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Chemistry

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Also known as: Diprolene, Diprosone, 5593-20-4, Maxivate, Diprolene af, Alphatrex
Molecular Formula
C28H37FO7
Molecular Weight
504.6  g/mol
InChI Key
CIWBQSYVNNPZIQ-XYWKZLDCSA-N
FDA UNII
826Y60901U

Betamethasone Dipropionate
Betamethasone Dipropionate is the 17,21-dipropionate ester of betamethasone, a synthetic glucocorticoid with metabolic, immunosuppressive and anti-inflammatory actions. Betamethasone dipropionate binds to specific intracellular glucocorticoid receptors and subsequently binds to DNA to modify gene expression. The synthesis of certain anti-inflammatory proteins is induced while the synthesis of certain inflammatory mediators is inhibited. As a result, there is an overall reduction in chronic inflammation and autoimmune reactions.
1 2D Structure

Betamethasone Dipropionate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate
2.1.2 InChI
InChI=1S/C28H37FO7/c1-6-23(33)35-15-22(32)28(36-24(34)7-2)16(3)12-20-19-9-8-17-13-18(30)10-11-25(17,4)27(19,29)21(31)14-26(20,28)5/h10-11,13,16,19-21,31H,6-9,12,14-15H2,1-5H3/t16-,19-,20-,21-,25-,26-,27-,28-/m0/s1
2.1.3 InChI Key
CIWBQSYVNNPZIQ-XYWKZLDCSA-N
2.1.4 Canonical SMILES
CCC(=O)OCC(=O)C1(C(CC2C1(CC(C3(C2CCC4=CC(=O)C=CC43C)F)O)C)C)OC(=O)CC
2.1.5 Isomeric SMILES
CCC(=O)OCC(=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)OC(=O)CC
2.2 Other Identifiers
2.2.1 UNII
826Y60901U
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Augmented Betamethasone Dipropionate

2. Beloderm

3. Betamethasone Propionate

4. Betamethasone-17,21-dipropionate

5. Diprolene

6. Diprosone

7. Maxivate

2.3.2 Depositor-Supplied Synonyms

1. Diprolene

2. Diprosone

3. 5593-20-4

4. Maxivate

5. Diprolene Af

6. Alphatrex

7. Diproderm

8. Psorion

9. Betamethasone 17,21-dipropionate

10. Rinderon Dp

11. Diprosis

12. Diprospan

13. Sch 11460

14. Sch-11460

15. S-3440

16. Betamethasone (as Dipropionate)

17. Betamethasone-17,21-dipropionate

18. Chebi:31276

19. Nsc-758415

20. Pregna-1,4-diene-3,20-dione,9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11b,16b)-

21. Beta-methasone 17,21-dipropionate

22. 826y60901u

23. [2-[(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Propanoate

24. (11-beta,16-beta)-9-chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione

25. 9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl Dipropanoate

26. 9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

27. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate

28. Einecs 227-005-2

29. Brn 3638108

30. .beta.-methasone 17,21-dipropionate

31. Betamethasone Dipropionate (diprolene)

32. S 3440

33. Diprolene (tn)

34. Unii-826y60901u

35. Ncgc00159360-02

36. Ncgc00159443-02

37. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)-

38. Sernivo (tn)

39. Rinderon-dp (tn)

40. Betamethasone Dipropionate [usan:usp:jan]

41. Betamethasone-dipropionate

42. Dsstox_cid_2672

43. Betamethasone Diprop

44. Schembl7519

45. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

46. Dsstox_rid_76683

47. Dsstox_gsid_22672

48. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-di(propionate)

49. Betamethasone-17,21-dipropionate 100 Microg/ml In Acetonitrile

50. Chembl1200384

51. Dtxsid2022672

52. Component Of Betasone (salt/mix)

53. Component Of Alphatrex (salt/mix)

54. Amy22130

55. Zinc4212137

56. Tox21_113343

57. Bdbm50421892

58. S1688

59. Akos015969733

60. Betamethasone Dipropionate (jp17/usp)

61. Ccg-269732

62. Cs-7549

63. Ks-5303

64. Nsc 758415

65. Betamethasone Dipropionate [jan]

66. Betamethasone Dipropionate [usan]

67. Ncgc00159443-01

68. Ncgc00159443-05

69. (11beta,16beta)-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl Dipropanoate

70. 2-((2s,10s,11s,13s,15s,17s,1r,14r)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxo -14-propanoyloxytetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-o Xoethyl Propanoate

71. Betamethasone Dipropionate [mart.]

72. Betamethasone Dipropionate [vandf]

73. Hy-13571

74. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 17,21-dipropionate

75. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)

76. Betamethasone Dipropionate [usp-rs]

77. Betamethasone Dipropionate [who-dd]

78. Cas-5593-20-4

79. Betamethasone Dipropionate, Augmented

80. B3166

81. Betamethasone 17,21-dipropionate [mi]

82. Betamethasone Dipropionate [green Book]

83. Betamethasone Dipropionate [orange Book]

84. D01637

85. Ab01274713-01

86. Ab01274713_02

87. Betamethasone 17.alpha.,21-dipropionate

88. Betamethasone Dipropionate [ep Monograph]

89. Betamethasone Dipropionate [usp Monograph]

90. Wynzora Component Betamethasone Dipropionate

91. Enstilar Component Betamethasone Dipropionate

92. Lotrisone Component Betamethasone Dipropionate

93. Q4897349

94. Taclonex Component Betamethasone Dipropionate

95. Betamethasone Dipropionate Component Of Enstilar

96. Betamethasone Dipropionate Component Of Taclonex

97. Betamethasone Dipropionate Component Of Wynzora

98. Brd-k58148589-001-03-6

99. Leo-90100 Component Betamethasone Dipropionate

100. Betamethasone Dipropionate Component Of Lotrisone

101. Betamethasone Dipropionate Component Of Leo-90100

102. Betamethasone-17,21-dipropionate 100 Microg/ml In Methanol

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

104. 9-fluoro-11.beta.-hydroxy-16.beta.-methyl-3,20-dioxo-17-(propionyloxy)pregna-1,4-dien-21-yl Propionate #

105. 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17,21-dipropionate

106. 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene- 17,21-diyl Dipropionate

107. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methyl-,17,21-dipropionate

108. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 504.6 g/mol
Molecular Formula C28H37FO7
XLogP33.6
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count8
Rotatable Bond Count8
Exact Mass504.25233168 g/mol
Monoisotopic Mass504.25233168 g/mol
Topological Polar Surface Area107 Ų
Heavy Atom Count36
Formal Charge0
Complexity1050
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 6  
Drug NameBetamethasone dipropionate
PubMed HealthBetamethasone Dipropionate (On the skin)
Drug ClassesCorticosteroid, Strong
Drug LabelBetamethasone Dipropionate Lotion USP 0.05% (Augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a sli...
Active IngredientBetamethasone dipropionate
Dosage FormLotion; Ointment, augmented; Ointment; Lotion, augmented; Cream; Cream, augmented; Gel, augmented
RouteTopical
Strengtheq 0.05% base
Market StatusPrescription
CompanyGlenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Teva; Perrigo New York; Taro; Fougera; Tolmar

2 of 6  
Drug NameDiprolene
PubMed HealthBetamethasone Dipropionate, Augmented (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelDIPROLENE (augmented betamethasone dipropionate) Ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a...
Active IngredientBetamethasone dipropionate
Dosage FormOintment, augmented; Lotion, augmented
RouteTopical
Strengtheq 0.05% base
Market StatusPrescription
CompanyMerck Sharp Dohme

3 of 6  
Drug NameDiprolene af
PubMed HealthBetamethasone Dipropionate, Augmented (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelDIPROLENE AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degre...
Active IngredientBetamethasone dipropionate
Dosage FormCream, augmented
RouteTopical
Strengtheq 0.05% base
Market StatusPrescription
CompanyMerck Sharp Dohme

4 of 6  
Drug NameBetamethasone dipropionate
PubMed HealthBetamethasone Dipropionate (On the skin)
Drug ClassesCorticosteroid, Strong
Drug LabelBetamethasone Dipropionate Lotion USP 0.05% (Augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a sli...
Active IngredientBetamethasone dipropionate
Dosage FormLotion; Ointment, augmented; Ointment; Lotion, augmented; Cream; Cream, augmented; Gel, augmented
RouteTopical
Strengtheq 0.05% base
Market StatusPrescription
CompanyGlenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Teva; Perrigo New York; Taro; Fougera; Tolmar

5 of 6  
Drug NameDiprolene
PubMed HealthBetamethasone Dipropionate, Augmented (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelDIPROLENE (augmented betamethasone dipropionate) Ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a...
Active IngredientBetamethasone dipropionate
Dosage FormOintment, augmented; Lotion, augmented
RouteTopical
Strengtheq 0.05% base
Market StatusPrescription
CompanyMerck Sharp Dohme

6 of 6  
Drug NameDiprolene af
PubMed HealthBetamethasone Dipropionate, Augmented (On the skin)
Drug ClassesCorticosteroid, Very Strong
Drug LabelDIPROLENE AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degre...
Active IngredientBetamethasone dipropionate
Dosage FormCream, augmented
RouteTopical
Strengtheq 0.05% base
Market StatusPrescription
CompanyMerck Sharp Dohme

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.)


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

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MALPENSA","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"7500","totalValueFC":"3755.9","currency":"USD","unitRateINR":"653250","date":"06-Feb-2025","totalValueINR":"326625","totalValueInUsd":"3755.9","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"8210050","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIET HEINKADE 55 1019 GM AMSTEDRAM SDNF NL","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738866600,"product":"BETAMETHASONE DIPROPIONATE MICRONIZED BETAMETHASONE DIPROPIONATE MICRONIZED","address":"UNIT NO.24 STEEL MADE INDL.ESTATE","city":"MUMBAI","supplier":"AXPLORA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.29","actualQuantity":"0.29","unit":"KGS","unitRateFc":"6000","totalValueFC":"1768.7","currency":"USD","unitRateINR":"530400","date":"07-Feb-2025","totalValueINR":"153816","totalValueInUsd":"1768.7","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"8234280","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIA PAVIA, 1 GROPELLO CAIROLI PV SDNF IT","customerAddress":"UNIT NO.24 STEEL MADE INDL.ESTATE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739730600,"product":"BETAMETHASONE DIPROPIONATE USP BETAMETHASONE DIPROPIONATE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"AXPLORA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"5000","totalValueFC":"10165.1","currency":"USD","unitRateINR":"442000","date":"17-Feb-2025","totalValueINR":"884000","totalValueInUsd":"10165.1","indian_port":"Bombay Air","hs_no":"29372200","bill_no":"8399777","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA PAVIA 1- 27027 GROPELLO CAIROLI (PV) CAIROLI, , Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742149800,"product":"BETAMETHASONE DIPROPIONATE MICR. LOT: 5433MO00222. CAT: 75433MO. NDC NO: 53183-0433-1BETAMETHASONE DIPROPIONATE MICR. LOT: 5433MO00222. CAT: 7543","address":"1003-GIDC,","city":"DIST.SURENDRANAGAR\/GUJARAT","supplier":"TEVA PHARMACEUTICAL INDUSTRIES","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"MEPRO PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"4492","totalValueFC":"227.7","currency":"USD","unitRateINR":"394397.6","date":"17-Mar-2025","totalValueINR":"19719.88","totalValueInUsd":"227.7","indian_port":"Ahmedabad Air","hs_no":"29372200","bill_no":"8929364","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"MILAN - MALPENSA","supplierAddress":"SEDE LEGALE: PIAZZALE L. CADORNA 4, 20123 MILANO, IT SDNF ITALY","customerAddress":"1003-GIDC,"}]
02-Jan-2021
28-Mar-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - OINTMENT, AUGMENTED;TOPICAL - EQ 0.0...DOSAGE - OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE

USFDA APPLICATION NUMBER - 18741

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DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **F...DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18827

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DOSAGE - CREAM;TOPICAL - EQ 0.05% BASE

USFDA APPLICATION NUMBER - 19137

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DOSAGE - OINTMENT;TOPICAL - EQ 0.05% BASE

USFDA APPLICATION NUMBER - 19141

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DOSAGE - CREAM, AUGMENTED;TOPICAL - EQ 0.05% ...DOSAGE - CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19555

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DOSAGE - LOTION, AUGMENTED;TOPICAL - EQ 0.05%...DOSAGE - LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19716

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DOSAGE - OINTMENT;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 21852

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DOSAGE - SUSPENSION;TOPICAL - 0.064%;0.005%

USFDA APPLICATION NUMBER - 22185

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ABOUT THIS PAGE

Looking for 5593-20-4 / Betamethasone Dipropionate API manufacturers, exporters & distributors?

Betamethasone Dipropionate manufacturers, exporters & distributors 1

14

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

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

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

API | Excipient name

Betamethasone Dipropionate

Synonyms

Diprolene, Diprosone, 5593-20-4, Maxivate, Diprolene af, Alphatrex

Cas Number

5593-20-4

Unique Ingredient Identifier (UNII)

826Y60901U

About Betamethasone Dipropionate

Betamethasone Dipropionate is the 17,21-dipropionate ester of betamethasone, a synthetic glucocorticoid with metabolic, immunosuppressive and anti-inflammatory actions. Betamethasone dipropionate binds to specific intracellular glucocorticoid receptors and subsequently binds to DNA to modify gene expression. The synthesis of certain anti-inflammatory proteins is induced while the synthesis of certain inflammatory mediators is inhibited. As a result, there is an overall reduction in chronic inflammation and autoimmune reactions.

TACLONEX Manufacturers

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

TACLONEX Suppliers

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

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

TACLONEX USDMF

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

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

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

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

TACLONEX KDMF

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

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

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

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

TACLONEX CEP

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

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

TACLONEX WC

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

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

TACLONEX 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 TACLONEX as an active pharmaceutical ingredient (API).

Finished drug products

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

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

TACLONEX GMP

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

TACLONEX CoA

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

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

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