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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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  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Dapagliflozin

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
Neuland

06

LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Dapagliflozin

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

07

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  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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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, corticosteroids, cyto...

Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
Aarti Industries Company Banner

08

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Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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Dapagliflozin

About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...

Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory therapeutic areas, Ami offers a wide range of APIs, intermediates, key starting materials, as well as contract bulk manufacturing services. Ami's manufacturing units in Gujarat and Karnataka feature dedicated clean rooms for APIs and adhere to international standards like EU-GMP, WHO-GMP, PMDA, and COFEPRIS. Ami serves as a reliable partner for contract development and manufacturing, offering generic APIs to global pharma companies across more than 60 countries.
AMI Lifesciences

09

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Dapagliflozin

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

10

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Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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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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06-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

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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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Chemicals America
Not Confirmed

LG Chem

South Korea
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Chemicals America
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

Chemicals America
Not Confirmed
Chemicals America
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

Chemicals America
Not Confirmed
Chemicals America
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
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Chemicals America
Not Confirmed

AstraZeneca

United Kingdom
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Chemicals America
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

Chemicals America
Not Confirmed
Chemicals America
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
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Chemicals America
Not Confirmed

Sequana Medical

Belgium
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Chemicals America
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

Chemicals America
Not Confirmed
Chemicals America
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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09

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

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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10

AstraZeneca

United Kingdom
arrow
Chemicals America
Not Confirmed

AstraZeneca

United Kingdom
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Chemicals America
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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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 461432-22-4

End Use API : Dapagliflozin

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 461432-23-5

End Use API : Dapagliflozin

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

CAS Number : 461432-25-7

End Use API : Dapagliflozin

About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...

Shandong Chenghui Shuangda Pharmaceutical

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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...

Cohance

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

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...

Virupaksha

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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 Industries Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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...

Aarti Industries Company Banner

09

Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed
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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...

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Chemicals America
Not Confirmed
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Chemicals America
Not Confirmed
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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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Europe

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AstraZeneca AB (2)

United Kingdom
Vietnam Medi-Pharm Expo
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AstraZeneca AB (2)

United Kingdom
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Dapagliflozin

Brand Name : Forxiga

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

AstraZeneca AB (2)

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca AB (2)

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

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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03

AstraZeneca AG

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca AG

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : Film-Coated Tablets

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

AstraZeneca AG

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca AG

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Metformini hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Filmtabl

Dosage Strength : 10mg/1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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05

AstraZeneca AG

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca AG

United Kingdom
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Vietnam Medi-Pharm Expo
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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06

AstraZeneca AG

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca AG

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Metformini hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Filmtabl

Dosage Strength : 5mg/500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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07

AstraZeneca AG

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca AG

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Saxagliptinum; Dapagliflozinum

Brand Name : Qtern

Dosage Form : Filmtabl

Dosage Strength : 5mg/10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Country
Vietnam Medi-Pharm Expo
Not Confirmed
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Country
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Vietnam Medi-Pharm Expo
Not Confirmed

Metformin; Dapagliflozin

Brand Name : 60 Icandra 50/850Mg Film-Coated Tablets

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Spain

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2care4

Country
Vietnam Medi-Pharm Expo
Not Confirmed
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2care4

Country
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Not Confirmed

Dapagliflozin

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

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10

Farm Agon

Country
Vietnam Medi-Pharm Expo
Not Confirmed
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Farm Agon

Country
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Not Confirmed

Dapagliflozin

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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Canada

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APOTEX INC

Canada
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APOTEX INC

Canada
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Not Confirmed

DAPAGLIFLOZIN

Brand Name : APO-DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2527197

Regulatory Info :

Registration Country : Canada

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02

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : AURO-DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2531402

Regulatory Info :

Registration Country : Canada

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03

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
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DAPAGLIFLOZIN

Brand Name : AURO-DAPAGLIFLOZIN / METFORMIN

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2533073

Regulatory Info :

Registration Country : Canada

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04

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : GLN-DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2519860

Regulatory Info :

Registration Country : Canada

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05

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : JAMP DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2531364

Regulatory Info :

Registration Country : Canada

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06

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : M-DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2535297

Regulatory Info :

Registration Country : Canada

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07

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
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DAPAGLIFLOZIN

Brand Name : NRA-DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2538334

Regulatory Info :

Registration Country : Canada

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08

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : PMS-DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2531550

Regulatory Info :

Registration Country : Canada

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Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : PRO-DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2537664

Regulatory Info :

Registration Country : Canada

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Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : SANDOZ DAPAGLIFLOZIN

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2518740

Regulatory Info :

Registration Country : Canada

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Australia

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AstraZeneca Pty Ltd

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca Pty Ltd

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

AstraZeneca Pty Ltd

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca Pty Ltd

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

AstraZeneca Pty Ltd

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca Pty Ltd

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

AstraZeneca Pty Ltd

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca Pty Ltd

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

AstraZeneca Pty Ltd

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca Pty Ltd

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

AstraZeneca Pty Ltd

United Kingdom
Vietnam Medi-Pharm Expo
Not Confirmed
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AstraZeneca Pty Ltd

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : tablet

Dosage Strength : 10 mg

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

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Vietnam Medi-Pharm Expo
Not Confirmed
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Dapagliflozin

Brand Name : Dapagliflozin 10 mg Ascend

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

DAPAGLIFLOZIN

Brand Name : GLUDAPZIN 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Cipla Medpro (Pty) Ltd

South Africa
Vietnam Medi-Pharm Expo
Not Confirmed
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Cipla Medpro (Pty) Ltd

South Africa
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Synglutra 10/1000

Dosage Form : ERT

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Cipla Medpro (Pty) Ltd

South Africa
Vietnam Medi-Pharm Expo
Not Confirmed
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Cipla Medpro (Pty) Ltd

South Africa
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Sagalatin 5

Dosage Form : FCT

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Cipla Medpro (Pty) Ltd

South Africa
Vietnam Medi-Pharm Expo
Not Confirmed
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Cipla Medpro (Pty) Ltd

South Africa
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Sagalatin 10

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Brand Name : Daptica 5 mg

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
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Dapagliflozin

Brand Name : DEPAGLOZ 5

Dosage Form : FCT

Dosage Strength : mg1

Packaging : 30X11

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
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Dapagliflozin

Brand Name : Avaxiga 5

Dosage Form : FCT

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

Vietnam Medi-Pharm Expo
Not Confirmed
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Vietnam Medi-Pharm Expo
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dapagliflozin

Brand Name : DAPIFLO 5 mg

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Vietnam Medi-Pharm Expo
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Vietnam Medi-Pharm Expo
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dapagliflozin

Brand Name : DAPIFLO 10 mg

Dosage Form : TAB

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin

Brand Name : Dapagliflozin

Dosage Form : Film-Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin

Dosage : Film-Coated Tablet

Dosage Strength : 5MG

Brand Name : Dapagliflozin

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin

Brand Name : Dapagliflozin

Dosage Form : Film-Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin

Dosage : Film-Coated Tablet

Dosage Strength : 10MG

Brand Name : Dapagliflozin

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Atorvastatin

Brand Name : Dapagliflozin ; Atorva...

Dosage Form : Capsule

Dosage Strength : 10MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Atorvastatin

Dosage : Capsule

Dosage Strength : 10MG; 10MG

Brand Name : Dapagliflozin ; Atorva...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Atorvastatin

Brand Name : Dapagliflozin ; Atorva...

Dosage Form : Capsule

Dosage Strength : 10MG; 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Atorvastatin

Dosage : Capsule

Dosage Strength : 10MG; 20MG

Brand Name : Dapagliflozin ; Atorva...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Atorvastatin

Brand Name : Dapagliflozin ; Atorva...

Dosage Form : Capsule

Dosage Strength : 10MG; 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Atorvastatin

Dosage : Capsule

Dosage Strength : 10MG; 40MG

Brand Name : Dapagliflozin ; Atorva...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Rosuvastatin Calcium

Brand Name : Dapagliflozin; Rosuvas...

Dosage Form : Capsule

Dosage Strength : 10MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Rosuvastatin Calcium

Dosage : Capsule

Dosage Strength : 10MG; 10MG

Brand Name : Dapagliflozin; Rosuvas...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Rosuvastatin Calcium

Brand Name : Dapagliflozin ; Rosuva...

Dosage Form : Capsule

Dosage Strength : 10MG; 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Rosuvastatin Calcium

Dosage : Capsule

Dosage Strength : 10MG; 20MG

Brand Name : Dapagliflozin ; Rosuva...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Rosuvastatin Calcium

Brand Name : Dapagliflozin; Rosuvas...

Dosage Form : Capsule

Dosage Strength : 10MG; 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Rosuvastatin Calcium

Dosage : Capsule

Dosage Strength : 10MG; 5MG

Brand Name : Dapagliflozin; Rosuvas...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Ramipril

Brand Name : Dapagliflozin; Ramipri...

Dosage Form : Capsule

Dosage Strength : 10MG; 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Ramipril

Dosage : Capsule

Dosage Strength : 10MG; 5MG

Brand Name : Dapagliflozin; Ramipri...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Dapagliflozin; Ramipril

Brand Name : Dapagliflozin; Ramipri...

Dosage Form : Capsule

Dosage Strength : 10MG; 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Dapagliflozin; Ramipril

Dosage : Capsule

Dosage Strength : 10MG; 10MG

Brand Name : Dapagliflozin; Ramipri...

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals
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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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Fillers, Diluents & Binders

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  • fda
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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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Coating Systems & Additives

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DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

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

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Direct Compression

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Disintegrants & Superdisintegrants

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Lubricants & Glidants

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Thickeners and Stabilizers

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Granulation

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Controlled & Modified Release

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Film Formers & Plasticizers

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Chewable & Orodispersible Aids

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Taste Masking

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Vietnam Medi-Pharm Expo
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Topical

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Rheology Modifiers

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Emulsifying Agents

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Parenteral

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API Stability Enhancers

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Coloring Agents

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DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

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

Surfactant & Foaming Agents

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Digital Content read-more

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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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Global Sales Information

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US Medicaid Prescriptions

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01

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin/Saxagliptin HCl

Drug Cost (USD) : 1,720,271

Year : 2023

Prescribers : 421

Prescriptions : 1952

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02

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin/Saxagliptin HCl

Drug Cost (USD) : 2,009,101

Year : 2022

Prescribers : 481

Prescriptions : 2304

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03

Brand Name : Farxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Farxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin Propanediol

Drug Cost (USD) : 2,584,621,150

Year : 2022

Prescribers : 638800

Prescriptions : 2665029

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04

Brand Name : Xigduo XR

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Xigduo XR

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin/Metformin HCl

Drug Cost (USD) : 153,804,791

Year : 2022

Prescribers : 35699

Prescriptions : 161366

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05

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin/Saxagliptin HCl

Drug Cost (USD) : 2,228,866

Year : 2021

Prescribers : 583

Prescriptions : 2559

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06

Brand Name : Farxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Farxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin Propanediol

Drug Cost (USD) : 1,421,505,274

Year : 2021

Prescribers : 385693

Prescriptions : 1540905

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07

Brand Name : Xigduo XR

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Xigduo XR

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin/Metformin HCl

Drug Cost (USD) : 114,228,126

Year : 2021

Prescribers : 29188

Prescriptions : 129660

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08

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Qtern

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin/Saxagliptin HCl

Drug Cost (USD) : 1,986,364

Year : 2020

Prescribers : 581

Prescriptions : 2477

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09

Brand Name : Farxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Farxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin Propanediol

Drug Cost (USD) : 736,787,564

Year : 2020

Prescribers : 193920

Prescriptions : 858348

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10

Brand Name : Xigduo XR

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Xigduo XR

United Kingdom
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Company : Astrazeneca

Dapagliflozin/Metformin HCl

Drug Cost (USD) : 73,873,720

Year : 2020

Prescribers : 19955

Prescriptions : 93057

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Regulatory FDF Prices

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01

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 26.631

Published in :

Country : Norway

RX/OTC/DISCN :

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02

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 49.082

Published in :

Country : Norway

RX/OTC/DISCN :

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03

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 52.25

Published in :

Country : Norway

RX/OTC/DISCN :

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04

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 147.26

Published in :

Country : Norway

RX/OTC/DISCN :

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05

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 159.93

Published in :

Country : Norway

RX/OTC/DISCN :

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06

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Price Per Pack (Euro) : 24.398

Published in :

Country : Norway

RX/OTC/DISCN :

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07

Brand Name : Forxiga

United Kingdom
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Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Price Per Pack (Euro) : 44.803

Published in :

Country : Norway

RX/OTC/DISCN :

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08

Brand Name : Forxiga

United Kingdom
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

United Kingdom
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5 mg

Price Per Pack (Euro) : 47.663

Published in :

Country : Norway

RX/OTC/DISCN :

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09

Brand Name : Forxiga

Country
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

Country
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 49.082

Published in :

Country : Norway

RX/OTC/DISCN :

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10

Brand Name : Forxiga

Country
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Brand Name : Forxiga

Country
arrow
Vietnam Medi-Pharm Expo
Not Confirmed

Dapagliflozin

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Price Per Pack (Euro) : 159.93

Published in :

Country : Norway

RX/OTC/DISCN :

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Market Place

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Patents & EXCLUSIVITIES

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US Patents

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01

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Chemicals America
Not Confirmed

ASTRAZENECA AB

United Kingdom
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Chemicals America
Not Confirmed

DAPAGLIFLOZIN

US Patent Number : 7851502*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202293

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-02-19

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02

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Chemicals America
Not Confirmed

ASTRAZENECA AB

United Kingdom
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Chemicals America
Not Confirmed

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

US Patent Number : 6515117*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 209091

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-04-04

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03

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Chemicals America
Not Confirmed

ASTRAZENECA AB

United Kingdom
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Chemicals America
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 7919598

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 205649

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-16

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04

ASTRAZENECA AB

United Kingdom
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Chemicals America
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

US Patent Number : 8628799

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210874

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-07-13

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05

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Chemicals America
Not Confirmed

ASTRAZENECA AB

United Kingdom
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Chemicals America
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 8501698

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 205649

Patent Use Code : U-493

Delist Requested :

Patent Use Description : TREATMENT OF TYPE 2 DI...

Patent Expiration Date : 2027-06-20

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06

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Chemicals America
Not Confirmed

ASTRAZENECA AB

United Kingdom
arrow
Chemicals America
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 7919598

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 205649

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-16

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07

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Chemicals America
Not Confirmed

ASTRAZENECA AB

United Kingdom
arrow
Chemicals America
Not Confirmed

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 6515117

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 205649

Patent Use Code : U-493

Delist Requested :

Patent Use Description : TREATMENT OF TYPE 2 DI...

Patent Expiration Date : 2025-10-04

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08

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Chemicals America
Not Confirmed

ASTRAZENECA AB

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DAPAGLIFLOZIN

US Patent Number : 8361972*PED

Drug Substance Claim :

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Application Number : 202293

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Patent Expiration Date : 2028-09-21

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DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

US Patent Number : 8361972*PED

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Application Number : 209091

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Patent Expiration Date : 2028-09-21

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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 9616028

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 205649

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Patent Use Description :

Patent Expiration Date : 2030-11-12

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Exclusivity Code : M-298

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ABOUT THIS PAGE

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

Dapagliflozin manufacturers, exporters & distributors 1

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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.

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.

Forxiga (TN) Manufacturers

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

Forxiga (TN) Suppliers

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

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

Forxiga (TN) USDMF

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

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

click here to find a list of Forxiga (TN) suppliers with USDMF on PharmaCompass.

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

Forxiga (TN) KDMF

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

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

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

click here to find a list of Forxiga (TN) suppliers with KDMF on PharmaCompass.

Forxiga (TN) WC

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

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

Forxiga (TN) 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 Forxiga (TN) as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Forxiga (TN) 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 Forxiga (TN) 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 Forxiga (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Forxiga (TN) NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Forxiga (TN) suppliers with NDC on PharmaCompass.

Forxiga (TN) GMP

Forxiga (TN) 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 Forxiga (TN) 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 Forxiga (TN) GMP manufacturer or Forxiga (TN) GMP API supplier for your needs.

Forxiga (TN) CoA

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

Forxiga (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Forxiga (TN) 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.

Forxiga (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Forxiga (TN) EP), Forxiga (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Forxiga (TN) 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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