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1. Clopidogrel
2. Clopidogrel Besilate
3. Clopidogrel Besylate
4. Clopidogrel Hydrochloride
5. Clopidogrel Mepha
6. Clopidogrel Napadisilate
7. Clopidogrel Sandoz
8. Clopidogrel, (+)(s)-isomer
9. Clopidogrel-mepha
10. Iscover
11. Pcr 4099
12. Pcr-4099
13. Plavix
14. Sc 25989c
15. Sc 25990c
16. Sr 25989
1. 120202-66-6
2. Clopidogrel Sulfate
3. Clopidogrel Hydrogen Sulfate
4. Iscover
5. Plavix
6. Clopidogrel Bisulphate
7. Clopidogrel Hemisulfate
8. (s)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate Sulfate
9. Clopidogrel Hydrogen Sulphate
10. Clopidogrel Bms
11. Clopidogrel Sulphate
12. Sr 25990c
13. Clopidogrel (hydrogen Sulfate)
14. Isocover
15. Pidogrel
16. Clopidogrel-bgr
17. Clopidogrel-bms
18. Clopidogrel Teva
19. Clopidogrel Zentiva
20. Clopidogrel (plavix)
21. Clopidogrel Ratiopharm
22. Sr-25990c
23. S-(+)-clopidogrel Hydrogen Sulfate
24. Clopidogrel (as Bisulfate)
25. (s)-(+)-clopidogrel Sulfate
26. 08i79htp27
27. 120202-66-6 (sulfate)
28. Pm-103
29. Methyl (s)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetate Sulfate
30. 144077-07-6
31. Myogrel
32. Clopidogrel Hydrogensulfate
33. Plavix (tn)
34. Dsstox_cid_26024
35. Dsstox_rid_81297
36. Dsstox_gsid_46024
37. Plavitor
38. Osvix
39. Chebi:3759
40. Chembl1083385
41. Methyl (2s)-2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate Sulfate
42. Methyl (2s)-2-(2-chlorophenyl)-2-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)acetate;sulfuric Acid
43. Sulfuric Acid Methyl (2s)-2-(2-chlorophenyl)-2-{4h,5h,6h,7h-thieno[3,2-c]pyridin-5-yl}acetate
44. Clopidogrel Bisulfate [usan]
45. Cas-135046-48-9
46. Unii-08i79htp27
47. R-(-)-clopidogrel Hydrogen Sulfate
48. Clopidogrel Bisulfate [usan:usp]
49. Isocover (tn)
50. Clopidogrel Bisolfato
51. (s)-(+)-clopidogrel Hydrogen Sulfate
52. Bisulfato De Clopidogrel
53. Bissulfato De Clopidogrel
54. Ncgc00159321-02
55. (+)-clopidogrel Bisulfate
56. (+) Clopidogrel Bisulfate
57. Methyl Alphas-(2-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate Sulfate (1:1)
58. Clopidogrel Bisulfate (usp)
59. Clopidogrel Sulfate (jp17)
60. Schembl33556
61. Clopidogrel Hydrogen Sulphate
62. Spectrum1503710
63. Mdco-157
64. (+)-clopidogrel Hydrogen Sulfate
65. Clopidogrel Sulfate [jan]
66. Dtxsid601016080
67. Hms1922g16
68. Hms2093i13
69. Hms3884g15
70. Pharmakon1600-01503710
71. Amy40591
72. Clopidogrel Sulfate Tablets (jp17)
73. Tox21_111570
74. Ccg-39568
75. Clopidogrel Bisulfate [vandf]
76. Mfcd00876395
77. Nsc758613
78. S1415
79. Clopidogrel Bisulfate [mart.]
80. Akos015900408
81. Clopidogrel Bisulfate [usp-rs]
82. Clopidogrel Bisulfate [who-dd]
83. Tox21_111570_1
84. Ac-2135
85. Cs-1882
86. Dv-7314
87. Ks-1045
88. S65c842
89. Clopidogrel (as Hydrogen Sulfate)
90. Clopidogrel Hydrogen Sulfate [mi]
91. Ncgc00163329-03
92. 111ge004
93. Bc164326
94. Hy-17459
95. Methyl (+)-(s)-alpha-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate, Sulfate (1:1)
96. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, 6,7-dihydro-alpha-(2-chlorophenyl)-, Methyl Ester, (s)-, Sulfate
97. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, Alpha-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (alphas)-, Sulfate (1:1)
98. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, Alpha-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (s)-, Sulfate (1:1)
99. Thieno[3,2-c]pyridine-5(4h)-acetic Acid,a-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (as)-, Sulfate (1:1)
100. Clopidogrel Bisulfate [orange Book]
101. Clopidogrel Bisulfate [usp Monograph]
102. Sw219457-1
103. Clopidogrel Hydrogen Sulfate [ema Epar]
104. D00769
105. Duocover Component Clopidogrel Bisulfate
106. Duoplavin Component Clopidogrel Bisulfate
107. Clopidogrel Hydrogen Sulphate [ema Epar]
108. Clopidogrel Bisulfate Component Of Duocover
109. Clopidogrel Bisulfate Component Of Duoplavin
110. Clopidogrel Hydrogen Sulfate [ep Monograph]
111. Sr-05000002068
112. J-006637
113. Sr-05000002068-1
114. (+)-clopidogrel1r(-)camphor-10-sulphonic Acid Salt
115. (s)-(+)-clopidogrel Hydrogensulfate, >=98% (hplc)
116. Q27888063
117. Z1550648767
118. (s)-(+)-clopidogrel Bisulfate;(s)-(+)-clopidogrel Hydrogen Sulfate
119. Clopidogrel Bisulfate, United States Pharmacopeia (usp) Reference Standard
120. Clopidogrel Hydrogen Sulfate, European Pharmacopoeia (ep) Reference Standard
121. Clopidogrel/acetylsalicyclic Acid Teva Component Clopidogrel Bisulfate
122. (s)-(+)-methyl (2-chlorophenyl)(6,7-dihydro-4h-thieno(3,2-c)pyrid-5-yl)acetate Bisulfate
123. Clopidogrel Bisulfate Component Of Clopidogrel/acetylsalicyclic Acid Teva
124. Clopidogrel Bisulfate, Pharmaceutical Secondary Standard; Certified Reference Material
125. Clopidogrel For System Suitability, European Pharmacopoeia (ep) Reference Standard
126. Methyl(s)-2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4h)-yl)acetatesulfate
127. (s)-(+)-methyl 2-(4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-yl)-2-(2-chlorophenyl)acetate Hydrogen Sulfate
128. (s)-(2-chloro-phenyl)-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)-acetic Acid Methyl Ester Sulfuric Acid Salt
129. (s)-methyl-(2-chloro-phenyl)-(6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl)-acetate H2so4
130. Methyl (+)-(s)-.alpha.-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate, Sulfate (1:1)
131. Methyl (+)-(s)-.alpha.-(o-chlorophenyl)-6,7-dihydrothieno(3,2-c)pyridine-5(4h)-acetate, Sulphate (1:1)
132. Methyl (2s)-2-(2-chlorophenyl)-2-{4h,5h,6h,7h-thieno[3,2-c]pyridin-5-yl}acetate; Sulfuric Acid
133. Methyl (s)-(+)-2-(2-chlorophenyl)-2-[6,7-dihydro-4h-thieno[3,2-c]pyridin-5-yl]acetate Sulfate
134. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (s)-, Sulfate (1:1)
135. Thieno(3,2-c)pyridine-5(4h)-acetic Acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, Methyl Ester, (s)-, Sulphate (1:1)
| Molecular Weight | 419.9 g/mol |
|---|---|
| Molecular Formula | C16H18ClNO6S2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 4 |
| Exact Mass | 419.0264073 g/mol |
| Monoisotopic Mass | 419.0264073 g/mol |
| Topological Polar Surface Area | 141 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 463 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Clopidogrel bisulfate |
| Drug Label | Clopidogrel bisulfate USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisul... |
| Active Ingredient | Clopidogrel bisulfate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 300mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Wockhardt; Mylan Pharms; Actavis Elizabeth; Teva Pharms; Macleods Pharms; Mutual Pharm; Gate Pharms; Teva; Apotex; Accord Hlthcare; Sciegen Pharms; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Dr Reddys Labs; Sun Pharma Global; Roxane |
| 2 of 4 | |
|---|---|
| Drug Name | Plavix |
| PubMed Health | Clopidogrel (By mouth) |
| Drug Classes | Platelet Aggregation Inhibitor |
| Drug Label | Plavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel... |
| Active Ingredient | Clopidogrel bisulfate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 75mg base; eq 300mg base |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
| 3 of 4 | |
|---|---|
| Drug Name | Clopidogrel bisulfate |
| Drug Label | Clopidogrel bisulfate USP is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate sulfate (1:1). The molecular formula of clopidogrel bisul... |
| Active Ingredient | Clopidogrel bisulfate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 300mg base; eq 75mg base |
| Market Status | Prescription |
| Company | Wockhardt; Mylan Pharms; Actavis Elizabeth; Teva Pharms; Macleods Pharms; Mutual Pharm; Gate Pharms; Teva; Apotex; Accord Hlthcare; Sciegen Pharms; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Dr Reddys Labs; Sun Pharma Global; Roxane |
| 4 of 4 | |
|---|---|
| Drug Name | Plavix |
| PubMed Health | Clopidogrel (By mouth) |
| Drug Classes | Platelet Aggregation Inhibitor |
| Drug Label | Plavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)--(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel... |
| Active Ingredient | Clopidogrel bisulfate |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 75mg base; eq 300mg base |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
- Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Adult patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Secondary prevention of atherothrombotic events
Clopidogrel is indicated in:
- Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Adult patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
- Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
* Secondary prevention of atherothrombotic events:
Clopidogrel is indicated in:
- Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Adult patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)
Clopidogrel in combination with ASA is indicated in:
- Adult patients with moderate to high-risk TIA (ABCD2 score 4) or minor IS (NIHSS 3) within 24 hours of either the TIA or IS event.
* Prevention of atherothrombotic and thromboembolic events in atrial fibrillation:
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Prevention of atherothrombotic events Clopidogrel is indicated in:
Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
Prevention Secondary prevention of atherothrombotic events Clopidogrel is indicated in:
- Adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Adult patients suffering from acute coronary syndrome:
- Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
- ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
- Prevention of atherothrombotic and thromboembolic events in atrial fibrillation:
- In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
* Secondary prevention of atherothrombotic events:
Clopidogrel is indicated in:
- adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;
- adult patients suffering from acute coronary syndrome:
- non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA);
- ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
- In patients with moderate to high-risk Transient Ischemic Attack (TIA) or minor Ischemic Stroke (IS)
Clopidogrel in combination with ASA is indicated in:
- Adult patients with moderate to high-risk TIA (ABCD2 score 4) or minor IS (NIHSS 3) within 24 hours of either the TIA or IS event.
* Prevention of atherothrombotic and thromboembolic events in atrial fibrillation:
In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-K antagonists and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
- patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
For further information please refer to section 5. 1.
Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:
- Patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease.
- Patients suffering from acute coronary syndrome:
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA).
ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Platelet Aggregation Inhibitors
Drugs or agents which antagonize or impair any mechanism leading to blood platelet aggregation, whether during the phases of activation and shape change or following the dense-granule release reaction and stimulation of the prostaglandin-thromboxane system. (See all compounds classified as Platelet Aggregation Inhibitors.)
Purinergic P2Y Receptor Antagonists
Compounds that bind to and block the stimulation of PURINERGIC P2Y RECEPTORS. Included under this heading are antagonists for specific P2Y receptor subtypes. (See all compounds classified as Purinergic P2Y Receptor Antagonists.)
B01AC04
B01AC04
B01AC04
B01AC03
B01AC04
B01AC04
B01AC04
B01AC04
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DOSAGE - TABLET;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 20839
DOSAGE - TABLET;ORAL - EQ 75MG BASE
USFDA APPLICATION NUMBER - 20839
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A Osvix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Osvix, including repackagers and relabelers. The FDA regulates Osvix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Osvix 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 Osvix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Osvix supplier is an individual or a company that provides Osvix active pharmaceutical ingredient (API) or Osvix finished formulations upon request. The Osvix suppliers may include Osvix API manufacturers, exporters, distributors and traders.
click here to find a list of Osvix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Osvix DMF (Drug Master File) is a document detailing the whole manufacturing process of Osvix active pharmaceutical ingredient (API) in detail. Different forms of Osvix DMFs exist exist since differing nations have different regulations, such as Osvix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Osvix DMF submitted to regulatory agencies in the US is known as a USDMF. Osvix USDMF includes data on Osvix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Osvix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Osvix 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 Osvix Drug Master File in Japan (Osvix JDMF) empowers Osvix 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 Osvix JDMF during the approval evaluation for pharmaceutical products. At the time of Osvix 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 Osvix 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 Osvix Drug Master File in Korea (Osvix KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Osvix. The MFDS reviews the Osvix KDMF as part of the drug registration process and uses the information provided in the Osvix KDMF to evaluate the safety and efficacy of the drug.
After submitting a Osvix 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 Osvix API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Osvix suppliers with KDMF on PharmaCompass.
A Osvix CEP of the European Pharmacopoeia monograph is often referred to as a Osvix Certificate of Suitability (COS). The purpose of a Osvix CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Osvix EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Osvix to their clients by showing that a Osvix CEP has been issued for it. The manufacturer submits a Osvix CEP (COS) as part of the market authorization procedure, and it takes on the role of a Osvix CEP holder for the record. Additionally, the data presented in the Osvix CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Osvix DMF.
A Osvix CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Osvix 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 Osvix suppliers with CEP (COS) on PharmaCompass.
A Osvix written confirmation (Osvix WC) is an official document issued by a regulatory agency to a Osvix manufacturer, verifying that the manufacturing facility of a Osvix active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Osvix APIs or Osvix finished pharmaceutical products to another nation, regulatory agencies frequently require a Osvix WC (written confirmation) as part of the regulatory process.
click here to find a list of Osvix 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 Osvix as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Osvix 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 Osvix 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 Osvix and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Osvix NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Osvix suppliers with NDC on PharmaCompass.
Osvix 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 Osvix 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 Osvix GMP manufacturer or Osvix GMP API supplier for your needs.
A Osvix CoA (Certificate of Analysis) is a formal document that attests to Osvix's compliance with Osvix specifications and serves as a tool for batch-level quality control.
Osvix CoA mostly includes findings from lab analyses of a specific batch. For each Osvix 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.
Osvix may be tested according to a variety of international standards, such as European Pharmacopoeia (Osvix EP), Osvix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Osvix USP).
