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Chemistry

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Also known as: 21462-39-5, Clindamycin hcl, Cleocin, Clinsol, Clintabs, Antirobe
Molecular Formula
C18H34Cl2N2O5S
Molecular Weight
461.4  g/mol
InChI Key
AUODDLQVRAJAJM-XJQDNNTCSA-N
FDA UNII
T20OQ1YN1W

Clindamycin Hydrochloride
An antibacterial agent that is a semisynthetic analog of LINCOMYCIN.
1 2D Structure

Clindamycin Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,4R)-N-[(1S,2S)-2-chloro-1-[(2R,3R,4S,5R,6R)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride
2.1.2 InChI
InChI=1S/C18H33ClN2O5S.ClH/c1-5-6-10-7-11(21(3)8-10)17(25)20-12(9(2)19)16-14(23)13(22)15(24)18(26-16)27-4;/h9-16,18,22-24H,5-8H2,1-4H3,(H,20,25);1H/t9-,10+,11-,12+,13-,14+,15+,16+,18+;/m0./s1
2.1.3 InChI Key
AUODDLQVRAJAJM-XJQDNNTCSA-N
2.1.4 Canonical SMILES
CCCC1CC(N(C1)C)C(=O)NC(C2C(C(C(C(O2)SC)O)O)O)C(C)Cl.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)O)O)O)[C@H](C)Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
T20OQ1YN1W
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 7 Chloro 7 Deoxylincomycin

2. 7-chloro-7-deoxylincomycin

3. Chlolincocin

4. Chlorlincocin

5. Cleocin

6. Clindamycin

7. Clindamycin Monohydrochloride

8. Clindamycin Monohydrochloride, Monohydrate

9. Dalacin C

10. Hydrochloride, Clindamycin

11. Monohydrate Clindamycin Monohydrochloride

12. Monohydrochloride, Clindamycin

13. Monohydrochloride, Monohydrate Clindamycin

2.3.2 Depositor-Supplied Synonyms

1. 21462-39-5

2. Clindamycin Hcl

3. Cleocin

4. Clinsol

5. Clintabs

6. Antirobe

7. Sobelin

8. Clindamycin (hydrochloride)

9. Dalacin C

10. T20oq1yn1w

11. Clindamycin (as Hydrochloride)

12. Nsc-756696

13. (2s,4r)-n-((1s,2s)-2-chloro-1-((2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(methylthio)tetrahydro-2h-pyran-2-yl)propyl)-1-methyl-4-propylpyrrolidine-2-carboxamide Hydrochloride

14. U-21251f

15. 21462-39-5 (hcl)

16. Benzaclin

17. Dalacin (tn)

18. Mfcd07793327

19. (2s,4r)-n-[(1s,2s)-2-chloro-1-[(2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride

20. Methyl-7-chloro-6,7,8-trideoxy-6-[[[(2s,4r)-1-methyl-4-propyl-2-pyrrolidinyl]carbonyl]amino]-1-thio-l-threo-?-d-galacto-octopyranoside Hydrochloride

21. Cleocin Hydrochloride

22. C18h33cln2o5s.hcl

23. Clinimycin Hcl

24. Antirobe Vet.

25. Cleocin Hcl

26. Sobelin Hcl

27. Ncgc00016752-01

28. Clindamycin Hcl (dalacin)

29. Unii-t20oq1yn1w

30. Cleocin Hydrochloride (tn)

31. Schembl3153

32. Cas-21462-39-5

33. Dsstox_cid_25428

34. Dsstox_rid_80872

35. Dsstox_gsid_45428

36. Chembl1200588

37. Dtxsid4045428

38. Hy-b0408a

39. Chebi:176915

40. Act02688

41. Amy33461

42. Einecs 244-398-6

43. Tox21_110591

44. Clindamycin Hydrochloride [mi]

45. Akos015843964

46. Akos015960823

47. Clindamycin Hydrochloride (jp17/usp)

48. Ccg-269349

49. Clindamycin Hydrochloride [jan]

50. Nsc 756696

51. 7-chloro-7-deoxylincomycin Hydrochloride

52. Clindamycin Hydrochloride [mart.]

53. Clindamycin Hydrochloride [vandf]

54. Ac-12179

55. As-13649

56. Clindamycin Hydrochloride [usp-rs]

57. Clindamycin Hydrochloride [usp:ban:jan]

58. Clindamycin Hydrochloride [who-dd]

59. Clindamycin Hydrochloride Anhydrous

60. U 21251f

61. 7(s)-chloro-7-deoxylincomycin Hyddrochloride

62. Clindamycin Hydrochloride [green Book]

63. Clindamycin Hydrochloride [ep Monograph]

64. Clindamycin Hydrochloride [orange Book]

65. D02132

66. Ec 244-398-6

67. Clindamycin Hydrochloride [usp Monograph]

68. Clindamycin Hydrochloride, Lincosamide Antibiotic

69. 462c395

70. A815398

71. A915128

72. Clindamycin Hydrochloride 100 Microg/ml In Methanol

73. Clindamycin Hydrochloride 1000 Microg/ml In Methanol

74. Q27289558

75. Clindamycin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

76. (2s,4r)-n-((1s,2s)-2-chloro-1-((2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-(methylthio)tetrahydro-2h-pyran-2-yl)propyl)-1-methyl-4-propylpyrrolidine-2-carboxamidehydrochloride

77. (2s,4r)-n-[(1s,2s)-2-chloro-1-[(2r,3r,4s,5r,6r)-3,4,5-trihydroxy-6-methylsulanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride

78. (4r)-n-[(1s,2s)-2-chloro-1-[(3r,4r,6r)-3,4,5-trihydroxy-6-methylsulfanyl-tetrahydropyran-2-yl]propyl]-1-methyl-4-propyl-pyrrolidine-2-carboxamide Hydrochloride;clindamycin Hydrochloride

79. (4r)-n-[(1s,2s)-2-chloro-1-[(3r,4s,5r,6r)-3,4,5-trihydroxy-6-methylsulfanyloxan-2-yl]propyl]-1-methyl-4-propylpyrrolidine-2-carboxamide;hydrochloride

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

81. 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-, Monohydrochloride

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

83. L-threo-alpha-d-galacto-octopyranoside, Methyl 7-chloro-6,7,8-trideoxy-6-(((1-methyl-4-propyl-l-2-pyrrolidinyl)carbonyl)amino)-1-thio-, Monohydrochloride, Trans-alpha-

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

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

2.4 Create Date
2007-05-07
3 Chemical and Physical Properties
Molecular Weight 461.4 g/mol
Molecular Formula C18H34Cl2N2O5S
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass460.1565488 g/mol
Monoisotopic Mass460.1565488 g/mol
Topological Polar Surface Area128 Ų
Heavy Atom Count28
Formal Charge0
Complexity502
Isotope Atom Count0
Defined Atom Stereocenter Count9
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 12  
Drug NameAcanya
PubMed HealthBenzoyl Peroxide/Clindamycin (On the skin)
Drug ClassesAntiacne, Antibacterial
Active IngredientBenzoyl peroxide; clindamycin phosphate
Dosage FormGel
RouteTopical
Strength1.2%; 2.5%
Market StatusPrescription
CompanyDow Pharm

2 of 12  
Drug NameBenzaclin
Active IngredientBenzoyl peroxide; clindamycin phosphate
Dosage FormGel
RouteTopical
Strength5%; eq 1% base
Market StatusPrescription
CompanyValeant Bermuda

3 of 12  
Drug NameCleocin
Drug LabelClindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.CLEOCIN HCl Capsules contain cl...
Active IngredientClindamycin palmitate hydrochloride; Clindamycin phosphate
Dosage FormSuppository; Swab; For solution; Cream
RouteTopical; Vaginal; Oral
Strengtheq 1% base; 100mg; eq 2% base; eq 75mg base/5ml
Market StatusPrescription
CompanyPharmacia And Upjohn

4 of 12  
Drug NameCleocin hydrochloride
PubMed HealthBenzoyl Peroxide/Clindamycin (On the skin)
Drug ClassesAntiacne, Antibacterial
Drug LabelClindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.CLEOCIN HCl Capsules contain cl...
Active IngredientClindamycin hydrochloride
Dosage FormCapsule
RouteOral
Strengtheq 300mg base; eq 150mg base; eq 75mg base
Market StatusPrescription
CompanyPharmacia And Upjohn

5 of 12  
Drug NameClindamycin hydrochloride
PubMed HealthClindamycin (Vaginal)
Drug ClassesAntibiotic
Drug LabelDESCRIPTIONClindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.The chemical name fo...
Active IngredientClindamycin hydrochloride
Dosage FormCapsule
RouteOral
Strengtheq 300mg base; eq 150mg base; eq 75mg base
Market StatusPrescription
CompanyCorepharma; Watson Labs; Mylan Pharms; Ranbaxy; Lannett; Teva; Aurobindo Pharma; Zydus Pharms Usa

6 of 12  
Drug NameDuac
Active IngredientBenzoyl peroxide; clindamycin phosphate
Dosage FormGel
RouteTopical
Strength5%; 1.2%
Market StatusPrescription
CompanyStiefel

7 of 12  
Drug NameAcanya
PubMed HealthBenzoyl Peroxide/Clindamycin (On the skin)
Drug ClassesAntiacne, Antibacterial
Active IngredientBenzoyl peroxide; clindamycin phosphate
Dosage FormGel
RouteTopical
Strength1.2%; 2.5%
Market StatusPrescription
CompanyDow Pharm

8 of 12  
Drug NameBenzaclin
Active IngredientBenzoyl peroxide; clindamycin phosphate
Dosage FormGel
RouteTopical
Strength5%; eq 1% base
Market StatusPrescription
CompanyValeant Bermuda

9 of 12  
Drug NameCleocin
Drug LabelClindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.CLEOCIN HCl Capsules contain cl...
Active IngredientClindamycin palmitate hydrochloride; Clindamycin phosphate
Dosage FormSuppository; Swab; For solution; Cream
RouteTopical; Vaginal; Oral
Strengtheq 1% base; 100mg; eq 2% base; eq 75mg base/5ml
Market StatusPrescription
CompanyPharmacia And Upjohn

10 of 12  
Drug NameCleocin hydrochloride
PubMed HealthBenzoyl Peroxide/Clindamycin (On the skin)
Drug ClassesAntiacne, Antibacterial
Drug LabelClindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.CLEOCIN HCl Capsules contain cl...
Active IngredientClindamycin hydrochloride
Dosage FormCapsule
RouteOral
Strengtheq 300mg base; eq 150mg base; eq 75mg base
Market StatusPrescription
CompanyPharmacia And Upjohn

11 of 12  
Drug NameClindamycin hydrochloride
PubMed HealthClindamycin (Vaginal)
Drug ClassesAntibiotic
Drug LabelDESCRIPTIONClindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.The chemical name fo...
Active IngredientClindamycin hydrochloride
Dosage FormCapsule
RouteOral
Strengtheq 300mg base; eq 150mg base; eq 75mg base
Market StatusPrescription
CompanyCorepharma; Watson Labs; Mylan Pharms; Ranbaxy; Lannett; Teva; Aurobindo Pharma; Zydus Pharms Usa

12 of 12  
Drug NameDuac
Active IngredientBenzoyl peroxide; clindamycin phosphate
Dosage FormGel
RouteTopical
Strength5%; 1.2%
Market StatusPrescription
CompanyStiefel

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.)


Protein Synthesis Inhibitors

Compounds which inhibit the synthesis of proteins. They are usually ANTI-BACTERIAL AGENTS or toxins. Mechanism of the action of inhibition includes the interruption of peptide-chain elongation, the blocking the A site of ribosomes, the misreading of the genetic code or the prevention of the attachment of oligosaccharide side chains to glycoproteins. (See all compounds classified as Protein Synthesis Inhibitors.)


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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CHINA China, , China China","customerAddress":"26D, GANESAPURAM,,K.PUDUR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1761503400,"product":"CLINDAMYCIN PHOSPHATE EP (FOR TESTING) TEST LICENCE NO SW\/OD\/11\/2025\/0000015392 DATE 09.09.2025CLINDAMYCIN PHOSPHATE EP","address":"A-38, NANDJYOT IND. EST","city":"MUMBAI","supplier":"HUBEI YITAI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"AGIO PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"3.50","actualQuantity":"3.5","unit":"KGS","unitRateFc":"430","totalValueFC":"1510.6","currency":"USD","unitRateINR":"38141","date":"27-Oct-2025","totalValueINR":"133493.5","totalValueInUsd":"1510.6","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"5337496","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"TIANMEN,HUBEI, 431700CHINA SDNF SDNF CHINA","customerAddress":"A-38, NANDJYOT IND. EST"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1761503400,"product":"CLINDAMYCIN HYDROCHLORIDE IP (LIST 3 SR.NO.11) CLINDAMYCIN HYDROCHLORIDE IP (LIST 3 SR.NO.11)","address":"DARABSHAW HOUSE LEVEL 1 SHOORJI","city":"MUMBAI","supplier":"SKYPHARMA LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"NHAVA SHEVA BUSINESS PARK PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"61","totalValueFC":"61227.5","currency":"USD","unitRateINR":"5410.7","date":"27-Oct-2025","totalValueINR":"5410700","totalValueInUsd":"61227.5","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29419090","bill_no":"5332166","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"291 BRIGHTON ROAD SOUTH CROYDON UN ITED KINGDOM CR2 6EQ CLIENT NAME - BEHALF OF HANGZHOU DAWN RAY PHARMA UNITED KINGDOM","customerAddress":"DARABSHAW HOUSE LEVEL 1 SHOORJI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1762540200,"product":"CLINDAMYCIN HYDROCHLORIDE IP (LIST 3 SR.NO.11) CLINDAMYCIN HYDROCHLORIDE IP (LIST 3 SR.NO.11)","address":"215, MAHINDER CHAMBERS, W.T. PATIL","city":"MUMBAI, M.S.","supplier":"HANGZHOU DAWN RAY PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"HUFORT HEALTHCARE PRIVATE LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"61","totalValueFC":"30712.4","currency":"USD","unitRateINR":"5459.5","date":"08-Nov-2025","totalValueINR":"2729750","totalValueInUsd":"30712.4","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29419090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"1613 GUANGYIN BUILDING,NO.42 E.FENGQI ROAD,HANGZHOU, SDNF CHINA","customerAddress":"215, MAHINDER CHAMBERS, W.T. PATIL"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1762799400,"product":"CLINDAMYCIN HYDROCHLORIDE USP CHEMICAL","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHINA PHARMA SHANGHAI CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"4800.00","actualQuantity":"4800","unit":"KGS","unitRateFc":"95","totalValueFC":"459175.8","currency":"USD","unitRateINR":"8502.5","date":"11-Nov-2025","totalValueINR":"40812000","totalValueInUsd":"459175.8","indian_port":"Madras Sea","hs_no":"29419019","bill_no":"4846","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE 402 NO 110 ZHAOHUA ROAD CHA NGNIN G DISTRICT SHANGHAI CHINA SDNF CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1762799400,"product":"CLINDAMYCIN HYDROCHLORIDE IP. 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01-Jan-2022
29-Nov-2025
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DOSAGE - CAPSULE;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 50162

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DOSAGE - CAPSULE;ORAL - EQ 300MG BASE

USFDA APPLICATION NUMBER - 50162

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DOSAGE - CAPSULE;ORAL - EQ 75MG BASE

USFDA APPLICATION NUMBER - 50162

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ABOUT THIS PAGE

Looking for 21462-39-5 / Clindamycin Hydrochloride API manufacturers, exporters & distributors?

Clindamycin Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Clindamycin Hydrochloride

Synonyms

21462-39-5, Clindamycin hcl, Cleocin, Clinsol, Clintabs, Antirobe

Cas Number

21462-39-5

Unique Ingredient Identifier (UNII)

T20OQ1YN1W

About Clindamycin Hydrochloride

An antibacterial agent that is a semisynthetic analog of LINCOMYCIN.

Cleocin Manufacturers

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

Cleocin Suppliers

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

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

Cleocin USDMF

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

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

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

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

Cleocin KDMF

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

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

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

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

Cleocin CEP

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

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

Cleocin WC

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

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

Cleocin 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 Cleocin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cleocin GMP

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

Cleocin CoA

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

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

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