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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
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
| Molecular Weight | 197.19 g/mol |
|---|---|
| Molecular Formula | C9H11NO4 |
| XLogP3 | -2.7 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 3 |
| Exact Mass | 197.06880783 g/mol |
| Monoisotopic Mass | 197.06880783 g/mol |
| Topological Polar Surface Area | 104 Ų |
| Heavy Atom Count | 14 |
| Formal Charge | 0 |
| Complexity | 209 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
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.
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.
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.
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.
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.)
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
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.
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
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
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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Registrant Name : Masung LS Co., Ltd.
Registration Date : 2023-11-23
Registration Number : 20231123-209-J-1573
Manufacturer Name : Zhejiang Wild Wind Pharmaceutical Co., Ltd
Manufacturer Address : Beijiang Industrial Zone, Geshan Town, Dongyang City, Zhejiang Province, China
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Submission : 1990-08-08
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Submission : 1969-05-07
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Submission : 1974-10-17
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Submission : 1976-04-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1649
Submission : 1971-02-01
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Certificate Number : R1-CEP 1999-001 - Rev 01
Status : Valid
Issue Date : 2007-10-19
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 1999-091 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2008-05-14
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 2005-161 - Rev 04
Status : Valid
Issue Date : 2018-01-25
Type : Chemical
Substance Number : 38
Certificate Number : R0-CEP 2020-161 - Rev 00
Status : Valid
Issue Date : 2022-03-14
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 2009-174 - Rev 02
Status : Valid
Issue Date : 2022-04-11
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 1999-187 - Rev 09
Status : Valid
Issue Date : 2022-03-24
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 2013-293 - Rev 01
Status : Valid
Issue Date : 2021-11-22
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 2011-253 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2018-05-15
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 1998-071 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2009-02-13
Type : Chemical
Substance Number : 38
Certificate Number : R1-CEP 2012-377 - Rev 00
Status : Valid
Issue Date : 2019-02-28
Type : Chemical
Substance Number : 38
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
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
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
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
Latest Date of Registration : 2018-04-12
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Date of Issue : 2019-06-17
Valid Till : 2022-06-16
Written Confirmation Number : WC-0030
Address of the Firm : Unit-II, Annavaram(Post), Chippada Village, Beemunipatnam Mandal, Visakhapatan...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Registrant Name : Roche Korea Co., Ltd.
Registration Date : 2023-03-21
Registration Number : 20220829-209-J-1351(1)
Manufacturer Name : Ajinomoto Co. Inc. Kawasaki ...
Manufacturer Address : 1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
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
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...
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-03-12
Registration Number : 20191021-209-J-458(2)
Manufacturer Name : Divi's Laboratories Limited ...
Manufacturer Address : Chippada Village Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District – 531...
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...
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...
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...
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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
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
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...
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
NDC Package Code : 51927-0049
Start Marketing Date : 2020-05-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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
NDC Package Code : 58624-0238
Start Marketing Date : 2000-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49452-2680
Start Marketing Date : 1990-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51846-1053
Start Marketing Date : 2012-08-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51846-1052
Start Marketing Date : 2012-04-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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, ...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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
Lead Product(s) : Etilevodopa,Carbidopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
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
Lead Product(s) : Etilevodopa,Carbidopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mitsubishi Tanabe Presents Data from Phase 3 BouNDless Trial of ND0612 in Parkinson's
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
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
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amneal Launches CREXONT® Extended-Release Capsules For Parkinson’s Disease
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
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
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amneal Receives FDA Approval for IPX203 for Parkinson’s Disease as CREXONT® Capsules
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
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
Lead Product(s) : Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Merz Therapeutics
Deal Size : $185.0 million
Deal Type : Acquisition
Merz Therapeutics Closes $185M Asset Purchase Agreement with Acorda Therapeutics
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
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
Lead Product(s) : Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Merz Pharma
Deal Size : $185.0 million
Deal Type : Acquisition
Merz Enters Asset Purchase Agreement With a US-based Biotech Company
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
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
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Zambon Group SpA
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Amneal Enters into Exclusive European Licensing Agreement with Zambon Biotech for IPX203
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
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
Lead Product(s) : Carbidopa,Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amneal Announces Complete Response Resubmission for IPX203 New Drug Application
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
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
Lead Product(s) : Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
PureIMS Prepares for Registration of Levodopa Cyclops DPI for OFF Episodes in Parkinson's
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
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
Lead Product(s) : Etilevodopa
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info : Prescription
Registration Country : Canada
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
Regulatory Info : Prescription
Registration Country : Canada
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
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Panamor At-50
Dosage Form : TAB
Dosage Strength : 250mg
Packaging : 9X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Carbilev 25/100
Dosage Form : TAB
Dosage Strength : 100mg
Packaging : 100X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : Norway
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Etilevodopa; Benserazide Hydrochloride
Dosage : Dispersible Tablet
Dosage Strength : 50MG; 12.5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Etilevodopa; Benserazide Hydrochloride
Dosage : Dispersible Tablet
Dosage Strength : 100MG; 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Etilevodopa; Benserazide Hydrochloride
Dosage : Immediate Release Caps...
Dosage Strength : 100MG; 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Etilevodopa; Benserazide Hydrochloride
Dosage : Capsule
Dosage Strength : 100 MG; 25MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Etilevodopa; Benserazide Hydrochloride
Dosage : Capsule
Dosage Strength : 200 MG; 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Etilevodopa; Benserazide Hydrochloride
Dosage : Extended Release Granu...
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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 Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Packaging :
Regulatory Info :
Etilevodopa; Benserazide Hydrochloride
Dosage : Extended Release Granu...
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 10MG;100MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET;ORAL - 25MG;100MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET;ORAL - 25MG;250MG
USFDA APPLICATION NUMBER - 17555
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
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
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - TABLET;ORAL - 12.5MG;200MG;50MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 18.75MG;200MG;75MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 25MG;200MG;100MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 31.25MG;200MG;125MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 37.5MG;200MG;150MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 50MG;200MG;200MG
USFDA APPLICATION NUMBER - 21485
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