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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
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
| Molecular Weight | 461.4 g/mol |
|---|---|
| Molecular Formula | C18H34Cl2N2O5S |
| Hydrogen Bond Donor Count | 5 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 7 |
| Exact Mass | 460.1565488 g/mol |
| Monoisotopic Mass | 460.1565488 g/mol |
| Topological Polar Surface Area | 128 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 502 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 9 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 12 | |
|---|---|
| Drug Name | Acanya |
| PubMed Health | Benzoyl Peroxide/Clindamycin (On the skin) |
| Drug Classes | Antiacne, Antibacterial |
| Active Ingredient | Benzoyl peroxide; clindamycin phosphate |
| Dosage Form | Gel |
| Route | Topical |
| Strength | 1.2%; 2.5% |
| Market Status | Prescription |
| Company | Dow Pharm |
| 2 of 12 | |
|---|---|
| Drug Name | Benzaclin |
| Active Ingredient | Benzoyl peroxide; clindamycin phosphate |
| Dosage Form | Gel |
| Route | Topical |
| Strength | 5%; eq 1% base |
| Market Status | Prescription |
| Company | Valeant Bermuda |
| 3 of 12 | |
|---|---|
| Drug Name | Cleocin |
| Drug Label | Clindamycin 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 Ingredient | Clindamycin palmitate hydrochloride; Clindamycin phosphate |
| Dosage Form | Suppository; Swab; For solution; Cream |
| Route | Topical; Vaginal; Oral |
| Strength | eq 1% base; 100mg; eq 2% base; eq 75mg base/5ml |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
| 4 of 12 | |
|---|---|
| Drug Name | Cleocin hydrochloride |
| PubMed Health | Benzoyl Peroxide/Clindamycin (On the skin) |
| Drug Classes | Antiacne, Antibacterial |
| Drug Label | Clindamycin 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 Ingredient | Clindamycin hydrochloride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 300mg base; eq 150mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
| 5 of 12 | |
|---|---|
| Drug Name | Clindamycin hydrochloride |
| PubMed Health | Clindamycin (Vaginal) |
| Drug Classes | Antibiotic |
| Drug Label | DESCRIPTIONClindamycin 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 Ingredient | Clindamycin hydrochloride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 300mg base; eq 150mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Corepharma; Watson Labs; Mylan Pharms; Ranbaxy; Lannett; Teva; Aurobindo Pharma; Zydus Pharms Usa |
| 6 of 12 | |
|---|---|
| Drug Name | Duac |
| Active Ingredient | Benzoyl peroxide; clindamycin phosphate |
| Dosage Form | Gel |
| Route | Topical |
| Strength | 5%; 1.2% |
| Market Status | Prescription |
| Company | Stiefel |
| 7 of 12 | |
|---|---|
| Drug Name | Acanya |
| PubMed Health | Benzoyl Peroxide/Clindamycin (On the skin) |
| Drug Classes | Antiacne, Antibacterial |
| Active Ingredient | Benzoyl peroxide; clindamycin phosphate |
| Dosage Form | Gel |
| Route | Topical |
| Strength | 1.2%; 2.5% |
| Market Status | Prescription |
| Company | Dow Pharm |
| 8 of 12 | |
|---|---|
| Drug Name | Benzaclin |
| Active Ingredient | Benzoyl peroxide; clindamycin phosphate |
| Dosage Form | Gel |
| Route | Topical |
| Strength | 5%; eq 1% base |
| Market Status | Prescription |
| Company | Valeant Bermuda |
| 9 of 12 | |
|---|---|
| Drug Name | Cleocin |
| Drug Label | Clindamycin 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 Ingredient | Clindamycin palmitate hydrochloride; Clindamycin phosphate |
| Dosage Form | Suppository; Swab; For solution; Cream |
| Route | Topical; Vaginal; Oral |
| Strength | eq 1% base; 100mg; eq 2% base; eq 75mg base/5ml |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
| 10 of 12 | |
|---|---|
| Drug Name | Cleocin hydrochloride |
| PubMed Health | Benzoyl Peroxide/Clindamycin (On the skin) |
| Drug Classes | Antiacne, Antibacterial |
| Drug Label | Clindamycin 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 Ingredient | Clindamycin hydrochloride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 300mg base; eq 150mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Pharmacia And Upjohn |
| 11 of 12 | |
|---|---|
| Drug Name | Clindamycin hydrochloride |
| PubMed Health | Clindamycin (Vaginal) |
| Drug Classes | Antibiotic |
| Drug Label | DESCRIPTIONClindamycin 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 Ingredient | Clindamycin hydrochloride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 300mg base; eq 150mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Corepharma; Watson Labs; Mylan Pharms; Ranbaxy; Lannett; Teva; Aurobindo Pharma; Zydus Pharms Usa |
| 12 of 12 | |
|---|---|
| Drug Name | Duac |
| Active Ingredient | Benzoyl peroxide; clindamycin phosphate |
| Dosage Form | Gel |
| Route | Topical |
| Strength | 5%; 1.2% |
| Market Status | Prescription |
| Company | Stiefel |
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.)
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DMF Number : 19176
Submission : 2006-02-14
Status : Active
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Date of Issue : 2020-06-25
Valid Till : 2021-12-22
Written Confirmation Number : WC-0348
Address of the Firm :
NDC Package Code : 14998-0003
Start Marketing Date : 2010-09-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-06
Pay. Date : 2013-07-09
DMF Number : 27266
Submission : 2013-07-08
Status : Active
Type : II
Certificate Number : CEP 2013-190 - Rev 02
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 582
Status : Valid
Registration Number : 303MF10077
Registrant's Address : No. 23,5th Donghai Avenue Zhejiang Chemical materials base Linhai zone, Linhai City, Zhejiang Province, China.
Initial Date of Registration : 2021-05-13
Latest Date of Registration : --
NDC Package Code : 67321-301
Start Marketing Date : 2015-02-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20210416-210-J-619
Manufacturer Name : Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.@HEC PHARM CO., LTD
Manufacturer Address : No. 23 Donghai 5th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Linhai City, Zhejiang Province China@No.3 Industrial Park of HEC, Yidu, Hubei Province, PR China
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DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-07-14
DMF Number : 20450
Submission : 2007-03-28
Status : Active
Type : II
Certificate Number : CEP 2010-281 - Rev 04
Issue Date : 2024-03-14
Type : Chemical
Substance Number : 582
Status : Valid
NDC Package Code : 39635-0002
Start Marketing Date : 2024-11-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Review : Reviewed
Rev. Date : 2014-08-26
Pay. Date : 2013-09-24
DMF Number : 20971
Submission : 2007-10-25
Status : Active
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Rev. Date : 2018-04-09
Pay. Date : 2018-01-31
DMF Number : 32342
Submission : 2018-01-08
Status : Active
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Certificate Number : R0-CEP 2022-223 - Rev 00
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 582
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-06-13
Pay. Date : 2018-04-19
DMF Number : 31876
Submission : 2017-08-01
Status : Active
Type : II
Certificate Number : R0-CEP 2021-013 - Rev 00
Issue Date : 2022-11-16
Type : Chemical
Substance Number : 582
Status : Valid
NDC Package Code : 69132-002
Start Marketing Date : 2017-09-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Number : 14539
Submission : 1999-11-18
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DMF Number : 7289
Submission : 1988-01-05
Status : Inactive
Type : II
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DMF Number : 13702
Submission : 1998-09-01
Status : Inactive
Type : II
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DMF Number : 18704
Submission : 2005-08-08
Status : Inactive
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DMF Number : 19176
Submission : 2006-02-14
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DMF Number : 7289
Submission : 1988-01-05
Status : Inactive
Type : II
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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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Rev. Date :
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DMF Number : 13371
Submission : 1998-09-01
Status : Inactive
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DMF Number : 18778
Submission : 2005-09-08
Status : Inactive
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 14539
Submission : 1999-11-18
Status : Inactive
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USDMF
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DMF Number : 14260
Submission : 1995-07-03
Status : Inactive
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Certificate Number : R1-CEP 2002-132 - Rev 03
Status : Valid
Issue Date : 2018-04-13
Type : Chemical
Substance Number : 582
Certificate Number : R1-CEP 2000-210 - Rev 08
Status : Valid
Issue Date : 2021-03-10
Type : Chemical
Substance Number : 582
Certificate Number : R1-CEP 2000-041 - Rev 09
Status : Valid
Issue Date : 2022-03-08
Type : Chemical
Substance Number : 582
Clindamycin Hydrochloride, Process 02
Certificate Number : CEP 2024-319 - Rev 00
Status : Valid
Issue Date : 2024-09-23
Type : Chemical
Substance Number : 582
Certificate Number : R0-CEP 2021-013 - Rev 00
Status : Valid
Issue Date : 2022-11-16
Type : Chemical
Substance Number : 582
Certificate Number : R0-CEP 2005-287 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2008-07-28
Type : Chemical
Substance Number : 582
Certificate Number : R0-CEP 2022-223 - Rev 00
Status : Valid
Issue Date : 2023-08-21
Type : Chemical
Substance Number : 582
Certificate Number : R1-CEP 2000-255 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2018-04-06
Type : Chemical
Substance Number : 582
Clindamycin Hydrochloride, BTC Process
Certificate Number : CEP 2013-190 - Rev 02
Status : Valid
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 582
Certificate Number : CEP 2010-281 - Rev 04
Status : Valid
Issue Date : 2024-03-14
Type : Chemical
Substance Number : 582
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Clindamycin hydrochloride monohydrate
Registration Number : 303MF10077
Registrant's Address : No. 23,5th Donghai Avenue Zhejiang Chemical materials base Linhai zone, Linhai City, ...
Initial Date of Registration : 2021-05-13
Latest Date of Registration : 2021-05-13
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DOSAGE - CAPSULE;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 50162
DOSAGE - CAPSULE;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 50162
DOSAGE - CAPSULE;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 50162
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170, Taped Density: 0.80
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
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ABOUT THIS PAGE
A Clindamycin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clindamycin Hydrochloride, including repackagers and relabelers. The FDA regulates Clindamycin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clindamycin Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clindamycin Hydrochloride supplier is an individual or a company that provides Clindamycin Hydrochloride active pharmaceutical ingredient (API) or Clindamycin Hydrochloride finished formulations upon request. The Clindamycin Hydrochloride suppliers may include Clindamycin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Clindamycin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Clindamycin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Clindamycin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Clindamycin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Clindamycin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Clindamycin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Clindamycin Hydrochloride USDMF includes data on Clindamycin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clindamycin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Clindamycin Hydrochloride suppliers with USDMF on PharmaCompass.
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 Hydrochloride Drug Master File in Japan (Clindamycin Hydrochloride JDMF) empowers Clindamycin Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Clindamycin Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Clindamycin Hydrochloride Drug Master File in Korea (Clindamycin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clindamycin Hydrochloride. The MFDS reviews the Clindamycin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Clindamycin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Clindamycin Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Clindamycin Hydrochloride suppliers with KDMF on PharmaCompass.
A Clindamycin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Clindamycin Hydrochloride Certificate of Suitability (COS). The purpose of a Clindamycin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clindamycin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clindamycin Hydrochloride to their clients by showing that a Clindamycin Hydrochloride CEP has been issued for it. The manufacturer submits a Clindamycin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clindamycin Hydrochloride CEP holder for the record. Additionally, the data presented in the Clindamycin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clindamycin Hydrochloride DMF.
A Clindamycin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clindamycin Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Clindamycin Hydrochloride written confirmation (Clindamycin Hydrochloride WC) is an official document issued by a regulatory agency to a Clindamycin Hydrochloride manufacturer, verifying that the manufacturing facility of a Clindamycin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clindamycin Hydrochloride APIs or Clindamycin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Clindamycin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Clindamycin Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Clindamycin Hydrochloride API and other APIs are published in this directory by the FDA.
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 Hydrochloride 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.
The NDC directory also contains data on finished compounded human drug products that contain Clindamycin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clindamycin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Clindamycin Hydrochloride suppliers with NDC on PharmaCompass.
Clindamycin Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Clindamycin Hydrochloride GMP API supplier for your needs.
A Clindamycin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Clindamycin Hydrochloride's compliance with Clindamycin Hydrochloride specifications and serves as a tool for batch-level quality control.
Clindamycin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Clindamycin Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Clindamycin Hydrochloride EP), Clindamycin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clindamycin Hydrochloride USP).
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