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Chemistry

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Also known as: 24729-96-2, Cleocin phosphate, Clindamycin 2-phosphate, Clindets, Cleocin t, Clindagel
Molecular Formula
C18H34ClN2O8PS
Molecular Weight
505.0  g/mol
InChI Key
UFUVLHLTWXBHGZ-MGZQPHGTSA-N
FDA UNII
EH6D7113I8

Clindamycin Phosphate
Clindamycin Phosphate is the phosphate salt form of clindamycin, a semi-synthetic, chlorinated broad spectrum antibiotic produced by chemical modification of lincomycin. Clindamycin phosphate is used in topical preparations.
1 2D Structure

Clindamycin Phosphate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2R,3R,4S,5R,6R)-6-[(1S,2S)-2-chloro-1-[[(2S,4R)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] dihydrogen phosphate
2.1.2 InChI
InChI=1S/C18H34ClN2O8PS/c1-5-6-10-7-11(21(3)8-10)17(24)20-12(9(2)19)15-13(22)14(23)16(18(28-15)31-4)29-30(25,26)27/h9-16,18,22-23H,5-8H2,1-4H3,(H,20,24)(H2,25,26,27)/t9-,10+,11-,12+,13+,14-,15+,16+,18+/m0/s1
2.1.3 InChI Key
UFUVLHLTWXBHGZ-MGZQPHGTSA-N
2.1.4 Canonical SMILES
CCCC1CC(N(C1)C)C(=O)NC(C2C(C(C(C(O2)SC)OP(=O)(O)O)O)O)C(C)Cl
2.1.5 Isomeric SMILES
CCC[C@@H]1C[C@H](N(C1)C)C(=O)N[C@@H]([C@@H]2[C@@H]([C@@H]([C@H]([C@H](O2)SC)OP(=O)(O)O)O)O)[C@H](C)Cl
2.2 Other Identifiers
2.2.1 UNII
EH6D7113I8
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cleocin Phosphate

2. Clindamycin-2-phosphate

3. Clindesse

4. Clindets

2.3.2 Depositor-Supplied Synonyms

1. 24729-96-2

2. Cleocin Phosphate

3. Clindamycin 2-phosphate

4. Clindets

5. Cleocin T

6. Clindagel

7. Clindesse

8. Evoclin

9. Clinda-derm

10. Dalacin P

11. Clindamycin-2-phosphate

12. Clindamycin 2-dihydrogen Phosphate

13. Clindamycin (phosphate)

14. Dalacin T

15. 7(s)-chloro-7-deoxylincomycin 2-phosphate

16. U 28508

17. U-28508

18. U-28,508

19. Eh6d7113i8

20. Nsc 618653

21. Nsc-618653

22. Dsstox_cid_28603

23. Dsstox_rid_82873

24. Dsstox_gsid_48677

25. [(2r,3r,4s,5r,6r)-6-[(1s,2s)-2-chloro-1-[[(2s,4r)-1-methyl-4-propylpyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyloxan-3-yl] Dihydrogen Phosphate

26. Clindamax

27. Evoclin (tn)

28. Dalacin-s (tn)

29. Clindamycin Injection

30. Cas-24729-96-2

31. Einecs 246-433-0

32. Clindamycin Phosphate Hydrate [jan]

33. Clindamycin Dihydrogenphosphat

34. Clinadac

35. Unii-eh6d7113i8

36. Clindamycin Phosphate Hydrate

37. Clindamycin Phosphate In Dextrose 5%

38. Clindamycin-2-dihydrogenphosphat

39. Ncgc00163494-01

40. Ncgc00166320-01

41. Clindamycin-phosphate

42. Clindac

43. Xaciato

44. Clindamycin Phosphate [usan:usp:jan]

45. Cleocin Phosphate In Dextrose 5% In Plastic Container

46. Clindamycin Phosphate In Dextrose 5% In Plastic Container

47. Schembl37148

48. Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo-alpha-d-galacto-octopyranoside 2-(dihydrogen Phosphate)

49. Chembl3184512

50. Dtxsid1048677

51. Bdbm241975

52. Clindamycin (as Phosphate)

53. Clindamycin Phosphate (jp17/usp)

54. Clindamycin Phosphate [jan]

55. Hy-b1064

56. Zinc4102185

57. Clindamycin Phosphate [usan]

58. Tox21_113055

59. Tox21_113410

60. Clindamycin Phosphate (u-28508e)

61. Clindamycin Phosphate [vandf]

62. Mfcd11982855

63. S2048

64. Clindamycin Phosphate [mart.]

65. Akos008901431

66. Clindamycin Phosphate [usp-rs]

67. Clindamycin Phosphate [who-dd]

68. Clindamycin Phosphate [who-ip]

69. Ccg-269736

70. Clindamycin Phosphate System Suitability

71. Cs-4620

72. Ncgc00386379-01

73. As-12554

74. L-threo-alpha-d-galacto-octapyranoside, Methyl 7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen Phosphate), (2s-trans)-

75. Methyl (2s-trans)-7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-l-threo-alpha-d-galacto-octopyranoside, 2-(dihydrogen Phosphate)

76. Clindamycin Phosphate [orange Book]

77. Duac Component Clindamycin Phosphate

78. Clindamycin Phosphate [ep Monograph]

79. Clindamycin Phosphate For System Suitability

80. Ziana Component Clindamycin Phosphate

81. Acanya Component Clindamycin Phosphate

82. Clindamycin Phosphate [usp Monograph]

83. Clindamycini Phosphas [who-ip Latin]

84. Veltin Component Clindamycin Phosphate

85. Clindamycin Phosphate Component Of Duac

86. Benzaclin Component Clindamycin Phosphate

87. Clindamycin 2-dihydrogen Phosphate [mi]

88. Clindamycin Phosphate Component Of Ziana

89. D01073

90. Idp-126 Component Clindamycin Phosphate

91. Ab01566857_01

92. Clindamycin Phosphate Component Of Acanya

93. Clindamycin Phosphate Component Of Veltin

94. A817470

95. Clindamycin Phosphate Component Of Benzaclin

96. Sr-01000872581

97. Sr-01000872581-1

98. Brd-k27771035-001-02-5

99. Q27106184

100. Clindamycin Phosphate System Suitability [usp-rs]

101. (2r,3r,4s,5r,6r)-6-((1s,2s)-2-chloro-1-((2s,4r)-1-methyl-4-propylpyrrolidine-2-carboxamido)propyl)-4,5-dihydroxy-2-(methylthio)tetrahydro-2h-pyran-3-yl Dihydrogen Phosphate

102. (2r,3r,4s,5r,6r)-6-((1s,2s)-2-chloro-1-((2s,4r)-1-methyl-4-propylpyrrolidine-2-carboxamido)propyl)-4,5-dihydroxy-2-(methylthio)tetrahydro-2h-pyran-3-yldihydrogenphosphate

103. (2s-trans)-methyl 7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1-thio-l-threo-.alpha.-d-galacto-octopyranoside 2-(dihydrogen Phosphate)

104. [(2r,3r,4s,5r,6r)-6-[(1s,2s)-2-chloro-1-[[(2s,4r)-1-methyl-4-propyl-pyrrolidine-2-carbonyl]amino]propyl]-4,5-dihydroxy-2-methylsulfanyl-tetrahydropyran-3-yl] Dihydrogen Phosphate

105. [(2r,4r,5r)-6-[(2s)-2-chloro-1-[[[(2s,4r)-1-methyl-4-propyl-2-pyrrolidinyl]-oxomethyl]amino]propyl]-4,5-dihydroxy-2-(methylthio)-3-oxanyl] Dihydrogen Phosphate

106. L-threo-.alpha.-d-galacto-octopyranoside, Methyl 7-chloro-6,7,8-trideoxy-6-((((2s,4r)-1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen Phosphate)

107. L-threo-.alpha.-d-galacto-octopyranoside, Methyl 7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen Phosphate), (2s-trans)-

108. Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-l-2-pyrrolidinecarboxamido)-1-thio-l-threo-.alpha.-d-galacto-octopyranoside 2-(dihydrogen Phosphate)

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 505.0 g/mol
Molecular Formula C18H34ClN2O8PS
XLogP3-1.2
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count10
Rotatable Bond Count9
Exact Mass504.1462019 g/mol
Monoisotopic Mass504.1462019 g/mol
Topological Polar Surface Area174 Ų
Heavy Atom Count31
Formal Charge0
Complexity658
Isotope Atom Count0
Defined Atom Stereocenter Count9
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 12  
Drug NameCleocin phosphate
Drug LabelCLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as p...
Active IngredientClindamycin phosphate
Dosage FormInjectable
RouteInjection
Strengtheq 150mg base/ml
Market StatusPrescription
CompanyPharmacia And Upjohn

2 of 12  
Drug NameCleocin t
Active IngredientClindamycin phosphate
Dosage FormGel; Lotion; Solution
RouteTopical
Strengtheq 1% base
Market StatusPrescription
CompanyPharmacia And Upjohn

3 of 12  
Drug NameClindagel
Drug LabelClindagel (clindamycin phosphate gel) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene g...
Active IngredientClindamycin phosphate
Dosage FormGel
RouteTopical
Strengtheq 1% base
Market StatusPrescription
CompanyPrecision Dermat

4 of 12  
Drug NameClindamycin phosphate
PubMed HealthClindamycin (Injection)
Drug ClassesAntibiotic, Antimalarial
Drug LabelClindamycin Injection, USP, a water soluble ester of clindamycin and phosphoric acid, is a sterile solution for intramuscular or intravenous use.May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 6.5 range 5.5to 7.0.Clin...
Active IngredientClindamycin phosphate
Dosage FormLotion; Gel; Swab; Injectable; Cream; Aerosol, foam; Solution
RouteTopical; Injection; Vaginal
Strengtheq 1% base; 1%; eq 150mg base/ml; eq 2% base
Market StatusPrescription
CompanyWockhardt; Sagent Strides; Bedford; Fougera Pharms; Fresenius Kabi Usa; Hospira; Hikma Maple; Versapharm; Perrigo Uk Finco; Perrigo New York; Taro Pharm Inds; Fougera; G And W Labs

5 of 12  
Drug NameClindesse
Drug LabelCLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to...
Active IngredientClindamycin phosphate
Dosage FormCream
RouteVaginal
Strengtheq 2% base
Market StatusPrescription
CompanyLumara Health

6 of 12  
Drug NameClindets
Drug LabelClindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is meth...
Active IngredientClindamycin phosphate
Dosage FormSwab
RouteTopical
Strengtheq 1% base
Market StatusPrescription
CompanyPerrigo

7 of 12  
Drug NameCleocin phosphate
Drug LabelCLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as p...
Active IngredientClindamycin phosphate
Dosage FormInjectable
RouteInjection
Strengtheq 150mg base/ml
Market StatusPrescription
CompanyPharmacia And Upjohn

8 of 12  
Drug NameCleocin t
Active IngredientClindamycin phosphate
Dosage FormGel; Lotion; Solution
RouteTopical
Strengtheq 1% base
Market StatusPrescription
CompanyPharmacia And Upjohn

9 of 12  
Drug NameClindagel
Drug LabelClindagel (clindamycin phosphate gel) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene g...
Active IngredientClindamycin phosphate
Dosage FormGel
RouteTopical
Strengtheq 1% base
Market StatusPrescription
CompanyPrecision Dermat

10 of 12  
Drug NameClindamycin phosphate
PubMed HealthClindamycin (Injection)
Drug ClassesAntibiotic, Antimalarial
Drug LabelClindamycin Injection, USP, a water soluble ester of clindamycin and phosphoric acid, is a sterile solution for intramuscular or intravenous use.May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 6.5 range 5.5to 7.0.Clin...
Active IngredientClindamycin phosphate
Dosage FormLotion; Gel; Swab; Injectable; Cream; Aerosol, foam; Solution
RouteTopical; Injection; Vaginal
Strengtheq 1% base; 1%; eq 150mg base/ml; eq 2% base
Market StatusPrescription
CompanyWockhardt; Sagent Strides; Bedford; Fougera Pharms; Fresenius Kabi Usa; Hospira; Hikma Maple; Versapharm; Perrigo Uk Finco; Perrigo New York; Taro Pharm Inds; Fougera; G And W Labs

11 of 12  
Drug NameClindesse
Drug LabelCLEOCIN T Topical Solution and CLEOCIN T Topical Lotion contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. CLEOCIN T Topical Gel contains clindamycin phosphate, USP, at a concentration equivalent to...
Active IngredientClindamycin phosphate
Dosage FormCream
RouteVaginal
Strengtheq 2% base
Market StatusPrescription
CompanyLumara Health

12 of 12  
Drug NameClindets
Drug LabelClindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is meth...
Active IngredientClindamycin phosphate
Dosage FormSwab
RouteTopical
Strengtheq 1% base
Market StatusPrescription
CompanyPerrigo

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Lincosamide Antibacterial [EPC]; Lincosamides [CS]; Neuromuscular Blockade [PE]; Decreased Sebaceous Gland Activity [PE]

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04-Jan-2021
29-Apr-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 300MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 300MG BASE/50ML (EQ 6MG BASE/ML)

USFDA APPLICATION NUMBER - 208083

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 600MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 600MG BASE/50ML (EQ 12MG BASE/ML)

USFDA APPLICATION NUMBER - 208083

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 900MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 900MG BASE/50ML (EQ 18MG BASE/ML)

USFDA APPLICATION NUMBER - 208083

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DOSAGE - INJECTABLE;INJECTION - EQ 150MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 150MG BASE/ML

USFDA APPLICATION NUMBER - 50441

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

USFDA APPLICATION NUMBER - 50537

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DOSAGE - LOTION;TOPICAL - EQ 1% BASE

USFDA APPLICATION NUMBER - 50600

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DOSAGE - GEL;TOPICAL - EQ 1% BASE

USFDA APPLICATION NUMBER - 50615

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DOSAGE - GEL;TOPICAL - 5%;1.2%

USFDA APPLICATION NUMBER - 50741

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DOSAGE - GEL;TOPICAL - 5%;EQ 1% BASE

USFDA APPLICATION NUMBER - 50756

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DOSAGE - SUPPOSITORY;VAGINAL - 100MG

USFDA APPLICATION NUMBER - 50767

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DOSAGE - GEL;TOPICAL - EQ 1% BASE

USFDA APPLICATION NUMBER - 50782

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DOSAGE - CREAM;VAGINAL - EQ 2% BASE

USFDA APPLICATION NUMBER - 50793

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DOSAGE - AEROSOL, FOAM;TOPICAL - 1% **Federal...DOSAGE - AEROSOL, FOAM;TOPICAL - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50801

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DOSAGE - GEL;TOPICAL - 1.2%;0.025%

USFDA APPLICATION NUMBER - 50803

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ABOUT THIS PAGE

Looking for 24729-96-2 / Clindamycin Phosphate API manufacturers, exporters & distributors?

Clindamycin Phosphate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Clindamycin Phosphate 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 Clindamycin Phosphate manufacturer or Clindamycin Phosphate supplier for your needs.

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

API | Excipient name

Clindamycin Phosphate

Synonyms

24729-96-2, Cleocin phosphate, Clindamycin 2-phosphate, Clindets, Cleocin t, Clindagel

Cas Number

24729-96-2

Unique Ingredient Identifier (UNII)

EH6D7113I8

About Clindamycin Phosphate

Clindamycin Phosphate is the phosphate salt form of clindamycin, a semi-synthetic, chlorinated broad spectrum antibiotic produced by chemical modification of lincomycin. Clindamycin phosphate is used in topical preparations.

EVOCLIN Manufacturers

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

EVOCLIN Suppliers

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

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

EVOCLIN USDMF

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

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

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

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

EVOCLIN KDMF

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

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

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

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

EVOCLIN CEP

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

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

EVOCLIN WC

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

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

EVOCLIN 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 EVOCLIN as an active pharmaceutical ingredient (API).

Finished drug products

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

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

EVOCLIN GMP

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

EVOCLIN CoA

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

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

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