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1. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4s-(4alpha,4aalpha,5alpha,5aalpha,6alpha,12aalpha))-
2. Alpha 6 Deoxyoxytetracycline
3. Alpha-6-deoxyoxytetracycline
4. Atridox
5. Bmy 28689
6. Bmy-28689
7. Bmy28689
8. Bu 3839t
9. Bu-3839t
10. Bu3839t
11. Doxycycline
12. Doxycycline Calcium
13. Doxycycline Calcium Salt (1:2)
14. Doxycycline Chinoin
15. Doxycycline Hemiethanolate
16. Doxycycline Hyclate
17. Doxycycline Monohydrate
18. Doxycycline Monohydrochloride, 6 Epimer
19. Doxycycline Monohydrochloride, 6-epimer
20. Doxycycline Monohydrochloride, Dihydrate
21. Doxycycline Phosphate (1:1)
22. Doxycycline-chinoin
23. Hydramycin
24. Oracea
25. Periostat
26. Vibra Tabs
27. Vibra-tabs
28. Vibramycin
29. Vibramycin Novum
30. Vibravenos
1. Doxycycline Hyclate
2. 24390-14-5
3. Atridox
4. Periostat
5. Vibra-tabs
6. Doxyprex
7. Monodoks
8. Tetraclean
9. Doxy-lemmon
10. Doxychel Hyclate
11. Vibramycin
12. Acticlate
13. Mespafin
14. Tetradox
15. Doxy
16. Doxycycline Hydrochloride Hemiethanolate Hemihydrate
17. Retens
18. Doxicrisol
19. Vibraveineuse
20. Vibravenos
21. Azudoxat
22. Clinofug
23. Diocimex
24. Duradoxal
25. Granudoxy
26. Ronaxan
27. Zadorin
28. Spanor
29. Unacil
30. Acticlate Cap
31. 19xts3t51u
32. Nsc-741421
33. 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide Monohydrochloride, Compound With Ethyl Alcohol (2:1), Monohydrate
34. Vivox
35. 6-deoxy-5-hydroxytetracycline Hydrochloride Hemihydrate
36. (4s,4ar,5s,5ar,6r,12ar)-4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide;ethanol;hydrate;dihydrochloride
37. Dentista
38. Doxteric
39. Doxy 100
40. 10592-13-9
41. Mfcd07357237
42. Doxy 200
43. Doxycycline Hyclate (internal Use)
44. Unii-19xts3t51u
45. Doryx Mpc
46. Doxycycline Hyclate [usan:usp]
47. Doxycyclini Hyclas
48. Periostat (tn)
49. (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide;ethanol;hydrate;dihydrochloride
50. Vibra-tabs (tn)
51. Lymepak (tn)
52. Doxylar
53. Lymepak
54. Doryx (tn)
55. Wc 2031
56. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Hydrochloride, (4s,4ar,5s,5ar,6r,12as)-, Compd. With Ethanol, Hydrate (2:2:1:1)
57. Doxycycline Hyclate (usp)
58. Chembl3989740
59. Doxycycline Hyclate [vandf]
60. (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Compound With Ethanol (2:1) Dihydrochloride Hydrate
61. Amy32700
62. Doxycycline Hyclate [usp-rs]
63. Doxycycline Hyclate [who-dd]
64. Doxycycline Hyclate [who-ip]
65. S4163
66. Wc2031
67. Akos025402170
68. Ac-6017
69. Ccg-270611
70. Ds-9077
71. Nsc 741421
72. Doxycycline Hyclate [green Book]
73. Doxycycline Hyclate [ep Impurity]
74. Doxycycline Hyclate [orange Book]
75. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, Compd. With Ethanol (2:1), Monohydrate, (4s-(4alpha,4aalpha,5alpha,5aalpha,6alpha,12aalpha))-
76. 2-naphthacenecarboxamide, 4beta-(dimeethylamino)-1,4,4abeta,5,5abeta,6,11,12a-octahydro-3,5beta,10,12,12abeta-pentahydroxy-6beta-methyl-1,11-dioxo-, Monohydrochloride, Compd. With Ethyl Alcohol (2:1), Monohydrate
77. Bd166236
78. Doxycycline Hyclate [ep Monograph]
79. Doxycycline Hydrochloride Hydrate (jp17)
80. Doxycyclini Hyclas [who-ip Latin]
81. Ethanol, Compd. With (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide Monohydrochloride (1:2), Monohydrate
82. Doxycycline Hyclate [usp Monograph]
83. Doxycycline, Hyclate - Cas 24390-14-5
84. Sw219440-1
85. Sw219440-2
86. D02129
87. Doxycycline Hydrochloride Hydrate [jan]
88. Doxycycline Hyclate 100 Microg/ml In Acetonitrile
89. Q27116248
90. Z2791720087
91. Doxycycline Hydrochloride Hemiethanolate Hemihydrate [mi]
92. Doxycycline Hyclate Is Known As A Broad-spectrum Tetracycline Antibiotic.
93. (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide - Ethanol (2:1) Dihydrochloride Hydrate
94. Bis((4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide) Ethanol Hydrate Dihydrochloride
| Molecular Weight | 1025.9 g/mol |
|---|---|
| Molecular Formula | C46H58Cl2N4O18 |
| Hydrogen Bond Donor Count | 16 |
| Hydrogen Bond Acceptor Count | 20 |
| Rotatable Bond Count | 4 |
| Exact Mass | 1024.3123164 g/mol |
| Monoisotopic Mass | 1024.3123164 g/mol |
| Topological Polar Surface Area | 385 Ų |
| Heavy Atom Count | 70 |
| Formal Charge | 0 |
| Complexity | 958 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 12 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 6 |
| 1 of 10 | |
|---|---|
| Drug Name | Atridox |
| Drug Label | DORYX Capsules contain specially coated pellets of doxycycline hyclate, a broad-spectrum antibiotic synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate is... |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | System, extended release |
| Route | Periodontal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Tolmar |
| 2 of 10 | |
|---|---|
| Drug Name | Doryx |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Tablet, delayed release |
| Route | Oral |
| Strength | eq 100mg base; eq 80mg base; eq 200mg base; eq 150mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Mayne Pharma |
| 3 of 10 | |
|---|---|
| Drug Name | Doxy 100 |
| PubMed Health | Doxycycline (Injection) |
| Drug Classes | Antibiotic, Antimalarial, Antiprotozoal |
| Drug Label | Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is... |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 100mg base/vial |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa |
| 4 of 10 | |
|---|---|
| Drug Name | Doxy 200 |
| PubMed Health | Doxycycline (Subgingival) |
| Drug Classes | Antibacterial |
| Drug Label | Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows:with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline i... |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 200mg base/vial |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa |
| 5 of 10 | |
|---|---|
| Drug Name | Doxycycline hyclate |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Tablet; Capsule, delayed release; Capsule; Tablet, delayed release |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 150mg base; eq 20mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Corepharma; Mutual Pharma; Vintage Pharms; Hikma Intl Pharms; Mylan Pharms; Blu Caribe; Ivax Sub Teva Pharms; Actavis Elizabeth; Larken Labs; Lannett; Mutual Pharm; Actavis Labs Fl; Medicis; Chartwell Life Sci; Mylan; Impax Labs; Heritage Pharms |
| 6 of 10 | |
|---|---|
| Drug Name | Doryx |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Tablet, delayed release |
| Route | Oral |
| Strength | eq 100mg base; eq 80mg base; eq 200mg base; eq 150mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Mayne Pharma |
| 7 of 10 | |
|---|---|
| Drug Name | Doxy 100 |
| PubMed Health | Doxycycline (Injection) |
| Drug Classes | Antibiotic, Antimalarial, Antiprotozoal |
| Drug Label | Doxycycline for Injection, USP is a sterile, lyophilized powder prepared from a solution of doxycycline hyclate, ascorbic acid and mannitol in Water for Injection. Doxycycline hyclate is a broad spectrum antibiotic derived from oxytetracycline. It is... |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 100mg base/vial |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa |
| 8 of 10 | |
|---|---|
| Drug Name | Doxy 200 |
| PubMed Health | Doxycycline (Subgingival) |
| Drug Classes | Antibacterial |
| Drug Label | Doxycycline hyclate is a broad-spectrum antibiotic synthetically derived from oxytetracycline. The structural formula is as follows:with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46. The chemical designation for doxycycline i... |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 200mg base/vial |
| Market Status | Prescription |
| Company | Fresenius Kabi Usa |
| 9 of 10 | |
|---|---|
| Drug Name | Doxycycline hyclate |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | Tablet; Capsule, delayed release; Capsule; Tablet, delayed release |
| Route | Oral |
| Strength | eq 100mg base; eq 50mg base; eq 150mg base; eq 20mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Corepharma; Mutual Pharma; Vintage Pharms; Hikma Intl Pharms; Mylan Pharms; Blu Caribe; Ivax Sub Teva Pharms; Actavis Elizabeth; Larken Labs; Lannett; Mutual Pharm; Actavis Labs Fl; Medicis; Chartwell Life Sci; Mylan; Impax Labs; Heritage Pharms |
| 10 of 10 | |
|---|---|
| Drug Name | Atridox |
| Drug Label | DORYX Capsules contain specially coated pellets of doxycycline hyclate, a broad-spectrum antibiotic synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration.The structural formula for doxycycline hyclate is... |
| Active Ingredient | Doxycycline hyclate |
| Dosage Form | System, extended release |
| Route | Periodontal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Tolmar |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
Antimalarials
Agents used in the treatment of malaria. They are usually classified on the basis of their action against plasmodia at different stages in their life cycle in the human. (From AMA, Drug Evaluations Annual, 1992, p1585) (See all compounds classified as Antimalarials.)
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Certificate Number : R1-CEP 2004-163 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2011-06-01
Type : Chemical
Substance Number : 272
Certificate Number : CEP 1996-066 - Rev 07
Status : Valid
Issue Date : 2024-07-18
Type : Chemical
Substance Number : 272
Certificate Number : R1-CEP 2001-038 - Rev 02
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Issue Date : 2015-03-19
Type : Chemical
Substance Number : 272
Certificate Number : R0-CEP 2003-225 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2005-04-15
Type : Chemical
Substance Number : 272
Certificate Number : R1-CEP 2014-175 - Rev 00
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Issue Date : 2022-02-10
Type : Chemical
Substance Number : 272
Certificate Number : CEP 2022-336 - Rev 00
Status : Valid
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 272
Certificate Number : R2-CEP 1992-018 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2004-02-19
Type : Chemical
Substance Number : 272
Certificate Number : R1-CEP 1997-002 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2014-11-14
Type : Chemical
Substance Number : 272
Certificate Number : R1-CEP 1999-100 - Rev 05
Status : Valid
Issue Date : 2022-05-06
Type : Chemical
Substance Number : 272
Certificate Number : CEP 2000-165 - Rev 08
Status : Valid
Issue Date : 2025-02-04
Type : Chemical
Substance Number : 272
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DOSAGE - TABLET;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 205931
DOSAGE - TABLET;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 205931
DOSAGE - TABLET;ORAL - EQ 100MG BASE
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USFDA APPLICATION NUMBER - 50007
DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federa...DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50007
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 1...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 50582
DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 7...DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - EQ 75MG BASE
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DOSAGE - SYSTEM, EXTENDED RELEASE;PERIODONTAL...DOSAGE - SYSTEM, EXTENDED RELEASE;PERIODONTAL - 50MG
USFDA APPLICATION NUMBER - 50751
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 10...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50795
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 12...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50795
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 15...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50795
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 50795
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50795
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 60...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 60MG BASE
USFDA APPLICATION NUMBER - 50795
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 75...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50795
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 80...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 80MG BASE
USFDA APPLICATION NUMBER - 50795
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Doxycycline Hyclate
Drug Cost (USD) : 37,447
Year : 2022
Prescribers : 31
Prescriptions : 70
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Doxycycline Hyclate
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Doxycycline Hyclate
Drug Cost (USD) : 120,620,857
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Prescribers : 2822990
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Doxycycline Hyclate
Drug Cost (USD) : 64,227
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Doxycycline Hyclate
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Doxycycline Hyclate
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Company :
Doxycycline Hyclate
Drug Cost (USD) : 460,070
Year : 2019
Prescribers : 481
Prescriptions : 1728
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Doxycycline Hyclate
Drug Cost (USD) : 137,197,650
Year : 2019
Prescribers : 3261719
Prescriptions : 4739124
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Doxycycline Hyclate
Drug Cost (USD) : 67,939
Year : 2019
Prescribers : 63
Prescriptions : 110
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company :
Doxycycline Calcium
Drug Cost (USD) : 207,058
Year : 2019
Prescribers : 713
Prescriptions : 1112
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
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PharmaCompass offers a list of Doxycycline Hyclate 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 Doxycycline Hyclate manufacturer or Doxycycline Hyclate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doxycycline Hyclate manufacturer or Doxycycline Hyclate supplier.
PharmaCompass also assists you with knowing the Doxycycline Hyclate API Price utilized in the formulation of products. Doxycycline Hyclate API Price is not always fixed or binding as the Doxycycline Hyclate Price is obtained through a variety of data sources. The Doxycycline Hyclate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vivox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vivox, including repackagers and relabelers. The FDA regulates Vivox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vivox 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 Vivox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vivox supplier is an individual or a company that provides Vivox active pharmaceutical ingredient (API) or Vivox finished formulations upon request. The Vivox suppliers may include Vivox API manufacturers, exporters, distributors and traders.
click here to find a list of Vivox suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vivox DMF (Drug Master File) is a document detailing the whole manufacturing process of Vivox active pharmaceutical ingredient (API) in detail. Different forms of Vivox DMFs exist exist since differing nations have different regulations, such as Vivox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vivox DMF submitted to regulatory agencies in the US is known as a USDMF. Vivox USDMF includes data on Vivox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vivox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vivox 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 Vivox Drug Master File in Japan (Vivox JDMF) empowers Vivox 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 Vivox JDMF during the approval evaluation for pharmaceutical products. At the time of Vivox 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 Vivox 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 Vivox Drug Master File in Korea (Vivox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vivox. The MFDS reviews the Vivox KDMF as part of the drug registration process and uses the information provided in the Vivox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vivox 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 Vivox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vivox suppliers with KDMF on PharmaCompass.
A Vivox CEP of the European Pharmacopoeia monograph is often referred to as a Vivox Certificate of Suitability (COS). The purpose of a Vivox CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vivox EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vivox to their clients by showing that a Vivox CEP has been issued for it. The manufacturer submits a Vivox CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vivox CEP holder for the record. Additionally, the data presented in the Vivox CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vivox DMF.
A Vivox CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vivox 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 Vivox suppliers with CEP (COS) on PharmaCompass.
A Vivox written confirmation (Vivox WC) is an official document issued by a regulatory agency to a Vivox manufacturer, verifying that the manufacturing facility of a Vivox active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vivox APIs or Vivox finished pharmaceutical products to another nation, regulatory agencies frequently require a Vivox WC (written confirmation) as part of the regulatory process.
click here to find a list of Vivox 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 Vivox as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vivox 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 Vivox 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 Vivox and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vivox NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vivox suppliers with NDC on PharmaCompass.
Vivox 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 Vivox 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 Vivox GMP manufacturer or Vivox GMP API supplier for your needs.
A Vivox CoA (Certificate of Analysis) is a formal document that attests to Vivox's compliance with Vivox specifications and serves as a tool for batch-level quality control.
Vivox CoA mostly includes findings from lab analyses of a specific batch. For each Vivox 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.
Vivox may be tested according to a variety of international standards, such as European Pharmacopoeia (Vivox EP), Vivox JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vivox USP).
