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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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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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    • Development Update
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    Mankind Pharma Launches Justoza to Treat Diabetes, Heart Failure & CKD

    Details:

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


    Lead Product(s): Dapagliflozin

    Therapeutic Area: Endocrinology Brand Name: Justoza

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 22, 2021

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    01

    Mankind Pharma

    India
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    BIO International Convention
    Attending
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    Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

    Lead Product(s) : Dapagliflozin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mankind Pharma Launches Justoza to Treat Diabetes, Heart Failure & CKD

    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

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    LG Chem Sets Sights on Global Market with Launch of Diabetes Combination Therapy Zemidapa

    Details:

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


    Lead Product(s): Dapagliflozin,Gemigliptin

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Zemidapa

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 13, 2025

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    02

    LG Chem

    South Korea
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    American Thoracic Society
    Not Confirmed

    LG Chem

    South Korea
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    American Thoracic Society
    Not Confirmed
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    Lead Product(s) : Dapagliflozin,Gemigliptin

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    LG Chem Sets Sights on Global Market with Launch of Diabetes Combination Therapy Zemidapa

    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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    Nectar Life Care Launches Affordable Anti-Diabetic Range of Medicines

    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

    Nectar Lifecare

    India
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    American Thoracic Society
    Not Confirmed

    Nectar Lifecare

    India
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    American Thoracic Society
    Not Confirmed
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    Lead Product(s) : Dapagliflozin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Nectar Life Care Launches Affordable Anti-Diabetic Range of Medicines

    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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    Akums Combines Two Potent Diabetes Medicines for Enhanced Treatment Efficacy

    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

    Akums Lifesciences

    India
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    American Thoracic Society
    Not Confirmed

    Akums Lifesciences

    India
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    American Thoracic Society
    Not Confirmed
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    Lead Product(s) : Dapagliflozin,Pioglitazone

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Akums Combines Two Potent Diabetes Medicines for Enhanced Treatment Efficacy

    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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    Farxiga approved in the US for the treatment of paediatric type-2 diabetes

    Details:

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


    Lead Product(s): Dapagliflozin

    Therapeutic Area: Endocrinology Brand Name: Farxiga

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 06, 2024

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    05

    AstraZeneca

    United Kingdom
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    American Thoracic Society
    Not Confirmed

    AstraZeneca

    United Kingdom
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    American Thoracic Society
    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.

    Lead Product(s) : Dapagliflozin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Farxiga approved in the US for the treatment of paediatric type-2 diabetes

    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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    Mascot Sets New Diabetes Care Standard with DCGI-Approved Dapagliflozin FDC

    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

    Mascot Health

    India
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    American Thoracic Society
    Not Confirmed

    Mascot Health

    India
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    American Thoracic Society
    Not Confirmed
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    Lead Product(s) : Glimepiride,Dapagliflozin,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Mascot Sets New Diabetes Care Standard with DCGI-Approved Dapagliflozin FDC

    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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    Sequana Medical announces Positive Data from Non-Randomized Cohort in US Phase 1/2a MOJAVE Study of DSR® 2.0 for Treatment of Heart Failure

    Details:

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


    Lead Product(s): Icodextrin,Dapagliflozin,Dextrose

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

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

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 29, 2023

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    07

    Sequana Medical

    Belgium
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    American Thoracic Society
    Not Confirmed

    Sequana Medical

    Belgium
    arrow
    American Thoracic Society
    Not Confirmed
    • fda
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    Lead Product(s) : Icodextrin,Dapagliflozin,Dextrose

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sequana Medical announces Positive Data from Non-Randomized Cohort in US Phase 1/2a MOJAVE Study o...

    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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    USV Launches Jalra Trio for Management of Type 2 Diabetes in India

    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

    USV Private Limited

    India
    arrow
    American Thoracic Society
    Not Confirmed

    USV Private Limited

    India
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    American Thoracic Society
    Not Confirmed
    • fda
    • EDQM
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    Lead Product(s) : Vildagliptin,Dapagliflozin,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    USV Launches Jalra Trio for Management of Type 2 Diabetes in India

    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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    Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Type 2 diabetes

    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

    Glenmark Pharmaceuticals

    India
    arrow
    American Thoracic Society
    Not Confirmed

    Glenmark Pharmaceuticals

    India
    arrow
    American Thoracic Society
    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.

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

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Typ...

    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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    Farxiga Extended in The US to Reduce Risk of Cardiovascular Death and Hospitalisation for Heart Failure to A Broader Range of Patients

    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
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    American Thoracic Society
    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.

    Lead Product(s) : Dapagliflozin

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Farxiga Extended in The US to Reduce Risk of Cardiovascular Death and Hospitalisation for Heart Fa...

    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

    Shandong Chenghui Shuangda Pharmace...

    China
    CPhI China
    Booth #W1A30
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    • fda
    • EDQM
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    Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

    (5-bromo-2-chlorophenyl)(4- ethoxyphenyl)methanone

    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

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    02

    Shandong Chenghui Shuangda Pharmace...

    China
    CPhI China
    Booth #W1A30
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    Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

    5-bromo-2-chloro-4’- ethoxydiphenylmethane

    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

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    03

    Shandong Chenghui Shuangda Pharmace...

    China
    CPhI China
    Booth #W1A30
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    Virtual BoothChina's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.

    [(2R,3R,4R,5S,6S)-3,4,5- triacetyloxy-6-[4-chloro-...

    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...

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    04

    Cohance Lifesciences

    India
    STLE Annual Meeting
    Not Confirmed
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    (5-Bromo-2-chlorophenyl)(4-ethoxyphenyl)methanone

    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

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    05

    Cohance Lifesciences

    India
    STLE Annual Meeting
    Not Confirmed
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    • fda
    • EDQM
    • WHO-GMP

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

    5-Bromo-2-chloro-4'-ethoxydiphenylmethane

    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

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    06

    Faran Shimi Pharmaceutical

    Iran
    STLE Annual Meeting
    Not Confirmed
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    1-Benzyl-4-piperidone

    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

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    07

    Faran Shimi Pharmaceutical

    Iran
    STLE Annual Meeting
    Not Confirmed
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    Dapagliflozin Tetraacetate

    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

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    08

    Virupaksha Organics

    India
    CPhI WW Frankfurt
    Booth #11.0F34
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    Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

    5-Bromo-2-chloro-4-ethoxydiphenylmethane

    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

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    09

    Aarti Pharmalabs

    India
    STLE Annual Meeting
    Not Confirmed
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    Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

    4-(5-bromo-2-chlorobenzyl) phenyl ethyl ether

    CAS Number : 461432-23-5

    End Use API : Dapagliflozin

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

    Aarti Industries Company Banner

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    10

    Aarti Pharmalabs

    India
    STLE Annual Meeting
    Not Confirmed
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    • fda
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    • WHO-GMP

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

    (2S)-2-(8-amino-1-bromoimidazo[1,5-a] pyrazin-3-yl...

    CAS Number : 461432-25-7

    End Use API : Dapagliflozin

    About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...

    Aarti Industries Company Banner

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    01

    Egis Pharmaceuticals PLC

    Hungary
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    PharmaVenue
    Attending
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag Hungary
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin

    Brand Name :

    Dosage Form : Film Coated Tablet

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

    Portfolio PDF

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    02

    Egis Pharmaceuticals PLC

    Hungary
    arrow
    PharmaVenue
    Attending
    • fda
    • EDQM
    • WHO-GMP

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

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    Flag Hungary
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin

    Brand Name :

    Dosage Form : Film Coated Tablet

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    03

    Egis Pharmaceuticals PLC

    Hungary
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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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    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin; Atorvastatin

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 20MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    04

    Egis Pharmaceuticals PLC

    Hungary
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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.

    Contact Supplier Contact Supplier
    Flag Hungary
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin; Atorvastatin

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 40MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    05

    Egis Pharmaceuticals PLC

    Hungary
    arrow
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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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    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin; Ramipril

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    06

    Egis Pharmaceuticals PLC

    Hungary
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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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    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin; Bisoprolol Fumarate

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 2.5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    07

    Egis Pharmaceuticals PLC

    Hungary
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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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    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin; Bisoprolol Fumarate

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    08

    Egis Pharmaceuticals PLC

    Hungary
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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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    Registration Country : Hungary

    Dapagliflozin; Rosuvastatin

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    09

    Egis Pharmaceuticals PLC

    Hungary
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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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    Regulatory Info :

    Registration Country : Hungary

    Dapagliflozin; Rosuvastatin

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 20MG

    Packaging :

    Approval Date :

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    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    Egis Pharmaceuticals PLC

    Hungary
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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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    Registration Country : Hungary

    Dapagliflozin; Eplerenone

    Brand Name :

    Dosage Form : Capsule

    Dosage Strength : 10MG; 25MG

    Packaging :

    Approval Date :

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    Regulatory Info :

    Registration Country : Hungary

    Egis Pharmaceuticals

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    Europe

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    01

    ASTRAZENECA AB

    United Kingdom
    STLE Annual Meeting
    Not Confirmed
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    ASTRAZENECA AB

    United Kingdom
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    STLE Annual Meeting
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    Regulatory Info :

    Registration Country : Italy

    Dapagliflozin

    Brand Name : Forxiga

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

    Dosage Strength : 28 cpr riv 10 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    AstraZeneca AB (2)

    United Kingdom
    STLE Annual Meeting
    Not Confirmed
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    AstraZeneca AB (2)

    United Kingdom
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    STLE Annual Meeting
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    Regulatory Info :

    Registration Country : Norway

    Dapagliflozin

    Brand Name : Forxiga

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 10 mg

    Packaging : Calendar Gasket

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    AstraZeneca AB (2)

    United Kingdom
    STLE Annual Meeting
    Not Confirmed
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    AstraZeneca AB (2)

    United Kingdom
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    Regulatory Info :

    Registration Country : Norway

    Dapagliflozin

    Brand Name : Forxiga

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 10 mg

    Packaging : Blister, endose

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Metformini hydrochloridum; Dapagliflozinum

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

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    Brand Name : Forxiga

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    Dosage Strength : 10 mg

    Packaging : Blister

    Approval Date :

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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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    01

    ASTRAZENECA AB

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

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    Patent Expiration Date : 2030-11-12

    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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    Patent Expiration Date : 2030-06-16

    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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    Patent Expiration Date : 2027-12-20

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    US Patent Number : 8501698*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 205649

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    Patent Expiration Date : 2027-12-20

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    Patent Expiration Date : 2025-10-13

    DAPAGLIFLOZIN

    US Patent Number : 8431685*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 202293

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    Patent Expiration Date : 2025-10-13

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    Patent Expiration Date : 2025-06-30

    DAPAGLIFLOZIN

    US Patent Number : 7456254

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 202293

    Patent Use Code : U-2139

    Delist Requested :

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    Patent Expiration Date : 2025-06-30

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    Patent Expiration Date : 2029-12-16

    DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

    US Patent Number : 7919598

    Drug Substance Claim : Y

    Drug Product Claim :

    Application Number : 209091

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    Patent Expiration Date : 2029-12-16

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    Patent Expiration Date : 2025-06-30

    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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    Patent Expiration Date : 2026-04-04

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

    US Patent Number : 6515117*PED

    Drug Substance Claim :

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    Application Number : 210874

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    Patent Use Description :

    Patent Expiration Date : 2026-04-04

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    American Thoracic Society
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    Patent Expiration Date : 2026-04-04

    DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    US Patent Number : 6515117*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 205649

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    Patent Use Description :

    Patent Expiration Date : 2026-04-04

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    Patent Expiration Date : 2025-10-13

    DAPAGLIFLOZIN

    US Patent Number : 8431685*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 202293

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    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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