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Chemistry

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Also known as: Betamethasone 17-valerate, 2152-44-5, Betnovate, Betaderm, Luxiq, Beta-val
Molecular Formula
C27H37FO6
Molecular Weight
476.6  g/mol
InChI Key
SNHRLVCMMWUAJD-SUYDQAKGSA-N
FDA UNII
9IFA5XM7R2

Betamethasone Valerate
The 17-valerate derivative of BETAMETHASONE. It has substantial topical anti-inflammatory activity and relatively low systemic anti-inflammatory activity.
1 2D Structure

Betamethasone Valerate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] pentanoate
2.1.2 InChI
InChI=1S/C27H37FO6/c1-5-6-7-23(33)34-27(22(32)15-29)16(2)12-20-19-9-8-17-13-18(30)10-11-24(17,3)26(19,28)21(31)14-25(20,27)4/h10-11,13,16,19-21,29,31H,5-9,12,14-15H2,1-4H3/t16-,19-,20-,21-,24-,25-,26-,27-/m0/s1
2.1.3 InChI Key
SNHRLVCMMWUAJD-SUYDQAKGSA-N
2.1.4 Canonical SMILES
CCCCC(=O)OC1(C(CC2C1(CC(C3(C2CCC4=CC(=O)C=CC43C)F)O)C)C)C(=O)CO
2.1.5 Isomeric SMILES
CCCCC(=O)O[C@@]1([C@H](C[C@@H]2[C@@]1(C[C@@H]([C@]3([C@H]2CCC4=CC(=O)C=C[C@@]43C)F)O)C)C)C(=O)CO
2.2 Other Identifiers
2.2.1 UNII
9IFA5XM7R2
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 17-valerate, Betamethasone

2. Betamethasone 17 Valerate

3. Betamethasone 17-valerate

4. Betnovate

5. Flubenisolonvalerate

6. Valerate, Betamethasone

2.3.2 Depositor-Supplied Synonyms

1. Betamethasone 17-valerate

2. 2152-44-5

3. Betnovate

4. Betaderm

5. Luxiq

6. Beta-val

7. Betatrex

8. Tokuderm

9. Valnac

10. Betamethasone-17-valerate

11. Celestoderm

12. Bedermin

13. Bextasol

14. Stanoval

15. Rinderon V

16. Dermovaleas

17. Betneval

18. Dermosol

19. Beta-methasone 17-valerate

20. Ecoval 70

21. Betamethasone 17a-valerate

22. Betamethasone (as Valerate)

23. 9ifa5xm7r2

24. Chebi:31277

25. Betamethasone Valerate (betnovate)

26. Nsc-755912

27. [(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] Pentanoate

28. Betnovateat

29. Celeston Valerate

30. 9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17-valerate

31. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17-valerate

32. 9-fluoro-11beta,21-dihydroxy-16beta-methyl-3,20-dioxopregna-1,4-dien-17-yl Pentanoate

33. 9-fluoro-11beta,21-dihydroxy-16beta-methyl-3,20-dioxopregna-1,4-dien-17-yl Valerate

34. Topagen (veterinary)

35. Gentocin (veterinary)

36. Betamethasone Valerate (betamethasone 17-valerate)

37. Bettamousse

38. Betaval

39. Fuciderm

40. Betoid

41. Celestoderm V

42. Celestoderm-v

43. Betnesol V

44. Betnesol-v

45. Celestan V

46. Celestan-v

47. Celestane V

48. Ncgc00274064-01

49. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16-methyl-17-((1-oxopentyl)oxy)-, (11.beta.,16.beta.)-

50. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16-methyl-17-[(1-oxopentyl)oxy]-, (11.beta.,16.beta.)-

51. Einecs 218-439-3

52. Betamethasoni Valeras

53. Rinderon-v (tn)

54. Betamethasone-valerate

55. Luxiq (tn)

56. Topagen (salt/mix)

57. Beta-val (tn)

58. Betatrex (salt/mix)

59. Gentocin (salt/mix)

60. Chlorophytum Borivilanum

61. Betamethason-17-valerate

62. Dsstox_cid_2673

63. Unii-9ifa5xm7r2

64. Schembl7270

65. Chembl1497

66. Dsstox_rid_76684

67. Dsstox_gsid_22673

68. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16-methyl-17-((1-oxopentyl)oxy)-, (11beta,16beta)-

69. Betamethasone 17alpha-valerate

70. Dtxsid7022673

71. Hy-b0727

72. Zinc3882052

73. Betamethasone Valerate (jp17/usp)

74. Betamethasone Valerate [jan]

75. Tox21_302288

76. Betamethasone Valerate [usan]

77. S1690

78. Betamethasone Valerate [vandf]

79. Akos015994704

80. Betamethasone Valerate [mart.]

81. Betamethasone Valerate [usp-rs]

82. Betamethasone Valerate [who-dd]

83. Betamethasone Valerate [who-ip]

84. Ccg-269509

85. Ks-1198

86. Nsc 755912

87. 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methylpregna-1,4-diene-3,20-dione-17-valerate

88. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17-valerate

89. Betamethasone 17-valerate [mi]

90. Betamethasone Valerate [usan:usp:jan]

91. Ncgc00255185-01

92. (11beta,16beta)-9-fluoro-11,21-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-17-yl Pentanoate

93. (2s,10s,11s,13s,15s,17s,1r,14r)-1-fluoro-17-hydroxy-14-(2-hydroxyacetyl)-2,13, 15-trimethyl-5-oxotetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl Pe Ntanoate

94. Betamethasone Valerate [green Book]

95. Cas-2152-44-5

96. Betamethasone Valerate [orange Book]

97. Betamethasone Valerate [ep Monograph]

98. Betamethasone Valerate For System Suitability

99. Betamethasoni Valeras [who-ip Latin]

100. Cs-0009628

101. Betamethasone Valerate [usp Monograph]

102. D01357

103. Ab01274710-01

104. Ab01274710_02

105. 152m445

106. A815447

107. Q6445931

108. Betamethasone 17a-valerate 100 Microg/ml In Methanol

109. Brd-k34032314-001-04-1

110. (11.beta.,16.beta.)-9.alpha.-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17.alpha.-valerate

111. (8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-17-yl Pentanoate

112. 9-fluoro-11.beta.,21-dihydroxy-16.beta.-methyl-3,20-dioxopregna-1,4-dien-17-yl Pentanoate #

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 476.6 g/mol
Molecular Formula C27H37FO6
XLogP33.6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass476.25741706 g/mol
Monoisotopic Mass476.25741706 g/mol
Topological Polar Surface Area101 Ų
Heavy Atom Count34
Formal Charge0
Complexity957
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameBetamethasone valerate
PubMed HealthBetamethasone Valerate (On the skin)
Drug ClassesCorticosteroid, Intermediate
Drug LabelLuxq Foam contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents.Betamethasone valerate is 9-...
Active IngredientBetamethasone valerate
Dosage FormLotion; Ointment; Cream; Aerosol, foam
RouteTopical
Strength0.12%; eq 0.1% base
Market StatusPrescription
CompanySti Pharma; Actavis Mid Atlantic; Perrigo; Fougera

2 of 2  
Drug NameBetamethasone valerate
PubMed HealthBetamethasone Valerate (On the skin)
Drug ClassesCorticosteroid, Intermediate
Drug LabelLuxq Foam contains betamethasone valerate, USP, a synthetic corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory agents.Betamethasone valerate is 9-...
Active IngredientBetamethasone valerate
Dosage FormLotion; Ointment; Cream; Aerosol, foam
RouteTopical
Strength0.12%; eq 0.1% base
Market StatusPrescription
CompanySti Pharma; Actavis Mid Atlantic; Perrigo; Fougera

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


Glucocorticoids

A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

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BRASIL SUL 1660,BATISTA, ANAOPOLIS-GO;BRAZILSDNF Brazil","customerAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"BETAMETHASONE VALERATE MICRONIZED - (QTY 366 G)","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"FARMABIOS S P A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ALEMBIC PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"0.37","actualQuantity":"0.366","unit":"KGS","unitRateFc":"5000","totalValueFC":"1851","currency":"USD","unitRateINR":"422750","date":"22-Jul-2024","totalValueINR":"154726.5","totalValueInUsd":"1851","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"4647077","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA PAVIA 1, 27027GROPELLO CAIROLI (PV)SDNF IT","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723141800,"product":"BETAMETHASONE VALERATE (IP STANDARD)","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"AURISCO PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"820","totalValueFC":"165410.6","currency":"USD","unitRateINR":"69372","date":"09-Aug-2024","totalValueINR":"13874400","totalValueInUsd":"165410.6","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"4959589","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BADU INDUSTRIAL PARK ZONE, TIANTAI,ZHEJIANG PROVINCE 317200 P.R.CHINASDNF China","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"BETAMETHASONE VALERATE (IP STANDARD)","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"AURISCO PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"820","totalValueFC":"165899.4","currency":"USD","unitRateINR":"69577","date":"26-Aug-2024","totalValueINR":"13915400","totalValueInUsd":"165899.4","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"5253764","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BADU INDUSTRIAL PARK ZONE, TIANTAI,ZHEJIANG PROVINCE 317200 P.R.CHINASDNF China","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"BETAMETHASONE VALERATE(RE-IMPORT)(SB NO. 4618682 DT.13.10.2023)","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,","city":"BOMBAY ,MAHARASHTRA","supplier":"FAREVA VILLA RICA SAS","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"ANUH PHARMA LTD","customerCountry":"INDIA","quantity":"3.92","actualQuantity":"3.924","unit":"KGS","unitRateFc":"1400","totalValueFC":"6734.1","currency":"USD","unitRateINR":"143945.6","date":"31-Aug-2024","totalValueINR":"564842.46","totalValueInUsd":"6734.1","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"5348368","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOGOTA","supplierAddress":"KM 43 VIA PANAMERICANA CALI POPAYAN-VILLA RICA 77041-0000 CAUCA,COLUMBIA Colombia","customerAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736447400,"product":"BETAMETHASONE VALERATE (IP STANDARD) BETAMETHASONE VALERATE (IP STANDARD)","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"AURISCO PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"120.00","actualQuantity":"120","unit":"KGS","unitRateFc":"780","totalValueFC":"94002.5","currency":"USD","unitRateINR":"67548","date":"10-Jan-2025","totalValueINR":"8105760","totalValueInUsd":"94002.5","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"7713022","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BADU INDUSTRIAL PARK ZONE, TIANTAI, ZHEJIANG PROVINCE 317200 P.R.CHINA SDNF China","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741372200,"product":"BETAMETHASONE VALERATE USP ( MICRONIZED) BETAMETHASONE VALERATE USP ( MICRONIZED)","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"FARMABIOS S P A","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ALEMBIC PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.55","actualQuantity":"2548","unit":"GMS","unitRateFc":"5","totalValueFC":"12913.9","currency":"USD","unitRateINR":"439","date":"08-Mar-2025","totalValueINR":"1118572","totalValueInUsd":"12913.9","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"8785954","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN","supplierAddress":"SOCIETA CON SOCIO-UNICO VIA PAVIA12 7027 GROPELLO CAIROLI(PV)ITALY SDNF ITALY","customerAddress":"ALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746815400,"product":"BETAMETHASONE VALERATE MICRONIZED BETAMETHASONE VALERATE MICRONIZED","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"FARMABIOS S P A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ENCUBE ETHICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"2600","totalValueFC":"5221.3","currency":"USD","unitRateINR":"222430","date":"10-May-2025","totalValueINR":"444860","totalValueInUsd":"5221.3","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"9992241","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA PAVIA - 1 27027,GROPELLO CAIROLI (PV SDNF IT","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"}]
03-Jan-2022
30-Jun-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CREAM;TOPICAL - EQ 0.1% BASE

USFDA APPLICATION NUMBER - 18861

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DOSAGE - OINTMENT;TOPICAL - EQ 0.1% BASE

USFDA APPLICATION NUMBER - 18865

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DOSAGE - LOTION;TOPICAL - EQ 0.1% BASE

USFDA APPLICATION NUMBER - 18866

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DOSAGE - AEROSOL, FOAM;TOPICAL - 0.12% **Fede...DOSAGE - AEROSOL, FOAM;TOPICAL - 0.12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20934

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ABOUT THIS PAGE

Looking for 2152-44-5 / Betamethasone Valerate API manufacturers, exporters & distributors?

Betamethasone Valerate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Betamethasone Valerate 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 Betamethasone Valerate manufacturer or Betamethasone Valerate supplier for your needs.

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

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

API | Excipient name

Betamethasone Valerate

Synonyms

Betamethasone 17-valerate, 2152-44-5, Betnovate, Betaderm, Luxiq, Beta-val

Cas Number

2152-44-5

Unique Ingredient Identifier (UNII)

9IFA5XM7R2

About Betamethasone Valerate

The 17-valerate derivative of BETAMETHASONE. It has substantial topical anti-inflammatory activity and relatively low systemic anti-inflammatory activity.

BETADERM Manufacturers

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

BETADERM Suppliers

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

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

BETADERM USDMF

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

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

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

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

BETADERM KDMF

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

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

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

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

BETADERM CEP

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

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

BETADERM WC

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

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

BETADERM 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 BETADERM as an active pharmaceutical ingredient (API).

Finished drug products

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

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

BETADERM GMP

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

BETADERM CoA

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

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

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