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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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ORDER","customerCountry":"CANADA","quantity":"0.77","actualQuantity":"0.768","unit":"KGS","unitRateFc":"221211.3","totalValueFC":"167752.9","currency":"USD","unitRateINR":18559626.302083332,"date":"17-Dec-2024","totalValueINR":"14253793","totalValueInUsd":"167752.9","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"6531903","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK, KURLA, MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"DESMOPRESSIN ACETATE","year":"2021","qtr":"Q1","strtotime":1612722600,"product":"DESMOPRESSIN ACETATE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGARHIGHWAY SATELLITE CROSS ROADS,","city":"AHMEDABAD\/GUJRAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"ZYDUS 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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 GROUP","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":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"6.8","unit":"GMS","unitRateFc":"600","totalValueFC":"4564","currency":"EUR","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 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":"2023","qtr":"Q4","strtotime":1703615400,"product":"DESMOPRESSIN ACETATE USP","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"POLYPEPTIDE GROUP","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.002","unit":"KGS","unitRateFc":"400000","totalValueFC":"1331.3","currency":"EUR","unitRateINR":"55410000","date":"27-Dec-2023","totalValueINR":"110820","totalValueInUsd":"1331.3","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"9431965","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"LIMHAMNSVAGEN 108-PO BOX 30089-SE-20061 LIMHAMN-SWEDEN Limhamn, , Sweden Sweden","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":"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"}]
08-Jan-2021
19-Dec-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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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

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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.

DDAVP Manufacturers

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

DDAVP Suppliers

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

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

DDAVP USDMF

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

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

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

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

DDAVP KDMF

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

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

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

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

DDAVP CEP

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

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

DDAVP WC

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

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

DDAVP 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 DDAVP as an active pharmaceutical ingredient (API).

Finished drug products

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

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

DDAVP GMP

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

DDAVP CoA

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

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

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