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Chemistry

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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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C-24,","city":"HYDERABAD. AP","supplier":"HIKMA PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"17.63","actualQuantity":"17.627","unit":"KGS","unitRateFc":"2500","totalValueFC":"45547","currency":"USD","unitRateINR":"215993.8","date":"16-Jul-2024","totalValueINR":"3807323.48","totalValueInUsd":"45547","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4527796","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMMAN","supplierAddress":"INDUSTRIAL AREA,BAYADER WADI AL-SEEJORDAN,PO BOX-182400,AMMAN-11118,JORDAN Jordan","customerAddress":"MSN HOUSE, PLOT NO. C-24,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723573800,"product":"DAPAGLIFLOZIN PROPANEDIOL HYDRATE","address":"A-802, CRESCENZO, C\/38-39,,G-BLOCK","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"ZENTIVA","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"2200","totalValueFC":"55473.1","currency":"USD","unitRateINR":"186120","date":"14-Aug-2024","totalValueINR":"4653000","totalValueInUsd":"55473.1","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"5047268","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"XUNQIAO , LINHAI ZHEJIANG 317024 CHINASDNF China","customerAddress":"A-802, CRESCENZO, C\/38-39,,G-BLOCK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732127400,"product":"DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE","address":"2ND FLOOR, SERENE CHAMBERS,","city":"","supplier":"KRKA","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA - BRNIK","customer":"LAURUS LABS","customerCountry":"INDIA","quantity":"1.49","actualQuantity":"1.488","unit":"KGS","unitRateFc":"3681.2","totalValueFC":"5536.8","currency":"USD","unitRateINR":"314008.3","date":"21-Nov-2024","totalValueINR":"467244.4","totalValueInUsd":"5536.8","indian_port":"Hyderabad Air","hs_no":"29329990","bill_no":"6798339","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"SMARJESKA CESTA 6 NOVO MESTO 8501 S I SDNF Slovenia","customerAddress":"2ND FLOOR, SERENE CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735842600,"product":"DAPAGLIFLOZIN DAPAGLIFLOZIN","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSZAWA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"119.20","actualQuantity":"119.2","unit":"KGS","unitRateFc":"8580","totalValueFC":"1027136.7","currency":"USD","unitRateINR":"743030","date":"03-Jan-2025","totalValueINR":"88569176","totalValueInUsd":"1027136.7","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29329990","bill_no":"7589545","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSZAWA","supplierAddress":"UI PELPLINSKA 19 83 200 STARROGARD GDANSKI SDNF POLAND","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739903400,"product":"DAPAGLIFLOZIN ICH.B.NO.DAI05-24005 RETURN OF THE GOODS UP ONNO MBE20242500116 DT. 31.05.2024DAPAGLIFLOZIN ICH.B.NO.DAI05-24005","address":"MOREPEN VILLAGE, NALAGARH ROAD,","city":"","supplier":"JSC ALIUM","supplierCountry":"RUSSIA","foreign_port":"SHEREMETYEVO","customer":"MOREPEN LABORATORIES","customerCountry":"INDIA","quantity":"22.00","actualQuantity":"22","unit":"KGS","unitRateFc":"1300","totalValueFC":"29072.2","currency":"N\/A","unitRateINR":"114920","date":"19-Feb-2025","totalValueINR":"2528240","totalValueInUsd":"29072.2","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8448780","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHEREMETYEVO","supplierAddress":"BLD, 2, TERRITORY OF BLOCK A,OBOLEN SK SETTLEMENT, SERPUKHOV,MOSCOW REG ION RUSSIAN FEDERATION -142279 RUSSIA","customerAddress":"MOREPEN VILLAGE, NALAGARH ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"DAPAGLIFLOZIN AMORPHOUS","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HONOUR LAB","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"116.39","actualQuantity":"116.39","unit":"KGS","unitRateFc":"1603.7","totalValueFC":"188121.2","currency":"USD","unitRateINR":"140000","date":"26-Mar-2025","totalValueINR":"16294600","totalValueInUsd":"188121.2","indian_port":"Vizag-HIPL SEZ","hs_no":"29329990","bill_no":"9103650","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD N.NARASAPURAM VILLAGE NAKKAPALLY M SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743532200,"product":"DAPAGLIFLOZIN STAGE III","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED SEZ UNIT","supplierCountry":"INDIA","foreign_port":"DAHEJ","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"191.07","actualQuantity":"191.07","unit":"KGS","unitRateFc":"495.7","totalValueFC":"96586.6","currency":"USD","unitRateINR":"43272","date":"02-Apr-2025","totalValueINR":"8267981.04","totalValueInUsd":"96586.6","indian_port":"Dahez-SEZ","hs_no":"29329990","bill_no":"9238922","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DAHEJ","supplierAddress":"Plot No. Z\/15,Dahej SEZ Limited, P.O. Dahej Tal. Vagra, SDNF India","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745865000,"product":"DAPAGLIFLOZIN AMORPHOUS","address":"8-3-166\/7\/1, HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HONOUR LAB","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1157.4","totalValueFC":"11682","currency":"USD","unitRateINR":"100000","date":"29-Apr-2025","totalValueINR":"1000000","totalValueInUsd":"11682","indian_port":"Vizag-HIPL SEZ","hs_no":"29329990","bill_no":"9765723","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD N.NARASAPURAM VILLAGE,NAKKAPALLY MA SDNF India","customerAddress":"8-3-166\/7\/1, HETERO HOUSE,"}]
02-Jan-2021
29-Apr-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
arrow
American Thoracic Society
Not Confirmed

LG Chem

South Korea
arrow
American Thoracic Society
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

American Thoracic Society
Not Confirmed
American Thoracic Society
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

American Thoracic Society
Not Confirmed
American Thoracic Society
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
American Thoracic Society
Not Confirmed

AstraZeneca

United Kingdom
arrow
American Thoracic Society
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

American Thoracic Society
Not Confirmed
American Thoracic Society
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
American Thoracic Society
Not Confirmed

Sequana Medical

Belgium
arrow
American Thoracic Society
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

American Thoracic Society
Not Confirmed
American Thoracic Society
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

American Thoracic Society
Not Confirmed
American Thoracic Society
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
American Thoracic Society
Not Confirmed

AstraZeneca

United Kingdom
arrow
American Thoracic Society
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 BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

CAS Number : 3612-20-2

End Use API : Dapagliflozin

About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

Faran Shimi Pharmaceutical

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

CAS Number : 461432-25-7

End Use API : Dapagliflozin

About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

Faran Shimi Pharmaceutical

08

  • 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

09

  • 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...

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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...

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Dapagliflozin

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Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

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Approval Date :

Application Number :

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

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Dapagliflozin

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Dapagliflozin; Atorvastatin

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Dosage Form : Capsule

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Registration Country : Hungary

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Dapagliflozin; Atorvastatin

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Dapagliflozin; Ramipril

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Dapagliflozin; Bisoprolol Fumarate

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Dapagliflozin; Bisoprolol Fumarate

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Dapagliflozin; Rosuvastatin

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Dapagliflozin; Rosuvastatin

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Dapagliflozin; Eplerenone

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Europe

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Dapagliflozin

Brand Name : Forxiga

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

Dosage Strength : 28 cpr riv 10 mg

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Registration Country : Italy

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Dapagliflozin

Brand Name : Forxiga

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Calendar Gasket

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Application Number :

Regulatory Info :

Registration Country : Norway

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Dapagliflozin

Brand Name : Forxiga

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Blister, endose

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Brand Name : Forxiga

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Dosage Strength : 5 mg

Packaging : Blister, endose

Approval Date :

Application Number :

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Registration Country : Norway

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Metformin; Dapagliflozin

Brand Name : Xigduo

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 5MG; 850MG

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Metformini hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Filmtabl

Dosage Strength : 10mg/500mg

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Registration Country : Switzerland

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Metformini hydrochloridum; Dapagliflozinum

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Dosage Strength : 5mg/1000mg

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Registration Country : Switzerland

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Brand Name : 60 Icandra 50/1000Mg Film-Coated Tablets

Dosage Form : Film Coated Tablet

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Registration Country : Spain

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Metformin; Dapagliflozin

Brand Name : Eucreas 50/1000Mg 60 Tablets Coated Film

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Registration Country : Spain

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Dapagliflozin

Brand Name : Forxiga

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 10 mg

Packaging : Blister

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Application Number :

Regulatory Info :

Registration Country : Norway

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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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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

US Patent Number : 9616028

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210874

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-11-12

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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

US Patent Number : 7919598*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 210874

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-06-16

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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 8501698*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 205649

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-12-20

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DAPAGLIFLOZIN

US Patent Number : 8431685*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202293

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-10-13

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DAPAGLIFLOZIN

US Patent Number : 7456254

Drug Substance Claim :

Drug Product Claim :

Application Number : 202293

Patent Use Code : U-2139

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-06-30

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US Patent Number : 7919598

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 209091

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-16

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US Patent Number : 7456254

Drug Substance Claim :

Drug Product Claim :

Application Number : 202293

Patent Use Code : U-2139

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-06-30

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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

US Patent Number : 6515117*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 210874

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-04-04

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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

US Patent Number : 6515117*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 205649

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-04-04

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DAPAGLIFLOZIN

US Patent Number : 8431685*PED

Drug Substance Claim :

Drug Product Claim :

Application Number : 202293

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-10-13

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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.

Dapagliflozin Manufacturers

A Dapagliflozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapagliflozin, including repackagers and relabelers. The FDA regulates Dapagliflozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapagliflozin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

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

Dapagliflozin Suppliers

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

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

Dapagliflozin USDMF

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

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

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

Dapagliflozin 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 Drug Master File in Japan (Dapagliflozin JDMF) empowers Dapagliflozin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Dapagliflozin JDMF during the approval evaluation for pharmaceutical products. At the time of Dapagliflozin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

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

After submitting a Dapagliflozin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dapagliflozin API can apply through the Korea Drug Master File (KDMF).

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

Dapagliflozin WC

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

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

Dapagliflozin 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Dapagliflozin GMP

Dapagliflozin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Dapagliflozin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dapagliflozin GMP manufacturer or Dapagliflozin GMP API supplier for your needs.

Dapagliflozin CoA

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

Dapagliflozin CoA mostly includes findings from lab analyses of a specific batch. For each Dapagliflozin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

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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