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    Chemistry

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    Also known as: 63675-72-9, Sular, Nisocor, Baymycard, Nisoldipin, Zadipina
    Molecular Formula
    C20H24N2O6
    Molecular Weight
    388.4  g/mol
    InChI Key
    VKQFCGNPDRICFG-UHFFFAOYSA-N
    FDA UNII
    4I8HAB65SZ
    Nisoldipine
    A dihydropyridine calcium channel antagonist that acts as a potent arterial vasodilator and antihypertensive agent. It is also effective in patients with cardiac failure and angina.
    Nisoldipine is a Dihydropyridine Calcium Channel Blocker. The mechanism of action of nisoldipine is as a Calcium Channel Antagonist. The physiologic effect of nisoldipine is by means of Decreased Blood Pressure.
    1 2D Structure

    Nisoldipine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-O-methyl 5-O-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
    2.1.2 InChI
    InChI=1S/C20H24N2O6/c1-11(2)10-28-20(24)17-13(4)21-12(3)16(19(23)27-5)18(17)14-8-6-7-9-15(14)22(25)26/h6-9,11,18,21H,10H2,1-5H3
    2.1.3 InChI Key
    VKQFCGNPDRICFG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C(C(=C(N1)C)C(=O)OCC(C)C)C2=CC=CC=C2[N+](=O)[O-])C(=O)OC
    2.2 Other Identifiers
    2.2.1 UNII
    4I8HAB65SZ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Bay K 5552

    2.3.2 Depositor-Supplied Synonyms

    1. 63675-72-9

    2. Sular

    3. Nisocor

    4. Baymycard

    5. Nisoldipin

    6. Zadipina

    7. Bay K 5552

    8. Nisoldipinum

    9. Syscor

    10. 3-isobutyl 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    11. Nisoldipinum [inn-latin]

    12. Nisoldipino [inn-spanish]

    13. Bay-k-5552

    14. Bay-k 5552

    15. Geomatrix 16e

    16. Nisoldipine (stn)

    17. Chebi:76917

    18. Methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    19. 3-o-methyl 5-o-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    20. Nsc-759106

    21. 4i8hab65sz

    22. Chembl441428

    23. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, Methyl 2-methylpropyl Ester

    24. Nisoldipino

    25. Nisoldipine 100 Microg/ml In Methanol

    26. Ncgc00164633-01

    27. Dsstox_cid_3371

    28. Dsstox_rid_76999

    29. Dsstox_gsid_23371

    30. 3-methyl 5-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    31. Smr000466370

    32. Cas-63675-72-9

    33. Sular (tn)

    34. Sr-05000002009

    35. Einecs 264-407-7

    36. Mfcd00478055

    37. Unii-4i8hab65sz

    38. Brn 0454188

    39. Nisoldipine (jan/usan/inn)

    40. Nisoldipine;

    41. Nisoldipine,(s)

    42. Nisoldipine [usan:inn:ban:jan]

    43. (+-)-isobutyl Methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate

    44. Isobutyl 1,4-dihydro-5-methoxycarbonyl-2,6-dimethyl-4-(2-nitrophenyl)-3-pyridincarboxylat

    45. Nisoldipine, ~97%

    46. Nisoldipine [mi]

    47. Nisoldipine [inn]

    48. Nisoldipine [jan]

    49. (.+/-.)-nisoldipine

    50. Nisoldipine [usan]

    51. Nisoldipine [vandf]

    52. Baymycard, Norvasc, Syscor

    53. Chembl1726

    54. Nisoldipine [mart.]

    55. Schembl39779

    56. (+/-)-nisoldipine

    57. Nisoldipine [usp-rs]

    58. Nisoldipine [who-dd]

    59. 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Methyl 2-methylpropyl Ester

    60. Mls000759498

    61. Mls001424102

    62. Mls002153943

    63. Bidd:gt0684

    64. Gtpl2524

    65. Chembl3192341

    66. Dtxsid0023371

    67. Nisoldipine, >=98% (hplc)

    68. Nisoldipine [orange Book]

    69. Hms2051o18

    70. Hms2089k20

    71. Hms2093f15

    72. Hms2097e13

    73. Hms2231l20

    74. Hms3393o18

    75. Hms3651k17

    76. Hms3714e13

    77. Hms3744o19

    78. Hms3884i08

    79. Pharmakon1600-01505390

    80. Bcp22696

    81. Tox21_112251

    82. Tox21_302365

    83. Ac-987

    84. Bbl028683

    85. Bdbm50101963

    86. Bdbm50227259

    87. Dl-255

    88. Nsc759106

    89. S1748

    90. Stk631543

    91. Akos005563632

    92. Akos037515714

    93. Tox21_112251_1

    94. Ccg-100894

    95. Ccg-213412

    96. Cs-1131

    97. Db00401

    98. Ks-5188

    99. Nc00144

    100. Nsc 759106

    101. Bay K 5552;bay-k 5552;sular

    102. Isobutyl Methyl 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate

    103. O5-isobutyl O3-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    104. Ncgc00164633-02

    105. Ncgc00164633-03

    106. Ncgc00255136-01

    107. 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic Acid Isobutyl Methyl Ester

    108. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, Methyl 2-methylpropyl Ester, (+-)-

    109. 6-bromo-2,3-dimethoxybenzoicacid

    110. Bn164147

    111. Hy-17402

    112. (+/-)-bay-k-5552

    113. Sbi-0206830.p001

    114. ((c)i)-nisoldipine-d4(2-nitrophenyl-d4)

    115. Ft-0601599

    116. N0900

    117. Sw219237-1

    118. C07699

    119. D00618

    120. Ab01275444-01

    121. Ab01275444_02

    122. 675n729

    123. A834466

    124. Q3342150

    125. Sr-05000002009-1

    126. Sr-05000002009-2

    127. Sr-05000002009-3

    128. Brd-a84465106-001-01-2

    129. Z277942268

    130. 3-isobutyl5-methyl2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    131. Isobutyl Methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    132. (.+/-.)-isobutyl Methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate

    133. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, 3-methyl 5-(2-methylpropyl) Ester

    134. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, Methyl 2-methylpropyl Ester, (+/-)-

    135. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, Methyl 2-methylpropyl Ester, (.+/-.)-

    136. 3-isobutyl 5-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate #

    137. Methyl 2-methylpropyl-1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate, Dl-

    138. O5-isobutyl O3-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate;nisoldipine

    139. O5-methyl O3-(2-methylpropyl) 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 388.4 g/mol
    Molecular Formula C20H24N2O6
    XLogP33.3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count7
    Exact Mass388.16343649 g/mol
    Monoisotopic Mass388.16343649 g/mol
    Topological Polar Surface Area110 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity704
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    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 NameNisoldipine
    PubMed HealthNisoldipine (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
    Drug LabelNisoldipine is an extended-release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is ()-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate, C20H24N2O6, and has the struct...
    Active IngredientNisoldipine
    Dosage FormTablet, extended release
    RouteOral
    Strength34mg; 8.5mg; 30mg; 25.5mg; 17mg; 40mg; 20mg
    Market StatusPrescription
    CompanyMylan

    2 of 4  
    Drug NameSular
    PubMed HealthNisoldipine (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
    Drug LabelSULAR (nisoldipine) is an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, C20H24...
    Active IngredientNisoldipine
    Dosage FormTablet, extended release
    RouteOral
    Strength34mg; 8.5mg; 17mg
    Market StatusPrescription
    CompanyShionogi

    3 of 4  
    Drug NameNisoldipine
    PubMed HealthNisoldipine (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
    Drug LabelNisoldipine is an extended-release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is ()-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-(o-nitrophenyl)-3,5-pyridinedicarboxylate, C20H24N2O6, and has the struct...
    Active IngredientNisoldipine
    Dosage FormTablet, extended release
    RouteOral
    Strength34mg; 8.5mg; 30mg; 25.5mg; 17mg; 40mg; 20mg
    Market StatusPrescription
    CompanyMylan

    4 of 4  
    Drug NameSular
    PubMed HealthNisoldipine (By mouth)
    Drug ClassesAntianginal, Antihypertensive, Cardiovascular Agent
    Drug LabelSULAR (nisoldipine) is an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, C20H24...
    Active IngredientNisoldipine
    Dosage FormTablet, extended release
    RouteOral
    Strength34mg; 8.5mg; 17mg
    Market StatusPrescription
    CompanyShionogi

    4.2 Drug Indication

    For the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Nisoldipine, a dihydropyridine calcium-channel blocker, is used alone or with an angiotensin-converting enzyme inhibitor, to treat hypertension, chronic stable angina pectoris, and Prinzmetal's variant angina. Nisoldipine is similar to other peripheral vasodilators. Nisoldipine inhibits the influx of extra cellular calcium across the myocardial and vascular smooth muscle cell membranes possibly by deforming the channel, inhibiting ion-control gating mechanisms, and/or interfering with the release of calcium from the sarcoplasmic reticulum. The decrease in intracellular calcium inhibits the contractile processes of the myocardial smooth muscle cells, causing dilation of the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased total peripheral resistance, decreased systemic blood pressure, and decreased afterload.

    5.2 MeSH Pharmacological Classification

    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.)

    Vasodilator Agents

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

    Calcium Channel Blockers

    A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    NISOLDIPINE
    5.3.2 FDA UNII
    4I8HAB65SZ
    5.3.3 Pharmacological Classes
    Decreased Blood Pressure [PE]; Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]; Calcium Channel Antagonists [MoA]
    5.4 ATC Code

    C - Cardiovascular system

    C08 - Calcium channel blockers

    C08C - Selective calcium channel blockers with mainly vascular effects

    C08CA - Dihydropyridine derivatives

    C08CA07 - Nisoldipine

    5.5 Absorption, Distribution and Excretion

    Absorption

    Relatively well absorbed into the systemic circulation with 87% of the radiolabeled drug recovered in urine and feces. The absolute bioavailability of nisoldipine is about 5%.

    Route of Elimination

    Although 60-80% of an oral dose undergoes urinary excretion, only traces of unchanged nisoldipine are found in urine.

    5.6 Metabolism/Metabolites

    Pre-systemic metabolism in the gut wall, and this metabolism decreases from the proximal to the distal parts of the intestine. Nisoldipine is highly metabolized; 5 major urinary metabolites have been identified. The major biotransformation pathway appears to be the hydroxylation of the isobutyl ester. A hydroxylated derivative of the side chain, present in plasma at concentrations approximately equal to the parent compound, appears to be the only active metabolite and has about 10% of the activity of the parent compound. Cytochrome P450 enzymes are believed to play a major role in the metabolism of nisoldipine. The particular isoenzyme system responsible for its metabolism has not been identified, but other dihydropyridines are metabolized by cytochrome P450 IIIA4.

    Nisoldipine has known human metabolites that include 2,6-Dimethyl-5-(2-methylpropoxycarbonyl)-4-(2-nitrophenyl)-1,4-dihydropyridine-3-carboxylic acid, 5-O-(1-hydroxy-2-methylpropyl) 3-O-methyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate, and Dehydro Nisoldipine.

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

    5.7 Biological Half-Life

    7-12 hours

    5.8 Mechanism of Action

    By deforming the channel, inhibiting ion-control gating mechanisms, and/or interfering with the release of calcium from the sarcoplasmic reticulum, Nisoldipine inhibits the influx of extracellular calcium across the myocardial and vascular smooth muscle cell membranes The decrease in intracellular calcium inhibits the contractile processes of the myocardial smooth muscle cells, causing dilation of the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased total peripheral resistance, decreased systemic blood pressure, and decreased afterload.

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    14-Jun-2023
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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20356

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 17MG

    USFDA APPLICATION NUMBER - 20356

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20356

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25.5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 34MG

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20356

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8.5MG

    USFDA APPLICATION NUMBER - 20356

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

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

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

    API | Excipient name

    Nisoldipine

    Synonyms

    63675-72-9, Sular, Nisocor, Baymycard, Nisoldipin, Zadipina

    Cas Number

    63675-72-9

    Unique Ingredient Identifier (UNII)

    4I8HAB65SZ

    About Nisoldipine

    A dihydropyridine calcium channel antagonist that acts as a potent arterial vasodilator and antihypertensive agent. It is also effective in patients with cardiac failure and angina.

    Nisoldipine Manufacturers

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

    Nisoldipine Suppliers

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

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

    Nisoldipine USDMF

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

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

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

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

    Nisoldipine WC

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

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

    Nisoldipine 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 Nisoldipine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Nisoldipine GMP

    Nisoldipine 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 Nisoldipine 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 Nisoldipine GMP manufacturer or Nisoldipine GMP API supplier for your needs.

    Nisoldipine CoA

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

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

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