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ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 17 USDMF, 7 EU WC, 38 KDMF, 18 NDC API, 34 Listed Suppliers, $ API Reference Price

42 API Suppliers
17 USDMF
7 EU WC
38 KDMF
18 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers, 4 Europe, 3 South Africa

7 FDF Dossiers
4 Europe
3 South Africa

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 2 DKSH, 1 Faran Shimi Pharmaceutical, 6 Gangwal Healthcare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 9 Kerry, 1 Kima Chemical, 11 Microlex e.U, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 2 Prachin Chemical, 7 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Sigachi Industries, 1 The Dow Chemical Company, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

26 Fillers, Diluents & Binders, 16 Thickeners and Stabilizers, 15 Direct Compression, 11 Lubricants & Glidants, 9 Co-Processed Excipients, 6 Granulation, 6 Disintegrants & Superdisintegrants, 4 Controlled & Modified Release, 4 Rheology Modifiers, 4 Coating Systems & Additives, 3 Solubilizers, 3 Emulsifying Agents, 2 Chewable & Orodispersible Aids, 2 Film Formers & Plasticizers, 2 Taste Masking, 1 API Stability Enhancers

excipientsByApplications
26 Fillers, Diluents & Binders
16 Thickeners and Stabilizers
15 Direct Compression
11 Lubricants & Glidants
9 Co-Processed Excipients
6 Granulation
6 Disintegrants & Superdisintegrants
4 Controlled & Modified Release
4 Rheology Modifiers
4 Coating Systems & Additives
3 Solubilizers
3 Emulsifying Agents
2 Chewable & Orodispersible Aids
2 Film Formers & Plasticizers
2 Taste Masking
1 API Stability Enhancers

DIGITAL CONTENT

3 NEWS #PharmaBuzz

media
3 NEWS #PharmaBuzz

MARKET PLACE

13 APIs

marketPlace
13 APIs

ANALYTICAL

2 BioAnalytical Methods

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2 BioAnalytical Methods

Polpharma Dapagliflozin Propanediol Monohydrate

Synopsis

ACTIVE PHARMA INGREDIENTS

42

API Suppliers

17

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

7

EU WC

38

KDMF

18

NDC API

0

VMF

34

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 3,090

MARKET PLACE

13

API

0

FDF

6INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

7

FDF Dossiers

0

FDA Orange Book

FDA (Orange Book)

4

Europe

0

Canada

0

Australia

3

South Africa

0

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

3

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

NA

Annual Reports (USD Million)

NA

Finished Drug Prices

NA

67 RELATED EXCIPIENT COMPANIES

114EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 960404-48-2, Dapagliflozin propanediol monohydrate, Dapagliflozin propanediol hydrate, Farxiga, Dapagliflozin ((2s)-1,2-propanediol, hydrate), Bms-512148-05

Molecular Formula

C₂₄H₃₅ClO₉

Molecular Weight

503.0 g/mol

InChI Key

GOADIQFWSVMMRJ-UPGAGZFNSA-N

FDA UNII

887K2391VH

Dapagliflozin Propanediol Monohydrate

Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.

1 2D Structure

Dapagliflozin Propanediol Monohydrate

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;(2S)-propane-1,2-diol;hydrate

2.1.2 InChI

InChI=1S/C21H25ClO6.C3H8O2.H2O/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;1-3(5)2-4;/h3-8,10,17-21,23-26H,2,9,11H2,1H3;3-5H,2H2,1H3;1H2/t17-,18-,19+,20-,21+;3-;/m10./s1

2.1.3 InChI Key

GOADIQFWSVMMRJ-UPGAGZFNSA-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.CC(CO)O.O

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.C[C@@H](CO)O.O

2.2 Other Identifiers

2.2.1 UNII

887K2391VH

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. Dapagliflozin

7. Farxiga

8. Forxiga

2.3.2 Depositor-Supplied Synonyms

1. 960404-48-2

2. Dapagliflozin Propanediol Monohydrate

3. Dapagliflozin Propanediol Hydrate

4. Farxiga

5. Dapagliflozin ((2s)-1,2-propanediol, Hydrate)

6. Bms-512148-05

7. Dapagliflozin S-propylene Glycol Monohydrate

8. Dapagliflozin Propylene Glycolate Hydrate

9. Chebi:85079

10. Dapagliflozin Propanediol [usan]

11. Dapagliflozin Mixture With Propylene Glycol, Hydrate

12. 887k2391vh

13. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol;(2s)-propane-1,2-diol;hydrate

14. Dapagliflozin [usan:inn]

15. Dapagliflozin Propylene Glycol Hydrate

16. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol Compound With (s)-propane-1,2-diol (1:1) Hydrate

17. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-, Compd. With (2s)-1,2-propanediol, Hydrate (1:1:1)

18. Unii-887k2391vh

19. Dapagliflozin Propylene Glycolate Hydrate [jan]

20. Dapagliflozin (s)-propylene Glycol Hydrate

21. Chembl2103802

22. Dtxsid00914678

23. Ex-a2824

24. Dapagliflozin Propylene Glycol

25. Hy-10450a

26. Mfcd28167768

27. S5566

28. Akos027250601

29. Ccg-269711

30. Ac-29230

31. As-64915

32. Dapagliflozin (2s)-1,2-propanediol Hydrate

33. F20667

34. Bms-512148 (2s)-1,2-propanediol, Hydrate

35. Dapagliflozin (2s)-1,2-propanediol Monohydrate

36. Xigduo Component Dapagliflozin Propanediol

37. A900162

38. Dapagliflozin Propanediol Component Of Xigduo

39. Dapagliflozin Propanediol Monohydrate [who-dd]

40. Q27158320

41. Dapagliflozin Propanediol Monohydrate [ema Epar]

42. Dapagliflozin Compound With (2s)-1,2-propanediol Hydrate

43. Dapagliflozin Compound With (2s)-1,2-propanediol Hydrate [mi]

44. (2s)-propane-1,2-diol (2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol Hydrate

45. (2s)-propane-1,2-diol--(1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol--water (1/1/1)

46. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro- 2h-pyran-3,4,5-triol, (2s)-propane-1,2-diol (1:1) Monohydrate

47. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol (s)-propane-1,2-diol Hydrate

48. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, (2s)-propane-1,2-diol (1:1) Monohydrate

49. 1700615-13-9

2.4 Create Date

2008-09-29

3 Chemical and Physical Properties

Molecular Formula	C₂₄H₃₅ClO₉
Molecular Weight	503.0 g/mol
Hydrogen Bond Donor Count	7
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	7
Exact Mass	502.1969604 g/mol
Monoisotopic Mass	502.1969604 g/mol
Topological Polar Surface Area	141 Å²
Heavy Atom Count	34
Formal Charge	0
Complexity	493
Isotope Atom Count	0
Defined Atom Stereocenter Count	6
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Drug Indication

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.

5 Pharmacology and Biochemistry

5.1 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.)

5.2 ATC Code

A10BK01

A10BK01

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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"}]

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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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