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    Chemistry

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    Also known as: 137862-53-4, Diovan, Tareg, Cgp 48933, Provas, Exforge
    Molecular Formula
    C24H29N5O3
    Molecular Weight
    435.5  g/mol
    InChI Key
    ACWBQPMHZXGDFX-QFIPXVFZSA-N
    FDA UNII
    80M03YXJ7I
    Valsartan
    A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.
    Valsartan is an Angiotensin 2 Receptor Blocker. The mechanism of action of valsartan is as an Angiotensin 2 Receptor Antagonist.
    1 2D Structure

    Valsartan

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-3-methyl-2-[pentanoyl-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic acid
    2.1.2 InChI
    InChI=1S/C24H29N5O3/c1-4-5-10-21(30)29(22(16(2)3)24(31)32)15-17-11-13-18(14-12-17)19-8-6-7-9-20(19)23-25-27-28-26-23/h6-9,11-14,16,22H,4-5,10,15H2,1-3H3,(H,31,32)(H,25,26,27,28)/t22-/m0/s1
    2.1.3 InChI Key
    ACWBQPMHZXGDFX-QFIPXVFZSA-N
    2.1.4 Canonical SMILES
    CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NNN=N3)C(C(C)C)C(=O)O
    2.1.5 Isomeric SMILES
    CCCCC(=O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NNN=N3)[C@@H](C(C)C)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    80M03YXJ7I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 48933, Cgp

    2. Cgp 48933

    3. Diovan

    4. Kalpress

    5. Miten

    6. N-valeryl-n-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)valine

    7. Nisis

    8. Provas

    9. Tareg

    10. Vals

    2.3.2 Depositor-Supplied Synonyms

    1. 137862-53-4

    2. Diovan

    3. Tareg

    4. Cgp 48933

    5. Provas

    6. Exforge

    7. Cgp-48933

    8. (s)-2-(n-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)pentanamido)-3-methylbutanoic Acid

    9. 137863-60-6

    10. Prexxartan

    11. Mfcd00865840

    12. N-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)-n-valeryl-l-valine

    13. (2s)-3-methyl-2-[pentanoyl-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic Acid

    14. Nsc-758927

    15. Chembl1069

    16. L-valine, N-(1-oxopentyl)-n-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-

    17. 80m03yxj7i

    18. Chebi:9927

    19. (s)-2-(n-((2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl)pentanamido)-3-methylbutanoic Acid

    20. L-valine, N-(1-oxopentyl)-n-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-

    21. Kalpress

    22. Miten

    23. Nisis

    24. Vals

    25. (s)-n-valeryl-n-{[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]-methyl}-valine

    26. N-(1-oxopentyl)-n-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-l-valine

    27. Valzaar

    28. Valtan

    29. [3h]valsartan

    30. (2~{s})-3-methyl-2-[pentanoyl-[[4-[2-(2~{h}-1,2,3,4-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic Acid

    31. Smr000466318

    32. Diovan (tn)

    33. Unii-80m03yxj7i

    34. Valpression

    35. Valsartana

    36. Varexan

    37. Hsdb 7519

    38. Valsartan [usan:usp:inn:ban]

    39. Valsartan,(s)

    40. Valsartan- Bio-x

    41. (2s)-3-methyl-2-(pentanoyl-((4-(2-(2h-tetrazol-5-yl)phenyl)phenyl)methyl)amino)butanoic Acid

    42. (2s)-3-methyl-2-[pentanoyl-[[4-[2-(1h-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic Acid

    43. Valsartan (diovan)

    44. Spectrum_001796

    45. Valsartan [inn]

    46. Valsartan [jan]

    47. Valsartan [mi]

    48. Valsartan [hsdb]

    49. Valsartan [usan]

    50. Spectrum2_001120

    51. Spectrum3_001831

    52. Spectrum4_000749

    53. Spectrum5_001582

    54. Valsartan [vandf]

    55. Prexxartan (oral Solution)

    56. Valsartan [mart.]

    57. Ec 604-045-2

    58. Schembl2542

    59. Valsartan [usp-rs]

    60. Valsartan [who-dd]

    61. Bspbio_003501

    62. Gtpl593

    63. Kbiogr_001078

    64. Kbioss_002289

    65. Valsartan [ema Epar]

    66. Mls000759423

    67. Mls001424088

    68. Bidd:gt0345

    69. Spectrum1505209

    70. Spbio_001260

    71. Valsartan (jp17/usp/inn)

    72. Gtpl3937

    73. Valsartan [ep Impurity]

    74. Valsartan [orange Book]

    75. Dtxsid6023735

    76. Valsartan [ep Monograph]

    77. Valsartan, >=98% (hplc)

    78. Dafiro Component Valsartan

    79. Kbio2_002287

    80. Kbio2_004855

    81. Kbio2_007423

    82. Kbio3_003006

    83. Ezr-104

    84. Val-489

    85. Valsartan [usp Monograph]

    86. Copalia Component Valsartan

    87. Exforge Component Valsartan

    88. Imprida Component Valsartan

    89. Hms1922l21

    90. Hms2051l12

    91. Hms2093k22

    92. Hms2232f05

    93. Hms3651e04

    94. Hms3715p12

    95. Pharmakon1600-01505209

    96. Entresto Component Valsartan

    97. Valturna Component Valsartan

    98. (2r)-3-methyl-2-[pentanoyl[[2'-(1h-tetrazol-5-yl)biphenyl-4-yl]methyl]amino]butanoic Acid (valsartan (r)-enantiomer)

    99. Act02671

    100. Bcp05184

    101. Zinc3875259

    102. Bdbm50049186

    103. Nsc758927

    104. S1894

    105. Dafiro-hct Component Valsartan

    106. Diovan Hct Component Valsartan

    107. Valsartan Component Of Copalia

    108. Valsartan Component Of Exforge

    109. Akos015914315

    110. Akos015994698

    111. Byvalson Component Of Valsartan

    112. Copalia-hct Component Valsartan

    113. Exforge Hct Component Valsartan

    114. Imprida-hct Component Valsartan

    115. Valsartan Component Of Byvalson

    116. Valsartan Component Of Entresto

    117. Valsartan Component Of Immprida

    118. Valsartan Component Of Valturna

    119. Ac-4543

    120. Am90287

    121. Ccg-101028

    122. Ccg-221275

    123. Cs-1967

    124. Db00177

    125. Ds-1248

    126. Ks-1194

    127. Nc00278

    128. Nsc 758927

    129. N-(1-oxopentyl)-n-[[2'-(2h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-l-valine

    130. N-pentanoyl-n-{[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl}-l-valine

    131. Ncgc00178027-08

    132. Ncgc00178027-11

    133. Valsartan Component Of Dafiro-hct

    134. Valsartan Component Of Diovan Hct

    135. Bv164506

    136. Hy-18204

    137. Valsartan Component Of Copalia-hct

    138. Valsartan Component Of Exforge Hct

    139. Valsartan Component Of Imprida-hct

    140. Sbi-0206738.p001

    141. Sw197658-2

    142. V-120

    143. V0112

    144. 62v534

    145. D00400

    146. Ab00639940-06

    147. Ab00639940-08

    148. Ab00639940_09

    149. Ab00639940_11

    150. Q155472

    151. Sr-05000001928

    152. J-007068

    153. Sr-05000001928-1

    154. Brd-k45158365-001-02-3

    155. Brd-k45158365-001-05-6

    156. Valsartan, European Pharmacopoeia (ep) Reference Standard

    157. N-valeryl-n-[2'-(5-tetrazolyl)biphenyl-4-ylmethyl]-l-valine

    158. Valsartan, United States Pharmacopeia (usp) Reference Standard

    159. N-valeryl-n-[2'-(1h-tetrazol-5-yl)biphenyl-4-ylmethyl]-l-valine

    160. Valsartan, Pharmaceutical Secondary Standard; Certified Reference Material

    161. (5)-2-{n-[(2'-(1h-tetrazol-5-yl)biphenyl-4-yl)methyl]pentanamido}-3-methylbutanoic Acid

    162. (s)-3-methyl-2-{pentanoyl-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric Acid

    163. 3-methyl-2-{pentanoyl-[2''-(1h-tetrazol-5-yl)-biphenyl-4-yl]-amino}-butyric Acid

    164. L-valine,n-(1-oxopentyl)-n-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-3-yl]methyl]- (9ci)

    165. L-valine,n-(1-oxopentyl)-n-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-3-yl]methyl]-(9ci)

    166. N-(1-oxopentyl)-n-[[2'-(1h-tetrazol-5-yl) [1,1'-bi-phenyl]-4-yl]methyl]-l-valine

    167. N-(1-oxopentyl)-n-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-(l)-valine

    168. N-pentanoyl-n-{[2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl}-l-valine

    169. Valsartan For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    170. Valsartan For System Suitability, European Pharmacopoeia (ep) Reference Standard

    171. (2~{s})-3-methyl-2-[pentanoyl-[[4-[2-(2~{h}-1,2,3,4-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic Acid; Diovan; Tareg; Provas; Exforge; N-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)-n-valeryl-l-valine

    172. (2s)-3-methyl-2-[n-({4-[2-(2h-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)pentanamido]butanoic Acid

    173. (2s)-3-methyl-2-[pentanoyl-[[4-[2-(2h-tetrazol-5-yl)phenyl]phenyl]methyl]amino]butanoic Acid.

    174. (2s)-3-methyl-2-{n-pentanoyl-n'-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butanoic Acid

    175. (2s)-3-methyl-2-{pentanoyl-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric Acid

    176. (s)-2-(n-((2'-(1h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)pentanamido)-3-methylbutanoicacid

    177. (s)-2-(n-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)pentanamido)-3-methylbutanoic Acid

    178. (s)-3-methyl-2-[n-({4-[2-(2h-1,2,3,4-tetrazol-5-yl) Phenyl]phenyl}methyl)pentanamido]butanoic Acid

    179. (s)-3-methyl-2-[n-({4-[2-(2h-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)pentanamido]butanoic Acid

    180. (s)-3-methyl-2-{pentanoyl-[-2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric Acid

    181. (s)-3-methyl-2-{pentanoyl-[2''-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric Acid

    182. (s)-3-methyl-2-{pentanoyl-[2''-(2h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric Acid

    183. (s)-n-(1-carboxy-2-methyl-prop-1-yl)-n-pentanoyl-n-[2'(1h-tetrazol-5-yl)biphenyl-4-yl-methyl]amine

    184. (s)-n-(1-carboxy-2-methyl-prop-1-yl)-n-pentanoyl-n-[2'-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amine

    185. (s)-n-(1-carboxy-2-methyl-prop-1-yl)-n-pentanoyl-n-[2'-(1h-tetrazol-5-yl)biphenyl-4-ylmethyl]-amine

    186. 2-{[2''-(2,3-dihydro-1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-pentanoyl-amino}-3-methyl-butyric Acid

    187. 3-methyl-2-{((s)-pentanoyl)-[2''-(1h-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amino}-butyric Acid

    188. U35

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 435.5 g/mol
    Molecular Formula C24H29N5O3
    XLogP34.4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count10
    Exact Mass435.22703980 g/mol
    Monoisotopic Mass435.22703980 g/mol
    Topological Polar Surface Area112 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity608
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameDiovan
    PubMed HealthValsartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelDiovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2-(1H-tetrazol-5-yl) [1,1-biphenyl]-4-yl]methyl]-L-valin...
    Active IngredientValsartan
    Dosage FormTablet
    RouteOral
    Strength160mg; 80mg; 40mg; 320mg
    Market StatusPrescription
    CompanyNovartis

    2 of 4  
    Drug NameValsartan
    PubMed HealthValsartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelDiovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2-(1H-tetrazol-5-yl) [1,1-biphenyl]-4-yl]methyl]-L-valin...
    Active IngredientValsartan
    Dosage FormTablet
    Routeoral; Oral
    Strength160mg; 320mg; 80mg; 40mg
    Market StatusTentative Approval; Prescription
    CompanyOhm Labs; Ivax Pharms; Alembic Pharms; Mylan Labs; Aurobindo Pharma; Lupin; Watson Labs; Dr Reddys Labs

    3 of 4  
    Drug NameDiovan
    PubMed HealthValsartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelDiovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2-(1H-tetrazol-5-yl) [1,1-biphenyl]-4-yl]methyl]-L-valin...
    Active IngredientValsartan
    Dosage FormTablet
    RouteOral
    Strength160mg; 80mg; 40mg; 320mg
    Market StatusPrescription
    CompanyNovartis

    4 of 4  
    Drug NameValsartan
    PubMed HealthValsartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelDiovan (valsartan) is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype.Valsartan is chemically described as N-(1-oxopentyl)-N-[[2-(1H-tetrazol-5-yl) [1,1-biphenyl]-4-yl]methyl]-L-valin...
    Active IngredientValsartan
    Dosage FormTablet
    Routeoral; Oral
    Strength160mg; 320mg; 80mg; 40mg
    Market StatusTentative Approval; Prescription
    CompanyOhm Labs; Ivax Pharms; Alembic Pharms; Mylan Labs; Aurobindo Pharma; Lupin; Watson Labs; Dr Reddys Labs

    4.2 Therapeutic Uses

    Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Diovan is an angiotensin II receptor blocker (ARB) indicated for: treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    Diovan is an angiotensin II receptor blocker (ARB) indicated for: reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    Diovan is an angiotensin II receptor blocker (ARB) indicated for: treatment of heart failure (NYHA class II-IV); Diovan significantly reduced hospitalization for heart failure. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    For more Therapeutic Uses (Complete) data for VALSARTAN (6 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: FETAL TOXICITY. When pregnancy is detected, discontinue Diovan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Diovan as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Diovan, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Diovan for hypotension, oliguria, and hyperkalemia.

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    Angiotensin II (A-II) is the main effector of the renin-angiotensin system. A-II functions by binding its type 1 (AT1) receptors to cause vasoconstriction and retention of sodium and fluid. Several AT1 receptor antagonists-a group of drugs collectively called "sartans"-have been marketed during the past few years for treatment of hypertension and heart failure. At least 15 case reports describe oligohydramnios, fetal growth retardation, pulmonary hypoplasia, limb contractures, and calvarial hypoplasia in various combinations in association with maternal losartan, candesartan, valsartan, or telmisartan treatment during the second or third trimester of pregnancy. Stillbirth or neonatal death is frequent in these reports, and surviving infants may exhibit renal damage. The fetal abnormalities, which are strikingly similar to those produced by maternal treatment with angiotensin-converting enzyme (ACE) inhibitors during the second and third trimesters of pregnancy, are probably related to extreme sensitivity of the fetus to the hypotensive action of these drugs. ...

    PMID:15669052 Alwan S et al; Birth Defects Res A Clin Mol Teratol 73 (2): 123-30 (2005)

    Valsartan is distributed into milk in rats. It is not known whether valsartan is distributed into human milk. Discontinue nursing or the drug because of potential risk in nursing infants.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2077

    For more Drug Warnings (Complete) data for VALSARTAN (21 total), please visit the HSDB record page.

    4.4 Drug Indication

    Valsartan is indicated for the treatment of hypertension to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It is also indicated for the treatment of heart failure (NYHA class II-IV) and for left ventricular dysfunction or failure after myocardial infarction when the use of an angiotensin-converting enzyme inhibitor (ACEI) is not appropriate.

    FDA Label

    Treatment of essential hypertension.

    Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

    Heart failure following recent myocardial infarction, Treatment of heart failure, Treatment of hypertension

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Valsartan inhibits the pressor effects of angiotensin II with oral doses of 80 mg inhibiting the pressor effect by about 80% at peak with approximately 30% inhibition persisting for 24 hours. Removal of the negative feedback of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients. Minimal decreases in plasma aldosterone were observed after administration of valsartan. In multiple-dose studies in hypertensive patients, valsartan had no notable effects on total cholesterol, fasting triglycerides, fasting serum glucose, or uric acid. **Hypotension** Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated hypertension treated with valsartan alone. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of valsartan, or the treatment should start under close medical supervision. Caution should be observed when initiating therapy in patients with heart failure. Patients with heart failure given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. In controlled trials in heart failure patients, the incidence of hypotension in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. **Impaired Renal Function** Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on valsartan. **Hyperkalemia** Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of valsartan may be required.

    5.2 MeSH Pharmacological Classification

    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.)

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    VALSARTAN
    5.3.2 FDA UNII
    80M03YXJ7I
    5.3.3 Pharmacological Classes
    Angiotensin 2 Receptor Blocker [EPC]; Angiotensin 2 Receptor Antagonists [MoA]
    5.4 ATC Code

    C09DB01

    C09CA03

    S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448

    C09CA03

    S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448

    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

    C09CA03 - Valsartan

    5.5 Absorption, Distribution and Excretion

    Absorption

    After one oral dose, the antihypertensive activity of valsartan begins within approximately 2 hours and peaks within 4-6 hours in most patients. Food decreases the exposure to orally administered valsartan by approximately 40% and peak plasma concentration by approximately 50%. AUC and Cmax values of valsartan genereally increase linearly with increasing dose over the therapeutic dose range. Valsartan does not accumulate appreciably in plasma following repetitive administration.

    Route of Elimination

    Valsartan, when administered as an oral solution, is primarily recovered in feces (about 83% of dose) and urine (about 13% of dose). The recovery is mainly as unchanged drug, with only about 20% of dose recovered as metabolites.

    Volume of Distribution

    The steady state volume of distribution of valsartan after intravenous administration is small (17 L), indicating that valsartan does not distribute into tissues extensively.

    Clearance

    Following intravenous administration, plasma clearance of valsartan is approximately 2 L/hour and its renal clearance is 0.62 L/hour (about 30% of total clearance).

    Valsartan, when administered as an oral solution, is primarily recovered in feces (about 83% of dose) and urine (about 13% of dose). The recovery is mainly as unchanged drug, with only about 20% of dose recovered as metabolites. ... Following intravenous administration, plasma clearance of valsartan is about 2 L/hr and its renal clearance is 0.62 L/hr (about 30% of total clearance).

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    Absolute bioavailability for the capsule formulation is approximately 25% (range, 10-35%). Food decreases the area under the plasma concentration-time curve (AUC) and peak plasma concentration by approximately 40 and 50%, respectively.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 2860

    Valsartan peak plasma concentration is reached 2 to 4 hours after dosing. Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours. Absolute bioavailability for Diovan is about 25% (range 10% to 35%). The bioavailability of the suspension is 1.6 times greater than with the tablet. With the tablet, food decreases the exposure (as measured by AUC) to valsartan by about 40% and peak plasma concentration (Cmax) by about 50%. AUC and Cmax values of valsartan increase approximately linearly with increasing dose over the clinical dosing range. Valsartan does not accumulate appreciably in plasma following repeated administration.

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    The steady state volume of distribution of valsartan after intravenous administration is small (17 L), indicating that valsartan does not distribute into tissues extensively. Valsartan is highly bound to serum proteins (95%), mainly serum albumin.

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    For more Absorption, Distribution and Excretion (Complete) data for VALSARTAN (6 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Valsartan undergoes minimal liver metabolism and is not biotransformed to a high degree, as only approximately 20% of a single dose is recovered as metabolites. The primary metabolite, accounting for about 9% of dose, is valeryl 4-hydroxy valsartan. In vitro metabolism studies involving recombinant CYP 450 enzymes indicated that the CYP 2C9 isoenzyme is responsible for the formation of valeryl-4-hydroxy valsartan. Valsartan does not inhibit CYP 450 isozymes at clinically relevant concentrations. CYP 450 mediated drug interaction between valsartan and coadministered drugs are unlikely because of the low extent of metabolism.

    Valsartan is known to be excreted largely as unchanged compound and is minimally metabolized in man. Although the only notable metabolite is 4-hydroxyvaleryl metabolite (4-OH valsartan), the responsible enzyme has not been clarified at present. The current in vitro studies were conducted to identify the cytochrome P450 (CYP) enzymes involved in the formation of 4-OH valsartan. Valsartan was metabolized to 4-OH valsartan by human liver microsomes and the Eadie-Hofstee plots were linear. The apparent Km and Vmax values for the formation of 4-OH valsartan were 41.9-55.8 microM and 27.2-216.9 pmol min(-1) mg(-1) protein, respectively. There was good correlation between the formation rates of 4-OH valsartan and diclofenac 4'-hydroxylase activities (representative CYP2C9 activity) of 11 individual microsomes (r = 0.889). No good correlation was observed between any of the other CYP enzyme marker activities (CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A). Among the recombinant CYP enzymes examined (CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4, 3A5 and 4A11), CYP2C9 notably catalysed 4-hydroxylation of valsartan. For the specific CYP inhibitors or substrates examined (furafylline, diclofenac, S(+)-mephenytoin, quinidine and troleandomycin), only diclofenac inhibited the formation of 4-OH valsartan. These results showed that CYP2C9 is the only form responsible for 4-hydroxylation of valsartan in human liver microsomes. Although CYP2C9 is involved in valsartan metabolism, CYP-mediated drug-drug interaction between valsartan and other co-administered drugs would be negligible.

    PMID:16192110 Nakashima A et al; Xenobiotica 35 (6): 589-602 (2005)

    ... Valsartan, when administered as an oral solution, is primarily recovered in feces (about 83% of dose) and urine (about 13% of dose). The recovery is mainly as unchanged drug, with only about 20% of dose recovered as metabolites. The primary metabolite, accounting for about 9% of dose, is valeryl 4-hydroxy valsartan. In vitro metabolism studies involving recombinant CYP 450 enzymes indicated that the CYP 2C9 isoenzyme is responsible for the formation of valeryl-4-hydroxy valsartan. Valsartan does not inhibit CYP 450 isozymes at clinically relevant concentrations. CYP 450 mediated drug interaction between valsartan and coadministered drugs are unlikely because of the low extent of metabolism. ...

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    Valsartan has known human metabolites that include 4-hydroxy-valsartan.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    After intravenous (IV) administration, valsartan demonstrates bi-exponential decay kinetics, with an average elimination half-life of about 6 hours.

    Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours.

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    ... In an investigation of pharmacokinetics and pharmacodynamics in normotensive male volunteers, valsartan was rapidly absorbed with the maximal plasma concentration occurring 2-3 hr after oral administration. The elimination half-life was about 4-6 hr, valsartan was poorly metabolized, and most of the drug was excreted via feces. ...

    PMID:12491811 Kimura M et al; Nippon Yakurigaku Zasshi 120 (5): 353-60 (2002)

    5.8 Mechanism of Action

    Valsartan belongs to the angiotensin II receptor blocker (ARB) family of drugs, which selectively bind to angiotensin receptor 1 (AT1) and prevent angiotensin II from binding and exerting its hypertensive effects. These include vasoconstriction, stimulation and synthesis of aldosterone and ADH, cardiac stimulation, and renal reabsorption of sodium among others. Overall, valsartan's physiologic effects lead to reduced blood pressure, lower aldosterone levels, reduced cardiac activity, and increased excretion of sodium. Valsartan also affects the renin-angiotensin aldosterone system (RAAS), which plays an important role in hemostasis and regulation of kidney, vascular, and cardiac functions. Pharmacological blockade of RAAS via AT1 receptor blockade inhibits negative regulatory feedback within RAAS which is a contributing factor to the pathogenesis and progression of cardiovascular disease, heart failure, and renal disease. In particular, heart failure is associated with chronic activation of RAAS, leading to inappropriate fluid retention, vasoconstriction, and ultimately a further decline in left ventricular function. ARBs have been shown to have a protective effect on the heart by improving cardiac function, reducing afterload, increasing cardiac output and prevent ventricular hypertrophy. The angiotensin-converting enzyme inhibitor (ACEI) class of medications (which includes drugs such as [ramipril], [lisinopril], and [perindopril]) inhibits the conversion of angiotensin I to angiotensin II by inhibiting the ACE enzyme but does not prevent the formation of all angiotensin II. ARB activity is unique in that it blocks all angiotensin II activity, regardless of where or how it was synthesized. Valsartan is commonly used for the management of hypertension, heart failure, and type 2 diabetes-associated nephropathy, particularly in patients who are unable to tolerate ACE inhibitors. ARBs such as valsartan have been shown in a number of large-scale clinical outcomes trials to improve cardiovascular outcomes including reducing risk of myocardial infarction, stroke, the progression of heart failure, and hospitalization. Valsartan also slows the progression of diabetic nephropathy due to its renoprotective effects. Improvements in chronic kidney disease with valsartan include both clinically and statistically significant decreases in urinary albumin and protein excretion in patients diagnosed with type 2 diabetes and in nondiabetic patients diagnosed with chronic kidney disease. Valsartan also binds to the AT2 receptor, however AT2 is not known to be associated with cardiovascular homeostasis like AT1. Valsartan has about 20,000-fold higher affinity for the AT1 receptor than for the AT2 receptor. The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked AT2 receptor.

    Valsartan, a nonpeptide tetrazole derivative, is an angiotensin II type 1 (AT1) receptor antagonist. Valsartan has pharmacologic actions similar to those of losartan; however, unlike losartan, valsartan is not a prodrug and its pharmacologic activity does not depend on hydrolysis in the liver. Valsartan blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects, by selectively inhibiting access of angiotensin II to AT1 receptors within many tissues, including vascular smooth muscle and the adrenal gland. By comparison, angiotensin-converting enzyme (ACE, kininase II) inhibitors block the conversion of angiotensin I to angiotensin II; however, the blockade of angiotensin II production by ACE inhibitors is not complete since the vasopressor hormone can be formed via other enzymes that are not blocked by ACE inhibitors. Because valsartan, unlike ACE inhibitors, does not inhibit ACE, the drug does not interfere with response to bradykinins and substance P; a beneficial consequence is the absence of certain ACE inhibitor-induced adverse effects (e.g., cough), but possible renal and/or cardioprotective effects may be sacrificed. Valsartan also does not interfere with angiotensin II synthesis.

    American Society of Health-System Pharmacists 2014; Drug Information 2014. Bethesda, MD. 2014, p. 2077

    Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Diovan (valsartan) blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT1 receptor than for the AT2 receptor. The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked AT2 receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT1 receptor about one-200th that of valsartan itself. Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.

    NIH; DailyMed. Current Medication Information for Diovan (Valsartan) Tablet (Revised: March 2014). Available from, as of May 28, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213

    Recent studies demonstrated that the antihypertensive drug valsartan improved spatial and episodic memory in mouse models of Alzheimer's Disease (AD) and human subjects with hypertension. However, the molecular mechanism by which valsartan can regulate cognitive function is still unknown. The effect of valsartan on dendritic spine formation in primary hippocampal neurons, which is correlated with learning and memory /was investigated/. /It was/ found that valsartan promotes spinogenesis in developing and mature neurons. In addition, /it was found/ that valsartan increases the puncta number of PSD-95 and trends toward an increase in the puncta number of synaptophysin. Moreover, valsartan increased the cell surface levels of AMPA receptors and selectively altered the levels of spinogenesis-related proteins, including CaMKIIa and phospho-CDK5. These data suggest that valsartan may promote spinogenesis by enhancing AMPA receptor trafficking and synaptic plasticity signaling.

    PMID:24012668 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3840727 Sohn YI et al; Biochem Biophys Res Commun 439 (4):464-70 (2013)

    The mechanisms underlying the myocardial protection of valsartan against ischemia/reperfusion (I/R) injury are complicated and remain unclear. The aim of this study was to investigate whether autophagy machinery was involved in the protection against I/R injury that is induced by valsartan. In vivo rat hearts were subjected to ischemia by 30 min ligation of the left anterior descending coronary artery, followed by a 120 min reperfusion. 3-methyladenine (3-MA), a specific inhibitor on autophagic sequestration, was used to inhibit autophagy. The hemodynamics, infarct size of the ventricle and LC3B protein were measured. Western blot analysis was performed to investigate the mechanism by which autophagy was induced by valsartan. Valsartan preconditioning resulted in a significant decrease in infarct size and induced autophagy in the rat heart subjected to I/R injury. The hemodynamics assay showed that the valsartan-induced cardiac functional recovery was attenuated by 3-MA. By contrast, 3-MA decreased the improvement induced by valsartan on the histology and infarction of the rat heart subjected to I/R injury. Valsartan preconditioning induced autophagy via the AKT/mTOR/S6K pathway, independent of Beclin1. In conclusion, valsartan preconditioning induced autophagy via the AKT/mTOR/S6K pathway, which contributed to the myocardial protection against I/R injury.

    PMID:24084854 Wu X et al; Mol Med Rep 8 (6): 1824-30 (2013)

    For more Mechanism of Action (Complete) data for VALSARTAN (18 total), please visit the HSDB record page.

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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Jai Radhe Sales

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    09

    HRV Global Life Sciences

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI WW Frankfurt
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    HRV Global Life Sciences

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    10

    Zeon Pharma Industries India Pvt L...

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Virtual BoothZeon Pharma is a manufacturer and supplier of APIs & Intermediates.

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    Zeon Pharma Industries India Pvt Ltd

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    01

    Biophore India Pharmaceuticals Pvt ...

    India
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    iPHEX India
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Valsartan

    About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

    Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
    Biophore

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    02

    Octavius Pharma Pvt. Ltd

    India
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    Vietnam Medi-Pharm Expo
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Valsartan

    About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...

    Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio includes DC granules, herbal/food supplements, APIs, and finished formulations such as tablets, capsules, syrups, ointments, etc. With WHO-GMP certification and a DSIR certified R&D center, we ensure quality and innovation. We export to LATAM, the Middle East, Africa, Asia, and CIS regions, and offer expert consulting in formulation development and marketing support.
    Octavius Pharma

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    03

    LGM Pharma

    U.S.A
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    ChemOutsourcing
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Valsartan

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
    LGM Pharma CB

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    04

    Metrochem API Private Limited

    India
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    Vietnam Medi-Pharm Expo
    Attending
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Valsartan

    About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Metrochem

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    05

    Nuray Chemicals Private Limited

    India
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    CPhI WW Frankfurt
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    Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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    Valsartan

    About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

    Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
    Nuray Chemicals

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    06

    Dr. Reddy's Laboratories

    India
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    CPhI Korea
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Valsartan

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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    07

    IOL Chemicals and Pharmaceuticals

    India
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    Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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    Valsartan

    About the Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty ch...

    With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty chemicals. As an API-based company, IOL Chemicals has substantial manufacturing capacities that provide economies of scale and cost advantages. It also has extensive expertise in specialty chemicals. IOL Chemicals’ API portfolio includes various therapeutic categories such as pain management, anti-diabetic, anti-hypertensive and anti-convulsant. IOL Chemicals is a backward-integrated company that produces all intermediates and key starting materials for ibuprofen.
    IOL Chemicals

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    08

    Jai Radhe Sales

    India
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    Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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    Valsartan

    About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

    Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
    Jai Radhe Sales

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    09

    HRV Global Life Sciences

    India
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    CPhI WW Frankfurt
    Attending
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Valsartan

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    10

    Zeon Pharma Industries India Pvt Lt...

    India
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    Vietnam Medi-Pharm Expo
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    Virtual BoothZeon Pharma is a manufacturer and supplier of APIs & Intermediates.

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    Valsartan

    About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...

    Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish formulations/Excipients, Phytochemicals/Enzymes & Intermediate and also has a GMP certified Manufacturing facility for Phytochemicals/Herbal extract and Enzymes through our associates.
    Zeon Pharma Industries India Pvt Ltd

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    API Reference Price

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AG","customerCountry":"SWITZERLAND","quantity":"3647.00","actualQuantity":"3647","unit":"KGS","unitRateFc":"148.1","totalValueFC":"531017.9","currency":"USD","unitRateINR":11097.869207567865,"date":"15-Mar-2022","totalValueINR":"40473929","totalValueInUsd":"531017.9","indian_port":"Vizag-DLL SEZ","hs_no":"29339990","bill_no":"4000414","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-DLL SEZ","supplierAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD, HYDERABAD,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648146600,"product":"SACUBITRIL VALSARTAN SODIUM HYDRATE","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"DIVIS LABORATORIES LTDDSN SEZ UNIT","supplierCountry":"INDIA","foreign_port":"BASEL","customer":"NOVARTIS PHARMA 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PU DONG","customer":"AET LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"99.00","actualQuantity":"99","unit":"KGS","unitRateFc":"220","totalValueFC":"21869.3","currency":"USD","unitRateINR":"18821","date":"13-May-2025","totalValueINR":"1863279","totalValueInUsd":"21869.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2034073","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.6,AIRPORT NORTH ROAD,SANZAO TOWN JINWAN DISTRICT,ZHUHAI GUANGDONG P.R. CHINA CN","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748889000,"product":"SACUBITRIL VALSARTAN SODIUM ON COLLOIDAL SILICON DIOXIDE","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO LABS LTD","customerCountry":"INDIA","quantity":"314.95","actualQuantity":"314.95","unit":"KGS","unitRateFc":"694.4","totalValueFC":"219923.3","currency":"USD","unitRateINR":"60000","date":"03-Jun-2025","totalValueINR":"18897000","totalValueInUsd":"219923.3","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"2433228","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD N.NARASAPURAM VILLAGE NAKKAPALLY M SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749493800,"product":"VALSARTAN USP VALSARTAN USP","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AJANTA PHARMA LTD","customerCountry":"INDIA","quantity":"45.30","actualQuantity":"45.3","unit":"KGS","unitRateFc":"68","totalValueFC":"3110","currency":"USD","unitRateINR":"5899","date":"10-Jun-2025","totalValueINR":"267224.7","totalValueInUsd":"3110","indian_port":"JNPT","hs_no":"29339990","bill_no":"2568584","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"XUNQIAO LINHAI ZHEJIANG 317024,CHIN A SDNF China","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750012200,"product":"VALSARTAN DISODIUMC(FOC) VALSARTAN DISODIUM","address":"#28 CANTON ROWS, PETBASHEERBAD","city":"HYDERABAD","supplier":"ZHEJIANG TIANYU PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"1100.00","actualQuantity":"1100","unit":"KGS","unitRateFc":"350","totalValueFC":"388694.7","currency":"USD","unitRateINR":"30362.5","date":"16-Jun-2025","totalValueINR":"33398750","totalValueInUsd":"388694.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2692645","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"Jiangkou Development Zone Huangyan Taizhou Zhejiang China CN","customerAddress":"#28 CANTON ROWS, PETBASHEERBAD"}]
    06-Jan-2022
    27-Jun-2025
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    Drugs in Development

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    Lupin Receives U.S. FDA Approval for Sacubitril and Valsartan Tablets

    Details:

    Entresto-Generic (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 24, 2025

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    01

    Lupin Ltd

    India
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    Lupin Ltd

    India
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lupin Receives U.S. FDA Approval for Sacubitril and Valsartan Tablets

    Details : Entresto-Generic (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure.

    Product Name : Entresto-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 24, 2025

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    USV Introduces OnArni, FDC of Sacubitril, Valsartan, For HF Management

    Details:

    OnArni (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: OnArni

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 15, 2024

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    02

    USV Private Limited

    India
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    Not Confirmed

    USV Private Limited

    India
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    Not Confirmed
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    USV Introduces OnArni, FDC of Sacubitril, Valsartan, For HF Management

    Details : OnArni (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.

    Product Name : OnArni

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 15, 2024

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    Zydus Lifesciences gets USFDA nod to market chronic heart failure treatment drug

    Details:

    Enresto-Generic (sacubitril and valsartan) is an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 07, 2024

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    Zydus Lifesciences

    India
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    Zydus Lifesciences

    India
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    Not Confirmed
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Zydus Lifesciences gets USFDA nod to market chronic heart failure treatment drug

    Details : Enresto-Generic (sacubitril and valsartan) is an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.

    Product Name : Entresto-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 07, 2024

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    Novartis Gains Approval for Entresto for Pediatric Chronic Heart Failure

    Details:

    Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Otsuka Pharmaceutical

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 02, 2024

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    Novartis Pharmaceuticals Corporation

    Switzerland
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    Not Confirmed

    Novartis Pharmaceuticals Corporation

    Switzerland
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    Not Confirmed
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Otsuka Pharmaceutical

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis Gains Approval for Entresto for Pediatric Chronic Heart Failure

    Details : Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.

    Product Name : Entresto

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 02, 2024

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    Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

    Details:

    A eneric formulation of sacubitril and valsartan, an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 29, 2024

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    Alembic Pharmaceuticals Limited

    India
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    Not Confirmed

    Alembic Pharmaceuticals Limited

    India
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    Not Confirmed
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

    Details : A eneric formulation of sacubitril and valsartan, an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.

    Product Name : Entresto-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    May 29, 2024

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    Exemed Receives CDSCO Nod For Study of Sacubitril Plus Valsartan Sustained-Release Tablet

    Details:

    Sacubright (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Sacubright

    Study Phase: Phase IIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 10, 2024

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    Exemed Pharmaceuticals

    India
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    Not Confirmed

    Exemed Pharmaceuticals

    India
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    Not Confirmed
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Exemed Receives CDSCO Nod For Study of Sacubitril Plus Valsartan Sustained-Release Tablet

    Details : Sacubright (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.

    Product Name : Sacubright

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    April 10, 2024

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    Novartis Gets Japan Approval for Entresto Granular Tablets for Pediatric Heart Failure Use

    Details:

    Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Otsuka Pharmaceutical

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 26, 2024

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    07

    Novartis Pharmaceuticals Corporation

    Switzerland
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed

    Novartis Pharmaceuticals Corporation

    Switzerland
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Otsuka Pharmaceutical

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis Gets Japan Approval for Entresto Granular Tablets for Pediatric Heart Failure Use

    Details : Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.

    Product Name : Entresto

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 26, 2024

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    Biocon Unit Gets USFDA Nod For Generic Drug

    Details:

    Sacubitril and valsartan is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 09, 2024

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    08

    Biocon

    India
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed

    Biocon

    India
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    Not Confirmed
    • fda
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Biocon Unit Gets USFDA Nod For Generic Drug

    Details : Sacubitril and valsartan is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.

    Product Name : Entresto-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    February 09, 2024

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    Novartis Entresto Receives Positive CHMP Opinion for Pediatric Heart Failure

    Details:

    Entresto contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. It inhibits neprilysin via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 receptor via valsartan in pediatric heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Otsuka Pharmaceutical

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 31, 2023

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    09

    Novartis Pharmaceuticals Corporation

    Switzerland
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed

    Novartis Pharmaceuticals Corporation

    Switzerland
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    Not Confirmed
    • fda
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    • WHO-GMP
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Otsuka Pharmaceutical

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Novartis Entresto Receives Positive CHMP Opinion for Pediatric Heart Failure

    Details : Entresto contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. It inhibits neprilysin via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 receptor via valsartan in pedia...

    Product Name : Entresto

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 31, 2023

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    Lupin Launches Sacubitril and Valsartan Combination Drug for Heart Failure Patients

    Details:

    Sacubitril and Valsartan drug inhibits neprilysin and blocks angiotensin II type-I receptor, increasing the levels of peptides degraded by neprilysin. It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure.


    Lead Product(s): Sacubitril Sodium,Valsartan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Valentas

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 18, 2023

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    10

    Lupin Ltd

    India
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed

    Lupin Ltd

    India
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    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Sacubitril Sodium,Valsartan

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Lupin Launches Sacubitril and Valsartan Combination Drug for Heart Failure Patients

    Details : Sacubitril and Valsartan drug inhibits neprilysin and blocks angiotensin II type-I receptor, increasing the levels of peptides degraded by neprilysin. It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure.

    Product Name : Valentas

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    January 18, 2023

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    INTERMEDIATE SUPPLIERS

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    01

    IOL Chemicals and Pharmaceuticals

    India
    CPhI Korea
    Attending
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    Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

    L-Valine,N-[(2'-cyano[1,1'-biphenyl]-4-yl)methyl]-...

    CAS Number : 482577-59-3

    End Use API : Valsartan

    About The Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermedia...

    IOL Chemicals

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    02

    PMC Isochem

    France
    CPhI WW Frankfurt
    Booth #12.0D50
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    Virtual BoothPMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

    3,5-Dimethyl-4-hydroxybenzaldehyde

    CAS Number : 2233-18-3

    End Use API : Valsartan

    About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...

    PMC Isochem

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    03

    Alembic Limited

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    Alembic Limited

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    N-[(2-Cynobiphenyl-4-yl)methyl]-(L)Valine Methyl E...

    CAS Number : 482577-59-3

    End Use API : Valsartan

    About The Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and ...

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    04

    Blue Jet Healthcare

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
    arrow

    Blue Jet Healthcare

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    L-Valine methyl ester HCl

    CAS Number : 6306-52-1

    End Use API : Valsartan

    About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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    05

    Blue Jet Healthcare

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
    arrow

    Blue Jet Healthcare

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
    arrow
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    • EDQM
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    N-[(2?-Cyanobiphenyl-4-yl)methyl]- (L)valine methy...

    CAS Number : 482577-59-3

    End Use API : Valsartan

    About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

    blank

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    06

    Louis Pharmaceuticals

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
    arrow

    Louis Pharmaceuticals

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
    arrow
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    L-Valine Methyl Ester Hydrochloride

    CAS Number : 6306-52-1

    End Use API : Valsartan

    About The Company : Louis Pharmaceuticals Private Limited is an Advanced Intermediates Manufacturing firm. The Company is established in 2009 and has an integrated focus from vario...

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    07

    Louis Pharmaceuticals

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    Louis Pharmaceuticals

    India
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    4-Bromomethyl-2-cyanobiphenyl (Br-OTBN)

    CAS Number : 114772-54-2

    End Use API : Valsartan

    About The Company : Louis Pharmaceuticals Private Limited is an Advanced Intermediates Manufacturing firm. The Company is established in 2009 and has an integrated focus from vario...

    blank

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    08

    Ningbo Syntame Biotech

    China
    Vietnam Medi-Pharm Expo
    Not Confirmed
    arrow

    Ningbo Syntame Biotech

    China
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    L-Valine methyl ester hydrochloride

    CAS Number : 6306-52-1

    End Use API : Valsartan

    About The Company : Syntame is a Pharm- Heatlh technology company jointly sponsored by two PhD from Hong Kong Polytechnic University & Zhejiang University. We always focus on the m...

    blank

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    09

    Ningbo Syntame Biotech

    China
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    Ningbo Syntame Biotech

    China
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    N-[(2?-cyano[1,1’biphenyl]-4-yl)methyl]-methyl e...

    CAS Number : 482577-59-3

    End Use API : Valsartan

    About The Company : Syntame is a Pharm- Heatlh technology company jointly sponsored by two PhD from Hong Kong Polytechnic University & Zhejiang University. We always focus on the m...

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    10

    Pluviaendo

    Turkey
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    Pluviaendo

    Turkey
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    Valsarthan Methyl Ester

    CAS Number : 137863-17-3

    End Use API : Valsartan

    About The Company : Pluvia Consumer Health is a multinational pharmaceutical company with its head office in Turkey/Istanbul & with unique molecules & know-how. Our portfolio conta...

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    FDF Dossiers

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    01

    Octavius Pharma Pvt. Ltd

    India
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
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    • WHO-GMP

    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Valsartan

    Brand Name : Valsartan

    Dosage Form : DC Granules

    Dosage Strength : 80MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    02

    Octavius Pharma Pvt. Ltd

    India
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Valsartan

    Brand Name : Valsartan

    Dosage Form : DC Granules

    Dosage Strength : 320MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

    Portfolio PDF

    Product Web Link

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    Digital Content

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    03

    Octavius Pharma Pvt. Ltd

    India
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Valsartan

    Brand Name : Valsartan

    Dosage Form : Tablet

    Dosage Strength : 80MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

    Portfolio PDF

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    04

    Octavius Pharma Pvt. Ltd

    India
    arrow
    Vietnam Medi-Pharm Expo
    Not Confirmed
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Valsartan

    Brand Name : Valsartan

    Dosage Form : Tablet

    Dosage Strength : 320MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    05

    Octavius Pharma Pvt. Ltd

    India
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Regulatory Info :

    Registration Country : India

    Valsartan; Amlodipine

    Brand Name : Valsartan; Amlodipine

    Dosage Form : DC Granules

    Dosage Strength : 80MG; 5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    06

    Octavius Pharma Pvt. Ltd

    India
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Regulatory Info :

    Registration Country : India

    Valsartan; Amlodipine

    Brand Name : Valsartan; Amlodipine

    Dosage Form : DC Granules

    Dosage Strength : 320MG; 5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    07

    Octavius Pharma Pvt. Ltd

    India
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    Not Confirmed
    • fda
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    • WHO-GMP

    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Regulatory Info :

    Registration Country : India

    Valsartan; Amlodipine

    Brand Name : Valsartan; Amlodipine

    Dosage Form : DC Granules

    Dosage Strength : 320MG; 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    08

    Octavius Pharma Pvt. Ltd

    India
    arrow
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Registration Country : India

    Valsartan; Hydrochlorothiazide

    Brand Name : Valsartan; Hydrochlorothiazide

    Dosage Form : DC Granules

    Dosage Strength : 160MG; 12.5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    09

    Octavius Pharma Pvt. Ltd

    India
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Regulatory Info :

    Registration Country : India

    Valsartan; Hydrochlorothiazide

    Brand Name : Valsartan; Hydrochlorothiazide

    Dosage Form : DC Granules

    Dosage Strength : 320MG; 12.5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    10

    Octavius Pharma Pvt. Ltd

    India
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    Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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    Registration Country : India

    Valsartan; Hydrochlorothiazide

    Brand Name : Valsartan; Hydrochlorothiazide

    Dosage Form : Tablet

    Dosage Strength : 160MG; 12.5MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Octavius Pharma

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    DRUG PRODUCT COMPOSITIONS

    Do you need Business Intel? Ask us

    DOSAGE - TABLET;ORAL - EQ 5MG BASE;80MG

    USFDA APPLICATION NUMBER - 206302

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    DOSAGE - TABLET;ORAL - 12.5MG;160MG

    USFDA APPLICATION NUMBER - 20818

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    DOSAGE - TABLET;ORAL - 12.5MG;320MG

    USFDA APPLICATION NUMBER - 20818

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    DOSAGE - TABLET;ORAL - 12.5MG;80MG

    USFDA APPLICATION NUMBER - 20818

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    DOSAGE - TABLET;ORAL - 25MG;160MG

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    ABOUT THIS PAGE

    Looking for 137862-53-4 / Valsartan API manufacturers, exporters & distributors?

    Valsartan manufacturers, exporters & distributors 1

    39

    PharmaCompass offers a list of Valsartan 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 Valsartan manufacturer or Valsartan supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Valsartan manufacturer or Valsartan supplier.

    PharmaCompass also assists you with knowing the Valsartan API Price utilized in the formulation of products. Valsartan API Price is not always fixed or binding as the Valsartan Price is obtained through a variety of data sources. The Valsartan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Valsartan

    Synonyms

    137862-53-4, Diovan, Tareg, Cgp 48933, Provas, Exforge

    Cas Number

    137862-53-4

    Unique Ingredient Identifier (UNII)

    80M03YXJ7I

    About Valsartan

    A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 Manufacturers

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2, including repackagers and relabelers. The FDA regulates AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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 AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 Suppliers

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 supplier is an individual or a company that provides AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 active pharmaceutical ingredient (API) or AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 finished formulations upon request. The AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers may include AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 API manufacturers, exporters, distributors and traders.

    click here to find a list of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 USDMF

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 active pharmaceutical ingredient (API) in detail. Different forms of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 DMFs exist exist since differing nations have different regulations, such as AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 DMF submitted to regulatory agencies in the US is known as a USDMF. AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 USDMF includes data on AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers with USDMF on PharmaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 Drug Master File in Japan (AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 JDMF) empowers AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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 AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 JDMF during the approval evaluation for pharmaceutical products. At the time of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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 AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers with JDMF on PharmaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 KDMF

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

    Pharmaceutical companies submit a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 Drug Master File in Korea (AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2. The MFDS reviews the AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 KDMF as part of the drug registration process and uses the information provided in the AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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 AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers with KDMF on PharmaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP of the European Pharmacopoeia monograph is often referred to as a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 Certificate of Suitability (COS). The purpose of a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 to their clients by showing that a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP has been issued for it. The manufacturer submits a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP holder for the record. Additionally, the data presented in the AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 DMF.

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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 AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers with CEP (COS) on PharmaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 WC

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 written confirmation (AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 WC) is an official document issued by a regulatory agency to a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 manufacturer, verifying that the manufacturing facility of a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 APIs or AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 finished pharmaceutical products to another nation, regulatory agencies frequently require a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 WC (written confirmation) as part of the regulatory process.

    click here to find a list of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers with Written Confirmation (WC) on PharmaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 suppliers with NDC on PharmaCompass.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 GMP

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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 AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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 AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 GMP manufacturer or AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 GMP API supplier for your needs.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CoA

    A AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CoA (Certificate of Analysis) is a formal document that attests to AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2's compliance with AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 specifications and serves as a tool for batch-level quality control.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 CoA mostly includes findings from lab analyses of a specific batch. For each AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 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.

    AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 EP), AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AMLODIPINE,VALSARTAN; HYDROCHLOROTHIAZIDE-2 USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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