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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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LTD","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"UNDISCLOSED","customerCountry":"CANADA","quantity":"0.14","actualQuantity":"135","unit":"GMS","unitRateFc":"268","totalValueFC":"29033.3","currency":"USD","unitRateINR":18479.25,"date":"23-Jun-2025","totalValueINR":"2494698.75","totalValueInUsd":"29033.3","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"2939474","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753381800,"product":"DESMOPRESSIN ACETATE USP 2025 POWDER (SYNTHETIC),QTY: 40 G","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"PIRAMAL PHARMA LTD","supplierCountry":"INDIA","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"TO 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VAISHNODE","city":"AHMEDABAD","supplier":"SCINO PHARM TAIWAN LTD","supplierCountry":"TAIWAN","foreign_port":"#N\/A","customer":"CADILA HEALTHCARE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"11.2","unit":"GMS","unitRateFc":"2800","totalValueFC":"32631.1","currency":"USD","unitRateINR":"217035.9","date":"19-Jan-2022","totalValueINR":"2430801.55","totalValueInUsd":"32631.1","indian_port":"BOMBAY AIR","hs_no":"29371900","bill_no":"7147109","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646677800,"product":"DESMOPRESSIN GENERICUM DDAVP GENERICUM","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"POLYPEPTIDE LABORATORIES SWEDEN AB","supplierCountry":"DENMARK","foreign_port":"N\/A","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"475.2","totalValueFC":"4778.6","currency":"USD","unitRateINR":"36422.5","date":"08-Mar-2022","totalValueINR":"364225","totalValueInUsd":"4778.6","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29371900","bill_no":"1000358","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"LIMHAMNSVAGEN 108 PO BOX 30089 SE-200 61 LIMHAMN SE","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649356200,"product":"DESMOPRESSIN ACETATE USP","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"NA","customer":"CADILA HEALTHCARE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"6.8","unit":"GMS","unitRateFc":"600","totalValueFC":"4564","currency":"EURO","unitRateINR":"50640","date":"08-Apr-2022","totalValueINR":"344352","totalValueInUsd":"4564","indian_port":"BOMBAY AIR","hs_no":"29371900","bill_no":"8188979","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. 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 TIANJI B","supplierCountry":"CHINA","foreign_port":"NA","customer":"SWISS PARENTERALS LTD","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":"2024","qtr":"Q4","strtotime":1728239400,"product":"DESMOPRESSIN GENERICUM DDAVP GENERICUM","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"POLYPEPTIDE LABORATORIES SWEDEN AB","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"12","unit":"GMS","unitRateFc":"425.8","totalValueFC":"5159.7","currency":"USD","unitRateINR":"36129.2","date":"07-Oct-2024","totalValueINR":"433550","totalValueInUsd":"5159.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29371900","bill_no":"1001551","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"LIMHAMNSVAGEN 108 PO BOX 30089 SE-200 61 LIMHAMN SE","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"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":"POLYPEPTIDE LABORATORIES SWEDEN AB","supplierCountry":"SWEDEN","foreign_port":"COPENHAGEN","customer":"CAPLIN STERILES LTD","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":"2025","qtr":"Q2","strtotime":1749407400,"product":"DESMOPRESSIN ACETATE DESMOPRESSIN ACETATE","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"SINOPEP ALLSINO BIOPHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"RUBICON RESEARCH LTD","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"0.07","unit":"KGS","unitRateFc":"400000","totalValueFC":"28268.7","currency":"USD","unitRateINR":"34700000","date":"09-Jun-2025","totalValueINR":"2429000","totalValueInUsd":"28268.7","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"2555339","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.28 LINPU ROAD LIANYUNGANG INDUSTRIAL AREA ECO AND TECH DEVELOPMENT ZONE JIANGSU CN","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"DESMOPRESSIN ACETATE - 1100010591 - BATCH NO 0032404A DESMOPRESSIN ACETATE - 1100010591 - BATCH NO 0032404A","address":"L\/204, MANTRI WOODLANDS, B.G. ROAD,","city":"KARNATAKA STATE","supplier":"HYBIO PHARMACEUTICAL (WUHAN) CO ., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"TENSHI KAIZEN PRIVATE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"610","totalValueFC":"3111.2","currency":"USD","unitRateINR":"53466.5","date":"27-Jun-2025","totalValueINR":"267332.5","totalValueInUsd":"3111.2","indian_port":"Bangalore Air","hs_no":"29371900","bill_no":"2923434","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO 9, LINKONG WEST STREET HENGDIAN STREET, HUANGPI DISTRICT, WUHAN CIT Y, HUBEI PROVINCE CHINA, , China China","customerAddress":"L\/204, MANTRI WOODLANDS, B.G. ROAD,"}]
    19-Jan-2022
    31-Jul-2025
    KGS
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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

    Looking for 62288-83-9 / Desmopressin Acetate API manufacturers, exporters & distributors?

    Desmopressin Acetate manufacturers, exporters & distributors 1

    100

    PharmaCompass offers a list of Desmopressin Acetate 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 Desmopressin Acetate manufacturer or Desmopressin Acetate supplier for your needs.

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

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

    API | Excipient name

    Desmopressin Acetate

    Synonyms

    Octostim, Minirin, Ddavp, Stimate, Concentraid, Desmopressin acetate anhydrous

    Cas Number

    62288-83-9

    Unique Ingredient Identifier (UNII)

    1K12647SFC

    About 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.

    Stimate Manufacturers

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

    Stimate Suppliers

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

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

    Stimate USDMF

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

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

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

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

    Stimate KDMF

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

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

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

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

    Stimate CEP

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

    A Stimate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Stimate 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 Stimate suppliers with CEP (COS) on PharmaCompass.

    Stimate WC

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

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

    Stimate 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 Stimate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Stimate GMP

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

    Stimate CoA

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

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

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