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Chemistry

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Also known as: L-dopa, 59-92-7, Dopar, 3,4-dihydroxy-l-phenylalanine, 3-hydroxy-l-tyrosine, Bendopa
Molecular Formula
C9H11NO4
Molecular Weight
197.19  g/mol
InChI Key
WTDRDQBEARUVNC-LURJTMIESA-N
FDA UNII
46627O600J

Etilevodopa
The naturally occurring form of DIHYDROXYPHENYLALANINE and the immediate precursor of DOPAMINE. Unlike dopamine itself, it can be taken orally and crosses the blood-brain barrier. It is rapidly taken up by dopaminergic neurons and converted to DOPAMINE. It is used for the treatment of PARKINSONIAN DISORDERS and is usually given with agents that inhibit its conversion to dopamine outside of the central nervous system.
Levodopa is an Aromatic Amino Acid.
1 2D Structure

Etilevodopa

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
2.1.2 InChI
InChI=1S/C9H11NO4/c10-6(9(13)14)3-5-1-2-7(11)8(12)4-5/h1-2,4,6,11-12H,3,10H2,(H,13,14)/t6-/m0/s1
2.1.3 InChI Key
WTDRDQBEARUVNC-LURJTMIESA-N
2.1.4 Canonical SMILES
C1=CC(=C(C=C1CC(C(=O)O)N)O)O
2.1.5 Isomeric SMILES
C1=CC(=C(C=C1C[C@@H](C(=O)O)N)O)O
2.2 Other Identifiers
2.2.1 UNII
46627O600J
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3 Hydroxy L Tyrosine

2. 3-hydroxy-l-tyrosine

3. Dopaflex

4. Dopar

5. L 3,4 Dihydroxyphenylalanine

6. L Dopa

7. L-3,4-dihydroxyphenylalanine

8. L-dopa

9. Larodopa

10. Levopa

2.3.2 Depositor-Supplied Synonyms

1. L-dopa

2. 59-92-7

3. Dopar

4. 3,4-dihydroxy-l-phenylalanine

5. 3-hydroxy-l-tyrosine

6. Bendopa

7. Larodopa

8. Levopa

9. 3,4-dihydroxyphenylalanine

10. Brocadopa

11. Cidandopa

12. Insulamina

13. Maipedopa

14. Dopaidan

15. Dopalina

16. Dopasol

17. Eldopal

18. Eldopar

19. Pardopa

20. Prodopa

21. Syndopa

22. 3-(3,4-dihydroxyphenyl)-l-alanine

23. (-)-dopa

24. Dihydroxy-l-phenylalanine

25. Helfo-dopa

26. Dopaflex

27. Deadopa

28. Dopal-fher

29. Doparkine

30. Dopaston

31. Dopastral

32. Eldopatec

33. Eurodopa

34. Doparl

35. Doprin

36. Veldopa

37. L-3,4-dihydroxyphenylalanine

38. (2s)-2-amino-3-(3,4-dihydroxyphenyl)propanoic Acid

39. Levedopa

40. Levodopum

41. L-o-hydroxytyrosine

42. L-tyrosine, 3-hydroxy-

43. Dopa

44. (-)-3-(3,4-dihydroxyphenyl)-l-alanine

45. Ledopa

46. 3,4-dihydroxyphenyl-l-alanine

47. Dopaston Se

48. Beta-(3,4-dihydroxyphenyl)-l-alanine

49. L-(o-dihydroxyphenyl)alanine

50. L-(-)-dopa

51. L-3-hydroxytyrosine

52. L-beta-(3,4-dihydroxyphenyl)alanine

53. Weldopa

54. Parda

55. L-dihydroxyphenylalanine

56. L-3-(3,4-dihydroxyphenyl)alanine

57. (s)-2-amino-3-(3,4-dihydroxyphenyl)propanoic Acid

58. Ro 4-6316

59. Beta-(3,4-dihydroxyphenyl)alanine

60. Inbrija

61. Cvt-301

62. Alanine, 3-(3,4-dihydroxyphenyl)-, L-

63. Dihydroxyphenylalanine

64. Component Of Sinemet

65. Dopar (tn)

66. Chebi:15765

67. Beta-(3,4-dihydroxyphenyl)-alpha-l-alanine

68. L-beta-(3,4-dihydroxyphenyl)-alpha-alanine

69. Alanine, 3-(3,4-dihydroxyphenyl)-, (-)-

70. L(-)-dopa

71. (-)-(3,4-dihydroxyphenyl)alanine

72. Nsc-118381

73. L-.beta.-(3,4-dihydroxyphenyl)alanine

74. Chembl1009

75. .beta.-(3,4-dihydroxyphenyl)-l-alanine

76. L-(3,4-dihydroxyphenyl)alanine

77. L-tyrosine, 3-hydroxy-, Homopolymer

78. Nsc118381

79. .beta.-(3,4-dihydroxyphenyl)alanine

80. Cas-59-92-7

81. Ncgc00016270-04

82. Biodopa

83. Cerepap

84. Laradopa

85. Sobiodopa

86. L-(3,4-dihydroxyphenyl)-.alpha.-alanine

87. 46627o600j

88. Mfcd00002598

89. V-1512

90. C9h11no4

91. Helfo Dopa

92. 65170-01-6

93. Beta-(3,4-dihydroxyphenyl)-alpha-alanine

94. Atamet

95. Levodopum [inn-latin]

96. Bdbm50130192

97. L-o-dihydroxyphenylalanine

98. L Dopa

99. L-3

100. Ccris 3766

101. Hsdb 3348

102. Wln: Qvyz1r Cq Dq

103. 3,4-dihydroxyphenylalanine (van)

104. Sr-01000075384

105. Einecs 200-445-2

106. Nsc 118381

107. L-3,4-dihydrophenylalanine

108. Dopastone

109. Dopicar

110. Prolopa

111. (2s)-2-amino-3-(3,4-dihydroxyphenyl)propanoate

112. Unii-46627o600j

113. Prestwick_185

114. Levodopa (sinemet)

115. L-dopa; Levodopa

116. Madopa (salt/mix)

117. Levodopa [usan:usp:inn:ban:jan]

118. Spectrum_000454

119. 4-dihydroxyphenylalanine

120. Levodopa [hsdb]

121. Levodopa [usan]

122. Levodopa [inn]

123. Levodopa [jan]

124. Carbidopa Ep Impurity A

125. Levodopa [mi]

126. Levodopa [vandf]

127. Prestwick0_000017

128. Prestwick1_000017

129. Prestwick2_000017

130. Prestwick3_000017

131. Spectrum2_000496

132. Spectrum4_000539

133. Spectrum5_001899

134. Lopac-d-9628

135. Levodopa (jp15/usp)

136. Dsstox_cid_3209

137. Levodopa [mart.]

138. Bmse000322

139. Epitope Id:150927

140. Levodopa [usp-rs]

141. Levodopa [who-dd]

142. Levodopa [who-ip]

143. Dopa, L-

144. 3, 4-dihydroxyphenylalanine

145. Alanine,4-dihydroxyphenyl)-

146. Dsstox_rid_76926

147. Levodopa [ema Epar]

148. Dsstox_gsid_23209

149. Lopac0_000454

150. Schembl22655

151. Bspbio_000053

152. Bspbio_002354

153. Kbiogr_001177

154. Kbioss_000934

155. L-4-5-dihydroxyphenylalanine

156. Mls000028514

157. Bidd:gt0158

158. Divk1c_000452

159. Spectrum2300205

160. Levodopa (jp17/usp/inn)

161. Spbio_000391

162. Spbio_001974

163. Dhivy Component Levodopa

164. Duopa Component Levodopa

165. Levodopa [ep Impurity]

166. Levodopa [orange Book]

167. Bpbio1_000059

168. Gtpl3639

169. Levodopa [ep Monograph]

170. Rytary Component Levodopa

171. B-(3,4-dihydroxyphenyl)alanine

172. Dtxsid9023209

173. Levodopa [usp Monograph]

174. Wln: Qvyz1r Cq Dq -l

175. 3, 4-dihydroxy-l-phenylalanine

176. Bdbm60928

177. Hms501g14

178. Kbio1_000452

179. Kbio2_000934

180. Kbio2_003502

181. Kbio2_006070

182. Parcopa Component Levodopa

183. Stalevo Component Levodopa

184. Levodopum [who-ip Latin]

185. Alanine,4-dihydroxyphenyl)-, L-

186. Carbilev Component Levodopa

187. Corbilta Component Levodopa

188. Dopasnap Component Levodopa

189. Ipx203 Component Levodopa

190. L-(3, 4-dihydroxyphenyl)alanine

191. Ninds_000452

192. Hms1568c15

193. Hms1922j14

194. Hms2090o08

195. Hms2093n04

196. Hms2095c15

197. Hms2230b04

198. Hms3261k10

199. Hms3712c15

200. Levodopa Component Of Dhivy

201. Levodopa Component Of Duopa

202. Pharmakon1600-02300205

203. Zinc895199

204. H-phe{3,4-(oh)2}-oh

205. Hy-n0304

206. Ipx-203 Component Levodopa

207. Levodopa Component Of Rytary

208. Levodopa;3,4-dihydroxyphenylalanine

209. B-(3,4-dihydroxyphenyl)-l-alanine

210. Inbrija (levodopa Inhalation Powder)

211. Levodopa Component Of Parcopa

212. Levodopa Component Of Sinemet

213. Levodopa Component Of Stalevo

214. Tox21_110338

215. Tox21_500454

216. Ccg-39571

217. L-3-(3,4-dihydroxy-phenyl)alanine

218. L-3-(3,4-dihydroxyphenyl)-alanine

219. Nsc759573

220. Pdsp1_001541

221. Pdsp2_001525

222. S1726

223. Alanine, 3-(3,4-dihydroxyphenyl)-

224. Alanine,4-dihydroxyphenyl)-, (-)-

225. Levodopa Component Of Carbilev

226. Levodopa Component Of Corbilta

227. Levodopa Component Of Dopasnap

228. Akos010396267

229. B-(3,4-dihydroxyphenyl)-a-l-alanine

230. L-b-(3,4-dihydroxyphenyl)-a-alanine

231. .beta.-(3, 4-dihydroxyphenyl)alanine

232. Ac-8432

233. Am82124

234. Cs-1945

235. Db01235

236. Lp00454

237. Nsc-759573

238. Sdccgmls-0066924.p001

239. Sdccgsbi-0050439.p004

240. Idi1_000452

241. Ncgc00015384-01

242. Ncgc00016270-01

243. Ncgc00016270-06

244. Ncgc00016270-07

245. Ncgc00016270-09

246. Ncgc00016270-10

247. Ncgc00016270-22

248. Ncgc00093869-04

249. Ncgc00261139-01

250. As-13287

251. Bp-12850

252. Smr000058312

253. Sbi-0050439.p003

254. L-(3, 4-dihydroxyphenyl)-.alpha.-alanine

255. D0600

256. D9628

257. Eu-0100454

258. N1648

259. 59l927

260. Alanine, 3-(3, 4-dihydroxyphenyl)-, (-)-

261. C00355

262. D 9628

263. D00059

264. D70595

265. 3,4-dihydroxy-l-phenylalanine, >=98% (tlc)

266. Ab00052418-06

267. Ab00052418-07

268. Ab00052418_08

269. Ab00052418_09

270. A832543

271. Q300989

272. Q-201294

273. Sr-01000075384-1

274. Sr-01000075384-4

275. Sr-01000075384-6

276. Sr-01000075384-7

277. (s)-2-amino-3-(3,4-dihydroxy-phenyl)-propionic Acid

278. F0347-4695

279. Levodopa, British Pharmacopoeia (bp) Reference Standard

280. Levodopa, European Pharmacopoeia (ep) Reference Standard

281. Z1762772338

282. (2s)-2-amino-3-(3,4-dihydroxyphenyl)propanoic Acidl-dopa

283. 1e83f927-c221-46aa-b90a-81b33c5f3868

284. 3,4-dihydroxy-l-phenylalanine, Vetec(tm) Reagent Grade, 98%

285. Levodopa Component Of Levodopa/carbidopa/entacapone Orion

286. Levodopa, United States Pharmacopeia (usp) Reference Standard

287. Levodopa/carbidopa/entacapone Orion Component Levodopa

288. 3,4-dihydroxy-l-phenylalanine, Certified Reference Material, Tracecert(r)

289. Levodopa, Pharmaceutical Secondary Standard; Certified Reference Material

290. 122769-74-8

291. L-methyldopa ; (2s)-2-amino-3-(3,4-dihydroxyphenyl)-2-methylpropanoic Acid; 3-(3,4-dihydroxyphenyl)-?-methyl-l-alanine; 3-hydroxy-a-methyl-l-tyrosine

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 197.19 g/mol
Molecular Formula C9H11NO4
XLogP3-2.7
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count5
Rotatable Bond Count3
Exact Mass197.06880783 g/mol
Monoisotopic Mass197.06880783 g/mol
Topological Polar Surface Area104 Ų
Heavy Atom Count14
Formal Charge0
Complexity209
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Levodopa is indicated to alleviate symptoms and allow more normal body movements with improved muscle control in the treatment of idiopathic Parkinson's disease, postencephalitic parkinsonism, or symptomatic parkinsonism that may follow injury to the nervous system by carbon monoxide intoxication or manganese intoxication. It is also indicated in parkinsonism associated with cerebral arteriosclerosis. /Included in US product labeling/

MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional 21 st ed. Volume 1. MICROMEDEX Thomson Health Care, Englewood, CO. 2001. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1902


Levodopa, the metabolic precursor of dopamine, is the single most effective agent in the treatment of Parkinson's Disease.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 555


LEVODOPA AFFORDS ONLY SYMPTOMATIC RELIEF OF PARKINSONISM. IF DRUG IS STOPPED, ALL PREEXISTING SYMPTOMS GRADUALLY RETURN WITHIN WK OR TWO; UPON RESUMPTION OF L-DOPA THERAPY AFTER PERIOD OF WITHDRAWAL, PREVIOUS THERAPEUTIC RESPONSE IS REESTABLISHED AFTER WK OR MORE.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 235


...L-DOPA...HAS BEEN MORE CONSISTENTLY EFFECTIVE IN TREATMENT OF CHRONIC MANGANESE POISONING THAN IN PARKINSON'S DISEASE.

Doull, J., C.D. Klaassen, and M. D. Amdur (eds.). Casarett and Doull's Toxicology. 2nd ed. New York: Macmillan Publishing Co., 1980., p. 450


For more Therapeutic Uses (Complete) data for LEVODOPA (17 total), please visit the HSDB record page.


4.2 Drug Warning

PT WITH CARDIAC ARRHYTHMIAS OR HISTORY OF MYOCARDIAL INFARCTION SHOULD UNDERGO INITIAL THERAPY WITH LEVODOPA ONLY IN FACILITY EQUIPPED FOR INTENSIVE CORONARY CARE. ...DIABETIC PT...SHOULD BE CAREFULLY MONITORED FOR ANY NECESSITY TO MODIFY THEIR REGIMEN. CAUTION ALSO NECESSARY IN PT WITH HISTORY OF PEPTIC ULCER, CONVULSIONS...

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 233


DISCONTINUATION OF LEVODOPA THERAPY FOR 6-24 HR PRIOR TO GENERAL ANESTHESIA IS RECOMMENDED... SAFETY OF L-DOPA DURING PREGNANCY HAS NOT BEEN ESTABLISHED, HOWEVER, INFANTS SHOULD NOT BE NURSED BY MOTHERS RECEIVING DRUG SINCE IT MAY APPEAR IN MILK. ...DRUG MAY INHIBIT LACTATION.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 233


...IS CONTRAINDICATED IN PATIENTS WITH NARROW-ANGLE GLAUCOMA, ACUTE PSYCHOSIS, OR SEVERE PSYCHONEUROSIS. IT SHOULD NOT BE ADMIN TO PT WITH UNCOMPENSATED ENDOCRINE, RENAL, HEPATIC, CARDIOVASCULAR, OR PULMONARY DISEASE. /USE/...EXTREME CAUTION IN PT WITH ASTHMA OR EMPHYSEMA WHO MAY REQUIRE SYMPATHOMIMETIC DRUGS.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 233


SINCE LEVODOPA THERAPY...ASSOC WITH INCR GROWTH OF MELANOMA, PT WITH KNOWN MELANOMAS OR PIGMENTED LESIONS SHOULD BE CAREFULLY MONITORED FOR CHANGES IN SUCH LESIONS & DRUG WITHDRAWN IF CHANGES OCCUR.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 233


For more Drug Warnings (Complete) data for LEVODOPA (49 total), please visit the HSDB record page.


4.3 Drug Indication

Levodopa on its own is formulated as an oral inhalation powder indicated for intermittent treatment of off episodes in Parkinson's patients who are already being treated with carbidopa and levodopa. Levodopa is most commonly formulated as an oral tablet with a peripheral dopa decarboxylase inhibitor indicated for treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism following carbon monoxide intoxication or manganese intoxication.


FDA Label


Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinsons disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Levodopa is able to cross the blood-brain barrier while dopamine is not. The addition of a peripheral dopa decarboxylase inhibitor prevents the conversion of levodopa to dopamine in the periphery so that more levodopa can reach the blood-brain barrier. Once past the blood-brain barrier, levodopa is converted to dopamine by aromatic-L-amino-acid decarboxylase.


5.2 MeSH Pharmacological Classification

Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)


Dopamine Agents

Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
LEVODOPA
5.3.2 FDA UNII
46627O600J
5.3.3 Pharmacological Classes
Aromatic Amino Acid [EPC]; Amino Acids, Aromatic [CS]
5.4 ATC Code

N04BA01


N04BA02

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


N - Nervous system

N04 - Anti-parkinson drugs

N04B - Dopaminergic agents

N04BA - Dopa and dopa derivatives

N04BA01 - Levodopa


5.5 Absorption, Distribution and Excretion

Absorption

Orally inhaled levodopa reaches a peak concentration in 0.5 hours with a bioavailability than is 70% that of the immediate release levodopa tablets with a peripheral dopa decarboxylase inhibitor like carbidopa or benserazide.


Route of Elimination

After 48 hours, 0.17% of an orally administered dose is recovered in stool, 0.28% is exhaled, and 78.4% is recovered in urine


Volume of Distribution

168L for orally inhaled levodopa.


Clearance

Intravenously administered levodopa is cleared at a rate of 14.2mL/min/kg in elderly patients and 23.4mL/min/kg in younger patients. When given carbidopa, the clearance of levodopa was 5.8mL/min/kg in elderyly patients and 9.3mL/min/kg in younger patients.


...DRUG...MAY APPEAR IN MILK.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 233


AFTER IP INJECTION INTO MICE, BIOTRANSFORMATION OF 60% OF RADIOACTIVELY LABELLED DL-DOPA TAKES PLACE WITHIN 10 MIN, & PEAK DOPAMINE LEVELS ARE REACHED 20 MIN AFTER ADMIN. ...APPROX 0.1% OF DOSE WAS PRESENT IN THE BRAIN AS (14)C-L-DOPA OR (14)C-DOPAMINE. /DL-DOPA/

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 2: A Review of the Literature Published Between 1970 and 1971. London: The Chemical Society, 1972., p. 213


MORE THAN 95% OF LEVODOPA IS DECARBOXYLATED IN PERIPHERY BY WIDELY DISTRIBUTED EXTRACEREBRAL AROMATIC L-AMINO ACID DECARBOXYLASE. ...LITTLE UNCHANGED DRUG REACHES CEREBRAL CIRCULATION & PROBABLY LESS THAN 1% PENETRATES INTO CNS.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 230


MOST IS CONVERTED TO DOPAMINE... DOPAMINE METABOLITES ARE RAPIDLY EXCRETED IN URINE, ABOUT 80% OF RADIOACTIVELY LABELED DOSE BEING RECOVERED WITHIN 24 HR. ... THESE METABOLITES /3,4-DIHYDROXYPHENYLACETIC ACID & 3-METHOXY-4-HYDROXYPHENYLACETIC ACID/, AS WELL AS SMALL AMT OF LEVODOPA & DOPAMINE, ALSO APPEAR IN CEREBROSPINAL FLUID.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 231


For more Absorption, Distribution and Excretion (Complete) data for LEVODOPA (11 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Levodopa is either converted to dopamine by aromatic-L-amino-acid decarboxylase or O-methylated to 3-O-methyldopa by catechol-O-methyltransferase. 3-O-methyldopa cannot be metabolized to dopamine. Once levodopa is converted to dopamine, it is converted to sulfated or glucuronidated metabolites, epinephrine E, or homovanillic acid through various metabolic processes. The primary metabolites are 3,4-dihydroxyphenylacetic acid (13-47%) and homovanillic acid (23-39%).


MOST IS CONVERTED TO DOPAMINE... BIOTRANSFORMATION OF DOPAMINE PROCEEDS RAPIDLY...EXCRETION PRODUCTS, 3,4-DIHYDROXYPHENYLACETIC ACID...& 3-METHOXY-4-HYDROXYPHENYLACETIC ACID... SOME BIOCHEMICAL EVIDENCE INDICATES THAT ACCELERATION OF LEVODOPA METABOLISM OCCURS DURING PROLONGED THERAPY, POSSIBLY DUE TO ENZYME INDUCTION.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 230


MORE THAN 95%...IS DECARBOXYLATED...BY...AROMATIC L-AMINO ACID DECARBOXYLASE. ... A SMALL AMT /OF L-DOPA/ IS METHYLATED TO 3-O-METHYL-DOPA... MOST IS CONVERTED TO DOPAMINE, SMALL AMT OF WHICH IN TURN ARE METABOLIZED TO NOREPINEPHRINE & EPINEPHRINE.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 230


...IS ESTIMATED THAT ABOUT THREE FOURTHS OF DIETARY METHIONINE IS UTILIZED FOR METABOLISM OF LARGE THERAPEUTIC DOSES OF LEVODOPA.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 231


LEVODOPA (L-DOPA) IS FORMED IN MAMMALS FROM L-TYROSINE AS INTERMEDIARY METABOLITE IN ENZYMATIC SYNTHESIS OF CATECHOLAMINES.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 228


5.7 Biological Half-Life

2.3 hours for orally inhaled levodopa. Oral levodopa has a half life of 50 minutes but when combined with a peripheral dopa decarboxylase inhibitor, the half life is increased to 1.5 hours.


THE HALF-LIFE IN PLASMA IS SHORT (1-3 HR).

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 555


5.8 Mechanism of Action

Levodopa by various routes crosses the blood brain barrier, is decarboxylated to form dopamine. This supplemental dopamine performs the role that endogenous dopamine cannot due to a decrease of natural concentrations and stimulates dopaminergic receptors.


MOST WIDELY ACCEPTED THEORY IS THAT LEVODOPA INCR LEVEL OF DOPAMINE & THUS ACTIVATION OF DOPAMINE RECEPTORS IN EXTRA-PYRAMIDAL CENTERS IN THE BRAIN (PRIMARILY IN CAUDATE NUCLEUS & SUBSTANTIA NIGRA).

Evaluations of Drug Interactions. 2nd ed. and supplements. Washington, DC: American Pharmaceutical Assn., 1976, 1978., p. 124


The present data indicate that the major effects observed after administration of exogenous levodopa are not due to a direct action of levodopa on dopamine receptors, or to extrastriatal release of dopamine, but to conversion of levodopa to dopamine by serotonergic terminals and probably some intrastriatal cells.

PMID:11274784 Lopez A et al; Neuroscience 103(3) : 639-651 (2001)


EFFECTS OF LEVODOPA ON HUMAN & MURINE MELANOMA CELLS EXAMINED. WHEN EXPONENTIALLY GROWING CELLS WERE EXPOSED TO L-DOPA, CHARACTERISTIC INHIBITION OF THYMIDINE INCORPORATION OBSERVED.

PMID:6768447 WICK MM; CANCER RES 40 (5): 1414 (1980)


IN RATS, DOPAMINERGIC AGONISTS ALL CAUSED DECR IN SERUM PROLACTIN LEVELS.

HOROWSKI R ET AL; ARCH TOXICOL (SUPPL 2): 93 (1979)


API SUPPLIERS

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LGM Pharma

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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Zhejiang Wild Wind Pharmaceutical ...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

euroPLX 86 Munich
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China

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Maithri Drugs

India

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Maithri Drugs

India

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Alfa Chemicals

United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

euroPLX 86 Munich
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Alfa Chemicals

United Kingdom

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PVP Sociedade Anonima

Brazil

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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PVP Sociedade Anonima

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HOUSTON CYCLOTRON PARTNERS LP

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

euroPLX 86 Munich
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HOUSTON CYCLOTRON PARTNERS LP

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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elm-plastic GmbH

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

euroPLX 86 Munich
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elm-plastic GmbH

Germany

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F. Hoffmann-La Roche

Switzerland

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F. Hoffmann-La Roche

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Switzerland

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F. Hoffmann-La Roche

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GD Searle LLC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

euroPLX 86 Munich
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GD Searle LLC

U.S.A

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euroPLX 86 Munich
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Certificate Number : R1-CEP 1999-091 - Rev 03

Status : Withdrawn by Holder

Issue Date : 2008-05-14

Type : Chemical

Substance Number : 38

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Certificate Number : R1-CEP 2009-174 - Rev 02

Status : Valid

Issue Date : 2022-04-11

Type : Chemical

Substance Number : 38

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Certificate Number : R1-CEP 2013-293 - Rev 01

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Issue Date : 2021-11-22

Type : Chemical

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Certificate Number : R1-CEP 2011-253 - Rev 00

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Issue Date : 2018-05-15

Type : Chemical

Substance Number : 38

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Gabon
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Certificate Number : R1-CEP 1998-071 - Rev 01

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Certificate Number : R1-CEP 2012-377 - Rev 00

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JDMF

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Pharma Manufacturing 2024
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L-DIHYDROXYPHENYLALANINE

Registration Number : 302MF10140

Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo

Initial Date of Registration : 2020-11-26

Latest Date of Registration : 2020-11-26

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Pharma Manufacturing 2024
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Japanese Pharmacopoeia Levodopa (for manufacturing only)

Registration Number : 221MF10284

Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo

Initial Date of Registration : 2009-12-22

Latest Date of Registration : 2009-12-22

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Levodopa

Registration Number : 227MF10235

Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber ​​Hills, Gachibowli, Hyderabad-500 032, ...

Initial Date of Registration : 2015-09-24

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Japanese Pharmacopoeia Levodopa (for manufacturing only)

Registration Number : 221MF10029

Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China

Initial Date of Registration : 2009-02-09

Latest Date of Registration : 2009-02-09

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Levodopa (IP/BP/USP/Ph. Eur)

Date of Issue : 2019-06-17

Valid Till : 2022-06-16

Written Confirmation Number : WC-0030

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Levodopa (IP/USP/BP/Ph. Eur.)

Date of Issue : 2013-06-11

Valid Till : 2016-06-05

Written Confirmation Number : WC-0029

Address of the Firm : Unit-II, Sy. No. 36, 37 and 46, Plot No. 77, J. N. Pharmacity, Thanam (V), Paraw...

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American Pharma Summit
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Levodopa

Registrant Name : Roche Korea Co., Ltd.

Registration Date : 2023-03-21

Registration Number : 20220829-209-J-1351(1)

Manufacturer Name : Ajinomoto Co. Inc. Kawasaki ...

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Levodopa

Registrant Name : Alvogen Korea Co., Ltd.

Registration Date : 2022-08-29

Registration Number : 20220829-209-J-1351

Manufacturer Name : Ajinomoto Co. Inc. Kawasaki ...

Manufacturer Address : 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan

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Levodopa

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2019-10-21

Registration Number : 20191021-209-J-458

Manufacturer Name : Divi's Laboratories Limited ...

Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District – 531...

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Levodopa

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2020-03-12

Registration Number : 20191021-209-J-458(2)

Manufacturer Name : Divi's Laboratories Limited ...

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Levodopa

Registrant Name : Parmarine Co., Ltd.

Registration Date : 2020-03-09

Registration Number : 20191021-209-J-458(1)

Manufacturer Name : Divi's Laboratories Limited ...

Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District – 531...

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American Pharma Summit
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Levodopa

Registrant Name : Roche Korea Co., Ltd.

Registration Date : 2023-03-21

Registration Number : 20210810-209-J-943(1)

Manufacturer Name : Shandong Xinhua Pharmaceutic...

Manufacturer Address : East Chemical Zone of Zibo High & New Technology Development Zone, Zibo, Shandong, PR...

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American Pharma Summit
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Levodopa

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2021-08-10

Registration Number : 20210810-209-J-943

Manufacturer Name : Shandong Xinhua Pharmaceutic...

Manufacturer Address : East Chemical Zone of Zibo High & New Technology Development Zone, Zibo, Shandong, PR...

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American Pharma Summit
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Levodopa

Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

Registration Date : 2020-11-19

Registration Number : 20201119-209-J-784

Manufacturer Name : Zhejiang Huahai Pharmaceutic...

Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China

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American Pharma Summit
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Levodopa

Registrant Name : Masung LS Co., Ltd.

Registration Date : 2023-11-23

Registration Number : 20231123-209-J-1573

Manufacturer Name : Zhejiang Wild Wind Pharmaceu...

Manufacturer Address : Beijiang Industrial Zone, Geshan Town, Dongyang City, Zhejiang Province, China

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NDC API

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euroPLX 86 Munich
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LEVODOPA

NDC Package Code : 17333-059

Start Marketing Date : 1982-04-15

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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LEVODOPA

NDC Package Code : 62331-013

Start Marketing Date : 2004-03-17

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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Fagron Inc

Netherlands
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Fagron Inc

Netherlands
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LEVODOPA

NDC Package Code : 51552-1348

Start Marketing Date : 2004-09-01

End Marketing Date : 2024-11-30

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

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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LEVODOPA

NDC Package Code : 70600-019

Start Marketing Date : 2020-10-16

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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LEVODOPA

NDC Package Code : 51927-0049

Start Marketing Date : 2020-05-18

End Marketing Date : 2024-12-31

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Marketing Category : BULK INGREDIENT FOR HUMAN P...

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LEVODOPA

NDC Package Code : 58624-0234

Start Marketing Date : 2000-01-01

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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LEVODOPA

NDC Package Code : 58624-0238

Start Marketing Date : 2000-01-01

End Marketing Date : 2024-12-31

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Marketing Category : BULK INGREDIENT

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LEVODOPA

NDC Package Code : 49452-2680

Start Marketing Date : 1990-04-01

End Marketing Date : 2024-12-31

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Marketing Category : BULK INGREDIENT

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LEVODOPA

NDC Package Code : 51846-1053

Start Marketing Date : 2012-08-16

End Marketing Date : 2024-12-31

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Marketing Category : BULK INGREDIENT

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LEVODOPA

NDC Package Code : 51846-1052

Start Marketing Date : 2012-04-12

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (100kg/100kg)

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LGM Pharma

U.S.A
  • fda
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Etilevodopa

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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euroPLX 86 Munich
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Levodopa

About the Company : Bajaj Healthcare Ltd. is a company established in 1993, services various Pharmaceuticals, Nutraceutical and Food industries globally with a spirit of scrupulousness. Bajaj Healt...

Bajaj Healthcare Ltd. is a company established in 1993, services various Pharmaceuticals, Nutraceutical and Food industries globally with a spirit of scrupulousness. Bajaj Healthcare Ltd. have metamorphosed into specialty company and focused on development, manufacturing and supply of Amino Acids, Nutritional Supplements and Active Pharmaceutical Ingredients (API) for Pharmaceutical, Nutraceuticals and Food industries. Bajaj healthcare Ltd. in its shot life span has gained loyalty from national and international customers and our products enjoy good fame in the overseas market.
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Levodopa

About the Company : Chengdu Chen Green Biotechnology (Chen Green) is a company specializing in plant extracts, pharmaceutical raw materials, food additives and dietary supplements manufacturers and wh...

Chengdu Chen Green Biotechnology (Chen Green) is a company specializing in plant extracts, pharmaceutical raw materials, food additives and dietary supplements manufacturers and wholesalers. Since 2006, we have been honored and committed to serving all kinds of customers in the field of natural products and making continuous efforts for the cause of human health. Chenlu's sales headquarters is located in Chengdu, Sichuan Province, the hometown of pandas in China. The production base covers an area of ​​50 acres and is equipped with 3 plant extraction production lines.
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Etilevodopa

About the Company : Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture fo...

Divi's Laboratories Limited is a leading independent contract manufacturer of Active Pharmaceutical Ingredients and registered intermediates. We custom / exclusively manufacture for several Big Pharma companies under full cGMP. Customers regularly audit our facilities in areas of quality, EHS, business continuity etc. Unmatched Infrastructure:2 manufacturing sites. Both sites were successfully US-FDA Inspected No of DMFs 373 Pilot Plants30 Production Buildings39 Pharma Suites944 Reactors - 250 L to 30 KLTotal Capacity - 6676 M34 R&D Centers325 Scientists.
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Levodopa

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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Levodopa

About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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Hetero Drugs

India
euroPLX 86 Munich
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Hetero Drugs

India
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Levodopa

About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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Otto Brandes

Germany
euroPLX 86 Munich
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Otto Brandes

Germany
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Levodopa

About the Company : Otto Brandes Gmbh was founded in 1923 and is an independent distributor of high quality Pharmaceutical Active Ingredients and excipients for the pharmaceutical industry. We regard ...

Otto Brandes Gmbh was founded in 1923 and is an independent distributor of high quality Pharmaceutical Active Ingredients and excipients for the pharmaceutical industry. We regard ourselves as a service provider and focus on the customer`s interests. Our aim is to work together with you as a reliable and dependable partner, to achieve your requirements and objectives, enabling you to take a successful market position. Since 2015 we are a part of an internationally expanding group.
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Etilevodopa

About the Company : Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and mus...

Established in 1984, R L Fine Chem Pvt. Ltd. is one of the fastest growing API companies, with a leadership position in several APIs such as antihistamines, antidepressants and muscle relaxants. Acquired by private equity groups in 2016, it is one of India’s leading manufacturers of psychotropic substances. It supplies over 60 APIs to customers in more than 62 countries from FDA and EU-approved locations. R L Fine Chem is a technology-driven company with a focus on the in-house manufacture of key intermediates for our APIs. The company currently operates out of four facilities in the Indian states of Karnataka and Andhra Pradesh.
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Levodopa

About the Company : Established in 1943 as one of the national largest manufacturing and exporting bases in the chemical synthetic pharmaceuticals field, Shandong Xinhua Pharmaceutical Company Limited...

Established in 1943 as one of the national largest manufacturing and exporting bases in the chemical synthetic pharmaceuticals field, Shandong Xinhua Pharmaceutical Company Limited ("Shandong Xinhua") is a leading position in the manufacturing technology and capacity for antipyretics and analgesics in China and is an important manufacturer in China for the drugs for central nervous system, steroids, cardio cerebrovascular system as well as finished dosage forms and pharmaceutical intermediates.
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18-Jan-2021
29-Oct-2024
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Drugs in Development

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Details:

ABBV-951 (Foslevodopa/Foscarbidopa) is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous infusion that is being investigated for the treatment of advanced Parkinson's disease in patients whose motor symptoms are not controlled by oral medications.


Lead Product(s): Etilevodopa,Carbidopa

Therapeutic Area: Neurology Brand Name: ABBV-951

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 28, 2021

Abbvie Company Banner

01

AbbVie Inc

U.S.A
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euroPLX 86 Munich
Not Confirmed

Details : ABBV-951 (Foslevodopa/Foscarbidopa) is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous infusion that is being investigated for the treatment of advanced Parkinson's disease in patients whose motor symptoms are not controlled by ...

Brand Name : ABBV-951

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 28, 2021

Abbvie Company Banner

Details:

ND0612 is a continuous, subcutaneous infusion levodopa/carbidopa delivery system under development for patients with Parkinson's disease (PD) and motor fluctuations.


Lead Product(s): Etilevodopa,Carbidopa

Therapeutic Area: Neurology Brand Name: ND0612

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 30, 2024

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02

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : ND0612 is a continuous, subcutaneous infusion levodopa/carbidopa delivery system under development for patients with Parkinson's disease (PD) and motor fluctuations.

Brand Name : ND0612

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 30, 2024

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Details:

Crexont is a novel, oral carbidopa/levodopa (CD/LD) formulation that combines immediate-release granules and extended-release pellets. It indicated for the treatment of Parkinson’s disease


Lead Product(s): Carbidopa,Etilevodopa

Therapeutic Area: Neurology Brand Name: Crexont

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 23, 2024

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03

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : Crexont is a novel, oral carbidopa/levodopa (CD/LD) formulation that combines immediate-release granules and extended-release pellets. It indicated for the treatment of Parkinson’s disease

Brand Name : Crexont

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 23, 2024

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Details:

Crexont (carbidopa/levodopa) is a novel, oral extended-release capsule formulation. It is indicated for the treatment of parkinson's disease with motor fluctuations.


Lead Product(s): Carbidopa,Etilevodopa

Therapeutic Area: Neurology Brand Name: Crexont

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 07, 2024

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04

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : Crexont (carbidopa/levodopa) is a novel, oral extended-release capsule formulation. It is indicated for the treatment of parkinson's disease with motor fluctuations.

Brand Name : Crexont

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 07, 2024

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Details:

Merz purchases substantially all of the assets of Acorda, including the rights to Inbrija (levodopa inhalation powder), which is used when needed for OFF episodes in adults with Parkinson's disease.


Lead Product(s): Etilevodopa

Therapeutic Area: Neurology Brand Name: Inbrija

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Merz Therapeutics

Deal Size: $185.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition July 10, 2024

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05

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : Merz purchases substantially all of the assets of Acorda, including the rights to Inbrija (levodopa inhalation powder), which is used when needed for OFF episodes in adults with Parkinson's disease.

Brand Name : Inbrija

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 10, 2024

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Details:

Merz Therapeutics will acquire Acorda's assets, including Inbrija (levodopa inhalation) for OFF episodes in Parkinson’s and Ampyra (dalfampridine).


Lead Product(s): Etilevodopa

Therapeutic Area: Neurology Brand Name: Inbrija

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Merz Pharma

Deal Size: $185.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition April 02, 2024

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06

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : Merz Therapeutics will acquire Acorda's assets, including Inbrija (levodopa inhalation) for OFF episodes in Parkinson’s and Ampyra (dalfampridine).

Brand Name : Inbrija

Molecule Type : Small molecule

Upfront Cash : Undisclosed

April 02, 2024

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Details:

Through the licensing agreement, Zambon will commercialize IPX203, an oral formulation of carbidopa/levodopa extended-release capsules designed for the treatment of Parkinson’s disease.


Lead Product(s): Carbidopa,Etilevodopa

Therapeutic Area: Neurology Brand Name: IPX203

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Zambon Group SpA

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement February 27, 2024

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07

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : Through the licensing agreement, Zambon will commercialize IPX203, an oral formulation of carbidopa/levodopa extended-release capsules designed for the treatment of Parkinson’s disease.

Brand Name : IPX203

Molecule Type : Small molecule

Upfront Cash : Undisclosed

February 27, 2024

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Details:

IPX203 (carbidopa/levodopa) is a novel, oral extended-release capsule formulation. It is being evaluated in phase 3 clinical trials for the treatment of parkinson's disease with motor fluctuations.


Lead Product(s): Carbidopa,Etilevodopa

Therapeutic Area: Neurology Brand Name: IPX203

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 08, 2024

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08

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : IPX203 (carbidopa/levodopa) is a novel, oral extended-release capsule formulation. It is being evaluated in phase 3 clinical trials for the treatment of parkinson's disease with motor fluctuations.

Brand Name : IPX203

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 08, 2024

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Details:

Levodopa Cyclops™ is a levodopa dry powder inhaler which is being evaluated in phase 2 clinical trials for the fast and reliable relief of OFF episodes in Parkinson’s disease.


Lead Product(s): Etilevodopa

Therapeutic Area: Neurology Brand Name: Levodopa Cyclops

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 18, 2024

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09

PureIMS

Netherlands
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euroPLX 86 Munich
Not Confirmed

PureIMS

Netherlands
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euroPLX 86 Munich
Not Confirmed

Details : Levodopa Cyclops™ is a levodopa dry powder inhaler which is being evaluated in phase 2 clinical trials for the fast and reliable relief of OFF episodes in Parkinson’s disease.

Brand Name : Levodopa Cyclops

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 18, 2024

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Details:

INBRIJA® (levodopa) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa. INBRIJA utilizes ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation.


Lead Product(s): Etilevodopa

Therapeutic Area: Neurology Brand Name: Inbrija

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 06, 2023

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10

euroPLX 86 Munich
Not Confirmed
euroPLX 86 Munich
Not Confirmed

Details : INBRIJA® (levodopa) is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa. INBRIJA utilizes ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inha...

Brand Name : Inbrija

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 06, 2023

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INTERMEDIATES SUPPLIERS

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01

  • fda
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  • WHO-GMP

Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

CAS Number : 87745-27-5

End Use API : Etilevodopa

About The Company : USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Unio...

USV Private Limited

02

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed
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CAS Number : 105601-04-5

End Use API : Etilevodopa

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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03

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed
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CAS Number : 139306-10-8

End Use API : Etilevodopa

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

blank

04

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed
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CAS Number : 42252-34-6

End Use API : Etilevodopa

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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05

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed
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CAS Number : 120-14-9

End Use API : Etilevodopa

About The Company : Zhejiang NHU Co., Ltd. was founded in 1999 and listed in 2004 (stock code 002001). Since its establishment, the company has always adhered to the concept of inn...

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FDF Dossiers

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01

AbbVie Inc

U.S.A
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American Pharma Summit
Not Confirmed

CARBIDOPA; LEVODOPA

Brand Name : DUOPA

Dosage Form : SUSPENSION;ENTERAL

Dosage Strength : 4.63MG/ML;20MG/ML

Packaging :

Approval Date : 2015-01-09

Application Number : 203952

Regulatory Info : RX

Registration Country : USA

Abbvie Company Banner

02

AbbVie Inc

U.S.A
arrow
American Pharma Summit
Not Confirmed

Levodopa; Carbidopa

Brand Name : Duodopa

Dosage Form : Levodopa+Carbidopa 20Mg/Ml + 5Mg/Ml 100Ml 7 Units' Intestinal Use

Dosage Strength : 7 bags intestinal gel 100 ml 20 mg/ml + 5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Abbvie Company Banner

03

AbbVie Inc

U.S.A
arrow
American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Duodopa

Dosage Form : Intestinalgel

Dosage Strength : 20 mg/ml/5 mg/ml

Packaging : Plastic bag

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

04

AbbVie Inc

U.S.A
arrow
American Pharma Summit
Not Confirmed

Levodopa, Karbidopamonohydrat

Brand Name : Duodopa

Dosage Form : Intestinalgel

Dosage Strength : 20 mg/ml/5 mg/ml

Packaging : Plastic bag 7 100ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

05

AbbVie Inc

U.S.A
arrow
American Pharma Summit
Not Confirmed

CARBIDOPA (CARBIDOPA MONOHYDRATE)

Brand Name : DUODOPA

Dosage Form : GEL

Dosage Strength : 5MG/ML

Packaging : 7 CASSETTES (100G/EA)

Approval Date :

Application Number : 2292165

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

06

AbbVie Inc

U.S.A
arrow
American Pharma Summit
Not Confirmed

LEVODOPA

Brand Name : DUODOPA

Dosage Form : GEL

Dosage Strength : 20MG/ML

Packaging : 7 CASSETTES (100G/EA)

Approval Date :

Application Number : 2292165

Regulatory Info : Prescription

Registration Country : Canada

Abbvie Company Banner

07

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American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Panamor At-50

Dosage Form : TAB

Dosage Strength : 250mg

Packaging : 9X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

08

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American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Carbilev 25/100

Dosage Form : TAB

Dosage Strength : 100mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

09

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American Pharma Summit
Not Confirmed

CARBIDOPA; ENTACAPONE; LEVODOPA

Brand Name : STALEVO 150

Dosage Form : TABLET;ORAL

Dosage Strength : 37.5MG;200MG;150MG

Packaging :

Approval Date : 2003-06-11

Application Number : 21485

Regulatory Info : RX

Registration Country : USA

Fermion Orion Company Banner

10

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American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Stalevo

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 150 mg/37.5 mg/200 mg

Packaging : Bottle of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner
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Europe

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01

AbbVie

U.S.A
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American Pharma Summit
Not Confirmed

Levodopa; Carbidopa

Brand Name : Duodopa

Dosage Form : Levodopa+Carbidopa 20Mg/Ml + 5Mg/Ml 100Ml 7 Units' Intestinal Use

Dosage Strength : 7 bags intestinal gel 100 ml 20 mg/ml + 5 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Abbvie Company Banner

02

AbbVie

U.S.A
arrow
American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Duodopa

Dosage Form : Intestinalgel

Dosage Strength : 20 mg/ml/5 mg/ml

Packaging : Plastic bag

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

03

AbbVie AS

U.S.A
arrow
American Pharma Summit
Not Confirmed

Levodopa, Karbidopamonohydrat

Brand Name : Duodopa

Dosage Form : Intestinalgel

Dosage Strength : 20 mg/ml/5 mg/ml

Packaging : Plastic bag 7 100ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Abbvie Company Banner

04

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American Pharma Summit
Not Confirmed

Levodopa; Carbidopa; Entacapone

Brand Name : Corbilta

Dosage Form : Levodopa+Carbidopa+Entacapone 200+50+200Mg 100 Unita' Oral Use

Dosage Strength : 100 CPR 200 mg + 50 mg + 200 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Fermion Orion Company Banner

05

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American Pharma Summit
Not Confirmed

Levodopa; Carbidopa; Entacapone

Brand Name : Stalo

Dosage Form : Levodopa+Carbidopa+Entacapone 200+50+200Mg 100 Unita' Oral Use

Dosage Strength : 100 CPR 200 mg + 50 mg + 200 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Fermion Orion Company Banner

06

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American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Stalevo

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg/25 mg/200 mg

Packaging : Bottle of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

07

arrow
American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Stalevo

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 150 mg/37.5 mg/200 mg

Packaging : Bottle of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

08

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American Pharma Summit
Not Confirmed

Levodopa

Brand Name : Stalevo

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 50 mg/12.5 mg/200 mg

Packaging : Bottle of plastic

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

09

arrow
American Pharma Summit
Not Confirmed

Levodopa/carbidopa/entacapone

Brand Name : CORBILTA

Dosage Form : Film-Coated Tablet Oral

Dosage Strength : 125 mg/31.25 mg/200 mg

Packaging : 100 UNITS 125 + 31.25 + 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Fermion Orion Company Banner

10

arrow
American Pharma Summit
Not Confirmed

Levodopa/carbidopa/entacapone

Brand Name : STALEVO

Dosage Form : Film-Coated Tablet Oral

Dosage Strength : 150 mg/37.5 mg/200 mg

Packaging : 100 UNITS 150 + 37.5 + 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Fermion Orion Company Banner
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Listed Dossiers

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01

  • fda
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Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Dispersible Tablet

Dosage Strength : 50MG; 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Dispersible Tablet

Dosage Strength : 50MG; 12.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Dispersible Tablet

Dosage Strength : 100MG; 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Dispersible Tablet

Dosage Strength : 100MG; 25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Immediate Release Caps...

Dosage Strength : 50MG; 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Immediate Release Caps...

Dosage Strength : 50MG; 12.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Immediate Release Caps...

Dosage Strength : 100MG; 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Immediate Release Caps...

Dosage Strength : 100MG; 25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Immediate Release Caps...

Dosage Strength : 200 MG; 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Immediate Release Caps...

Dosage Strength : 200 MG; 50MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 50MG; 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Immediate Release Tabl...

Dosage Strength : 50MG; 12.5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 100 MG; 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Capsule

Dosage Strength : 100 MG; 25MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 200 MG; 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Capsule

Dosage Strength : 200 MG; 50MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Extended Release Granu...

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Extended Release Granu...

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Etilevodopa; Benserazide Hydrochloride

Brand Name :

Dosage Form : Extended Release Granu...

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Cohance

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Packaging :

Regulatory Info :

Etilevodopa; Benserazide Hydrochloride

Dosage : Extended Release Granu...

Dosage Strength :

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Cohance
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG;100MG

USFDA APPLICATION NUMBER - 17555

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DOSAGE - TABLET;ORAL - 25MG;100MG

USFDA APPLICATION NUMBER - 17555

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DOSAGE - TABLET;ORAL - 25MG;250MG

USFDA APPLICATION NUMBER - 17555

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19856

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19856

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - TABLET;ORAL - 12.5MG;200MG;50MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 18.75MG;200MG;75MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 25MG;200MG;100MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 31.25MG;200MG;125MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 37.5MG;200MG;150MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 50MG;200MG;200MG

USFDA APPLICATION NUMBER - 21485

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