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    Chemistry

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    Also known as: Octostim, Minirin, Ddavp, Stimate, Concentraid, Desmopressin acetate anhydrous
    Molecular Formula
    C48H68N14O14S2
    Molecular Weight
    1129.3  g/mol
    InChI Key
    MLSVJHOYXJGGTR-IFHOVBQLSA-N
    FDA UNII
    1K12647SFC
    Desmopressin Acetate
    A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR.
    1 2D Structure

    Desmopressin Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    acetic acid;(2S)-N-[(2R)-1-[(2-amino-2-oxoethyl)amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]-1-[(4R,7S,10S,13S,16S)-7-(2-amino-2-oxoethyl)-10-(3-amino-3-oxopropyl)-13-benzyl-16-[(4-hydroxyphenyl)methyl]-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carbonyl]pyrrolidine-2-carboxamide
    2.1.2 InChI
    InChI=1S/C46H64N14O12S2.C2H4O2/c47-35(62)15-14-29-40(67)58-32(22-36(48)63)43(70)59-33(45(72)60-18-5-9-34(60)44(71)56-28(8-4-17-52-46(50)51)39(66)53-23-37(49)64)24-74-73-19-16-38(65)54-30(21-26-10-12-27(61)13-11-26)41(68)57-31(42(69)55-29)20-25-6-2-1-3-7-25;1-2(3)4/h1-3,6-7,10-13,28-34,61H,4-5,8-9,14-24H2,(H2,47,62)(H2,48,63)(H2,49,64)(H,53,66)(H,54,65)(H,55,69)(H,56,71)(H,57,68)(H,58,67)(H,59,70)(H4,50,51,52);1H3,(H,3,4)/t28-,29+,30+,31+,32+,33+,34+;/m1./s1
    2.1.3 InChI Key
    MLSVJHOYXJGGTR-IFHOVBQLSA-N
    2.1.4 Canonical SMILES
    CC(=O)O.C1CC(N(C1)C(=O)C2CSSCCC(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N2)CC(=O)N)CCC(=O)N)CC3=CC=CC=C3)CC4=CC=C(C=C4)O)C(=O)NC(CCCN=C(N)N)C(=O)NCC(=O)N
    2.1.5 Isomeric SMILES
    CC(=O)O.C1C[C@H](N(C1)C(=O)[C@@H]2CSSCCC(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N2)CC(=O)N)CCC(=O)N)CC3=CC=CC=C3)CC4=CC=C(C=C4)O)C(=O)N[C@H](CCCN=C(N)N)C(=O)NCC(=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    1K12647SFC
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1-deamino-8-d-arginine Vasopressin

    2. 1-desamino-8-arginine Vasopressin

    3. Acetate, Desmopressin

    4. Adiuretin

    5. Adiuretin Sd

    6. Apo-desmopressin

    7. Arginine Vasopressin, Deamino

    8. Ddavp

    9. Deamino Arginine Vasopressin

    10. Desmogalen

    11. Desmopressin

    12. Desmopressin Monoacetate

    13. Desmopressin Monoacetate, Trihydrate

    14. Desmopressine Ferring

    15. Desmospray

    16. Desmotabs

    17. Ferring, Desmopressine

    18. Minirin

    19. Minurin

    20. Monoacetate, Desmopressin

    21. Monoacetate, Trihydrate Desmopressin

    22. Nocutil

    23. Octim

    24. Octostim

    25. Trihydrate Desmopressin Monoacetate

    26. Vasopressin, 1-deamino-8-d-arginine

    27. Vasopressin, 1-desamino-8-arginine

    28. Vasopressin, Deamino Arginine

    2.3.2 Depositor-Supplied Synonyms

    1. Octostim

    2. Minirin

    3. Ddavp

    4. Stimate

    5. Concentraid

    6. Desmopressin Acetate Anhydrous

    7. Noctiva

    8. 62288-83-9

    9. Ddavp (needs No Refrigeration)

    10. Desmospray

    11. Anhydrous Desmopressin Acetate

    12. Desmopressin Acetate Preservative Free

    13. Desmopressin Acetate (needs No Refrigeration)

    14. 1k12647sfc

    15. Desmopressin Acetate Hydrate

    16. Desmotabs

    17. Minirine

    18. Nocutil

    19. Octim

    20. Desmopressin Acetate Trihydrate

    21. Demopressin Acetate

    22. Ddavp Nasal Spray

    23. Ddavp Rhinal Tube

    24. Stimate Nasal Spray

    25. Noqdirna

    26. Presinex

    27. Desmomelt

    28. Unii-1k12647sfc

    29. Desmopressin Acetate [usan:jan]

    30. Chembl1200556

    31. Dtxsid4046864

    32. 16679-58-6(free Base)

    33. Desmopressin Acetate [mi]

    34. Stimate (needs No Refrigeration)

    35. Ex-a4285

    36. 1-(3-mercaptopropionic Acid)-8-d-arginine Vasopression Monoacetate

    37. Bdbm50247923

    38. Mfcd00133962

    39. Akos025311518

    40. Ccg-270644

    41. Desmopressin Monoacetate Anhydrous

    42. Anhydrous Desmopressin Acetate [mart.]

    43. (deamino-cys1,d-arg8)-vasopressin Acetate

    44. 789d983

    45. Q27252517

    46. 1-(3-mercaptopropionic Acid)-8-d-arginine-vasopressin Monoacetate (salt)

    47. Vasopressin, 1-(3-mercaptopropanoic Acid)-8-d-arginine-, Monoacetate (salt)

    48. Vasopressin,1-(3-mercaptopropanoic Acid)-8-d-arginine-,monoacetate(salt)(9ci)

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 1129.3 g/mol
    Molecular Formula C48H68N14O14S2
    Hydrogen Bond Donor Count14
    Hydrogen Bond Acceptor Count17
    Rotatable Bond Count19
    Exact Mass1128.44808525 g/mol
    Monoisotopic Mass1128.44808525 g/mol
    Topological Polar Surface Area526 Ų
    Heavy Atom Count78
    Formal Charge0
    Complexity2070
    Isotope Atom Count0
    Defined Atom Stereocenter Count7
    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 2  
    Drug NameDesmopressin acetate
    Drug LabelDesmopressin Nasal Spray Solution USP, 0.01% is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is:Mol. w...
    Active IngredientDesmopressin acetate
    Dosage FormInjectable; Spray, metered; Tablet; Solution
    RouteNasal; oral; Injection; Oral
    Strength0.01mg/spray; 0.004mg/ml; 0.2mg; 0.01%; 0.1mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Glenmark Generics; Teva Pharms; Hospira; Actavis Labs Fl; Apotex; Bausch And Lomb; Sun Pharm Inds; Teva Pharms Usa; Ferring

    2 of 2  
    Drug NameDesmopressin acetate
    Drug LabelDesmopressin Nasal Spray Solution USP, 0.01% is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is:Mol. w...
    Active IngredientDesmopressin acetate
    Dosage FormInjectable; Spray, metered; Tablet; Solution
    RouteNasal; oral; Injection; Oral
    Strength0.01mg/spray; 0.004mg/ml; 0.2mg; 0.01%; 0.1mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Glenmark Generics; Teva Pharms; Hospira; Actavis Labs Fl; Apotex; Bausch And Lomb; Sun Pharm Inds; Teva Pharms Usa; Ferring

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antidiuretic Agents

    Agents that reduce the excretion of URINE, most notably the octapeptide VASOPRESSINS. (See all compounds classified as Antidiuretic Agents.)

    Hemostatics

    Agents acting to arrest the flow of blood. Absorbable hemostatics arrest bleeding either by the formation of an artificial clot or by providing a mechanical matrix that facilitates clotting when applied directly to the bleeding surface. These agents function more at the capillary level and are not effective at stemming arterial or venous bleeding under any significant intravascular pressure. (See all compounds classified as Hemostatics.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Increased Coagulation Factor VIII Activity [PE]; Increased Coagulation Factor VIII Concentration [PE]; Vasopressin Analog [EPC]; Vasopressins [CS]; Factor VIII Activator [EPC]

    API Reference Price

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VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655317800,"product":"DESMOPRESSIN ACETATE","address":"OFFICE No. 62, 6th FLOOR, TITANIUM CORPORATE ROAD, PRAHALADNAGAR Conta","city":"AHMEDABAD","supplier":"SUZHOU TIANMA PHARMA GROUP CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"SWISS PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"820","totalValueFC":"999.4","currency":"USD","unitRateINR":"77968.2","date":"16-Jun-2022","totalValueINR":"77968.16","totalValueInUsd":"999.4","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"9131811","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"OFFICE No. 62, 6th FLOOR, TITANIUM CORPORATE ROAD, PRAHALADNAGAR Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656527400,"product":"500115 - DESMOPRESSIN GENERICUM BATCH NO 20-21-0317-01 \/ 20-21-0351-01","address":"PLOT NO.46,1ST PHASE,KIADB INDUSTRIAL AREA, HAROHALLI, KANAKA","city":"RAMANAGARA","supplier":"POLYPEPTIDE GROUP","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"TENSHI KAIZEN PRIVATE ","customerCountry":"INDIA","quantity":"0.17","actualQuantity":"170","unit":"GMS","unitRateFc":"360","totalValueFC":"61933.2","currency":"USD","unitRateINR":"28422","date":"30-Jun-2022","totalValueINR":"4831740","totalValueInUsd":"61933.2","indian_port":"BANGALORE AIR","hs_no":"29371900","bill_no":"9354469","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.46,1ST PHASE,KIADB INDUSTRIAL AREA, HAROHALLI, KANAKA"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656527400,"product":"500115 - DESMOPRESSIN GENERICUM DDAVP GENERICUM - BATCH NO 20-21-0317-01","address":"PLOT NO.46,1ST PHASE,KIADB INDUSTRIAL AREA, HAROHALLI, KANAKA","city":"RAMANAGARA","supplier":"POLYPEPTIDE GROUP","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"TENSHI KAIZEN PRIVATE ","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"30","unit":"GMS","unitRateFc":"360","totalValueFC":"11486","currency":"USD","unitRateINR":"29869.4","date":"30-Jun-2022","totalValueINR":"896082.5","totalValueInUsd":"11486","indian_port":"BANGALORE AIR","hs_no":"29371900","bill_no":"9354469","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.46,1ST PHASE,KIADB INDUSTRIAL AREA, HAROHALLI, KANAKA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703269800,"product":"DESMOPRESSIN ACETATE - API FOR TESTING PURPOSE","address":"24 TH FLOOR, SUNSHINE TOWER,","city":"MUMBAI","supplier":"FERRING PHARMACEUTICALS","supplierCountry":"GERMANY","foreign_port":"HAMBURG - FUHLSBUETT","customer":"FERRING PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"84.795","unit":"GMS","unitRateFc":"276.8","totalValueFC":"29485.5","currency":"EUR","unitRateINR":"28945.9","date":"23-Dec-2023","totalValueINR":"2454465.37","totalValueInUsd":"29485.5","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"9379451","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG - FUHLSBUETT","supplierAddress":"WITTLAND 11, D-24109 KIELP.O. BOX 2145, D-24020KIEL, GERMANY DE","customerAddress":"24 TH FLOOR, SUNSHINE TOWER,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"DESMOPRESSIN GENERICUM(DESMOPRESSIN ACETATE USP)","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"M\/S.POLYPEPTIDE LABORATORIES (SWEDEN) AB","supplierCountry":"SWEDEN","foreign_port":"COPENHAGEN","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"11","unit":"GMS","unitRateFc":"625","totalValueFC":"7506.6","currency":"USD","unitRateINR":"57341.3","date":"18-Oct-2024","totalValueINR":"630753.75","totalValueInUsd":"7506.6","indian_port":"Madras Air","hs_no":"29371900","bill_no":"6188788","productDescription":"API","marketType":"REGULATED MARKET","country":"SWEDEN","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"LIMHAMNSVAGEN 108 PO BOX 30089 SE-200 61 LIMHAMN SWEDEN SE","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734546600,"product":"DESMOPRESSIN ACETATE (TL NO: SW\/ND\/CT-17\/2024\/000005092) FORR&D PURPOSE NOT FOR SALEDESMOPRESSIN ACETATE (TL NO: SW\/ND\/CT-17\/2024\/000005092) FOR","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"1113.7","totalValueFC":"1122.7","currency":"USD","unitRateINR":"95392.5","date":"19-Dec-2024","totalValueINR":"95392.5","totalValueInUsd":"1122.7","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"7332338","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL INDUSTRIAL ELS VINYETS-ELS FOGA RS 08777-SANT QUINTL DE MEDIONA BAR CELONA Barcelona, , Spain Spain","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"}]
    02-Jan-2021
    19-Dec-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

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

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    Europe

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    01

    Farmak JSC

    Ukraine
    Cosmoprof
    Not Confirmed
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    Farmak JSC

    Ukraine
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    Cosmoprof
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Ukraine

    Desmopressin

    Brand Name : Uropres

    Dosage Form : Nasal Spray

    Dosage Strength : 0.1MG/ML

    Packaging : 2.5ML, 5ML

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Ukraine

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    02

    Ferring Pharmaceuticals Ltd.

    Switzerland
    Cosmoprof
    Not Confirmed
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    Ferring Pharmaceuticals Ltd.

    Switzerland
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    Cosmoprof
    Not Confirmed
    • fda
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    Flag Switzerland
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    Regulatory Info :

    Registration Country : Sweden

    desmopressin acetate

    Brand Name : Desmopressin Ferring

    Dosage Form : TABLET

    Dosage Strength : 0.1 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    03

    FERRING SpA

    Switzerland
    Cosmoprof
    Not Confirmed
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    FERRING SpA

    Switzerland
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    Cosmoprof
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Italy

    Desmopressin

    Brand Name : Minirin/Ddavp

    Dosage Form : Desmopressin 0,125Mg Spray Nasal Use

    Dosage Strength : nasal spray 0.125 mg 2.5 ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    04

    Ferring Pharmaceuticals AS

    Switzerland
    Cosmoprof
    Not Confirmed
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    Ferring Pharmaceuticals AS

    Switzerland
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    Cosmoprof
    Not Confirmed
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    Flag Switzerland
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    Regulatory Info :

    Registration Country : Norway

    Desmopressin

    Brand Name : Nocdurna

    Dosage Form : Smeltetablett

    Dosage Strength : 50 mcg

    Packaging : Blister, endose

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    05

    Ferring Legemidelr AS

    Switzerland
    Cosmoprof
    Not Confirmed
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    Ferring Legemidelr AS

    Switzerland
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    Cosmoprof
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Desmopressin acetate

    Brand Name : Minirin

    Dosage Form : Melting tablet

    Dosage Strength : 240 microg

    Packaging : Blisterpakning 30item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    Ferring Legemidelr AS

    Switzerland
    Cosmoprof
    Not Confirmed
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    Ferring Legemidelr AS

    Switzerland
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    Cosmoprof
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Desmopressin acetate

    Brand Name : Nocdurna

    Dosage Form : Melting tablet

    Dosage Strength : 50 micrograms

    Packaging : Endose blister pack 30 1item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    07

    Ferring AG

    Switzerland
    Cosmoprof
    Not Confirmed
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    Ferring AG

    Switzerland
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    Cosmoprof
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Desmopressini acetas

    Brand Name : Minirin

    Dosage Form : Tablet

    Dosage Strength : 0.1mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    Ferring AG

    Switzerland
    Cosmoprof
    Not Confirmed
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    Ferring AG

    Switzerland
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    Cosmoprof
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Desmopressini acetas

    Brand Name : Octostim

    Dosage Form : Inj L?s

    Dosage Strength : 15mcg/ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    Gebro Pharma GmbH

    Austria
    Cosmoprof
    Not Confirmed
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    Gebro Pharma GmbH

    Austria
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    Cosmoprof
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Sweden

    desmopressin acetate

    Brand Name : Nocutil

    Dosage Form : TABLET

    Dosage Strength : 0.2 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    10

    2care4

    Country
    Cosmoprof
    Not Confirmed
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    2care4

    Country
    arrow
    Cosmoprof
    Not Confirmed
    • fda
    • EDQM
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    Regulatory Info :

    Registration Country : Norway

    Desmopressin

    Brand Name : Desmopressin 2care4

    Dosage Form : Nose spray, resolution

    Dosage Strength : 10 mcg/dose

    Packaging : Bottle of dark glass with dose pump

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Only 10 entries up to this point, click to access all click full view read-more
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;NASAL - 0.01%

    USFDA APPLICATION NUMBER - 17922

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    DOSAGE - SPRAY, METERED;NASAL - 0.01MG/SPRAY ...DOSAGE - SPRAY, METERED;NASAL - 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17922

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    DOSAGE - INJECTABLE;INJECTION - 0.004MG/ML

    USFDA APPLICATION NUMBER - 18938

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    DOSAGE - TABLET;ORAL - 0.1MG

    USFDA APPLICATION NUMBER - 19955

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    DOSAGE - TABLET;ORAL - 0.2MG

    USFDA APPLICATION NUMBER - 19955

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    DOSAGE - SPRAY, METERED;NASAL - 0.00083MG/SPR...DOSAGE - SPRAY, METERED;NASAL - 0.00083MG/SPRAY

    USFDA APPLICATION NUMBER - 201656

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    DOSAGE - SPRAY, METERED;NASAL - 0.00166MG/SPR...DOSAGE - SPRAY, METERED;NASAL - 0.00166MG/SPRAY

    USFDA APPLICATION NUMBER - 201656

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    DOSAGE - SPRAY, METERED;NASAL - 0.15MG/SPRAY

    USFDA APPLICATION NUMBER - 20355

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    DOSAGE - SPRAY, METERED;NASAL - 0.01MG/SPRAY

    USFDA APPLICATION NUMBER - 21333

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    DOSAGE - TABLET;SUBLINGUAL - 0.0277MG

    USFDA APPLICATION NUMBER - 22517

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    DOSAGE - TABLET;SUBLINGUAL - 0.0553MG

    USFDA APPLICATION NUMBER - 22517

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    ABOUT THIS PAGE

    Desmopressin Manufacturers

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

    Desmopressin Suppliers

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

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

    Desmopressin USDMF

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

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

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

    Desmopressin 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 Desmopressin Drug Master File in Japan (Desmopressin JDMF) empowers Desmopressin 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 Desmopressin JDMF during the approval evaluation for pharmaceutical products. At the time of Desmopressin 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 Desmopressin suppliers with JDMF on PharmaCompass.

    Desmopressin KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

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

    After submitting a Desmopressin 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 Desmopressin API can apply through the Korea Drug Master File (KDMF).

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

    Desmopressin CEP

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

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

    click here to find a list of Desmopressin suppliers with CEP (COS) on PharmaCompass.

    Desmopressin WC

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

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

    Desmopressin 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 Desmopressin as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Desmopressin GMP

    Desmopressin 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 Desmopressin 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 Desmopressin GMP manufacturer or Desmopressin GMP API supplier for your needs.

    Desmopressin CoA

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

    Desmopressin CoA mostly includes findings from lab analyses of a specific batch. For each Desmopressin 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.

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