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    Also known as: Isosorbide 5-mononitrate, 16051-77-7, Imdur, Corangin, Monosorbitrate, Monoket
    Molecular Formula
    C6H9NO6
    Molecular Weight
    191.14  g/mol
    InChI Key
    YWXYYJSYQOXTPL-SLPGGIOYSA-N
    FDA UNII
    LX1OH63030
    Isosorbide Mononitrate
    Isosorbide Mononitrate is the mononitrate salt form of isosorbide, an organic nitrate with vasodilator activity. Isosorbide mononitrate relaxes vascular smooth muscle by formation of the free radical nitric oxide (NO), which is identical to the endothelium-derived relaxing factor (EDRF). NO activates guanylyl cyclase, thereby increasing the synthesis of cGMP within smooth muscle, resulting in dephosphorylation of light chain myosin and relaxation of peripheral arteries and veins. In addition, isosorbide mononitrate relaxes coronary arteries, thereby increasing the blood circulation through the ischemic area. (NCI05)
    Isosorbide mononitrate is a Nitrate Vasodilator. The physiologic effect of isosorbide mononitrate is by means of Vasodilation.
    1 2D Structure

    Isosorbide Mononitrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(3S,3aR,6R,6aS)-3-hydroxy-2,3,3a,5,6,6a-hexahydrofuro[3,2-b]furan-6-yl] nitrate
    2.1.2 InChI
    InChI=1S/C6H9NO6/c8-3-1-11-6-4(13-7(9)10)2-12-5(3)6/h3-6,8H,1-2H2/t3-,4+,5+,6+/m0/s1
    2.1.3 InChI Key
    YWXYYJSYQOXTPL-SLPGGIOYSA-N
    2.1.4 Canonical SMILES
    C1C(C2C(O1)C(CO2)O[N+](=O)[O-])O
    2.1.5 Isomeric SMILES
    C1[C@@H]([C@@H]2[C@H](O1)[C@@H](CO2)O[N+](=O)[O-])O
    2.2 Other Identifiers
    2.2.1 UNII
    LX1OH63030
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-ismn

    2. 5-ismn Durules

    3. Elantan

    4. Imdur

    5. Ismo

    6. Isosorbide-5-mononitrate

    7. Isosorbide-5-nitrate

    8. Monizid

    9. Mono Mac 50d

    10. Monocinque

    11. Monoket

    12. Mononit

    13. Olicard 40

    14. Olicard-retard

    2.3.2 Depositor-Supplied Synonyms

    1. Isosorbide 5-mononitrate

    2. 16051-77-7

    3. Imdur

    4. Corangin

    5. Monosorbitrate

    6. Monoket

    7. Elantan

    8. Mononit

    9. Isosorbide-5-mononitrate

    10. Isosorbide 5-nitrate

    11. Ismn

    12. Ismo

    13. Monolong

    14. Monopront

    15. Monosordil

    16. Nitramin

    17. Orasorbil

    18. Promocard

    19. Sigacora

    20. Sorbimon

    21. Turimonit

    22. Vasdilat

    23. Duride

    24. Imtrate

    25. Ismexin

    26. Medocor

    27. Monicor

    28. Olicard

    29. Pertil

    30. Uniket

    31. Ismox

    32. Monodur Durules

    33. Mono Corax

    34. Monisid

    35. Monocord

    36. Isosorbidi Mononitras [latin]

    37. Isosorbidi Mononitras

    38. Mononitrate D'isosorbide [french]

    39. Is 5-mn

    40. Mononitrate D'isosorbide

    41. Mononitrato De Isosorbida [spanish]

    42. 1,4:3,6-dianhydro-d-glucitol 5-nitrate

    43. Mononitrato De Isosorbida

    44. Iso-5-mononitrate

    45. Ahr-4698

    46. Is-5-mn

    47. D-glucitol, 1,4:3,6-dianhydro-, 5-nitrate

    48. Is-5mn

    49. 1,4:3,6-dianhydro-5-o-nitro-d-erythro-hexitol

    50. Monizid

    51. Bm 22.145

    52. Bm-22-145

    53. Vasotrate

    54. Epicordin

    55. Monoclair

    56. Monotrate

    57. Olicardin

    58. Percorina

    59. Edistol

    60. Etimonis

    61. Isomonat

    62. Isomonit

    63. Multitab

    64. Titarane

    65. Conpin

    66. Imazin

    67. Imodur

    68. Isomon

    69. Iturol

    70. Monis

    71. Nitex

    72. Plodin

    73. Ihd

    74. Monosigma

    75. Elantan Retard

    76. Mono-sanorania

    77. Monoket Retard

    78. Nsc-758619

    79. Elantan Long

    80. Imdur Durules

    81. Corangin Sr

    82. Mono Mack

    83. Mono-mack

    84. Conpin Retardkaps

    85. Diluted Isosorbide Mononitrate

    86. Fem-mono

    87. Ismn Lannacher

    88. Monoket Od

    89. Ismn Apogepha

    90. Ismn Heumann

    91. Ismn Basics

    92. Pentacard 20

    93. [(3s,3ar,6r,6as)-3-hydroxy-2,3,3a,5,6,6a-hexahydrofuro[3,2-b]furan-6-yl] Nitrate

    94. 1,4:3,6-dianhydro-5-o-nitro-d-glucitol

    95. Mono Corax Retard

    96. Chebi:6062

    97. Ismn Hexal

    98. Ismn Stada

    99. Monocord 20

    100. Monocord 40

    101. Monolong 40

    102. Monolong 60

    103. Ismn Atid

    104. Mononit 20

    105. Mononit 40

    106. Isopen-20

    107. Monocord 50 Sr

    108. Mononit Retard 50

    109. 5-ismn

    110. (3r,3as,6s,6ar)-6-hydroxy-hexahydrofuro[3,2-b]furan-3-yl Nitrate

    111. Imdur 60

    112. Ismn Abz

    113. Lx1oh63030

    114. Monit 20

    115. Ismn Al

    116. Ismo-20

    117. Isosorbide-5-nitrate

    118. Monocedocard

    119. Bm-22145

    120. Is 5mn

    121. Monosorb

    122. Bm-22.145

    123. (3r,3as,6s,6ar)-6-hydroxyhexahydrofuro[3,2-b]furan-3-yl Nitrate

    124. Bm 22.145is 5-mnahr-4698

    125. Glucitol, 1,4:3,6-dianhydro-, 5-nitrate, D-

    126. Monomax

    127. Ahr 4698

    128. Monosorb Xl 60

    129. Ccris 1911

    130. Imdur (tn)

    131. Isosorbide Mononitrate (isosorbide 5-nitrate)

    132. Ismo (tn)

    133. Bm 22-145

    134. Sr-05000001872

    135. Einecs 240-197-2

    136. Un3251

    137. Brn 5851319

    138. Leicester

    139. Unii-lx1oh63030

    140. Ncgc00159334-02

    141. Isorbide Mononitrate

    142. Mfcd00143462

    143. Isosorbide-mononitrate

    144. Isosobide-5-mononitrate

    145. 5-isosorbide Mononitrate

    146. Dsstox_cid_3176

    147. Isosorbide Mononitrate,(s)

    148. Chembl1311

    149. Dsstox_rid_76905

    150. Dsstox_gsid_23176

    151. Isosorbide Mononitrate [usan:usp:inn:ban:jan]

    152. Schembl26781

    153. Gtpl7052

    154. Dtxsid9023176

    155. Niosh/lz4385560

    156. Hms2093k07

    157. Hms3715i08

    158. Pharmakon1600-01503807

    159. Hy-b0642

    160. Zinc1849548

    161. Isosorbide Mononitrate [inn]

    162. Isosorbide Mononitrate [jan]

    163. Tox21_111581

    164. Isosorbide Mononitrate [usan]

    165. Nsc758619

    166. S4633

    167. Isosorbide Mononitrate [vandf]

    168. Akos005110986

    169. Isosorbide Mononitrate [mart.]

    170. Ac-8830

    171. Ccg-213200

    172. Cs-3495

    173. Db01020

    174. Isosorbide Mononitrate [who-dd]

    175. Nsc 758619

    176. Isosorbide Mononitrate (jp17/usp/inn)

    177. Ncgc00167981-01

    178. Ncgc00167981-03

    179. D-1,4:3,6-dianhydroglucitol 5-nitrate

    180. 1,4:3,6-dianhydrosorbitol 5-mononitrate

    181. Sbi-0206724.p001

    182. Cas-16051-77-7

    183. Isosorbide Mononitrate [orange Book]

    184. Bb 0261072

    185. I0403

    186. Isosorbide Dinitrate Isosorbide-5-mononitrate

    187. Isosorbide Mononitrate [usp Impurity]

    188. Lz43855600

    189. C07714

    190. D00630

    191. Diluted Isosorbide Mononitrate [usp-rs]

    192. W15583

    193. Ab01563284_01

    194. Q423401

    195. Sr-05000001872-1

    196. Sr-05000001872-2

    197. W-107977

    198. Brd-k82225283-001-01-5

    199. Diluted Isosorbide Mononitrate [usp Monograph]

    200. Isosobide-5-mononitrate [un3251] [flammable Solid]

    201. Isosorbide Mononitrate 1.0 Mg/ml In Dimethyl Sulfoxide

    202. Isosorbide Dinitrate Isosorbide-5-mononitrate [mi]

    203. Isosorbide Dinitrate, Diluted Impurity C [ep Impurity]

    204. [(3r,3as,6s,6ar)-6-hydroxy-2,3,3a,5,6,6a-hexahydrofuro[2,3-d]furan-3-yl] Nitrate

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 191.14 g/mol
    Molecular Formula C6H9NO6
    XLogP3-0.4
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count1
    Exact Mass191.04298701 g/mol
    Monoisotopic Mass191.04298701 g/mol
    Topological Polar Surface Area93.7 Ų
    Heavy Atom Count13
    Formal Charge0
    Complexity216
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    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 NameIsosorbide mononitrate
    PubMed HealthIsosorbide Mononitrate (By mouth)
    Drug ClassesAntianginal, Coronary Vasodilator
    Drug LabelIsosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins.Each tablet, for oral administration, contains either 30 mg, 60 mg...
    Active IngredientIsosorbide mononitrate
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength30mg; 120mg; 60mg; 10mg; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Ani Pharms; Torrent Pharms; Hikma Pharms; Dexcel; Nesher Pharms; Kremers Urban Pharms; Actavis Elizabeth

    2 of 4  
    Drug NameMonoket
    PubMed HealthIsosorbide Mononitrate (By mouth)
    Drug ClassesAntianginal, Coronary Vasodilator
    Drug Labelmonoket, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for monoket is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound h...
    Active IngredientIsosorbide mononitrate
    Dosage FormTablet
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyKremers Urban Pharms

    3 of 4  
    Drug NameIsosorbide mononitrate
    PubMed HealthIsosorbide Mononitrate (By mouth)
    Drug ClassesAntianginal, Coronary Vasodilator
    Drug LabelIsosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins.Each tablet, for oral administration, contains either 30 mg, 60 mg...
    Active IngredientIsosorbide mononitrate
    Dosage FormTablet, extended release; Tablet
    RouteOral
    Strength30mg; 120mg; 60mg; 10mg; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Ani Pharms; Torrent Pharms; Hikma Pharms; Dexcel; Nesher Pharms; Kremers Urban Pharms; Actavis Elizabeth

    4 of 4  
    Drug NameMonoket
    PubMed HealthIsosorbide Mononitrate (By mouth)
    Drug ClassesAntianginal, Coronary Vasodilator
    Drug Labelmonoket, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C6H9NO6 and the molecular weight is 191.14. The chemical name for monoket is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound h...
    Active IngredientIsosorbide mononitrate
    Dosage FormTablet
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyKremers Urban Pharms

    4.2 Drug Indication

    Isosorbide mononitrate is indicated for the prevention and management of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid to be useful in aborting an acute anginal episode.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Isosorbide mononitrate is an anti-anginal agent and vasodilator that relaxes vascular smooth muscle to prevent and manage angina pectoris. The pharmacological action is mediated by the active metabolite, [nitric oxide], which is released when isosorbide mononitrate is metabolized. Nitric oxide works on both arteries and veins, but predominantly veins: by relaxing veins and reducing the central venous pressure, nitric oxide causes venous pooling and a decrease in the venous return to the heart, thus decreasing cardiac preload. In healthy subjects, the stroke volume is decreased and venous pooling can occur in the standing posture, leading to postural hypotension and dizziness. At therapeutic doses of isosorbide mononitrate, nitric oxide has a bigger effect on larger muscular arteries over small resistance arteries. Arterial relaxation leads to reduced systemic vascular resistance and systolic blood (aortic) pressure, decreasing to decreased cardiac afterload. The direct dilator effect on coronary arteries opposes the coronary artery spasm in variant angina or angina pectoris. At larger doses, nitric oxide causes the resistance arteries and arterioles to dilate, reducing arterial pressure via coronary vasodilatation. This leads to increased coronary blood flow. Reduced cardiac preload and afterload caused by nitric oxide causes a reduction in myocardial oxygen consumption; decreased myocardial oxygen demand, along with increased coronary blood flow, leads to an increased in the oxygen content of coronary sinus blood and the relief from ischemia. The end effect of isosorbide mononitrate include decreased cardiac oxygen consumption, redistribution coronary flow toward ischemic areas via collaterals, and the relief of coronary spasms. Nitric oxide can also increase the rate of relaxation of cardiac muscles, which is an effect outside of vascular smooth muscles. Organic nitrates can also relax other types of smooth muscles, including esophageal and biliary smooth muscle. The anti-anginal activity of isosorbide mononitrate was observed about 1 hour after dosing, and the peak effect was achieved from 1-4 hours after dosing. The duration of anti-anginal action of at least 12 hours was observed with an asymmetrical dosing regimen.

    5.2 MeSH Pharmacological Classification

    Nitric Oxide Donors

    A diverse group of agents, with unique chemical structures and biochemical requirements, which generate NITRIC OXIDE. These compounds have been used in the treatment of cardiovascular diseases and the management of acute myocardial infarction, acute and chronic congestive heart failure, and surgical control of blood pressure. (Adv Pharmacol 1995;34:361-81) (See all compounds classified as Nitric Oxide Donors.)

    Vasodilator Agents

    Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ISOSORBIDE MONONITRATE
    5.3.2 FDA UNII
    LX1OH63030
    5.3.3 Pharmacological Classes
    Nitrates [CS]; Vasodilation [PE]; Nitrate Vasodilator [EPC]
    5.4 ATC Code

    C - Cardiovascular system

    C01 - Cardiac therapy

    C01D - Vasodilators used in cardiac diseases

    C01DA - Organic nitrates

    C01DA14 - Isosorbide mononitrate

    5.5 Absorption, Distribution and Excretion

    Absorption

    Upon oral administration, isosorbide mononitrate is rapidly and completely absorbed from the gastrointestinal tract. Isosorbide mononitrate has a dose-linear kinetics and the absolute bioavailability is nearly 100%. The Cmax is reached within 30 to 60 minutes following administration.

    Route of Elimination

    In a human radio-labelled drug study, about 93% of the total dose was excreted in the urine within 48 hours. Following oral administration of 20 mg, only 2% of isosorbide mononitrate was excreted unchanged in the urine within 24 hours. Among the excreted dose, nearly half of the dose was found de-nitrated in urine as isosorbide and sorbitol: approximately 30% is excreted as isosorbide and about 17% is the 2-glucuronide of mononitrate. These metabolites were not vasoactive or pharmacologically active. Renal excretion was complete after 5 days, and fecal excretion accounted for only 1% of drug elimination.

    Volume of Distribution

    The volume of distribution is approximately 0.6 L/kg, which is approximately the volume of total body water.

    Clearance

    The total body clearance is 115-120 mL/min.

    5.6 Metabolism/Metabolites

    Isosorbide mononitrate is not subject to first pass metabolism in human liver. Detectable metabolites include isosorbide, sorbitol, and 2-glucuronide of mononitrate, which are pharmacologically inactive.

    5.7 Biological Half-Life

    The elimination half-life of isosorbide mononitrate is about 5 hours. The elimination half-life of its metabolites, isosorbide and 2-glucuronide of mononitrate, are 8 hours and 6 hours, respectively.

    5.8 Mechanism of Action

    Isosorbide mononitrate acts as a prodrug for nitric oxide (NO), which is a potent vasodilator gas that is released when the drug is metabolized. NO activates soluble guanylyl cyclase in vascular endothelial cells, which increases the intracellular concentrations of cyclic GMP (cGMP). cGMP activates cGMP-dependent protein kinases, such as protein kinase G and I, which activates the downstream intracellular cascades. The downstream cascade results in reduced intracellular concentrations of calcium, caused by processes including inhibition of IP3-mediated pathway, phosphorylation of big calcium-activated potassium channel leading to cell hyperpolarization and reduced calcium influx, and increased calcium efflux via the Ca2+-ATPase-pump. Reduced intracellular calcium concentrations lead to the dephosphorylation of myosin light chains and the relaxation of smooth muscle cells.

    API Reference Price

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    28-Jan-2021
    22-Nov-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 20215

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    DOSAGE - TABLET;ORAL - 20MG

    USFDA APPLICATION NUMBER - 20215

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    USP

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    ABOUT THIS PAGE

    Isosorbide Mononitrate Manufacturers

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

    Isosorbide Mononitrate Suppliers

    A Isosorbide Mononitrate supplier is an individual or a company that provides Isosorbide Mononitrate active pharmaceutical ingredient (API) or Isosorbide Mononitrate finished formulations upon request. The Isosorbide Mononitrate suppliers may include Isosorbide Mononitrate API manufacturers, exporters, distributors and traders.

    click here to find a list of Isosorbide Mononitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Isosorbide Mononitrate USDMF

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

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

    click here to find a list of Isosorbide Mononitrate suppliers with USDMF on PharmaCompass.

    Isosorbide Mononitrate 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 Isosorbide Mononitrate Drug Master File in Japan (Isosorbide Mononitrate JDMF) empowers Isosorbide Mononitrate 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 Isosorbide Mononitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Isosorbide Mononitrate 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 Isosorbide Mononitrate suppliers with JDMF on PharmaCompass.

    Isosorbide Mononitrate KDMF

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

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

    After submitting a Isosorbide Mononitrate 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 Isosorbide Mononitrate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Isosorbide Mononitrate suppliers with KDMF on PharmaCompass.

    Isosorbide Mononitrate CEP

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

    A Isosorbide Mononitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isosorbide Mononitrate 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 Isosorbide Mononitrate suppliers with CEP (COS) on PharmaCompass.

    Isosorbide Mononitrate WC

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

    click here to find a list of Isosorbide Mononitrate suppliers with Written Confirmation (WC) on PharmaCompass.

    Isosorbide Mononitrate 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 Isosorbide Mononitrate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Isosorbide Mononitrate 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 Isosorbide Mononitrate 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 Isosorbide Mononitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isosorbide Mononitrate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Isosorbide Mononitrate suppliers with NDC on PharmaCompass.

    Isosorbide Mononitrate GMP

    Isosorbide Mononitrate 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 Isosorbide Mononitrate 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 Isosorbide Mononitrate GMP manufacturer or Isosorbide Mononitrate GMP API supplier for your needs.

    Isosorbide Mononitrate CoA

    A Isosorbide Mononitrate CoA (Certificate of Analysis) is a formal document that attests to Isosorbide Mononitrate's compliance with Isosorbide Mononitrate specifications and serves as a tool for batch-level quality control.

    Isosorbide Mononitrate CoA mostly includes findings from lab analyses of a specific batch. For each Isosorbide Mononitrate 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.

    Isosorbide Mononitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Isosorbide Mononitrate EP), Isosorbide Mononitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isosorbide Mononitrate 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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