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ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 30 USDMF, 12 CEP/COS, 1 JDMF, 5 EU WC, 2 KDMF, 6 NDC API, 9 Listed Suppliers, $ API Reference Price

39 API Suppliers
30 USDMF
12 CEP/COS
1 JDMF
5 EU WC
2 KDMF
6 NDC API
9 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

91 FDF Dossiers, 37 FDA Orange Book, 42 Europe, 4 Canada, 2 South Africa, 6 Listed Dossiers

91 FDF Dossiers
37 FDA Orange Book
42 Europe
4 Canada
2 South Africa
6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 20MG, TABLET, EXTENDED RELEASE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 60MG

drugProductComposition
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 20MG
TABLET, EXTENDED RELEASE;ORAL - 40MG
TABLET, EXTENDED RELEASE;ORAL - 60MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 4 SPI Pharma, 2 Seqens, 4 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 13 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

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70 Fillers, Diluents & Binders, 52 Coating Systems & Additives, 35 Direct Compression, 31 Controlled & Modified Release, 27 Thickeners and Stabilizers, 25 Solubilizers, 24 Granulation, 20 Disintegrants & Superdisintegrants, 19 Lubricants & Glidants, 18 Topical, 18 Film Formers & Plasticizers, 18 Co-Processed Excipients, 16 Parenteral, 10 Taste Masking, 9 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Rheology Modifiers

DIGITAL CONTENT

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2 US Medicaid Prescriptions, 52 Finished Drug Prices

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2 US Medicaid Prescriptions
52 Finished Drug Prices

MARKET PLACE

5 APIs

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5 APIs

REF. STANDARDS & IMPURITIES

2 EDQM , 4 USP , 7 Others

otherSolutions
2 EDQM
4 USP
7 Others

ANALYTICAL

3 BioAnalytical Methods

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3 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)

$ 55

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

35,632,152

Annual Reports (USD Million)

Finished Drug Prices

250 RELATED EXCIPIENT COMPANIES

425EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 75330-75-5, Mevinolin, Mevacor, Altoprev, Mevlor, Sivlor

Molecular Formula

C₂₄H₃₆O₅

Molecular Weight

404.5 g/mol

InChI Key

PCZOHLXUXFIOCF-BXMDZJJMSA-N

FDA UNII

9LHU78OQFD

A fungal metabolite isolated from cultures of Aspergillus terreus. The compound is a potent anticholesteremic agent. It inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It also stimulates the production of low-density lipoprotein receptors in the liver.

Lovastatin is a HMG-CoA Reductase Inhibitor. The mechanism of action of lovastatin is as a Hydroxymethylglutaryl-CoA Reductase Inhibitor.

1 2D Structure

Lovastatin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

[(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2S)-2-methylbutanoate

2.1.2 InChI

InChI=1S/C24H36O5/c1-5-15(3)24(27)29-21-11-14(2)10-17-7-6-16(4)20(23(17)21)9-8-19-12-18(25)13-22(26)28-19/h6-7,10,14-16,18-21,23,25H,5,8-9,11-13H2,1-4H3/t14-,15-,16-,18+,19+,20-,21-,23-/m0/s1

2.1.3 InChI Key

PCZOHLXUXFIOCF-BXMDZJJMSA-N

2.1.4 Canonical SMILES

CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC3CC(CC(=O)O3)O)C

2.1.5 Isomeric SMILES

CC[C@H](C)C(=O)O[C@H]1C[C@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@@H]3C[C@H](CC(=O)O3)O)C

2.2 Other Identifiers

2.2.1 UNII

9LHU78OQFD

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1 Alpha-isomer Lovastatin

2. 6 Methylcompactin

3. 6-methylcompactin

4. Alpha-isomer Lovastatin, 1

5. Lovastatin, (1 Alpha(s*))-isomer

6. Lovastatin, 1 Alpha Isomer

7. Lovastatin, 1 Alpha-isomer

8. Mevacor

9. Mevinolin

10. Mk 803

11. Mk-803

12. Mk803

13. Monacolin K

2.3.2 Depositor-Supplied Synonyms

1. 75330-75-5

2. Mevinolin

3. Mevacor

4. Altoprev

5. Mevlor

6. Sivlor

7. Mk-803

8. Monacolin K

9. Lovalord

10. Nergadan

11. Artein

12. 6alpha-methylcompactin

13. Lovalip

14. Lovastatine [french]

15. Lovastatinum [latin]

16. Lovastatina [spanish]

17. 6-alpha-methylcompactin

18. Mevinacor

19. Altocor

20. Hipovastin

21. Lovasterol

22. Cholestra

23. Closterol

24. Colevix

25. Hipolip

26. Lestatin

27. Lipivas

28. Lipofren

29. Lovastin

30. Lozutin

31. Paschol

32. Rodatin

33. Rovacor

34. Tecnolip

35. Teroltrat

36. Belvas

37. Lipdip

38. Taucor

39. Lovastatin [usan]

40. Mls000069585

41. 6.alpha.-methylcompactin

42. Msd 803

43. 9lhu78oqfd

44. [(1s,3r,7s,8s,8ar)-8-[2-[(2r,4r)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2s)-2-methylbutanoate

45. Nsc-758662

46. L-154803

47. Mk 803

48. 2beta,6alpha-dimethyl-8alpha-(2-methyl-1-oxobutoxy)-mevinic Acid Lactone

49. Smr000058779

50. (1s,3r,7s,8s,8ar)-8-{2-[(2r,4r)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2s)-2-methylbutanoate

51. (1s,3r,7s,8s,8ar)-8-{2-[(2r,4r)-4-hydroxy-6-oxotetrahydro-2h-pyran-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2s)-2-methylbutanoate

52. Lovastatine

53. Chebi:40303

54. C10aa02

55. Lovastatin (mevacor)

56. (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(2r,4r)-(tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl (s)-2-methyl-butyrate

57. Hsdb 6534

58. Ncgc00023509-03

59. Lovastatina

60. Lovastatinum

61. Dsstox_cid_784

62. Dsstox_rid_75788

63. Dsstox_gsid_20784

64. Butanoic Acid, 2-methyl-, (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2r,4r)-tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl]ethyl]-1-naphthalenyl Ester, (2s)-

65. Liposcler

66. 6 Alpha-methylcompactin

67. Rextat

68. Monakolin K

69. (s)-2-methylbutyric Acid, 8-ester With (4r,6r)-6-(2-((1s,2s,6r,8s,8ar)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2h-pyran-2-one

70. (1s,3r,7s,8s,8ar)-8-(2-((2r,4r)-4-hydroxy-6-oxotetrahydro-2h-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (s)-2-methylbutanoate

71. (s)-(1s,3r,7s,8s,8ar)-8-(2-((2r,4r)-4-hydroxy-6-oxotetrahydro-2h-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2-methylbutanoate

72. Mevacor (tn)

73. Chembl503

74. Lovastatin & Primycin

75. Lovastatin (usp/inn)

76. Sr-05000001880

77. (1s-(1alpha(r*),3alpha,7beta,8beta(2s*,4s*),8abeta))-2-methylbutanoic Acid 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl Ester

78. 1,2,6,7,8,8a-hexahydro-beta,delta-dihydroxy-2,6-dimethyl-8-(2-methyl-1-oxobutyoxy)-1-naphthaleneheptanoic Acid Delta-lactone

79. Unii-9lhu78oqfd

80. Brn 3631989

81. Mevinolin From Aspergillus Sp.

82. Ccris 8092

83. 1cqp

84. Lovastatin,(s)

85. Ml-530b

86. Lovastatin [usan:usp:inn:ban]

87. (+)-mevinolin

88. (2s)-2-methylbutanoic Acid (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-((2r,4r)-tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl Ester

89. (2s)-2-methylbutanoic Acid (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2r,4r)-tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl]ethyl]-1-naphthalenyl Ester

90. (s)-((1s,3r,7s,8s,8ar)-8-(2-((2r,4r)-4-hydroxy-6-oxotetrahydro-2h-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl) 2-methylbutanoate

91. [(1s,3r,7s,8s,8ar)-8-[2-[(2r,4r)-4-hydroxy-6-oxo-tetrahydropyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2s)-2-methylbutanoate

92. Lovastatin- Bio-x

93. Prestwick_819

94. Cas-75330-75-5

95. Mfcd00072164

96. Mevinolin (lovastatin)

97. Lovastatin (mevinolin)

98. Lovastatin [mi]

99. Lovastatin [inn]

100. Opera_id_1578

101. Prestwick0_000516

102. Prestwick1_000516

103. Prestwick2_000516

104. Prestwick3_000516

105. Spectrum3_001873

106. Spectrum5_001294

107. Lovastatin (mk-803)

108. Lovastatin [hsdb]

109. Lovastatin [vandf]

110. Ec 616-212-7

111. Lovastatin [mart.]

112. Schembl3136

113. Lovastatin [usp-rs]

114. Lovastatin [who-dd]

115. Us9115116, Lovastatin

116. Bidd:pxr0113

117. Bspbio_000471

118. Bspbio_001265

119. Bspbio_003346

120. Butanoic Acid, 2-methyl-, 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl Ester, (1s-(1alpha(r*),3alpha,7beta,8beta(2s*,4s*),8abeta))-

121. Cid_53232

122. Mls001055358

123. Mls006011867

124. Us9353061, Lovastatina

125. Bidd:gt0749

126. Divk1c_001032

127. Spectrum1503977

128. Spbio_002392

129. Bpbio1_000519

130. Gtpl2739

131. Megxm0_000398

132. Dtxsid5020784

133. Lovastatin [orange Book]

134. Schembl14227102

135. Acon0_000534

136. Acon1_000390

137. Bdbm34168

138. Hms503o05

139. Kbio1_001032

140. Kbio3_002848

141. Lovastatin [ep Monograph]

142. Simvastatin Impurity, Lovastatin-

143. Lovastatin For Peak Identification

144. Ninds_001032

145. Hms1569h13

146. Hms1792o07

147. Hms1923o13

148. Hms1990o07

149. Hms2089m06

150. Hms2093o03

151. Hms2096h13

152. Hms2236f07

153. Hms3039n16

154. Hms3259f10

155. Hms3268c03

156. Hms3403o07

157. Hms3412h19

158. Hms3676h19

159. Hms3713h13

160. Hms3884b03

161. Lovastatin [usp Monograph]

162. Pharmakon1600-01503977

163. Advicor Component Lovastatin

164. Act02620

165. Albb-027272

166. Butanoic Acid, 2-methyl-, (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-((2r,4r)-tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl Ester, (2s)-

167. Hy-n0504

168. Mk-803; Lovalip; Mevacor

169. Zinc3812841

170. Tox21_110888

171. Tox21_201475

172. Tox21_300268

173. Bbl024473

174. Ccg-39627

175. Nsc633781

176. Nsc758662

177. Nsc779704

178. S2061

179. Stk801953

180. Akos005267139

181. Lovastatin Component Of Advicor

182. Tox21_110888_1

183. Cs-1990

184. Db00227

185. Ks-1082

186. Mevinolin From Aspergillus Sp., Powder

187. Nc00713

188. Nsc 758662

189. Nsc-633781

190. Nsc-779704

191. Idi1_001032

192. Ncgc00023509-04

193. Ncgc00023509-05

194. Ncgc00023509-06

195. Ncgc00023509-07

196. Ncgc00023509-08

197. Ncgc00023509-09

198. Ncgc00023509-10

199. Ncgc00023509-11

200. Ncgc00023509-13

201. Ncgc00023509-14

202. Ncgc00023509-16

203. Ncgc00254157-01

204. Ncgc00259026-01

205. 74133-25-8

206. Ac-13961

207. Bl164644

208. Butanoic Acid, 2-methyl-, (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl Ester, (2s)-

209. G226

210. Smr000673570

211. Sbi-0051881.p002

212. L0214

213. N1632

214. Simvastatin Impurity E [ep Impurity]

215. En300-52515

216. C07074

217. D00359

218. Ab00052400-17

219. Ab00052400_18

220. Ab00052400_19

221. Mevinolin From Aspergillus Sp., >=98% (hplc)

222. 330l755

223. A838030

224. A838383

225. Q417740

226. Sr-01000000123

227. Sr-01000000123-3

228. Sr-05000001880-1

229. Sr-05000001880-2

230. Brd-k09416995-001-06-8

231. Brd-k09416995-001-21-7

232. Mevacor;monacolin K;mevinolin;6-alpha-methylcompactin

233. Simvastatin Impurity, Lovastatin- [usp Impurity]

234. Z1258578375

235. (1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-8-(2-((4r,6r)-4-hydroxy-2-oxo-2h-pyran-6-yl)ethyl)-3,7-dimethylnaphtyl(s)-2-methylbutyrat

236. (2s)-(1s,3r,7s,8s,8ar)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2r,4r)-tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl]ethyl]-1-naphthalenyl-2-methyl Butanoate

237. (2s)-2-methylbutanoic Acid [(1s,3r,7s,8s,8ar)-8-[2-[(2r,4r)-4-hydroxy-6-oxo-2-oxanyl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] Ester

238. (s)-((1s,3r,7s,8s,8ar)-8-(2-((2r,4r)-4-hydroxy-6-oxo-tetrahydro-2h-pyran-2-yl)ethyl)-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl) 2-methylbutanoate

239. (s)-2-methyl-butyric Acid (1s,3r,7s,8s,8ar)-8-[2-((3r,5r)-4-hydroxy-6-oxo-tetrahydro-pyran-2-yl)-ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl Ester

240. [(1s,3r,7s,8s,8ar)-3,7-dimethyl-8-[2-[(2r,4r)-4-oxidanyl-6-oxidanylidene-oxan-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2s)-2-methylbutanoate

241. [(1s,3r,7s,8s,8ar)-8-[2-[(2r,4r)-4-hydroxy-6-oxo-tetrahydropyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] 2-methylbutanoate

242. 1s,7s,8s,8ar)-8-{2-[(2r,4r)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2s)-2-methylbutanoate

243. 8-[2-(4-hydroxy-6-oxotetrahydro-2h-pyran-2-yl)ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydro-1-naphthale

244. Butanoic Acid, 2-methyl-, 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(tetrahydro-4-hydroxy-6-- Oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl Ester, (1s-(1alpha(r*),3alpha,7beta,8beta(2s*,4s*),8abeta))-

245. Butanoic Acid, 2-methyl-, 1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-(2-(tetrahydro-4-hydroxy-6-oxo-2h-pyran-2-yl)ethyl)-1-naphthalenyl Ester, (1s-(1.alpha.(r*),3.alpha.,7.beta.,8.beta.(2s*,4s*),8.alpha..beta.))-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₄H₃₆O₅
Molecular Weight	404.5 g/mol
XLogP3	4.3
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	7
Exact Mass	404.25627424 g/mol
Monoisotopic Mass	404.25627424 g/mol
Topological Polar Surface Area	72.8 Å²
Heavy Atom Count	29
Formal Charge	0
Complexity	666
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
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	Altoprev
PubMed Health	Lovastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Altoprev lovastatin extended-release tablets contain a cholesterol-lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding -hydroxyacid form....
Active Ingredient	Lovastatin
Dosage Form	Tablet, extended release
Route	Oral
Strength	60mg; 40mg; 20mg
Market Status	Prescription
Company	Andrx Labs

2 of 4
Drug Name	Lovastatin
PubMed Health	Lovastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the correspondingform. This is a principal metabolite and an inhibitor of 3-hyd...
Active Ingredient	Lovastatin
Dosage Form	Tablet
Route	Oral
Strength	10mg; 40mg; 20mg
Market Status	Prescription
Company	Teva; Apotex; Lupin; Sandoz; Actavis Elizabeth; Mutual Pharm; Carlsbad; Mylan

3 of 4
Drug Name	Altoprev
PubMed Health	Lovastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Altoprev lovastatin extended-release tablets contain a cholesterol-lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding -hydroxyacid form....
Active Ingredient	Lovastatin
Dosage Form	Tablet, extended release
Route	Oral
Strength	60mg; 40mg; 20mg
Market Status	Prescription
Company	Andrx Labs

4 of 4
Drug Name	Lovastatin
PubMed Health	Lovastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the correspondingform. This is a principal metabolite and an inhibitor of 3-hyd...
Active Ingredient	Lovastatin
Dosage Form	Tablet
Route	Oral
Strength	10mg; 40mg; 20mg
Market Status	Prescription
Company	Teva; Apotex; Lupin; Sandoz; Actavis Elizabeth; Mutual Pharm; Carlsbad; Mylan

4.2 Therapeutic Uses

Anticholesteremic Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors

National Library of Medicine's Medical Subject Headings. Lovastatin. Online file (MeSH, 2016). Available from, as of November 28, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Lovastatin is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of February 1, 2017: https://clinicaltrials.gov/ct2/results?term=LOVASTATIN&Search=Search

Lovastatin Tablets USP are indicated as an adjunct to diet to reduce total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present: 1. LDL-C remains > 189 mg/dL or 2. LDL-C remains > 160 mg/dL and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the adolescent patient. /Included in US product label/

NIH; DailyMed. Current Medication Information for Lovastatin (Lovastatin Tablet) (Updated: June 2016). Available from, as of February 1, 2017: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0e15feec-d27e-4861-8152-c5a8b8ccacd4

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin Tablets USP are indicated as an adjunct to diet for the reduction of elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C) levels in patients with primary hypercholesterolemia (Types IIa and IIb), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. /Included in US product label/

For more Therapeutic Uses (Complete) data for Lovastatin (9 total), please visit the HSDB record page.

4.3 Drug Warning

Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma.

Lovastatin is contraindicated in women who are or may become pregnant. The drug should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazard. If the patient becomes pregnant while receiving lovastatin, the drug should be discontinued immediately and the patient informed of the potential hazard to the fetus.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 1854

Maternal treatment with lovastatin may reduce the fetal levels of mevalonate, which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering drugs during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolemia. For these reasons, lovastatin should not be used in women who are pregnant, or can become pregnant. Lovastatin should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. Treatment should be immediately discontinued as soon as pregnancy is recognized.

There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including lovastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with lovastatin, promptly interrupt therapy. If an alternate etiology is not found, do not restart lovastatin.

Health Canada; Product Monograph for Lovastatin (20 mg and 40 mg Tablets USP), Drug Identification Number (DIN): 02344335 p.7 (Date of Revision: May 29, 2014). Available from, as of February 1, 2017: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

For more Drug Warnings (Complete) data for Lovastatin (30 total), please visit the HSDB record page.

4.4 Drug Indication

Lovastatin is indicated to reduce the risk of myocardial infarction, unstable angina, and the need for coronary revascularization procedures in individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C. It is indicated as an intervention alternative in individuals presenting dyslipidemia at risk of developing atherosclerotic vascular disease. The administration of this agent should be accompanied by the implementation of a fat and cholesterol-restricted diet. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin is indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. Lovastatin is also indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Lovastatin is indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls with Heterozygous Familial Hypercholesterolemia (HeFH) who are at least one year post-menarche, 10 to 17 years of age, with HeFH if after an adequate trial of diet therapy the following findings are present: LDL-C remains greater than 189 mg/dL or LDL-C remains greater than 160 mg/dL and there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the adolescent patient. Before administering lovastatin, it is important to rule out the presence of secondary causes of hypercholesterolemia and a lipid profile should be performed. Prescribing of statin medications is considered standard practice following any cardiovascular events and for people with a moderate to high risk of development of CVD. Statin-indicated conditions include diabetes mellitus, clinical atherosclerosis (including myocardial infarction, acute coronary syndromes, stable angina, documented coronary artery disease, stroke, trans ischemic attack (TIA), documented carotid disease, peripheral artery disease, and claudication), abdominal aortic aneurysm, chronic kidney disease, and severely elevated LDL-C levels.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Lovastatin is an oral antilipemic agent which reversibly inhibits HMG-CoA reductase. It is used to lower total cholesterol, low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apoB), non-high density lipoprotein-cholesterol (non-HDL-C), and trigleride (TG) plasma concentrations while increasing HDL-C concentrations. High LDL-C, low HDL-C and high TG concentrations in the plasma are associated with increased risk of atherosclerosis and cardiovascular disease. The total cholesterol to HDL-C ratio is a strong predictor of coronary artery disease and high ratios are associated with higher risk of disease. Increased levels of HDL-C are associated with lower cardiovascular risk. By decreasing LDL-C and TG and increasing HDL-C, lovastatin reduces the risk of cardiovascular morbidity and mortality. Elevated cholesterol levels, and in particular, elevated low-density lipoprotein (LDL) levels, are an important risk factor for the development of CVD. Use of statins to target and reduce LDL levels has been shown in a number of landmark studies to significantly reduce the risk of development of CVD and all-cause mortality. Statins are considered a cost-effective treatment option for CVD due to their evidence of reducing all-cause mortality including fatal and non-fatal CVD as well as the need for surgical revascularization or angioplasty following a heart attack. Evidence has shown that even for low-risk individuals (with <10% risk of a major vascular event occurring within 5 years) statins cause a 20%-22% relative reduction in major cardiovascular events (heart attack, stroke, coronary revascularization, and coronary death) for every 1 mmol/L reduction in LDL without any significant side effects or risks. Clinical studies have shown that lovastatin reduces LDL-C and total cholesterol by 25-40%. The 50% inhibitory dose is known to be of 46 mcg/kg which is translated into a reduction of approximately 30% of plasma cholesterol. **Myopathy/Rhabdomyolysis** Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is dose-related and is increased by high levels of HMG-CoA reductase inhibitory activity in plasma. In a clinical study (EXCEL) in which patients were carefully monitored and some interacting drugs were excluded, there was one case of myopathy among 4933 patients randomized to lovastatin 20 to 40 mg daily for 48 weeks, and 4 among 1649 patients randomized to 80 mg daily. Predisposing factors for myopathy include advanced age (65 years), female gender, uncontrolled hypothyroidism, and renal impairment. Chinese patients may also be at increased risk for myopathy. In most cases, muscle symptoms and CK increases resolved when treatment was promptly discontinued. The risk of myopathy during treatment with lovastatin may be increased with concurrent administration of interacting drugs such as [fenofibrate], [niacin], [gemfibrozil], [cyclosporine], and strong inhibitors of the CYP3A4 enzyme. Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with [colchicine], and caution should therefore be exercised when prescribing these two medications together. Real-world data from observational studies has suggested that 10-15% of people taking statins may experience muscle aches at some point during treatment. **Liver Dysfunction** Persistent increases (to more than 3 times the upper limit of normal) in serum transaminases occurred in 1.9% of adult patients who received lovastatin for at least one year in early clinical trials. When the drug was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels. The increases usually appeared 3 to 12 months after the start of therapy with lovastatin, and were not associated with jaundice or other clinical signs or symptoms. In the EXCEL study, the incidence of persistent increases in serum transaminases over 48 weeks was 0.1% for placebo, 0.1% at 20 mg/day, 0.9% at 40 mg/day, and 1.5% at 80 mg/day in patients on lovastatin. However, in post-marketing experience with lovastatin, symptomatic liver disease has been reported rarely at all dosages.

5.2 MeSH Pharmacological Classification

Anticholesteremic Agents

Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

LOVASTATIN

5.3.2 FDA UNII

9LHU78OQFD

5.3.3 Pharmacological Classes

Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]

5.4 ATC Code

C - Cardiovascular system

C10 - Lipid modifying agents

C10A - Lipid modifying agents, plain

C10AA - Hmg coa reductase inhibitors

C10AA02 - Lovastatin

5.5 Absorption, Distribution and Excretion

Absorption

Lovastatin Cmax was found to be 3.013ng/mL with a Tmax of 3.36 hours. Plasma concentrations of total radioactivity (lovastatin plus 14C-metabolites) peaked at 2 hours and declined rapidly to about 10% of peak by 24 hours postdose. Absorption of lovastatin, estimated relative to an intravenous reference dose, in each of four animal species tested, averaged about 30% of an oral dose. In animal studies, after oral dosing, lovastatin had high selectivity for the liver, where it achieved substantially higher concentrations than in non-target tissues. Lovastatin undergoes extensive first-pass extraction in the liver, its primary site of action, with subsequent excretion of drug equivalents in the bile. As a consequence of extensive hepatic extraction of lovastatin, the availability of drug to the general circulation is low and variable. In a single dose study in four hypercholesterolemic patients, it was estimated that less than 5% of an oral dose of lovastatin reaches the general circulation as active inhibitors. Following administration of lovastatin tablets the coefficient of variation, based on between-subject variability, was approximately 40% for the area under the curve (AUC) of total inhibitory activity in the general circulation. The peak concentrations of lovastatin when a dose of 10-40 mg is administered are reported to range from 1.04-4.03 ng/ml and an AUC of 14-53 ng.h/ml. This indicates that lovastatin presents a dose-dependent pharmacokinetic profile. When lovastatin was given under fasting conditions, plasma concentrations of both active and total inhibitors were on average about two-thirds those found when lovastatin was administered immediately after a standard test meal. Genetic differences in the OATP1B1 (Organic-Anion-Transporting Polypeptide 1B1) hepatic transporter encoded by the SCLCO1B1 gene (Solute Carrier Organic Anion Transporter family member 1B1) have been shown to impact lovastatin pharmacokinetics. Evidence from pharmacogenetic studies of the c.521T>C single nucleotide polymorphism (SNP) showed that lovastatin Cmax and AUC were 340 and 286% higher, respectively, for individuals homozygous for 521CC compared to homozygous 521TT individuals. The 521CC genotype is also associated with a marked increase in the risk of developing myopathy, likely secondary to increased systemic exposure. Other statin drugs impacted by this polymorphism include [rosuvastatin], [pitavastatin], [atorvastatin], [simvastatin], and [pravastatin]. While specific dosage instructions are not included in the available product monographs for lovastatin, individuals with the above-mentioned c.521CC OATP1B1 genotype should be monitored for development of adverse effects from increased exposure to the drug, such as muscle pain and risk of rhabdomyolysis, particularly at higher doses.

Route of Elimination

Following an oral dose of 14C-labeled lovastatin to man, 10% of the dose was excreted in urine and 83% in feces. The latter represents absorbed drug excreted in bile, together with unabsorbed drug.

Volume of Distribution

Lovastatin is able to cross the blood-brain barrier and placenta.

/MILK/ It is not known whether lovastatin is excreted in human milk.

Following an oral dose of (14)C-labeled lovastatin in man, 10% of the dose was excreted in urine and 83% in feces. The latter represents absorbed drug equivalents excreted in bile, as well as any unabsorbed drug. Plasma concentrations of total radioactivity (lovastatin plus (14)C-metabolites) peaked at 2 hours and declined rapidly to about 10% of peak by 24 hours postdose. Absorption of lovastatin, estimated relative to an intravenous reference dose, in each of four animal species tested, averaged about 30% of an oral dose. In animal studies, after oral dosing, lovastatin had high selectivity for the liver, where it achieved substantially higher concentrations than in non-target tissues. Lovastatin undergoes extensive first-pass extraction in the liver, its primary site of action, with subsequent excretion of drug equivalents in the bile. As a consequence of extensive hepatic extraction of lovastatin, the availability of drug to the general circulation is low and variable. In a single dose study in four hypercholesterolemic patients, it was estimated that less than 5% of an oral dose of lovastatin reaches the general circulation as active inhibitors. Following administration of lovastatin tablets the coefficient of variation, based on between-subject variability, was approximately 40% for the area under the curve (AUC) of total inhibitory activity in the general circulation.

Both lovastatin and its beta-hydroxyacid metabolite are highly bound (> 95%) to human plasma proteins. Animal studies demonstrated that lovastatin crosses the blood-brain and placental barriers.

Peak plasma concentrations of both active and total inhibitors were attained within 2 to 4 hours of dose administration.

5.6 Metabolism/Metabolites

Lovastatin is given as a lactone prodrug and thus, in order to produce its mechanism of action, it is required to be converted to the active beta-hydroxy form. This drug activation process does not seem to be related to CYP isoenzyme activity but rather to be controlled by the activity of serum paraoxonase. Lovastatin is metabolized by the microsomal hepatic enzyme system (Cytochrome P-450 isoform 3A4). The major active metabolites present in human plasma are the -hydroxy acid of lovastatin, its 6'-hydroxy, 6'-hydroxymethyl, and 6'-exomethylene derivatives. The uptake of lovastatin by the liver is enhanced by the activity of OATP1B1.

Lovastatin is metabolized by the microsomal hepatic enzyme system (Cytochrome P-450 isoform 3A4). The major active metabolites present in human plasma are the beta-hydroxy acid of lovastatin, its 6'-hydroxy, 6'-hydroxymethyl, and 6'-exomethylene derivatives.

Health Canada; Product Monograph for Lovastatin (20 mg and 40 mg Tablets USP), Drug Identification Number (DIN): 02344335 p.28 (Date of Revision: May 29, 2014). Available from, as of February 1, 2017: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

The major active metabolites present in human plasma are the beta-hydroxyacid of lovastatin, its 6'-hydroxy derivative, and two additional metabolites.

Lovastatin has known human metabolites that include 3-Hydroxylovastatin and 6'beta-Hydroxylovastatin.

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

5.7 Biological Half-Life

Lovastatin half-life is reported to be of 13.37 hours. The elimination half-life of the hydroxy acid form of lovastatin is reported to be of 0.7-3 hours.

5.8 Mechanism of Action

Lovastatin is a lactone which is readily hydrolyzed _in vivo_ to the corresponding -hydroxyacid and strong inhibitor of HMG-CoA reductase, a hepatic microsomal enzyme which catalyzes the conversion of HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A ) to mevalonate, an early rate-limiting step in cholesterol biosynthesis. At therapeutic lovastatin doses, HMG-CoA reductase is not completely blocked, thereby allowing biologically necessary amounts of mevalonate to be available. Because the conversion of HMG-CoA to mevalonate is an early step in the biosynthetic pathway for cholesterol, therapy with lovastatin would not be expected to cause an accumulation of potentially toxic sterols. Lovastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low density lipoprotein (LDL) receptors which increase hepatic uptake of LDL. Lovastatin also inhibits hepatic synthesis of very low density lipoprotein (VLDL). The overall effect is a decrease in plasma LDL and VLDL and a significant reduction in the risk of development of CVD and all-cause mortality. A significant effect on LDL-C reduction was seen within 2 weeks of initiation of lovastatin, and the maximum therapeutic response occurred within 4-6 weeks. The response was maintained during continuation of therapy. Single daily doses given in the evening were more effective than the same dose given in the morning, perhaps because cholesterol is synthesized mainly at night. When therapy with lovastatin is stopped, total cholesterol has been shown to return to pre-treatment levels. In vitro and in vivo animal studies also demonstrate that lovastatin exerts vasculoprotective effects independent of its lipid-lowering properties, also known as the pleiotropic effects of statins. This includes improvement in endothelial function, enhanced stability of atherosclerotic plaques, reduced oxidative stress and inflammation, and inhibition of the thrombogenic response. Statins have also been found to bind allosterically to 2 integrin function-associated antigen-1 (LFA-1), which plays an important role in leukocyte trafficking and in T cell activation. Lovastatin has been reported to have beneficial effects on certain cancers. This includes a multi-factorial stress-triggered cell death (apoptosis) and DNA degradation response in breast cancer cells. It has also been shown to inhibit histone deacetylase 2 (HDAC2) activity and increase the accumulation of acetylated histone-H3 and the expression of p21(WAF/CIP) in human cancer cells, suggesting that statins might serve as novel HDAC inhibitors for cancer therapy and chemoprevention.

The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), atorvastatin, cerivastatin, fluvastatin, pravastatin, lovastatin and simvastatin, reduce atherogenesis and cardiovascular morbidity. Besides, there is growing evidence that statins have immunomodulatory activities. Statins downregulate the expression of adhesion molecules, intercellular adhesion molecule-1 (ICAM-1), monocyte chemotactic protein-1 (MAC-1) and lymphocyte function-associated antigen-1 (LFA-1), on leucocytes and endothelial cells and, through binding to LFA-1, interfere with ICAM-1-LFA-1 interaction, which is crucial for activation of lymphocytes by antigen-presenting cells, ingress of leucocytes into the inflammation sites and immunologic cytotoxicity. Statins inhibit the inducible expression of major histocompatibility complex class II in several cell types including macrophages and downregulate the expression of T-helper-1 (Th1) chemokine receptors on T cells, leading further to inhibition of activation of lymphocytes and their infiltration into the inflammation sites. Statins block the induction of inducible nitric oxide synthase and the expression of several proinflammatory cytokines such as tumor necrosis factor-alpha and interferon-gamma in macrophages and possess antioxidant effects. These agents inhibit the proliferation of immunocytes and the activation of natural killer cells.

PMID:15186318 Namazi MR; Exp Dermatol 13 (6): 337-9 (2004)

Lovastatin, is a cholesterol-lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding beta-hydroxy acid form. This principal metabolite is a specific inhibitor of 3-hydroxy-3- methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and ratelimiting step in the biosynthesis of cholesterol.

Health Canada; Product Monograph for Lovastatin (20 mg and 40 mg Tablets USP), Drug Identification Number (DIN): 02344335 p.20 (Date of Revision: May 29, 2014). Available from, as of February 1, 2017: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

Lovastatin is a member of Statins, which are beneficial in a lot of immunologic cardiovascular diseases and T cell-mediated autoimmune diseases. Kv1.3 channel plays important roles in the activation and proliferation of T cells, and have become attractive target for immune-related disorders. The present study was designed to examine the block effect of Lovastatin on Kv1.3 channel in human T cells, and to clarify its new immunomodulatory mechanism. We found that Lovastatin inhibited Kv1.3 currents in a concentration- and voltage-dependent manner, and the IC50 for peak, end of the pulse was 39.81 +/- 5.11, 6.92 +/- 0.95 uM, respectively. Lovastatin also accelerated the decay rate of current inactivation and negatively shifted the steady-state inactivation curves concentration-dependently, without affecting the activation curve. However, 30 uM Lovastatin had no apparent effect on KCa current in human T cells. Furthermore, Lovastatin inhibited Ca(2+) influx, T cell proliferation as well as IL-2 production. The activities of NFAT1 and NF-kB p65/50 were down-regulated by Lovastatin, too. At last, Mevalonate application only partially reversed the inhibition of Lovastatin on IL-2 secretion, and the siRNA against Kv1.3 also partially reduced this inhibitory effect of Lovastatin. In conclusion, Lovastatin can exert immunodulatory properties through the new mechanism of blocking Kv1.3 channel.

PMID:26616555 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4663632 Zhao N et al; Sci Rep. 2015 Nov 30;5:17381. doi: 10.1038/srep17381

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Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677004200,"product":"LOVASTATIN","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C ITY P.O,","city":"BANGALORE,KARNATAKA","supplier":"LIVZON GROUP NINGXIA","supplierCountry":"CHINA","foreign_port":"NA","customer":"BIOCON","customerCountry":"INDIA","quantity":"6000.00","actualQuantity":"6000","unit":"KGS","unitRateFc":"47","totalValueFC":"286867.6","currency":"USD","unitRateINR":"3948.7","date":"22-Feb-2023","totalValueINR":"23692398.35","totalValueInUsd":"286867.6","indian_port":"MADRAS SEA","hs_no":"29329990","bill_no":"4745117","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C ITY P.O,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680719400,"product":"LOVASTATIN (NOT FOR MEDICAL USE)","address":"Kalpataru Inspire, 3rd 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NINGXIA","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"BIOCON","customerCountry":"INDIA","quantity":"8200.00","actualQuantity":"8200","unit":"KGS","unitRateFc":"43","totalValueFC":"357666.2","currency":"USD","unitRateINR":"3632.1","date":"01-Nov-2023","totalValueINR":"29783180.71","totalValueInUsd":"357666.2","indian_port":"Madras Sea","hs_no":"29329990","bill_no":"8566931","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"PHARMACEUTICAL CO.,LTD TOUSHI ROADWEST,301 PROVINCIAL HIGHWAY SOUTH,PINGLUO INDUSTRIAL PARK NINGXIA CHINA","customerAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702837800,"product":"LOVASTATIN.(PO NO:1530422334,DT:14.02.2023)(SEAL NO:BETA032836) 235 FIBER DRUMS PACKED ON 44 PALLETS.)","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"TEVA API","supplierCountry":"HUNGARY","foreign_port":"N\/A","customer":"DIVIS LABORATORIES","customerCountry":"INDIA","quantity":"6952.00","actualQuantity":"6952","unit":"KGS","unitRateFc":"174","totalValueFC":"1224917.5","currency":"USD","unitRateINR":"14667.1","date":"18-Dec-2023","totalValueINR":"101965992","totalValueInUsd":"1224917.5","indian_port":"Vizag-DLL SEZ","hs_no":"29322090","bill_no":"1001132","productDescription":"API","marketType":"REGULATED MARKET","country":"HUNGARY","selfForZScoreResived":"Pellets","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707849000,"product":"LOVASTATIN (NOT FOR MEDICINAL USE)","address":"159, C.S.T. 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ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"LIVZON GROUP NINGXIA ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"6000.00","actualQuantity":"6000","unit":"KGS","unitRateFc":"43","totalValueFC":"260459.2","currency":"USD","unitRateINR":"3637.8","date":"10-Sep-2024","totalValueINR":"21826800","totalValueInUsd":"260459.2","indian_port":"JNPT","hs_no":"29322090","bill_no":"5520327","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non Pharma","supplierPort":"SHANGHAI","supplierAddress":"AL CO.,LTD.TOUSHI ROAD WEST, 301 PR OVINCIALHIGHWAY SOUTH PINGLUO INDUS L PARK,NINGXIA CHINA CHINA","customerAddress":"159, C.S.T. 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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DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19643

DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19643

DOSAGE - TABLET;ORAL - 40MG **Federal Registe...DOSAGE - TABLET;ORAL - 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19643

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG

USFDA APPLICATION NUMBER - 21316

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG

USFDA APPLICATION NUMBER - 21316

DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG

USFDA APPLICATION NUMBER - 21316

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers

30 USDMF

12 CEP/COS

1 JDMF

5 EU WC

2 KDMF

6 NDC API

9 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

91 FDF Dossiers

37 FDA Orange Book

42 Europe

4 Canada

2 South Africa

6 Listed Dossiers

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

TABLET;ORAL - 20MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 40MG **Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 20MG

TABLET, EXTENDED RELEASE;ORAL - 40MG

TABLET, EXTENDED RELEASE;ORAL - 60MG

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EXCIPIENTS BY APPLICATIONS

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52 Coating Systems & Additives

35 Direct Compression

31 Controlled & Modified Release

27 Thickeners and Stabilizers

25 Solubilizers

24 Granulation

20 Disintegrants & Superdisintegrants

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

TABLET;ORAL - 20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons