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Also known as: 461432-26-8, Bms-512148, Forxiga, Bms 512148, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, Dagagflozin
Molecular Formula
C21H25ClO6
Molecular Weight
408.9  g/mol
InChI Key
JVHXJTBJCFBINQ-ADAARDCZSA-N
FDA UNII
1ULL0QJ8UC

Dapagliflozin
Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin selectively and potently inhibits SGLT2 compared to SGLT1, which is the cotransporter of glucose in the gut.
Dapagliflozin is a Sodium-Glucose Cotransporter 2 Inhibitor. The mechanism of action of dapagliflozin is as a Sodium-Glucose Transporter 2 Inhibitor.
1 2D Structure

Dapagliflozin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,3R,4R,5S,6R)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
2.1.2 InChI
InChI=1S/C21H25ClO6/c1-2-27-15-6-3-12(4-7-15)9-14-10-13(5-8-16(14)22)21-20(26)19(25)18(24)17(11-23)28-21/h3-8,10,17-21,23-26H,2,9,11H2,1H3/t17-,18-,19+,20-,21+/m1/s1
2.1.3 InChI Key
JVHXJTBJCFBINQ-ADAARDCZSA-N
2.1.4 Canonical SMILES
CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C3C(C(C(C(O3)CO)O)O)O)Cl
2.1.5 Isomeric SMILES
CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)[C@H]3[C@@H]([C@H]([C@@H]([C@H](O3)CO)O)O)O)Cl
2.2 Other Identifiers
2.2.1 UNII
1ULL0QJ8UC
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 408.9 g/mol
Molecular Formula C21H25ClO6
XLogP32.3
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count6
Exact Mass408.1339662 g/mol
Monoisotopic Mass408.1339662 g/mol
Topological Polar Surface Area99.4 Ų
Heavy Atom Count28
Formal Charge0
Complexity472
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameFarxiga
PubMed HealthDapagliflozin (By mouth)
Drug ClassesAntidiabetic
Drug LabelDapagliflozin 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 IngredientDapagliflozin
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyAstrazeneca Ab

2 of 2  
Drug NameFarxiga
PubMed HealthDapagliflozin (By mouth)
Drug ClassesAntidiabetic
Drug LabelDapagliflozin 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 IngredientDapagliflozin
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyAstrazeneca Ab

4.2 Drug Indication

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)


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 MeSH Pharmacological Classification

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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
DAPAGLIFLOZIN
5.3.2 FDA UNII
1ULL0QJ8UC
5.3.3 Pharmacological Classes
Sodium-Glucose Transporter 2 Inhibitors [MoA]; Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
5.4 ATC Code

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


5.5 Absorption, Distribution and Excretion

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.


5.6 Metabolism/Metabolites

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.


5.7 Biological Half-Life

13.8h.


5.8 Mechanism of Action

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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Dapagliflozin

About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...

Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio includes DC granules, herbal/food supplements, APIs, and finished formulations such as tablets, capsules, syrups, ointments, etc. With WHO-GMP certification and a DSIR certified R&D center, we ensure quality and innovation. We export to LATAM, the Middle East, Africa, Asia, and CIS regions, and offer expert consulting in formulation development and marketing support.
Octavius Pharma
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17-Jan-2022
30-Jun-2025
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Drugs in Development

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Details:

Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease. Launching API DMF grade dapagliflozin is an innovative futuristic approach to provide the best in class quality to the patients.


Lead Product(s): Dapagliflozin

Therapeutic Area: Endocrinology Brand Name: Justoza

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 22, 2021

Company Banner

01

Lead Product(s) : Dapagliflozin

Therapeutic Area : Endocrinology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease. Launching API DMF grade dapagliflozin is an innovative futuristic approach to provide the best in class quality to...

Product Name : Justoza

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 22, 2021

Company Banner

Details:

Zemidapa is a fixed-dose combination therapy that brings together two active ingredients: Zemiglo, Korea’s first domestically developed DPP-4 inhibitor, and dapagliflozin, an SGLT-2 inhibitor.


Lead Product(s): Dapagliflozin,Gemigliptin

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Zemidapa

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 13, 2025

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02

LG Chem

South Korea
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AGGSpend
Not Confirmed

LG Chem

South Korea
arrow
AGGSpend
Not Confirmed

Details : Zemidapa is a fixed-dose combination therapy that brings together two active ingredients: Zemiglo, Korea’s first domestically developed DPP-4 inhibitor, and dapagliflozin, an SGLT-2 inhibitor.

Product Name : Zemidapa

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 13, 2025

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Details:

Dapnec (dapagliflozin) is a SGLT2 inhibitor small molecule drug candidate, which is indicated for the treatment of Type 2 diabetes.


Lead Product(s): Dapagliflozin

Therapeutic Area: Endocrinology Brand Name: Dapnec

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 18, 2025

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03

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

Details : Dapnec (dapagliflozin) is a SGLT2 inhibitor small molecule drug candidate, which is indicated for the treatment of Type 2 diabetes.

Product Name : Dapnec

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 18, 2025

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Details:

Akums launched apagliflozin and pioglitazone combination tablets, which acts as a dual-action therapy. It is indicated for diabetes management.


Lead Product(s): Dapagliflozin,Pioglitazone

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 04, 2025

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04

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

Details : Akums launched apagliflozin and pioglitazone combination tablets, which acts as a dual-action therapy. It is indicated for diabetes management.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 04, 2025

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Details:

Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, for paediatric patients with type-2 diabetes aged 10 years and older.


Lead Product(s): Dapagliflozin

Therapeutic Area: Endocrinology Brand Name: Farxiga

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 06, 2024

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05

AstraZeneca

United Kingdom
arrow
AGGSpend
Not Confirmed

AstraZeneca

United Kingdom
arrow
AGGSpend
Not Confirmed

Details : Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, for paediatric patients with type-2 diabetes aged 10 years and older.

Product Name : Farxiga

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 06, 2024

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Details:

Dapagliflozin, metformin and glimepiride fixed dose combination is approved for the treatment of patients with type 2 diabetes.


Lead Product(s): Glimepiride,Dapagliflozin,Metformin

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 11, 2023

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06

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

Details : Dapagliflozin, metformin and glimepiride fixed dose combination is approved for the treatment of patients with type 2 diabetes.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 11, 2023

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Details:

DSR 2.0 (icodextrin, dextrose, dapagliflozin) is an implant small molecule drug combination, currently being investigated for heart failure management.


Lead Product(s): Icodextrin,Dapagliflozin,Dextrose

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: DSR 2.0

Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 29, 2023

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07

Sequana Medical

Belgium
arrow
AGGSpend
Not Confirmed

Sequana Medical

Belgium
arrow
AGGSpend
Not Confirmed

Details : DSR 2.0 (icodextrin, dextrose, dapagliflozin) is an implant small molecule drug combination, currently being investigated for heart failure management.

Product Name : DSR 2.0

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 29, 2023

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Details:

Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.


Lead Product(s): Vildagliptin,Dapagliflozin,Metformin

Therapeutic Area: Endocrinology Brand Name: Jalra Trio

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 08, 2023

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08

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

Details : Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.

Product Name : Jalra Trio

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 08, 2023

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Details:

Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.


Lead Product(s): Teneligliptin Hydrobromide,Dapagliflozin,Metformin

Therapeutic Area: Endocrinology Brand Name: Zita D

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 18, 2023

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Details : Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.

Product Name : Zita D

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 18, 2023

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Details:

Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, which reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Thus, reducing the risk of cardiovascular death and hospitalisation for heart failure.


Lead Product(s): Dapagliflozin

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Farxiga

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 05, 2023

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AstraZeneca

United Kingdom
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AGGSpend
Not Confirmed

AstraZeneca

United Kingdom
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AGGSpend
Not Confirmed

Details : Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, which reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Thus, reducing the risk of cardiovascular death and hospitalisati...

Product Name : Farxiga

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 05, 2023

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Europe

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ASTRAZENECA AB

United Kingdom
AGGSpend
Not Confirmed
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ASTRAZENECA AB

United Kingdom
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AGGSpend
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Dapagliflozin

Brand Name : Forxiga

Dosage Form : Dapagliflozin 10Mg 28 Units 10Mg Oral Use

Dosage Strength : 28 cpr riv 10 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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AstraZeneca AB (2)

United Kingdom
AGGSpend
Not Confirmed
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AstraZeneca AB (2)

United Kingdom
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AGGSpend
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Dapagliflozin

Brand Name : Forxiga

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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AstraZeneca AB (2)

United Kingdom
AGGSpend
Not Confirmed
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AstraZeneca AB (2)

United Kingdom
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AGGSpend
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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AstraZeneca AB (2)

United Kingdom
AGGSpend
Not Confirmed
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AstraZeneca AB (2)

United Kingdom
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AGGSpend
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Packaging : Calendar Gasket

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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AstraZeneca AB (2)

United Kingdom
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Not Confirmed
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AstraZeneca AB (2)

United Kingdom
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saxagliptin; Dapagliflozin

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

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AstraZeneca AB (2)

United Kingdom
AGGSpend
Not Confirmed
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AstraZeneca AB (2)

United Kingdom
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AGGSpend
Not Confirmed

Metformin; Dapagliflozin

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

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AstraZeneca AB (2)

United Kingdom
AGGSpend
Not Confirmed
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AstraZeneca AB (2)

United Kingdom
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AGGSpend
Not Confirmed

Metformin; Dapagliflozin

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

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AstraZeneca AG

United Kingdom
AGGSpend
Not Confirmed
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AstraZeneca AG

United Kingdom
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AGGSpend
Not Confirmed

Metformini hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Filmtabl

Dosage Strength : 10mg/500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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AstraZeneca AG

United Kingdom
AGGSpend
Not Confirmed
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AstraZeneca AG

United Kingdom
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AGGSpend
Not Confirmed

Metformini hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Filmtabl

Dosage Strength : 5mg/1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Country
AGGSpend
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Country
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Metformin; Dapagliflozin

Brand Name : Eucreas 50/100060 Mg Film-Coated Tablets

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 202293

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 202293

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Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

Grade : Oral

Category : Co-Processed Excipients, Fillers, Diluents & Binders

Brand Name : Microlose™

Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.

Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...

Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%

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DKSH

Switzerland
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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

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Brand Name : Farxiga/Forxiga

Dapagliflozin

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AGGSpend
Not Confirmed

Brand Name : Farxiga/Forxiga

United Kingdom
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Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2020 Revenue in Millions : 1,959

2019 Revenue in Millions : 1,543

Growth (%) : 27

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Brand Name : Forxiga

Dapagliflozin

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AGGSpend
Not Confirmed

Brand Name : Forxiga

Japan
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AGGSpend
Not Confirmed

Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2020 Revenue in Millions : 198

2019 Revenue in Millions : 163

Growth (%) : 22

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Brand Name : Farxiga/Forxiga

Dapagliflozin

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AGGSpend
Not Confirmed

Brand Name : Farxiga/Forxiga

United Kingdom
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AGGSpend
Not Confirmed

Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2021 Revenue in Millions : 3,000

2020 Revenue in Millions : 1,959

Growth (%) : 53

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Brand Name : Forxiga

Dapagliflozin

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AGGSpend
Not Confirmed

Brand Name : Forxiga

Japan
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AGGSpend
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Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2021 Revenue in Millions : 274

2020 Revenue in Millions : 190

Growth (%) : 55

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Brand Name : Forxiga

Dapagliflozin

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AGGSpend
Not Confirmed

Brand Name : Forxiga

Japan
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AGGSpend
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Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2022 Revenue in Millions : 400

2021 Revenue in Millions : 274

Growth (%) : 46

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Brand Name : Farxiga/Forxiga

Dapagliflozin

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AGGSpend
Not Confirmed

Brand Name : Farxiga/Forxiga

United Kingdom
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AGGSpend
Not Confirmed

Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2022 Revenue in Millions : 4,381

2021 Revenue in Millions : 3,000

Growth (%) : 46

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Brand Name : Farxiga/Forxiga

Dapagliflozin

arrow
AGGSpend
Not Confirmed

Brand Name : Farxiga/Forxiga

United Kingdom
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AGGSpend
Not Confirmed

Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2023 Revenue in Millions : 5,963

2022 Revenue in Millions : 4,381

Growth (%) : 36

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Brand Name : Forxiga

Dapagliflozin

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AGGSpend
Not Confirmed

Brand Name : Forxiga

Japan
arrow
AGGSpend
Not Confirmed

Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2023 Revenue in Millions : 488

2022 Revenue in Millions : 400

Growth (%) : 39

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Brand Name : Farxiga/Forxiga

Dapagliflozin

arrow
AGGSpend
Not Confirmed

Brand Name : Farxiga/Forxiga

United Kingdom
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AGGSpend
Not Confirmed

Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2024 Revenue in Millions : 7,656

2023 Revenue in Millions : 5,963

Growth (%) : 28

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Brand Name : Forxiga

Dapagliflozin

arrow
AGGSpend
Not Confirmed

Brand Name : Forxiga

Japan
arrow
AGGSpend
Not Confirmed

Dapagliflozin

Main Therapeutic Indication : Diabetes

Currency : USD

2024 Revenue in Millions : 563

2023 Revenue in Millions : 488

Growth (%) : 15

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ABOUT THIS PAGE

Looking for 461432-26-8 / Dapagliflozin API manufacturers, exporters & distributors?

Dapagliflozin manufacturers, exporters & distributors 1

64

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.

API | Excipient name

Dapagliflozin

Synonyms

461432-26-8, Bms-512148, Forxiga, Bms 512148, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, Dagagflozin

Cas Number

461432-26-8

Unique Ingredient Identifier (UNII)

1ULL0QJ8UC

About Dapagliflozin

Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin selectively and potently inhibits SGLT2 compared to SGLT1, which is the cotransporter of glucose in the gut.

Dapagliflozin Amorphous Manufacturers

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

Dapagliflozin Amorphous Suppliers

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

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

Dapagliflozin Amorphous USDMF

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

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

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

Dapagliflozin Amorphous JDMF

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 Amorphous Drug Master File in Japan (Dapagliflozin Amorphous JDMF) empowers Dapagliflozin Amorphous 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 Amorphous JDMF during the approval evaluation for pharmaceutical products. At the time of Dapagliflozin Amorphous 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 Amorphous suppliers with JDMF on PharmaCompass.

Dapagliflozin Amorphous KDMF

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

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

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

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

Dapagliflozin Amorphous WC

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

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

Dapagliflozin Amorphous NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Dapagliflozin Amorphous as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dapagliflozin Amorphous API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Dapagliflozin Amorphous as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Dapagliflozin Amorphous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dapagliflozin Amorphous NDC to their finished compounded human drug products, they may choose to do so.

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

Dapagliflozin Amorphous GMP

Dapagliflozin Amorphous 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 Amorphous 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 Amorphous GMP manufacturer or Dapagliflozin Amorphous GMP API supplier for your needs.

Dapagliflozin Amorphous CoA

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

Dapagliflozin Amorphous CoA mostly includes findings from lab analyses of a specific batch. For each Dapagliflozin Amorphous 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 Amorphous may be tested according to a variety of international standards, such as European Pharmacopoeia (Dapagliflozin Amorphous EP), Dapagliflozin Amorphous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dapagliflozin Amorphous USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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