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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 Weight 503.0 g/mol
    Molecular Formula C24H35ClO9
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count7
    Exact Mass502.1969604 g/mol
    Monoisotopic Mass502.1969604 g/mol
    Topological Polar Surface Area141 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity493
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    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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    Dapagliflozin Propanediol IH

    Date of Issue : 2022-07-28

    Valid Till : 2025-11-30

    Written Confirmation Number : WC-0390

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    Dapagliflozin Propanediol Monohydrate IHS

    Date of Issue : 2024-04-03

    Valid Till : 2027-01-21

    Written Confirmation Number : WC-0493

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    Dapagliflozin Propanediol USP

    Date of Issue : 2025-06-16

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    Date of Issue : 2025-09-18

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    Date of Issue : 2025-09-03

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    Date of Issue : 2025-12-24

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    Date of Issue : 2022-08-31

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    Date of Issue : 2022-08-31

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    Date of Issue : 2025-06-05

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    Registrant Name : Seongwoo Chemical Co., Ltd.

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    Registration Number : Su434-68-ND

    Manufacturer Name : Ami Lifesciences Pvt. Ltd.

    Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, ...

    AMI Lifesciences

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    07

    Honour Lab Limited

    India
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    CGT Asia
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    Dapagliflozin propanediol hydrate

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2024-04-03

    Registration Number : Su21-9-ND(7)

    Manufacturer Name : Honour Lab Limited

    Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapall...

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    08

    Honour Lab Limited

    India
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    CGT Asia
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    Dapagliflozin propanediol hydrate

    Registrant Name : Seongwoo Chemical Co., Ltd.

    Registration Date : 2026-03-10

    Registration Number : Number 21-9-ND(8)

    Manufacturer Name : Honour Lab Limited

    Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapall...

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    09

    Honour Lab Limited

    India
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    CGT Asia
    Not Confirmed
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    Dapagliflozin propanediol hydrate

    Registrant Name : Huseong Bio Co., Ltd.

    Registration Date : 2023-08-22

    Registration Number : Su21-9-ND(6)

    Manufacturer Name : Honour Lab Limited(Unit-III)

    Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapall...

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    10

    Honour Lab Limited

    India
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    CGT Asia
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    Dapagliflozin propanediol hydrate

    Registrant Name : Jeil Pharmaceutical Co., Ltd.

    Registration Date : 2023-07-28

    Registration Number : Su21-9-ND(5)

    Manufacturer Name : Honour Lab Limited

    Manufacturer Address : Unit-III, Plot No.4, Hetero Infrastructure SEZ Ltd, N. Narasapuram Village, Nakkapall...

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    01

    Dr. Reddys laboratories Limited

    India
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    MAGHREB Pharma Expo
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 71796-006

    Start Marketing Date : 2018-08-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    02

    Dr. Reddy's Laboratories Limited

    India
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    MAGHREB Pharma Expo
    Attending
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 71796-030

    Start Marketing Date : 2019-08-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Dr Reddy Company Banner

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    03

    Metrochem API Private Limited

    India
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    CPhI Japan
    Booth #1J-48
    • fda
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 42765-037

    Start Marketing Date : 2021-06-26

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (20kg/20kg)

    Marketing Category : BULK INGREDIENT

    Metrochem

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    04

    Cohance Lifesciences Limited

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

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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 76072-1014

    Start Marketing Date : 2019-07-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Cohance

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    05

    Honour Lab Limited

    India
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    CGT Asia
    Not Confirmed
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 69037-0038

    Start Marketing Date : 2014-01-08

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    DOTTIKON EXCLUSIVE SYNTHESIS AG

    Switzerland
    CGT Asia
    Not Confirmed
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    DOTTIKON EXCLUSIVE SYNTHESIS AG

    Switzerland
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    CGT Asia
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 54864-673

    Start Marketing Date : 2014-01-08

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    DOTTIKON EXCLUSIVE SYNTHESIS AG

    Switzerland
    CGT Asia
    Not Confirmed
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    DOTTIKON EXCLUSIVE SYNTHESIS AG

    Switzerland
    arrow
    CGT Asia
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 54864-668

    Start Marketing Date : 2022-06-02

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    EMNAR PHARMA PRIVATE LIMITED

    India
    CGT Asia
    Not Confirmed
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    EMNAR PHARMA PRIVATE LIMITED

    India
    arrow
    CGT Asia
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 71901-607

    Start Marketing Date : 2021-11-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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    09

    HIKAL LIMITED

    India
    CGT Asia
    Not Confirmed
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    HIKAL LIMITED

    India
    arrow
    CGT Asia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 66651-924

    Start Marketing Date : 2019-12-20

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    MSN Laboratories Private Limited

    India
    CGT Asia
    Not Confirmed
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    MSN Laboratories Private Limited

    India
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    CGT Asia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    DAPAGLIFLOZIN PROPANEDIOL

    NDC Package Code : 14501-0091

    Start Marketing Date : 2014-03-25

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    01

    Polpharma

    Poland
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    CPhI Japan
    Attending
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    Virtual BoothEuropean CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.

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    Dapagliflozin Propanediol Monohydrate

    About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...

    Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in Central Europe, it offers comprehensive API services from development to scale-up. Specializing in small molecule clinical candidates, Polpharma delivers customized, high-quality solutions with strong regulatory knowledge and advanced infrastructure. Globally recognized for complex chemistry, it is committed to precision, partnership, and progress. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Polpharma CB

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    02

    Dr. Reddy's Laboratories

    India
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    MAGHREB Pharma Expo
    Attending
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    • EDQM
    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Dapagliflozin Propanediol Monohydrate

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
    Dr Reddy Company Banner

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    03

    Metrochem API Private Limited

    India
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    CPhI Japan
    Booth #1J-48
    • fda
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    • WHO-GMP

    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Dapagliflozin Propanediol Monohydrate

    About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could 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
    Metrochem

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    04

    Shandong Chenghui Shuangda Pharmace...

    China
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    CPhI Japan
    Booth #1C-08
    • fda
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

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    Dapagliflozin Propanediol

    About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...

    Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished Formulation Technology Transfer. With 24 years' expertise, our 6 GMP workshops ensure 100-ton monthly cGMP-compliant capacity. We hold 21 NMPA-registered APIs, 4 US-DMF filings, 8 CEP applications, and passed US FDA, Korea MFDS, and global client audits. Note: Patent-protected products are for R&D use only per Patent Act, not for commercial sale.
    Shandong Chenghui Shuangda Pharmaceutical

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    05

    Neuland Laboratories

    India
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    CPhI Japan
    Booth #2G10
    • fda
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    Dapagliflozin Propanediol

    About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...

    Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compounds to NCEs and advanced intermediates. It manufactures APIs and intermediates in USFDA-approved facilities, applying advanced process chemistry in a regulatory-compliant environment for clinical and commercial stages. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Neuland

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    06

    Cohance Lifesciences

    India
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    CGT Asia
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Dapagliflozin Propanediol Monohydrate

    About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...

    Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expertise in complex chemistries, we provide end-to-end CDMO solutions to global innovators. As a global API player, we serve customers in nearly 60 countries with 80+ molecules, supported by robust R&D, regulatory capabilities, and advanced manufacturing infrastructure, including strong backward-integrated pellet manufacturing. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Cohance

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    07

    Egis Pharmaceuticals PLC

    Hungary
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    CPhI Japan
    Attending
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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 Propanediol

    About the Company : Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reach...

    Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reaches 100 countries with its APIs and finished products. Egis focuses on cardiovascular and central nervous system diseases, with offerings in diabetology, dermatology, and wound care. Its R&D emphasizes high-quality, value-added branded generics, and since 2023, Egis also provides CDMO and CMO services. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Egis Pharmaceuticals

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    08

    Jai Radhe Sales

    India
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    CGT Asia
    Not Confirmed
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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Dapagliflozin Propanediol Monohydrate

    About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

    Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Jai Radhe Sales

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    09

    Ami Lifesciences Private Limited

    India
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    CGT Asia
    Not Confirmed
    • fda
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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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    Dapagliflozin Propanediol

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

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    10

    Tenatra Exports

    India
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    CGT Asia
    Not Confirmed
    • fda
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    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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    Dapagliflozin Propanediol Monohydrate

    About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

    Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Tenatra

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    15-Jan-2022
    13-Feb-2026
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    DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

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    Forxiga (Dapagliflozin Propanediol) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Myocardial Infarction.


    Lead Product(s): Dapagliflozin Propanediol Monohydrate,Inapplicable

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Forxiga

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: AstraZeneca

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 10, 2023

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    Assistance Publique – Hôpitaux de Paris

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    Lead Product(s) : Dapagliflozin Propanediol Monohydrate,Inapplicable

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : AstraZeneca

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

    Details : Forxiga (Dapagliflozin Propanediol) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Myocardial Infarction.

    Product Name : Forxiga

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 10, 2023

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    Sun Pharma Dapagliflozin Glimepiride Metformin FDC gets CDSCO Panel Nod for Phase 3 Trial

    Details:

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


    Lead Product(s): Glimepiride,Dapagliflozin Propanediol Monohydrate,Metformin

    Therapeutic Area: Endocrinology Brand Name: Gemer Dapa

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 24, 2021

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    Sun Pharmaceutical Industries Limited

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    Lead Product(s) : Glimepiride,Dapagliflozin Propanediol Monohydrate,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sun Pharma Dapagliflozin Glimepiride Metformin FDC gets CDSCO Panel Nod for Phase 3 Trial

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

    Product Name : Gemer Dapa

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    November 24, 2021

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    Sun Pharma Acquires Rights to Trademarks of Three Diabetes Drug Brands in India from AstraZeneca

    Details:

    AstraZeneca India has granted rights to Sun Pharma to promote and distribute Dapagliflozin under the brand name Oxra. Sun Pharma also gained the rights to promote and distribute the Oxramet (Dapagliflozin + Metformin) and Oxraduo (Dapagliflozin + Saxagliptin).


    Lead Product(s): Dapagliflozin Propanediol Monohydrate,Inapplicable

    Therapeutic Area: Endocrinology Brand Name: Oxra

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Sun Pharmaceutical Industries Limited

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition May 28, 2021

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    AstraZeneca

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    Lead Product(s) : Dapagliflozin Propanediol Monohydrate,Inapplicable

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Sun Pharmaceutical Industries Limited

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Sun Pharma Acquires Rights to Trademarks of Three Diabetes Drug Brands in India from AstraZeneca

    Details : AstraZeneca India has granted rights to Sun Pharma to promote and distribute Dapagliflozin under the brand name Oxra. Sun Pharma also gained the rights to promote and distribute the Oxramet (Dapagliflozin + Metformin) and Oxraduo (Dapagliflozin + Saxagli...

    Product Name : Oxra

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    AstraZeneca Pharma, Abbott Healthcare Terminate Distribution Agreements for Diabetes Drug in India

    Details:

    After termination of the agreement, AstraZeneca India will continue to independently market Dapagliflozin, the combinations of Dapagliflozin and Metformin as well as Dapagliflozin and Saxagliptin in India under the brand names Forxiga, Xigduo and Qtern respectively.


    Lead Product(s): Dapagliflozin Propanediol Monohydrate,Metformin

    Therapeutic Area: Endocrinology Brand Name: Xigduo

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: AstraZeneca

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Termination May 28, 2021

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    Lead Product(s) : Dapagliflozin Propanediol Monohydrate,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : AstraZeneca

    Deal Size : Undisclosed

    Deal Type : Termination

    DEALS_DEV arrow-down

    AstraZeneca Pharma, Abbott Healthcare Terminate Distribution Agreements for Diabetes Drug in India

    Details : After termination of the agreement, AstraZeneca India will continue to independently market Dapagliflozin, the combinations of Dapagliflozin and Metformin as well as Dapagliflozin and Saxagliptin in India under the brand names Forxiga, Xigduo and Qtern r...

    Product Name : Xigduo

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    May 28, 2021

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    ABOUT THIS PAGE

    Looking for 1700615-13-9 / Dapagliflozin Propanediol Monohydrate API manufacturers, exporters & distributors?

    Dapagliflozin Propanediol Monohydrate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Dapagliflozin Propanediol Monohydrate 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 Propanediol Monohydrate manufacturer or Dapagliflozin Propanediol Monohydrate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dapagliflozin Propanediol Monohydrate manufacturer or Dapagliflozin Propanediol Monohydrate supplier.

    PharmaCompass also assists you with knowing the Dapagliflozin Propanediol Monohydrate API Price utilized in the formulation of products. Dapagliflozin Propanediol Monohydrate API Price is not always fixed or binding as the Dapagliflozin Propanediol Monohydrate Price is obtained through a variety of data sources. The Dapagliflozin Propanediol Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Dapagliflozin Propanediol Monohydrate

    Synonyms

    960404-48-2, Dapagliflozin propanediol hydrate, Farxiga, Dapagliflozin ((2s)-1,2-propanediol, hydrate), Bms-512148-05, Dapagliflozin s-propylene glycol monohydrate

    Cas Number

    1700615-13-9

    Unique Ingredient Identifier (UNII)

    887K2391VH

    About 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.

    dapagliflozin (S)-propylene glycol hydrate Manufacturers

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

    dapagliflozin (S)-propylene glycol hydrate Suppliers

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

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate USDMF

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

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

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with USDMF on PharmaCompass.

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

    After submitting a dapagliflozin (S)-propylene glycol hydrate 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 (S)-propylene glycol hydrate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with KDMF on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate CEP

    A dapagliflozin (S)-propylene glycol hydrate CEP of the European Pharmacopoeia monograph is often referred to as a dapagliflozin (S)-propylene glycol hydrate Certificate of Suitability (COS). The purpose of a dapagliflozin (S)-propylene glycol hydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of dapagliflozin (S)-propylene glycol hydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of dapagliflozin (S)-propylene glycol hydrate to their clients by showing that a dapagliflozin (S)-propylene glycol hydrate CEP has been issued for it. The manufacturer submits a dapagliflozin (S)-propylene glycol hydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a dapagliflozin (S)-propylene glycol hydrate CEP holder for the record. Additionally, the data presented in the dapagliflozin (S)-propylene glycol hydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the dapagliflozin (S)-propylene glycol hydrate DMF.

    A dapagliflozin (S)-propylene glycol hydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. dapagliflozin (S)-propylene glycol hydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with CEP (COS) on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate WC

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

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with Written Confirmation (WC) on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate 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 (S)-propylene glycol hydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of dapagliflozin (S)-propylene glycol hydrate suppliers with NDC on PharmaCompass.

    dapagliflozin (S)-propylene glycol hydrate GMP

    dapagliflozin (S)-propylene glycol hydrate 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 (S)-propylene glycol hydrate 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 (S)-propylene glycol hydrate GMP manufacturer or dapagliflozin (S)-propylene glycol hydrate GMP API supplier for your needs.

    dapagliflozin (S)-propylene glycol hydrate CoA

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

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