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1. 5-methyl-2-oxo-1,3-dioxolen-4-yl)methoxy-4-(1-hydroxy-1-methylethyl)-2-propyl-1-(4-(2-(tetrazol-5-yl)phenyl)phenyl)methylimidazol-5-carboxylate - T287346
2. Benicar
3. Cs 866
4. Cs-866
5. Cs866
6. Medoxomil, Olmesartan
7. Olmetec
8. Votum
1. 144689-63-4
2. Benicar
3. Olmetec
4. Cs-866
5. Cs 866
6. Nsc-758924
7. 6m97xtv3hd
8. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
9. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester
10. Ncgc00095136-01
11. Benevas
12. Olsertain
13. Olvance
14. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate
15. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate
16. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(2h-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate
17. Benicar (tn)
18. Olmetec (tn)
19. Cs866
20. Sr-05000001987
21. Unii-6m97xtv3hd
22. Votume
23. Openvas
24. Cs-866dm
25. Cs-866rn
26. Olmesartanmedoxomil
27. Olmesartan-medoxomil
28. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(1h-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
29. Olmesartan Medoxomil [usan:inn:ban]
30. Ks-1182
31. Olmesartan (medoxomil)
32. Spectrum_001944
33. Spectrum2_000506
34. Spectrum3_001676
35. Spectrum4_000740
36. Spectrum5_001556
37. Dsstox_cid_25924
38. Dsstox_rid_81226
39. Dsstox_gsid_45924
40. Schembl16403
41. Bspbio_003491
42. Gtpl591
43. Kbiogr_001040
44. Kbioss_002498
45. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl) (1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3-dioxol-4-yl) Methyl Ester
46. Mls006010109
47. Spectrum1505205
48. Spbio_000431
49. Olmesartan Medoxomil (benicar)
50. Chembl1200692
51. Dtxsid9045924
52. Chebi:31932
53. Kbio2_002490
54. Kbio2_005058
55. Kbio2_007626
56. Kbio3_002711
57. Hms1922l15
58. Hms2089k18
59. Hms2093k16
60. Hms3651e13
61. Hms3715n09
62. Hms3743o09
63. Olmesartan Medoxomil (jp17/usp)
64. Olmesartan Medoxomil [inn]
65. Olmesartan Medoxomil [jan]
66. Pharmakon1600-01505205
67. Olmesartan Medoxomil [usan]
68. Amy22222
69. Bcp05214
70. Zinc4149248
71. Olmesartan Medoxomil [vandf]
72. Tox21_111445
73. Bdbm50442892
74. Ccg-39596
75. Mfcd00944911
76. Nsc758924
77. Olmesartan Medoxomil [mart.]
78. S1604
79. Stl451024
80. Olmesartan Medoxomil [usp-rs]
81. Olmesartan Medoxomil [who-dd]
82. Akos015894907
83. Akos015914772
84. Ac-1601
85. Bcp9000555
86. Ccg-221184
87. Cs-0577
88. Nsc 758924
89. Olmesartan Medoxomil, >=98% (hplc)
90. Sb19327
91. Ncgc00095136-02
92. Ncgc00095136-03
93. Ncgc00095136-09
94. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate
95. Azor Component Olmesartan Medoxomil
96. Hy-17005
97. Olmesartan Medoxomil [orange Book]
98. Smr002203616
99. Olmesartan Medoxomil [ep Monograph]
100. Sbi-0206741.p001
101. Olmesartan Medoxomil [usp Monograph]
102. Cas-144689-63-4
103. Ft-0601603
104. O0510
105. Olmesartan Medoxomil Component Of Azor
106. Sw199650-2
107. D01204
108. Tribenzor Component Olmesartan Medoxomil
109. Ab01275443-01
110. Ab01275443_02
111. Ab01275443_03
112. Benicar Hct Component Olmesartan Medoxomil
113. 689o634
114. A808260
115. L001061
116. Olmesartan Medoxomil Component Of Tribenzor
117. J-501595
118. Olmesartan Medoxomil Component Of Benicar Hct
119. Sr-05000001987-1
120. Sr-05000001987-2
121. Brd-k78485176-001-02-9
122. Brd-k78485176-001-03-7
123. Q27888058
124. Z1550675457
125. Olmesartan Medoxomil, European Pharmacopoeia (ep) Reference Standard
126. Olmesartan Medoxomil, United States Pharmacopeia (usp) Reference Standard
127. Olmesartan Medoxomil For System Suitability, European Pharmacopoeia (ep) Reference Standard
128. Olmesartan Medoxomil, Pharmaceutical Secondary Standard; Certified Reference Material
129. (5-methyl-2-oxidanylidene-1,3-dioxol-4-yl)methyl 5-(2-oxidanylpropan-2-yl)-2-propyl-3-[[4-[2-(2h-1,2,3,4-tetrazol-5-yl)phenyl]phenyl]methyl]imidazole-4-carboxylate
130. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-i Midazole-5-carboxylate
131. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate
132. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 1-[[2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl]-4-(2-hydroxypr
133. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxy-2-propanyl)-2-propyl-1-[[2'-(1h-tetrazol-5-yl)-4-biphenylyl]methyl]-1h-imidazole-5-carboxylate
134. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl}-1h-imidazole-5-carboxylate
135. (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl1-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-4-(2-hydroxypropan-2-yl)-2-propyl-1h-imidazole-5-carboxylate
136. (5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl]imidazole-5-carboxylate
137. (5-methyl-2-oxo-1,3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenyl}methylimidazole-5-carboxylate
138. (5-methyl-2-oxo-1,3-dioxolen-4yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-{4-[2-(tetrazol-5-yl)phenyl]phenyl}methylimidazole-5-carboxylate
139. (5-methyl-2-oxo-2h-1,3-dioxol-4-yl)methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-{[2'-(1h-1,2,3,4-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl]methyl}-1h-imidazole-5-carboxylate
140. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, (5-methyl-2-oxo-1,3- Dioxol-4-yl)methyl Ester
141. 1h-imidazole-5-carboxylic Acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester
142. 5-(1-hydroxy-1-methylethyl)-2-propyl-3-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3h-imidazole-4-carboxylic Acid 5-methyl-2-oxo-[1,3]dioxol-4-ylmethyl Ester
143. 5-(2-hydroxypropan-2-yl)-2-propyl-3-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]-4-imidazolecarboxylic Acid (5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester
144. Olmesartan Medoxomil
145. 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-imidazole-5-carboxylic Acid-(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl Ester
Molecular Weight | 558.6 g/mol |
---|---|
Molecular Formula | C29H30N6O6 |
XLogP3 | 3.8 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 11 |
Exact Mass | 558.22268270 g/mol |
Monoisotopic Mass | 558.22268270 g/mol |
Topological Polar Surface Area | 154 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 969 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 6 | |
---|---|
Drug Name | Benicar |
Drug Label | BENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d... |
Active Ingredient | Olmesartan medoxomil |
Dosage Form | Tablet |
Route | Oral |
Strength | 5mg; 40mg; 20mg |
Market Status | Prescription |
Company | Daiichi Sankyo |
2 of 6 | |
---|---|
Drug Name | Benicar hct |
PubMed Health | Olmesartan (By mouth) |
Drug Classes | Cardiovascular Agent, Renal Protective Agent |
Active Ingredient | olmesartan medoxomil; Hydrochlorothiazide |
Dosage Form | Tablet |
Route | Oral |
Strength | 25mg; 12.5mg; 40mg; 20mg |
Market Status | Prescription |
Company | Daiichi Sankyo |
3 of 6 | |
---|---|
Drug Name | Olmesartan medoxomil |
PubMed Health | Olmesartan/Hydrochlorothiazide (By mouth) |
Drug Classes | Angiotensin II Receptor Antagonist/Thiazide Combination |
Drug Label | BENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d... |
Active Ingredient | Olmesartan medoxomil |
Dosage Form | Tablet |
Route | oral |
Strength | 5mg; 40mg; 20mg |
Market Status | Tentative Approval |
Company | Mylan Pharma; Sandoz |
4 of 6 | |
---|---|
Drug Name | Benicar |
Drug Label | BENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d... |
Active Ingredient | Olmesartan medoxomil |
Dosage Form | Tablet |
Route | Oral |
Strength | 5mg; 40mg; 20mg |
Market Status | Prescription |
Company | Daiichi Sankyo |
5 of 6 | |
---|---|
Drug Name | Benicar hct |
PubMed Health | Olmesartan (By mouth) |
Drug Classes | Cardiovascular Agent, Renal Protective Agent |
Active Ingredient | olmesartan medoxomil; Hydrochlorothiazide |
Dosage Form | Tablet |
Route | Oral |
Strength | 25mg; 12.5mg; 40mg; 20mg |
Market Status | Prescription |
Company | Daiichi Sankyo |
6 of 6 | |
---|---|
Drug Name | Olmesartan medoxomil |
PubMed Health | Olmesartan/Hydrochlorothiazide (By mouth) |
Drug Classes | Angiotensin II Receptor Antagonist/Thiazide Combination |
Drug Label | BENICAR (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-d... |
Active Ingredient | Olmesartan medoxomil |
Dosage Form | Tablet |
Route | oral |
Strength | 5mg; 40mg; 20mg |
Market Status | Tentative Approval |
Company | Mylan Pharma; Sandoz |
Antihypertensive Agents
Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)
Angiotensin II Type 1 Receptor Blockers
Agents that antagonize ANGIOTENSIN II TYPE 1 RECEPTOR. Included are ANGIOTENSIN II analogs such as SARALASIN and biphenylimidazoles such as LOSARTAN. Some are used as ANTIHYPERTENSIVE AGENTS. (See all compounds classified as Angiotensin II Type 1 Receptor Blockers.)
C09CA08
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
C - Cardiovascular system
C09 - Agents acting on the renin-angiotensin system
C09C - Angiotensin ii receptor blockers (arbs), plain
C09CA - Angiotensin ii receptor blockers (arbs), plain
C09CA08 - Olmesartan medoxomil
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28444
Submission : 2014-07-02
Status : Active
Type : II
NDC Package Code : 82231-116
Start Marketing Date : 2023-10-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Daiichi Sankyo Co., Ltd.
Registration Date : 2017-12-15
Registration Number : Su256-3-ND
Manufacturer Name : EUROAPI Hungary Ltd.
Manufacturer Address : To utca 1-5., Budapest, 1045, Hungary
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Certificate Number : R1-CEP 2014-295 - Rev 01
Issue Date : 2022-12-19
Type : Chemical
Substance Number : 2600
Status : Valid
Registration Number : 227MF10298
Registrant's Address : Joan Buscala, 10 E-08173 Sant Cugat del Valles, Barcelona, Spain
Initial Date of Registration : 2015-12-28
Latest Date of Registration : --
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2020-10-15
Registration Number : 473-27-ND
Manufacturer Name : Interquim SA
Manufacturer Address : c/ Joan Buscallà, 10, 08173 Sant Cugat Del Vallès (Barcelona), Spain
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-15
Pay. Date : 2012-12-03
DMF Number : 21931
Submission : 2008-09-04
Status : Active
Type : II
Certificate Number : R1-CEP 2012-170 - Rev 01
Issue Date : 2022-05-25
Type : Chemical
Substance Number : 2600
Status : Valid
Date of Issue : 2022-06-22
Valid Till : 2025-05-20
Written Confirmation Number : WC-0001
Address of the Firm :
NDC Package Code : 15894-0019
Start Marketing Date : 2015-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2014-12-18
Registration Number : No. 711-18-ND
Manufacturer Name : Teva API India Private Limited
Manufacturer Address : Plot No. Q1 to Q4 Industrial Area, Ghirongi, Malanpur, Distt.Bhind (MP), India_x000D_
Available Reg Filing : BR, ASMF |
Registrant Name : Korea Daiichi Sankyo Co., Ltd.
Registration Date : 2017-12-15
Registration Number : Su256-3-ND
Manufacturer Name : EUROAPI Hungary Ltd.
Manufacturer Address : To utca 1-5., Budapest, 1045, Hungary
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2020-10-15
Registration Number : 473-27-ND
Manufacturer Name : Interquim SA
Manufacturer Address : c/ Joan Buscallà, 10, 08173 Sant Cugat Del Vallès (Barcelona), Spain
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2014-12-18
Registration Number : No. 711-18-ND
Manufacturer Name : Teva API India Private Limit...
Manufacturer Address : Plot No. Q1 to Q4 Industrial Area, Ghirongi, Malanpur, Distt.Bhind (MP), India_x000D_
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2021-03-05
Registration Number : No. 6321-2-ND(4)
Manufacturer Name : Macleods Pharmaceuticals Lim...
Manufacturer Address : Plot No. 2209, GIDC Industrial Estate., At & Post : Sarigam, Tal-Umbergaon, City : Sa...
Registrant Name : JSP Co., Ltd.
Registration Date : 2023-05-08
Registration Number : No. 6321-2-ND(6)
Manufacturer Name : Macleods Pharmaceuticals Lim...
Manufacturer Address : Plot No. 2209, GIDC Industrial Estate., At & Post : Sarigam, Tal-Umbergaon, City : Sa...
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-02-27
Registration Number : No. 6321-2-ND(5)
Manufacturer Name : Macleods Pharmaceuticals Lim...
Manufacturer Address : Plot No. 2209, GIDC Industrial Estate., At & Post: Sarigam, Tal-Umbergaon, City: Sari...
Registrant Name : JSP Co., Ltd.
Registration Date : 2023-10-25
Registration Number : 3595-1-ND(9)
Manufacturer Name : Venkata Narayana Active Ingr...
Manufacturer Address : S.No.69, Chandrapadiya Village, Vinjamur Mandal Nellore District- 524228 Andhra Prade...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-03-18
Registration Number : No. 4766-2-ND(5)
Manufacturer Name : Zhejiang Huahai Pharmaceutic...
Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2021-07-11
Registration Number : No. 4766-2-ND(4)
Manufacturer Name : Zhejiang Huahai Pharmaceutic...
Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-06-24
Registration Number : No. 4766-2-ND(3)
Manufacturer Name : Zhejiang Huahai Pharmaceutic...
Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Olmesartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olmesartan, including repackagers and relabelers. The FDA regulates Olmesartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olmesartan 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 Olmesartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olmesartan supplier is an individual or a company that provides Olmesartan active pharmaceutical ingredient (API) or Olmesartan finished formulations upon request. The Olmesartan suppliers may include Olmesartan API manufacturers, exporters, distributors and traders.
click here to find a list of Olmesartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olmesartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Olmesartan active pharmaceutical ingredient (API) in detail. Different forms of Olmesartan DMFs exist exist since differing nations have different regulations, such as Olmesartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olmesartan DMF submitted to regulatory agencies in the US is known as a USDMF. Olmesartan USDMF includes data on Olmesartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olmesartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olmesartan 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 Olmesartan Drug Master File in Japan (Olmesartan JDMF) empowers Olmesartan 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 Olmesartan JDMF during the approval evaluation for pharmaceutical products. At the time of Olmesartan 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 Olmesartan 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 Olmesartan Drug Master File in Korea (Olmesartan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olmesartan. The MFDS reviews the Olmesartan KDMF as part of the drug registration process and uses the information provided in the Olmesartan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Olmesartan 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 Olmesartan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Olmesartan suppliers with KDMF on PharmaCompass.
A Olmesartan CEP of the European Pharmacopoeia monograph is often referred to as a Olmesartan Certificate of Suitability (COS). The purpose of a Olmesartan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Olmesartan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Olmesartan to their clients by showing that a Olmesartan CEP has been issued for it. The manufacturer submits a Olmesartan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Olmesartan CEP holder for the record. Additionally, the data presented in the Olmesartan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Olmesartan DMF.
A Olmesartan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Olmesartan 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 Olmesartan suppliers with CEP (COS) on PharmaCompass.
A Olmesartan written confirmation (Olmesartan WC) is an official document issued by a regulatory agency to a Olmesartan manufacturer, verifying that the manufacturing facility of a Olmesartan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olmesartan APIs or Olmesartan finished pharmaceutical products to another nation, regulatory agencies frequently require a Olmesartan WC (written confirmation) as part of the regulatory process.
click here to find a list of Olmesartan 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 Olmesartan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Olmesartan 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 Olmesartan 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 Olmesartan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olmesartan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Olmesartan suppliers with NDC on PharmaCompass.
Olmesartan 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 Olmesartan 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 Olmesartan GMP manufacturer or Olmesartan GMP API supplier for your needs.
A Olmesartan CoA (Certificate of Analysis) is a formal document that attests to Olmesartan's compliance with Olmesartan specifications and serves as a tool for batch-level quality control.
Olmesartan CoA mostly includes findings from lab analyses of a specific batch. For each Olmesartan 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.
Olmesartan may be tested according to a variety of international standards, such as European Pharmacopoeia (Olmesartan EP), Olmesartan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olmesartan USP).
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