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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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GDUFA

DMF Review : Complete

Rev. Date : 2013-09-10

Pay. Date : 2013-08-30

DMF Number : 13787

Submission : 1998-09-01

Status : Active

Type : II

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Pfizer Inc

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DMF Number : 14260

Submission : 1995-07-03

Status : Inactive

Type : II

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Shenzhen

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Status : Inactive

Type : II

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About the Company : HANGZHOU THINK CHEMICAL CO., LTD. (THINKCHEM) is an integrative corporation of trade, research and contract manufacture. With about ten years of business experiences on the marketi...

HANGZHOU THINK CHEMICAL CO., LTD. (THINKCHEM) is an integrative corporation of trade, research and contract manufacture. With about ten years of business experiences on the marketing & distribution, Thinkchem specializes in exporting pharmaceuticals, veterinary drugs, feed additives, intermediates, fine chemicals, plants extracts, pesticides, food & nutrition additives. Thinkchem is good at offering excellent outsourcing services to overseas customers as well as laboratory support. Thinkchem is equipped with modern lab apparatus including HPLC, GC. TLC AND NMR, motivated by a team of highly qualified personnel using these equipments.
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HENGDIAN GROUP was established in 1975, till now it has become a transnational,conglomerate group and been one of the largest private-owned enterprises in China. The Pharmaceutical & Chemical division has 3 sub-companies with over 3,000 employees of which over 30% are technicians; This division is mainly producing APIs, Agrochemical and Dyestuffs with related intermediates as well as other special chemicals. The group also focuses on CONTRACT MANUFACTURE service under GMP and confidential agreement with our clients.
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About the Company : Zhejiang Hisoar Pharmaceutical Co., Ltd. is located in Taizhou, Zhejiang. It is an IPO-listed company held by the DanKong Group, which mainly manufactures APIs, Formulations, Fine ...

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API Reference Price

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25-Jan-2021
14-Feb-2025
KGS
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DOSAGE - CAPSULE;ORAL - EQ 150MG BASE

USFDA APPLICATION NUMBER - 50162

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USFDA APPLICATION NUMBER - 50162

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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.

Clindamycin Hcl Manufacturers

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

Clindamycin Hcl Suppliers

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

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

Clindamycin Hcl USDMF

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

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

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

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

Clindamycin Hcl KDMF

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

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

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

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

Clindamycin Hcl CEP

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

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

Clindamycin Hcl WC

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

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

Clindamycin Hcl 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 Clindamycin Hcl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Clindamycin Hcl GMP

Clindamycin Hcl 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 Clindamycin Hcl 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 Clindamycin Hcl GMP manufacturer or Clindamycin Hcl GMP API supplier for your needs.

Clindamycin Hcl CoA

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

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

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