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Felodipine

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 16 USDMF, 9 CEP/COS, 1 JDMF, 3 EU WC, 17 KDMF, 6 NDC API, 10 Listed Suppliers, $ API Reference Price

21 API Suppliers
16 USDMF
9 CEP/COS
1 JDMF
3 EU WC
17 KDMF
6 NDC API
10 Listed Suppliers
$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

204 FDF Dossiers, 44 FDA Orange Book, 96 Europe, 8 Canada, 22 Australia, 7 South Africa, 27 Listed Dossiers

204 FDF Dossiers
44 FDA Orange Book
96 Europe
8 Canada
22 Australia
7 South Africa
27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Minakem, 5 SPI Pharma, 2 Seqens, 3 DKSH, 1 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 3 Aeon Procare, 1 Alcedo Pharmachem, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 14 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 2 Valens Pharmachem, 1 Vasa Pharmachem

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62 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 33 Direct Compression, 29 Controlled & Modified Release, 28 Solubilizers, 24 Thickeners and Stabilizers, 19 Granulation, 18 Co-Processed Excipients, 18 Topical, 16 Film Formers & Plasticizers, 14 Disintegrants & Superdisintegrants, 13 Parenteral, 13 Lubricants & Glidants, 9 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 7 Taste Masking, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Rheology Modifiers

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6 NEWS #PharmaBuzz

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GLOBAL SALES INFORMATION

75 Finished Drug Prices, 3 Annual Reports

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75 Finished Drug Prices
3 Annual Reports

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7 APIs, 2 FDF Dossiers

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7 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 Health Canada Patents

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10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 2 Others

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2 EDQM
1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

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1 BioAnalytical Methods

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 390

MARKET PLACE

API

FDF

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FINISHED DOSAGE FORMULATIONS

204

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

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Data Compilation #PharmaFlow

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Weekly News Recap #Phispers

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GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

682

Finished Drug Prices

224 RELATED EXCIPIENT COMPANIES

386EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 72509-76-3, Plendil, Flodil, Renedil, Feloday, Munobal

Molecular Formula

C₁₈H₁₉Cl₂NO₄

Molecular Weight

384.2 g/mol

InChI Key

RZTAMFZIAATZDJ-UHFFFAOYSA-N

FDA UNII

OL961R6O2C

A dihydropyridine calcium antagonist with positive inotropic effects. It lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels.

Felodipine is a Dihydropyridine Calcium Channel Blocker. The mechanism of action of felodipine is as a Calcium Channel Antagonist.

1 2D Structure

Felodipine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

5-O-ethyl 3-O-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

2.1.2 InChI

InChI=1S/C18H19Cl2NO4/c1-5-25-18(23)14-10(3)21-9(2)13(17(22)24-4)15(14)11-7-6-8-12(19)16(11)20/h6-8,15,21H,5H2,1-4H3

2.1.3 InChI Key

RZTAMFZIAATZDJ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCOC(=O)C1=C(NC(=C(C1C2=C(C(=CC=C2)Cl)Cl)C(=O)OC)C)C

2.2 Other Identifiers

2.2.1 UNII

OL961R6O2C

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Agon

2. Felo Biochemie

3. Felo Puren

4. Felo-puren

5. Felobeta

6. Felocor

7. Felodipin 1a Pharma

8. Felodipin Abz

9. Felodipin Al

10. Felodipin Azu

11. Felodipin Dura

12. Felodipin Heumann

13. Felodipin Ratiopharm

14. Felodipin Stada

15. Felodipin Von Ct

16. Felodipin-ratiopharm

17. Felodur

18. Felogamma

19. Fensel

20. Flodil

21. H 154 82

22. H 154-82

23. H 15482

24. Heumann, Felodipin

25. Modip

26. Munobal

27. Perfudal

28. Plendil

29. Renedil

30. Von Ct, Felodipin

2.3.2 Depositor-Supplied Synonyms

1. 72509-76-3

2. Plendil

3. Flodil

4. Renedil

5. Feloday

6. Munobal

7. Splendil

8. Dl-felodipine

9. Perfudal

10. Prevex

11. Hydac

12. Modip

13. Agon

14. Felodipina

15. Felodipinum

16. Felodipinum [inn-latin]

17. 3-ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

18. Felodipina [inn-spanish]

19. H 154/82

20. Felodipine (plendil)

21. C08ca02

22. Cgh-869

23. Plendil Er

24. 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylic Acid Ethyl Methyl Ester

25. 5-o-ethyl 3-o-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

26. Felogard

27. Mfcd00868316

28. Penedil

29. Preslow

30. Munobal Retard

31. Nsc-760343

32. Plendil Retard

33. H-154/82

34. Plendil Depottab

35. (+-)-ethyl Methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate

36. Mls000069629

37. Ol961r6o2c

38. Chebi:585948

39. Felodur Er

40. Agon Sr

41. 3-ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydro-3,5-pyridinedicarboxylate

42. Ethyl Methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

43. Ncgc00015455-03

44. Plandil

45. Smr000058204

46. C18h19cl2no4

47. Dsstox_cid_3042

48. Dsstox_rid_76848

49. Dsstox_gsid_23042

50. Felodipine [usan:ban:inn]

51. Logimax

52. Ethyl Methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate

53. (+/-)-ethyl Methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate

54. (rs)-3-ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

55. Plendil (tn)

56. Sr-01000075890

57. Brn 4331472

58. Unii-ol961r6o2c

59. Perfuda

60. Plendil;renedil

61. Felodipine, Solid

62. Felodipine,(s)

63. Felodipine [usan:usp:inn:ban]

64. 3,5-dicarboxylate

65. Felodipine- Bio-x

66. Prestwick_797

67. Cas-72509-76-3

68. 3,5-pyridinedicarboxylic Acid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, Ethyl Methyl Ester

69. Felodipine (dl Form)

70. Felodipine [mi]

71. Felodipine [inn]

72. Felodipine [jan]

73. Opera_id_1873

74. Prestwick0_000478

75. Prestwick1_000478

76. Prestwick2_000478

77. Prestwick3_000478

78. (.+/-.)-felodipine

79. Felodipine [usan]

80. Felodipine [vandf]

81. F 9677

82. Felodipine [mart.]

83. 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinecarboxylic Acid Ethyl Methyl Ester

84. Chembl1480

85. Felodipine [usp-rs]

86. Felodipine [who-dd]

87. Lopac0_000508

88. Schembl26398

89. Bspbio_000616

90. Ae-641/11429675

91. Mls001077361

92. Mls001333735

93. Mls002153409

94. Mls002153832

95. Mls003876820

96. Bidd:gt0733

97. Spbio_002555

98. Bpbio1_000678

99. Felodipine (jp17/usp/inn)

100. Gtpl4190

101. (r)-(+)-felodipine-[d5]

102. Chembl3196476

103. Dtxsid4023042

104. Felodipine [orange Book]

105. Schembl13460298

106. Felodipine [ep Monograph]

107. Felodipine [usp Impurity]

108. Lexxel Component Felodipine

109. Bdbm189379

110. Felodipine [usp Monograph]

111. Hms1569o18

112. Hms2089j05

113. Hms2096o18

114. Hms2232d24

115. Hms3259f12

116. Hms3261f17

117. Hms3651o21

118. Hms3713o18

119. Hms3884i14

120. Pharmakon1600-01505887

121. Bcp02192

122. Bcp22685

123. Hy-b0309

124. 2,6-dimethyl-1,4-dihydropyridine-

125. Tox21_110155

126. Tox21_500508

127. Ca-236

128. Nsc760343

129. S1885

130. Felodipine Component Of Lexxel

131. Akos015891545

132. Felodipine 100 Microg/ml In Methanol

133. Tox21_110155_1

134. Ac-2124

135. Bcp9000680

136. Ccg-204599

137. Db01023

138. Ks-1264

139. Lp00508

140. Nc00721

141. Nsc 760343

142. Sdccgsbi-0050492.p002

143. O5-ethyl O3-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

144. Ncgc00015455-04

145. Ncgc00015455-05

146. Ncgc00015455-06

147. Ncgc00015455-07

148. Ncgc00015455-08

149. Ncgc00015455-10

150. Ncgc00015455-24

151. Ncgc00024087-02

152. Ncgc00093906-01

153. Ncgc00093906-02

154. Ncgc00261193-01

155. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-4-(2,3-dichlorophenyl)-2,6-dimethyl-, Ethyl Methyl Ester

156. 3,5-pyridinedicarboxylic Acid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, Ethyl Methyl Ester, (+-)-

157. 4-(2,3-dichloro-phenyl)-2,6-dimethyl-1,4-dihydro-pyridine-3,5-dicarboxylic Acid 3-ethyl Ester 5-methyl Ester

158. Ac-24403

159. Bf164445

160. Felodipine 100 Microg/ml In Acetonitrile

161. Smr002529504

162. Sy053174

163. 3-ethyl 5-methyl 4-(2,3-dichlorophenyl)-

164. Eu-0100508

165. F0814

166. Ft-0626393

167. Ft-0660933

168. Ft-0668475

169. Sw219299-1

170. En300-70726

171. D00319

172. 509f763

173. Q420644

174. Sr-01000075890-1

175. Sr-01000075890-4

176. Brd-a30815329-001-03-0

177. Z239864852

178. Felodipine, European Pharmacopoeia (ep) Reference Standard

179. Felodipine, United States Pharmacopeia (usp) Reference Standard

180. 3-ethyl5-methyl4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate

181. (.+/-.) Ethyl Methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate

182. 3,5-pyridinedicarboxylic Acid 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, Ethyl Methyl Ester, (+/-)-

183. 3,5-pyridinedicarboxylic Acid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, 3-ethyl-5-methylester

184. 3-ethyl 5-methyl 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydro-3,5-pyridinedicarboxylate #

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₁₉Cl₂NO₄
Molecular Weight	384.2 g/mol
XLogP3	3.9
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	6
Exact Mass	383.0691135 g/mol
Monoisotopic Mass	383.0691135 g/mol
Topological Polar Surface Area	64.6 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	614
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Felodipine
PubMed Health	Felodipine (By mouth)
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2, 6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula...
Active Ingredient	Felodipine
Dosage Form	Tablet, extended release
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Vintage Pharms; Wockhardt; Glenmark Generics; Mutual Pharm; Aurobindo Pharma; Torrent Pharms; Ranbaxy Labs; Mylan; Heritage Pharms

2 of 4
Drug Name	Plendil
PubMed Health	Felodipine (By mouth)
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	PLENDIL (felodipine) is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its empirica...
Active Ingredient	Felodipine
Dosage Form	Tablet, extended release
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Astrazeneca

3 of 4
Drug Name	Felodipine
PubMed Health	Felodipine (By mouth)
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2, 6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula...
Active Ingredient	Felodipine
Dosage Form	Tablet, extended release
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Vintage Pharms; Wockhardt; Glenmark Generics; Mutual Pharm; Aurobindo Pharma; Torrent Pharms; Ranbaxy Labs; Mylan; Heritage Pharms

4 of 4
Drug Name	Plendil
PubMed Health	Felodipine (By mouth)
Drug Classes	Antianginal, Antihypertensive, Cardiovascular Agent
Drug Label	PLENDIL (felodipine) is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its empirica...
Active Ingredient	Felodipine
Dosage Form	Tablet, extended release
Route	Oral
Strength	2.5mg; 5mg; 10mg
Market Status	Prescription
Company	Astrazeneca

4.2 Drug Indication

For the treatment of mild to moderate essential hypertension.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Felodipine belongs to the dihydropyridine (DHP) class of calcium channel blockers (CCBs), the most widely used class of CCBs. There are at least five different types of calcium channels in Homo sapiens: L-, N-, P/Q-, R- and T-type. It was widely accepted that CCBs target L-type calcium channels, the major channel in muscle cells that mediates contraction; however, some studies have shown that felodipine also binds to and inhibits T-type calcium channels. T-type calcium channels are most commonly found on neurons, cells with pacemaker activity and on osteocytes. The pharmacologic significance of T-type calcium channel blockade is unknown. Felodipine also binds to calmodulin and inhibits calmodulin-dependent calcium release from the sarcoplasmic reticulum. The effect of this interaction appears to be minor. Another study demonstrated that felodipine attenuates the activity of calmodulin-dependent cyclic nucleotide phosphodiesterase (CaMPDE) by binding to the PDE-1B1 and PDE-1A2 enzyme subunits. CaMPDE is one of the key enzymes involved in cyclic nucleotides and calcium second messenger systems. Felodipine also acts as an antagonist to the mineralcorticoid receptor by competing with aldosterone for binding and blocking aldosterone-induced coactivator recruitment of the mineralcorticoid receptor. Felodipine is able to bind to skeletal and cardiac muscle isoforms of troponin C, one of the key regulatory proteins in muscle contraction. Though felodipine exhibits binding to many endogenous molecules, its vasodilatory effects are still thought to be brought about primarily through inhibition of voltage-gated L-type calcium channels. Similar to other DHP CCBs, felodipine binds directly to inactive calcium channels stabilizing their inactive conformation. Since arterial smooth muscle depolarizations are longer in duration than cardiac muscle depolarizations, inactive channels are more prevalent in smooth muscle cells. Alternative splicing of the alpha-1 subunit of the channel gives felodipine additional arterial selectivity. At therapeutic sub-toxic concentrations, felodipine has little effect on cardiac myocytes and conduction cells.

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.)

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.)

Vasodilator Agents

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

Anti-Arrhythmia Agents

Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

FELODIPINE

5.3.2 FDA UNII

OL961R6O2C

5.3.3 Pharmacological Classes

Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]; Calcium Channel Antagonists [MoA]

5.4 ATC Code

C08CA02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

C - Cardiovascular system

C08 - Calcium channel blockers

C08C - Selective calcium channel blockers with mainly vascular effects

C08CA - Dihydropyridine derivatives

C08CA02 - Felodipine

5.5 Absorption, Distribution and Excretion

Absorption

Is completely absorbed from the gastrointestinal tract; however, extensive first-pass metabolism through the portal circulation results in a low systemic availability of 15%. Bioavailability is unaffected by food.

Route of Elimination

Although higher concentrations of the metabolites are present in the plasma due to decreased urinary excretion, these are inactive. Animal studies have demonstrated that felodipine crosses the blood-brain barrier and the placenta.

Volume of Distribution

10 L/kg

Clearance

0.8 L/min [Young healthy subjects]

5.6 Metabolism/Metabolites

Hepatic metabolism primarily via cytochrome P450 3A4. Six metabolites with no appreciable vasodilatory effects have been identified.

5.7 Biological Half-Life

17.5-31.5 hours in hypertensive patients; 19.1-35.9 hours in elderly hypertensive patients; 8.5-19.7 in healthy volunteers.

5.8 Mechanism of Action

Felodipine decreases arterial smooth muscle contractility and subsequent vasoconstriction by inhibiting the influx of calcium ions through voltage-gated L-type calcium channels. It reversibly competes against nitrendipine and other DHP CCBs for DHP binding sites in vascular smooth muscle and cultured rabbit atrial cells. Calcium ions entering the cell through these channels bind to calmodulin. Calcium-bound calmodulin then binds to and activates myosin light chain kinase (MLCK). Activated MLCK catalyzes the phosphorylation of the regulatory light chain subunit of myosin, a key step in muscle contraction. Signal amplification is achieved by calcium-induced calcium release from the sarcoplasmic reticulum through ryanodine receptors. Inhibition of the initial influx of calcium decreases the contractile activity of arterial smooth muscle cells and results in vasodilation. The vasodilatory effects of felodipine result in an overall decrease in blood pressure. Felodipine may be used to treat mild to moderate essential hypertension.

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CEP/COS

01

Medichem, S.A. Celrà ES

Spain

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Not Confirmed

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Spain

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Digital Content

Felodipine

Certificate Number : R1-CEP 2004-213 - Rev 01

Status : Valid

Issue Date : 2012-05-18

Type : Chemical

Substance Number : 1013

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API Reference Price

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MARG, GOVANDI STATION ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686249000,"product":"FELODIPINE USP (FELODIPINE) LOT NO.A-220125","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.02","actualQuantity":"10.02","unit":"KGS","unitRateFc":"600","totalValueFC":"6100","currency":"USD","unitRateINR":"50040","date":"09-Jun-2023","totalValueINR":"501401.026","totalValueInUsd":"6100","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690914600,"product":"FELODIPINE","address":"ARVIND VITHAL GANDHI CHOWK,,B.S.D. 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MARG, GOVANDI STATION ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691433000,"product":"FELODIPINE USP FELODIPINE LOT NO.A-210256","address":"B\/2 MAHALAXMI CHAMBERS,22 BHULABHA I DESAI ROAD","city":"MUMBAI","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"600","totalValueFC":"10877.8","currency":"USD","unitRateINR":"49559.1","date":"08-Aug-2023","totalValueINR":"901074.24","totalValueInUsd":"10877.8","indian_port":"SAHAR AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS,22 BHULABHA I DESAI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691433000,"product":"FELODIPINE USP FELODIPINE LOT NO.A-220335","address":"B\/2 MAHALAXMI CHAMBERS,22 BHULABHA I DESAI ROAD","city":"MUMBAI","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"11.50","actualQuantity":"11.5","unit":"KGS","unitRateFc":"600","totalValueFC":"6949.7","currency":"USD","unitRateINR":"49559.1","date":"08-Aug-2023","totalValueINR":"575686.32","totalValueInUsd":"6949.7","indian_port":"SAHAR AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS,22 BHULABHA I DESAI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691433000,"product":"FELODIPINE USP FELODIPINE LOT NO.A-220335","address":"B\/2 MAHALAXMI CHAMBERS,22 BHULABHA I DESAI ROAD","city":"MUMBAI","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"14.00","actualQuantity":"14","unit":"KGS","unitRateFc":"600","totalValueFC":"8460.5","currency":"USD","unitRateINR":"49559.1","date":"08-Aug-2023","totalValueINR":"700835.52","totalValueInUsd":"8460.5","indian_port":"SAHAR AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS,22 BHULABHA I DESAI ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722018600,"product":"FELODIPINE PH EUR","address":"B.S.D.MARG, GOVANDI STATION ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"USV PRIVATE LIMITED","customerCountry":"INDIA","quantity":"8.15","actualQuantity":"8.15","unit":"KGS","unitRateFc":"450","totalValueFC":"3709.6","currency":"USD","unitRateINR":"38047.5","date":"27-Jul-2024","totalValueINR":"310087.13","totalValueInUsd":"3709.6","indian_port":"Bombay Air","hs_no":"29039990","bill_no":"4723835","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POLIGONO INDUSTRIAL DE CELRA 127 17460 CELRA ( GIRONA ) SPAIN SPAIN, ,SPAIN SPAIN","customerAddress":"B.S.D.MARG, GOVANDI STATION ROAD,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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INTERMEDIATES SUPPLIERS

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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 - 19834

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19834

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19834

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers

16 USDMF

9 CEP/COS

1 JDMF

3 EU WC

17 KDMF

6 NDC API

10 Listed Suppliers

$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

204 FDF Dossiers

44 FDA Orange Book

96 Europe

8 Canada

22 Australia

7 South Africa

27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders

46 Coating Systems & Additives

33 Direct Compression

29 Controlled & Modified Release

28 Solubilizers

24 Thickeners and Stabilizers

TABLET, EXTENDED RELEASE;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons