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    Chemistry

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    Also known as: 654671-78-0, Sitagliptin (phosphate), Mk-0431, Chembl393336, 494p4635i6, Mk0431
    Molecular Formula
    C16H18F6N5O5P
    Molecular Weight
    505.31  g/mol
    InChI Key
    IQFYVLUXQXSJJN-SBSPUUFOSA-N
    FDA UNII
    494P4635I6
    Sitagliptin Phosphate
    A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.
    1 2D Structure

    Sitagliptin Phosphate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;phosphoric acid
    2.1.2 InChI
    InChI=1S/C16H15F6N5O.H3O4P/c17-10-6-12(19)11(18)4-8(10)3-9(23)5-14(28)26-1-2-27-13(7-26)24-25-15(27)16(20,21)22;1-5(2,3)4/h4,6,9H,1-3,5,7,23H2;(H3,1,2,3,4)/t9-;/m1./s1
    2.1.3 InChI Key
    IQFYVLUXQXSJJN-SBSPUUFOSA-N
    2.1.4 Canonical SMILES
    C1CN2C(=NN=C2C(F)(F)F)CN1C(=O)CC(CC3=CC(=C(C=C3F)F)F)N.OP(=O)(O)O
    2.1.5 Isomeric SMILES
    C1CN2C(=NN=C2C(F)(F)F)CN1C(=O)C[C@@H](CC3=CC(=C(C=C3F)F)F)N.OP(=O)(O)O
    2.2 Other Identifiers
    2.2.1 UNII
    494P4635I6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 0431, Mk

    2. 4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8h)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine

    3. Anhydrous, Sitagliptin Phosphate

    4. Januvia

    5. Mk 0431

    6. Mk-0431

    7. Mk0431

    8. Monohydrate, Sitagliptin Monophosphate

    9. Monohydrate, Sitagliptin Phosphate

    10. Monophosphate Monohydrate, Sitagliptin

    11. Phosphate Anhydrous, Sitagliptin

    12. Phosphate Monohydrate, Sitagliptin

    13. Phosphate, Sitagliptin

    14. Sitagliptin

    15. Sitagliptin Monophosphate Monohydrate

    16. Sitagliptin Phosphate Anhydrous

    17. Sitagliptin Phosphate Monohydrate

    2.3.2 Depositor-Supplied Synonyms

    1. 654671-78-0

    2. Sitagliptin (phosphate)

    3. Mk-0431

    4. Chembl393336

    5. 494p4635i6

    6. Mk0431

    7. (2r)-4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8h)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine Phosphate Salt

    8. (3r)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;phosphoric Acid

    9. (r)-3-amino-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8h)-yl)-4-(2,4,5-trifluorophenyl)butan-1-one Phosphate

    10. 1-butanone, 3-amino-1-[5,6-dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8h)-yl]-4-(2,4,5-trifluorophenyl)-, (3r)-, Phosphate (1:1)

    11. Sitagliptin Monophosphate

    12. Sitagliptin Phosphate Anhydrous

    13. (3r)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)-1-butanone; Phosphoric Acid

    14. Mk 0431

    15. Sr-05000001748

    16. Unii-494p4635i6

    17. (2r)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8h)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine Phosphate Salt

    18. Mk 431

    19. Mk-0431 Phosphate

    20. Schembl877069

    21. Dtxsid10215789

    22. Hy-13749a

    23. Mfcd09952339

    24. Akos015896098

    25. Sitagliptin Phosphate [who-dd]

    26. Ks-1214

    27. 4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro(1,2,4)triazolo(4,3-a)pyrazin-7(8h)-yl)-1-(2,4,5-trifluorophenyl)butan-2-amine Phosphate

    28. Sitagliptin Monophosphate Anhydrous [mi]

    29. 671s780

    30. A835125

    31. Sr-05000001748-2

    32. Q27259224

    33. Sitagliptin Phosphate Anhydrous Component Of Janumet

    34. (3r)-3-amino-1-[5,6-dihydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazin-7(8h)-yl]-4-(2,4,5-trifluorophenyl)-1-butanone Phosphate

    35. (3r)-3-azanyl-1-[3-(trifluoromethyl)-6,8-dihydro-5h-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-[2,4,5-tris(fluoranyl)phenyl]butan-1-one; Phosphoric Acid

    36. 1,2,4-triazolo(4,3-a)pyrazine, 7-((3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8-tetrahydro-3-(trifluoromethyl)-, Phosphate (1:1)

    37. 1269630-53-6

    38. 7-((3r)-3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo(4,3-a)pyrazinemonophosphate

    39. 7-(3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine Phosphate

    2.4 Create Date
    2006-04-29
    3 Chemical and Physical Properties
    Molecular Weight 505.31 g/mol
    Molecular Formula C16H18F6N5O5P
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count4
    Exact Mass505.09497466 g/mol
    Monoisotopic Mass505.09497466 g/mol
    Topological Polar Surface Area155 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity616
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameJanuvia
    PubMed HealthSitagliptin (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelJANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahy...
    Active IngredientSitagliptin phosphate
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 25mg base
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    2 of 4  
    Drug NameSitagliptin phosphate
    Active IngredientSitagliptin phosphate
    Dosage FormTablet
    Routeoral; Oral
    Strengtheq 100mg base; 25mg; eq 50mg base; 100mg; 50mg; eq 25mg base
    Market StatusTentative Approval
    CompanyMylan Pharms; Apotex; Sandoz; Sun Pharma Global; Watson Labs

    3 of 4  
    Drug NameJanuvia
    PubMed HealthSitagliptin (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelJANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahy...
    Active IngredientSitagliptin phosphate
    Dosage FormTablet
    RouteOral
    Strengtheq 100mg base; eq 50mg base; eq 25mg base
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    4 of 4  
    Drug NameSitagliptin phosphate
    Active IngredientSitagliptin phosphate
    Dosage FormTablet
    Routeoral; Oral
    Strengtheq 100mg base; 25mg; eq 50mg base; 100mg; 50mg; eq 25mg base
    Market StatusTentative Approval
    CompanyMylan Pharms; Apotex; Sandoz; Sun Pharma Global; Watson Labs

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Hypoglycemic Agents

    Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)

    Incretins

    Peptides which stimulate INSULIN release from the PANCREATIC BETA CELLS following oral nutrient ingestion, or postprandially. (See all compounds classified as Incretins.)

    Dipeptidyl-Peptidase IV Inhibitors

    Compounds that suppress the degradation of INCRETINS by blocking the action of DIPEPTIDYL-PEPTIDASE IV. This helps to correct the defective INSULIN and GLUCAGON secretion characteristic of TYPE 2 DIABETES MELLITUS by stimulating insulin secretion and suppressing glucagon release. (See all compounds classified as Dipeptidyl-Peptidase IV Inhibitors.)

    API Reference Price

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AP","supplier":"VERBEN S A","supplierCountry":"INDIA","foreign_port":"MUNICH","customer":"SMS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"100.73","actualQuantity":"100.73","unit":"KGS","unitRateFc":"700","totalValueFC":"72156.1","currency":"USD","unitRateINR":"59709.3","date":"16-May-2024","totalValueINR":"6014513.38","totalValueInUsd":"72156.1","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"3507838","productDescription":"Re-export","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MUNICH","supplierAddress":"LUGANO BRANCHVIA F.PELLI 17P O BOX 6900 LUGANO CH","customerAddress":"PLOT NO.19-III, ROAD NO.71, OPP."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721154600,"product":"RE-IMPORT- SITAGLIPTIN PHOSPHATE (EXPORT INV NO:232410369 DT:30.03.2024 VIDE SB NO:8780352 DT: 30.03.2024 )","address":"26, VANDALUR - KELAMBAKKAM ROAD,","city":"CHENNAI. TAMIL NADU.","supplier":"DLS PHARMAG DMCC","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"VENKATA NARAYANA ACTIVE INGREDIENTS","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"325","totalValueFC":"332033.3","currency":"USD","unitRateINR":"27755","date":"17-Jul-2024","totalValueINR":"27755020.31","totalValueInUsd":"332033.3","indian_port":"Madras Air","hs_no":"29420090","bill_no":"4545754","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBAI","supplierAddress":"2208,1 LAKE PLAZAJUMEIRAH LAKES TOWERSP B 309045 DUBAI UNITED ARAB EMIRATES","customerAddress":"26, VANDALUR - KELAMBAKKAM ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722450600,"product":"SITAGLIPTIN SYSTEM SUITABILITY MIXTURE (QTY: 3 X 0.05 G, VALUE USD: 17.60\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00015","unit":"KGS","unitRateFc":"352000","totalValueFC":"54.5","currency":"USD","unitRateINR":"30481066.7","date":"01-Aug-2024","totalValueINR":"4572.16","totalValueInUsd":"54.5","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"4826736","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728412200,"product":"SITAGLIPTIN PHOSPHATE IP","address":"1544, LEVEL 15, EROS CORPORATE","city":"NEW DELHI","supplier":"DIVIS LABORATORIES LIMITED-DSN SEZ UNIT","supplierCountry":"INDIA","foreign_port":"DLL SEZ","customer":"MSD PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1720.38","actualQuantity":"1720.38","unit":"KGS","unitRateFc":"404.2","totalValueFC":"702214.9","currency":"USD","unitRateINR":"34297.5","date":"09-Oct-2024","totalValueINR":"59004698.64","totalValueInUsd":"702214.9","indian_port":"Vizag-DLL SEZ","hs_no":"29335990","bill_no":"6032567","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DLL SEZ","supplierAddress":"CHIPPADA VILLAGE ANNAVARAM POST BHEEMUNIPATNAM MANDAL VISAKHAPATNAM SDNF India","customerAddress":"1544, LEVEL 15, EROS CORPORATE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"SITAGLIPTIN PHOSPHATE ANH(SNP)CO USP(BR)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"MYLAN LABORATORIES LIMITED FDF UNIT-3","supplierCountry":"INDIA","foreign_port":"NASIK","customer":"VIATRIS","customerCountry":"INDIA","quantity":"446.15","actualQuantity":"446.152","unit":"KGS","unitRateFc":"638.1","totalValueFC":"287835.8","currency":"USD","unitRateINR":"54209.9","date":"26-Oct-2024","totalValueINR":"24185846.38","totalValueInUsd":"287835.8","indian_port":"Indore-EPZ\/SEZ","hs_no":"29339990","bill_no":"6350764","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NASIK","supplierAddress":"IPlot No 11,12 & 13, SEZ Phase II SEZ, Sector 3, Pithampur, Dist Dhar SDNF India","customerAddress":"564\/A\/22, ROAD NO.92"}]
    04-Jan-2021
    30-Oct-2024
    KGS
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    Average Price (USD/KGS)

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

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    Drugs in Development

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    NeuroBo Reports Positive DA-1241 Safety Data and Opens Enrollment for Phase 2a

    Details:

    DA-1241, a GPR119 agonist, is in Phase 2 trials with sitagliptin, a DPP4 inhibitor, for steatohepatitis treatment.


    Lead Product(s): DA-1241,Sitagliptin Phosphate

    Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: DA-1241

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 18, 2024

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    01

    NeuroBo Pharmaceuticals

    U.S.A
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    euroPLX 86 Munich
    Not Confirmed

    NeuroBo Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : DA-1241,Sitagliptin Phosphate

    Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    NeuroBo Reports Positive DA-1241 Safety Data and Opens Enrollment for Phase 2a

    Details : DA-1241, a GPR119 agonist, is in Phase 2 trials with sitagliptin, a DPP4 inhibitor, for steatohepatitis treatment.

    Brand Name : DA-1241

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 18, 2024

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    Cosmos Health Enters into Definitive Agreement to Acquire Type-2 Diabetes Treatment DIABIT-IS X

    Details:

    Through the acquisition, Cosmos will gain the license and rights for DIABIT-IS X, a drug that contains the active substance sitagliptin and is used in the treatment of type-2 diabetes.


    Lead Product(s): Sitagliptin Phosphate

    Therapeutic Area: Endocrinology Brand Name: DIABIT-IS X

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Cosmos Health

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition December 20, 2023

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    02

    Undisclosed

    Country
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    euroPLX 86 Munich
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    Undisclosed

    Country
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    euroPLX 86 Munich
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    Lead Product(s) : Sitagliptin Phosphate

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Cosmos Health

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Cosmos Health Enters into Definitive Agreement to Acquire Type-2 Diabetes Treatment DIABIT-IS X

    Details : Through the acquisition, Cosmos will gain the license and rights for DIABIT-IS X, a drug that contains the active substance sitagliptin and is used in the treatment of type-2 diabetes.

    Brand Name : DIABIT-IS X

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    December 20, 2023

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    Zydus Receives USFDA Approval for ZITUVIO™ to Treat Adult Patients with Type 2 Diabetes Mellitus

    Details:

    Zituvio (Sitagliptin) tablets A is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


    Lead Product(s): Sitagliptin Phosphate

    Therapeutic Area: Endocrinology Brand Name: Zituvio

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 20, 2023

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    03

    Zydus Lifesciences

    India
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    euroPLX 86 Munich
    Not Confirmed

    Zydus Lifesciences

    India
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    euroPLX 86 Munich
    Not Confirmed
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    Lead Product(s) : Sitagliptin Phosphate

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Zydus Receives USFDA Approval for ZITUVIO™ to Treat Adult Patients with Type 2 Diabetes Mellitus

    Details : Zituvio (Sitagliptin) tablets A is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    Brand Name : Zituvio

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 20, 2023

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    Akums Gets DCGI Nod for Triple Combination Diabetes Medication

    Details:

    Sitagliptin, Pioglitazone & Metformin are combined for the treatment of diabetes. Metformin, coupled with the functional and corrective influence of pioglitazone on beta-cell and metabolic syndrome and the stability of Sitagliptin, make an effective solution for diabetes.


    Lead Product(s): Sitagliptin Phosphate,Pioglitazone,Metformin

    Therapeutic Area: Endocrinology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 27, 2023

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    04

    Akums Drugs & Pharmaceuticals Ltd

    India
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    euroPLX 86 Munich
    Not Confirmed

    Akums Drugs & Pharmaceuticals Ltd

    India
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    euroPLX 86 Munich
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    Lead Product(s) : Sitagliptin Phosphate,Pioglitazone,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Akums Gets DCGI Nod for Triple Combination Diabetes Medication

    Details : Sitagliptin, Pioglitazone & Metformin are combined for the treatment of diabetes. Metformin, coupled with the functional and corrective influence of pioglitazone on beta-cell and metabolic syndrome and the stability of Sitagliptin, make an effective solu...

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 27, 2023

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    George Medicines Advances Triple Combination Candidate GMRx4 Into Phase II Clinical Development for First-Line Treatment of Type 2 Diabetes

    Details:

    GMRx4 is being developed to provide a synergistic effect from three best-in-class type 2 diabetes treatments – metformin, dapagliflozin and sitagliptin – and, in an ultra-low-dose, single pill formulation, aims to be a more effective, simpler and safer treatment regimen.


    Lead Product(s): Metformin,Dapagliflozin,Sitagliptin Phosphate

    Therapeutic Area: Endocrinology Brand Name: GMRx4

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: CUREator

    Deal Size: $1.0 million Upfront Cash: Undisclosed

    Deal Type: Financing July 20, 2022

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    George Medicines

    United Kingdom
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    euroPLX 86 Munich
    Not Confirmed

    George Medicines

    United Kingdom
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    Lead Product(s) : Metformin,Dapagliflozin,Sitagliptin Phosphate

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : CUREator

    Deal Size : $1.0 million

    Deal Type : Financing

    DEALS_DEV arrow-down

    George Medicines Advances Triple Combination Candidate GMRx4 Into Phase II Clinical Development fo...

    Details : GMRx4 is being developed to provide a synergistic effect from three best-in-class type 2 diabetes treatments – metformin, dapagliflozin and sitagliptin – and, in an ultra-low-dose, single pill formulation, aims to be a more effective, simpler and saf...

    Brand Name : GMRx4

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    July 20, 2022

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    Generics of MSD Diabetes Pill Set to Flood Market as Patent Expires

    Details:

    Januvia (sitagliptin), a class of dipeptidyl peptidase (DPP4) inhibitors, is used with a proper diet and exercise program and possibly with other medications to control high blood sugar.


    Lead Product(s): Sitagliptin Phosphate

    Therapeutic Area: Endocrinology Brand Name: Januvia

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Sun Pharmaceutical Industries Limited

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 07, 2022

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    06

    Merck & Co

    U.S.A
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    euroPLX 86 Munich
    Not Confirmed

    Merck & Co

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Sitagliptin Phosphate

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Sun Pharmaceutical Industries Limited

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Generics of MSD Diabetes Pill Set to Flood Market as Patent Expires

    Details : Januvia (sitagliptin), a class of dipeptidyl peptidase (DPP4) inhibitors, is used with a proper diet and exercise program and possibly with other medications to control high blood sugar.

    Brand Name : Januvia

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 07, 2022

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    Zent2U Announces Successful Pivotal BE Trial on Sitagliptin Development

    Details:

    Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones.


    Lead Product(s): Sitagliptin Phosphate

    Therapeutic Area: Endocrinology Brand Name: Sitagliptin-Generic

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 12, 2021

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    07

    Prague Scientific

    Czech Republic
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    euroPLX 86 Munich
    Not Confirmed

    Prague Scientific

    Czech Republic
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    euroPLX 86 Munich
    Not Confirmed
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    Lead Product(s) : Sitagliptin Phosphate

    Therapeutic Area : Endocrinology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Zent2U Announces Successful Pivotal BE Trial on Sitagliptin Development

    Details : Sitagliptin is a DPP-4 inhibitor, which is believed to exert its actions in patients with type 2 diabetes by slowing the inactivation of incretin hormones.

    Brand Name : Sitagliptin-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 12, 2021

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    Codexis and Merck Amend and Extend Supply Agreement for Enzyme Used in Manufacture of Sitagliptin

    Details:

    Under a research and development agreement, Codexis and Merck leveraged Codexis’ CodeEvolver® enzyme engineering platform technology to design a novel, proprietary enzyme to serve as a biocatalyst in the sitagliptin manufacturing process.


    Lead Product(s): Sitagliptin Phosphate

    Therapeutic Area: Endocrinology Brand Name: Januvia

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Merck & Co

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement September 09, 2021

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    08

    Codexis

    U.S.A
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    euroPLX 86 Munich
    Not Confirmed

    Codexis

    U.S.A
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    euroPLX 86 Munich
    Not Confirmed
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    Lead Product(s) : Sitagliptin Phosphate

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Merck & Co

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Codexis and Merck Amend and Extend Supply Agreement for Enzyme Used in Manufacture of Sitagliptin

    Details : Under a research and development agreement, Codexis and Merck leveraged Codexis’ CodeEvolver® enzyme engineering platform technology to design a novel, proprietary enzyme to serve as a biocatalyst in the sitagliptin manufacturing process.

    Brand Name : Januvia

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    September 09, 2021

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    Zydus Cadila Arm Receives US FDA Approval for Sitagliptin Base

    Details:

    Zydus’ Sitagliptin base contains the active moiety sitagliptin in a different form than used in the branded reference product, Januvia (sitagliptin phosphate).


    Lead Product(s): Sitagliptin Phosphate

    Therapeutic Area: Endocrinology Brand Name: Januvia

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 06, 2021

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    09

    Zydus Lifesciences

    India
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    euroPLX 86 Munich
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    India
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    Lead Product(s) : Sitagliptin Phosphate

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Zydus Cadila Arm Receives US FDA Approval for Sitagliptin Base

    Details : Zydus’ Sitagliptin base contains the active moiety sitagliptin in a different form than used in the branded reference product, Januvia (sitagliptin phosphate).

    Brand Name : Januvia

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 06, 2021

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    IOL Chemicals and Pharmaceuticals

    India
    CPhI India 2024
    Booth #1.C01
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    • fda
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    Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

    3- (Trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] Tr...

    CAS Number : 762240-92-6

    End Use API : Sitagliptin Phosphate

    About The Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermedia...

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    Aptra Synthesis

    India
    CPhI India 2024
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    Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

    (2,4,5-trifIuorophenyI)acetic acid

    CAS Number : 209995-38-0

    End Use API : Sitagliptin Phosphate

    About The Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilit...

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    Aptra Synthesis

    India
    CPhI India 2024
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    Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

    (3R)-3-Amino-1-[3-(trifIuoromethyI)-5,6,7,8-tetrah...

    CAS Number : 486460-32-6

    End Use API : Sitagliptin Phosphate

    About The Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilit...

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    Aptra Synthesis

    India
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    Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

    2,4,5-TrifIuoro-§-oxo-benzenebutanoic Acid Methyl...

    CAS Number : 769195-26-8

    End Use API : Sitagliptin Phosphate

    About The Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilit...

    Aptra Synthesis

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    Aptra Synthesis

    India
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    Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

    3-(Trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]tria...

    CAS Number : 762240-92-6

    End Use API : Sitagliptin Phosphate

    About The Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilit...

    Aptra Synthesis

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    Aptra Synthesis

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    Virtual BoothAptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.

    Sitagliptin keto amide

    CAS Number : 764667-65-4

    End Use API : Sitagliptin Phosphate

    About The Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilit...

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    Actis Generics Pvt Ltd

    India
    American Pharma Summit
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    3-(Trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]tria...

    CAS Number : 762240-92-6

    End Use API : Sitagliptin Phosphate

    About The Company : Actis Generics Pvt Ltd is a fast emerging APIs (Active Pharmaceutical Ingredients) & Intermediates manufacturer & supplier in India set up by a group of young p...

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    Actis Generics Pvt Ltd

    India
    American Pharma Summit
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    Actis Generics Pvt Ltd

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    (2Z)-4-Oxo-4-[3-(trifluoromethyl)-5,6-dihydro-[1,2...

    CAS Number : 764667-65-4

    End Use API : Sitagliptin Phosphate

    About The Company : Actis Generics Pvt Ltd is a fast emerging APIs (Active Pharmaceutical Ingredients) & Intermediates manufacturer & supplier in India set up by a group of young p...

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    Actis Generics Pvt Ltd

    India
    American Pharma Summit
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    (3R)-3-Amino-1-[3-(trifluoromethyl)-5,6,7,8-tetrah...

    CAS Number : 486460-32-6

    End Use API : Sitagliptin Phosphate

    About The Company : Actis Generics Pvt Ltd is a fast emerging APIs (Active Pharmaceutical Ingredients) & Intermediates manufacturer & supplier in India set up by a group of young p...

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    Almelo

    India
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    3-(Trifluoromethyl)-5,6,7,8- Tetrahydro-[1,2,4] Tr...

    CAS Number : CAS-762240-92-6

    End Use API : Sitagliptin Phosphate

    About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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    01

    WATSON LABS INC

    Ireland
    American Pharma Summit
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    WATSON LABS INC

    Ireland
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    American Pharma Summit
    Not Confirmed
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    RLD :

    TE Code :

    SITAGLIPTIN PHOSPHATE

    Brand Name : SITAGLIPTIN PHOSPHATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Approval Date :

    Application Number : 202327

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    WATSON LABS INC

    Ireland
    American Pharma Summit
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    WATSON LABS INC

    Ireland
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    American Pharma Summit
    Not Confirmed
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    RLD :

    TE Code :

    SITAGLIPTIN PHOSPHATE

    Brand Name : SITAGLIPTIN PHOSPHATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date :

    Application Number : 202327

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    MSD SUB MERCK

    India
    American Pharma Summit
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    RLD : Yes

    TE Code :

    METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

    Brand Name : JANUMET XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 1GM;EQ 50MG BASE

    Approval Date : 2012-02-02

    Application Number : 202270

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    MSD SUB MERCK

    India
    American Pharma Summit
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    MSD SUB MERCK

    India
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    American Pharma Summit
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    RLD : Yes

    TE Code :

    METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

    Brand Name : JANUMET XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 1GM;EQ 100MG BASE

    Approval Date : 2012-02-02

    Application Number : 202270

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    TEVA PHARMS USA

    Israel
    American Pharma Summit
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    TEVA PHARMS USA

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    American Pharma Summit
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    RLD :

    TE Code :

    SITAGLIPTIN PHOSPHATE

    Brand Name : SITAGLIPTIN PHOSPHATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 25MG

    Approval Date :

    Application Number : 202487

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    UNICHEM LABS LTD

    India
    American Pharma Summit
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    India
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    RLD :

    TE Code :

    SITAGLIPTIN PHOSPHATE

    Brand Name : SITAGLIPTIN PHOSPHATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 25MG BASE

    Approval Date :

    Application Number : 214693

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    MYLAN PHARMS INC

    U.S.A
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    TE Code :

    SITAGLIPTIN PHOSPHATE

    Brand Name : SITAGLIPTIN PHOSPHATE

    Dosage Form : TABLET; ORAL

    Dosage Strength : EQ 25MG BASE

    Approval Date :

    Application Number : 202473

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    MYLAN PHARMS INC

    U.S.A
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    SITAGLIPTIN PHOSPHATE

    Brand Name : SITAGLIPTIN PHOSPHATE

    Dosage Form : TABLET; ORAL

    Dosage Strength : EQ 50MG BASE

    Approval Date :

    Application Number : 202473

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    MYLAN PHARMS INC

    U.S.A
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    TE Code :

    SITAGLIPTIN PHOSPHATE

    Brand Name : SITAGLIPTIN PHOSPHATE

    Dosage Form : TABLET; ORAL

    Dosage Strength : EQ 100MG BASE

    Approval Date :

    Application Number : 202473

    RX/OTC/DISCN :

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    TE Code :

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    ZYDUS LIFESCIENCES

    India
    American Pharma Summit
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    ZYDUS LIFESCIENCES

    India
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    RLD : Yes

    TE Code :

    SITAGLIPTIN

    Brand Name : ZITUVIO

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Approval Date : 2023-10-18

    Application Number : 211566

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    DR. REDDY'S SRL

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    CPhI India 2024
    Booth #RH.E02
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Regulatory Info :

    Registration Country : Italy

    Sitagliptin; Metformin

    Brand Name : SITAGLIPTIN AND METFORMIN DR. REDDY'S

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 50 mg/1,000 mg

    Packaging : 56 UNITS (50+1000) MG - ORAL USE

    Approval Date :

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    Registration Country : Italy

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    DR. REDDY'S SRL

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    Registration Country : Italy

    Sitagliptin; Metformin

    Brand Name : SITAGLIPTIN AND METFORMIN DR. REDDY'S

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 50 mg/850 mg

    Packaging : 56 UNITS (50+850) MG - ORAL USE

    Approval Date :

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    Registration Country : Italy

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    Helvepharm AG

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Registration Country : Switzerland

    Metformin hydrochloride; Sitagliptin

    Brand Name : Sitagliptin Metformin Zentiva

    Dosage Form : Filmtabl

    Dosage Strength : 50/1000mg

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    Registration Country : Switzerland

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    Helvepharm AG

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Metformin hydrochloride; Sitagliptin

    Brand Name : Sitagliptin Metformin Zentiva

    Dosage Form : Filmtabl

    Dosage Strength : 50/500mg

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    Approval Date :

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    Registration Country : Switzerland

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    Helvepharm AG

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Registration Country : Switzerland

    Metformin hydrochloride; Sitagliptin

    Brand Name : Sitagliptin Metformin Zentiva

    Dosage Form : Filmtabl

    Dosage Strength : 50/500mg

    Packaging :

    Approval Date :

    Application Number :

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    Registration Country : Switzerland

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    Helvepharm AG

    France
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    American Pharma Summit
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Registration Country : Switzerland

    Metformin hydrochloride; Sitagliptin

    Brand Name : Sitagliptin Metformin Zentiva

    Dosage Form : Filmtabl

    Dosage Strength : 50/850mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Helvepharm AG

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    American Pharma Summit
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Regulatory Info :

    Registration Country : Switzerland

    Metformin hydrochloride; Sitagliptin

    Brand Name : Sitagliptin Metformin Zentiva

    Dosage Form : Filmtabl

    Dosage Strength : 50/850mg

    Packaging :

    Approval Date :

    Application Number :

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    Registration Country : Switzerland

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    Helvepharm AG

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Sitagliptin

    Brand Name : Sitagliptin Zentiva

    Dosage Form : Filmtabl

    Dosage Strength : 100mg

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    Helvepharm AG

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Sitagliptin

    Brand Name : Sitagliptin Zentiva

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    Helvepharm AG

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    American Pharma Summit
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    • fda
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    Sitagliptin

    Brand Name : Sitagliptin Zentiva

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 25mg

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 100MG BASE

    USFDA APPLICATION NUMBER - 21995

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    DOSAGE - TABLET;ORAL - EQ 25MG BASE

    USFDA APPLICATION NUMBER - 21995

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 21995

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    DOSAGE - TABLET;ORAL - 1GM;EQ 50MG BASE

    USFDA APPLICATION NUMBER - 22044

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    DOSAGE - TABLET;ORAL - 500MG;EQ 50MG BASE

    USFDA APPLICATION NUMBER - 22044

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