time of Dapagliflozin 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 Dapagliflozin 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 Dapagliflozin Drug Master File in Korea (Dapagliflozin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dapagliflozin. The MFDS reviews the Dapagliflozin KDMF as part of the drug registration process and uses the information provided in the Dapagliflozin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dapagliflozin 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 Dapagliflozin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dapagliflozin suppliers with KDMF on PharmaCompass.
A Dapagliflozin CEP of the European Pharmacopoeia monograph is often referred to as a Dapagliflozin Certificate of Suitability (COS). The purpose of a Dapagliflozin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dapagliflozin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dapagliflozin to their clients by showing that a Dapagliflozin CEP has been issued for it. The manufacturer submits a Dapagliflozin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dapagliflozin CEP holder for the record. Additionally, the data presented in the Dapagliflozin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dapagliflozin DMF.
A Dapagliflozin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dapagliflozin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Dapagliflozin suppliers with CEP (COS) on PharmaCompass.
A Dapagliflozin written confirmation (Dapagliflozin WC) is an official document issued by a regulatory agency to a Dapagliflozin manufacturer, verifying that the manufacturing facility of a Dapagliflozin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dapagliflozin APIs or Dapagliflozin finished pharmaceutical products to another nation, regulatory agencies frequently require a Dapagliflozin WC (written confirmation) as part of the regulatory process.
click here to find a list of Dapagliflozin 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 Dapagliflozin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dapagliflozin 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 Dapagliflozin 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 Dapagliflozin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dapagliflozin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dapagliflozin suppliers with NDC on PharmaCompass.
Dapagliflozin 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 Dapagliflozin 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 Dapagliflozin GMP manufacturer or Dapagliflozin GMP API supplier for your needs.
A Dapagliflozin CoA (Certificate of Analysis) is a formal document that attests to Dapagliflozin's compliance with Dapagliflozin specifications and serves as a tool for batch-level quality control.
Dapagliflozin CoA mostly includes findings from lab analyses of a specific batch. For each Dapagliflozin 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.
Dapagliflozin may be tested according to a variety of international standards, such as European Pharmacopoeia (Dapagliflozin EP), Dapagliflozin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dapagliflozin USP).
