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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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Nisoldipine

Registration Number : 217MF10589

Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY

Initial Date of Registration : 2005-09-14

Latest Date of Registration : 2010-04-13

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Nisoldipine

Registration Number : 217MF10719

Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo

Initial Date of Registration : 2005-10-07

Latest Date of Registration : 2010-02-12

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Nisoldipine

Date of Issue : 2022-06-17

Valid Till : 2025-02-07

Written Confirmation Number : WC-0082

Address of the Firm : Karakhadi Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist - Vadodara 391 450...

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NISOLDIPINE

NDC Package Code : 14593-864

Start Marketing Date : 2023-12-22

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (5kg/5kg)

Marketing Category : BULK INGREDIENT

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NDC Package Code : 49706-1607

Start Marketing Date : 2010-01-08

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Nisoldipine

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 market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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Nisoldipine

About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territory. DEAFARMA works with success in the pharmaceutical raw materials field through Agencies and professional relations with the most important European and Asiatic factories. Our partners are well known, reliable producers and all of them are operating in accordance with the latest GMP Rules. The APIs mentioned in the DEAFARMA catalogue are always supported by DMF and/or CEP.
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Nisoldipine

About the Company : ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIE...

ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIERRE we employ more than 220 people and two manufacturing sites, San Paolo d’Argon and Sovere, are both FDA inspected with no 483 form. We provide APIs of the highest quality and we are a reliable partner for the pharmaceutical industry worldwide.
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Nisoldipine

About the Company : Our work in the distribution sector starts and ends with the quality of human relations; first and foremost, it is trust that we want to build with you. The connections we build ar...

Our work in the distribution sector starts and ends with the quality of human relations; first and foremost, it is trust that we want to build with you. The connections we build are made to last. They are built on professionalism, respect and transparency. This is how we work, and how we have been working for a long time now, with our client partners and constituents. Unipex has been operational for 50 years, and has always remained true to its core business: the distribution of specialities. This is also why we are independent and we intend to stay that way. Our structure is simple, our commitment is absolute: we work directly with you.
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NISOLDIPINE

Brand Name : NISOLDIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8.5MG

Approval Date : 2023-04-10

Application Number : 216606

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-02-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1995-02-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2008-01-02

Application Number : 20356

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Luxembourg
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Not Confirmed
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COVIS

Luxembourg
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AGGSpend
Not Confirmed

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 17MG

Approval Date : 2008-01-02

Application Number : 20356

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

COVIS

Luxembourg
AGGSpend
Not Confirmed
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COVIS

Luxembourg
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AGGSpend
Not Confirmed

NISOLDIPINE

Brand Name : SULAR

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8.5MG

Approval Date : 2008-01-02

Application Number : 20356

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

MYLAN

U.S.A
AGGSpend
Not Confirmed
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MYLAN

U.S.A
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AGGSpend
Not Confirmed

NISOLDIPINE

Brand Name : NISOLDIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Approval Date : 2008-07-25

Application Number : 79051

RX/OTC/DISCN : RX

RLD : No

TE Code :

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08

MYLAN

U.S.A
AGGSpend
Not Confirmed
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MYLAN

U.S.A
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AGGSpend
Not Confirmed

NISOLDIPINE

Brand Name : NISOLDIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 2008-07-25

Application Number : 79051

RX/OTC/DISCN : RX

RLD : No

TE Code :

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09

MYLAN

U.S.A
AGGSpend
Not Confirmed
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MYLAN

U.S.A
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AGGSpend
Not Confirmed

NISOLDIPINE

Brand Name : NISOLDIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 17MG

Approval Date : 2011-01-26

Application Number : 91001

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

MYLAN

U.S.A
AGGSpend
Not Confirmed
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MYLAN

U.S.A
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AGGSpend
Not Confirmed

NISOLDIPINE

Brand Name : NISOLDIPINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 25.5MG

Approval Date : 2011-01-26

Application Number : 91001

RX/OTC/DISCN : RX

RLD : No

TE Code :

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DRUG PRODUCT COMPOSITIONS

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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**

USFDA APPLICATION NUMBER - 20356

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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**

USFDA APPLICATION NUMBER - 20356

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 34MG

USFDA APPLICATION NUMBER - 20356

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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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ABOUT THIS PAGE

Looking for 63675-72-9 / Nisoldipine API manufacturers, exporters & distributors?

Nisoldipine manufacturers, exporters & distributors 1

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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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