Synopsis
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CEP/COS
0
KDMF
0
VMF
0
FDF
0
FDA Orange Book
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
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Health Canada Patents
0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
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Annual Reports
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Finished Drug Prices
NA
1. Myo-inositol
2. Scyllo-inositol
3. Epi-inositol
4. Muco-inositol
5. Allo-inositol
6. I-inositol
7. 87-89-8
8. Meso-inositol
9. 1d-chiro-inositol
10. 1l-chiro-inositol
11. Neo-inositol
12. D-(+)-chiro-inositol
13. Cis-inositol
14. 643-12-9
15. 488-59-5
16. D-chiro-inositol
17. Myoinositol
18. Scyllitol
19. 6917-35-7
20. Cyclohexane-1,2,3,4,5,6-hexaol
21. 488-58-4
22. Cyclohexane-1,2,3,4,5,6-hexol
23. Quercinitol
24. Mesoinositol
25. 551-72-4
26. Cocositol
27. Meat Sugar
28. Myoinosite
29. Dambose
30. Chiro-inositol
31. Inositene
32. Inositina
33. L-chiro-inositol
34. Phaseomannite
35. Inosital
36. Inosite
37. Iso-inositol
38. Cyclohexitol
39. Phaseomannitol
40. Inositol, Myo-
41. Mesoinosit
42. Mesoinosite
43. Scyllite
44. Mesovit
45. Nucite
46. Mesol
47. 41546-34-3
48. 643-10-7
49. Cyclohexanehexol
50. 488-55-1
51. Inositol, Meso-
52. Cis-1,2,3,5-trans-4,6-cyclohexanehexol
53. L-inositol
54. D-myo-inositol
55. D-chiro Inositol
56. Bios I
57. Insitolum
58. Isoinositol
59. L-(-)-chiro-inositol
60. (-)-inositol
61. 488-54-0
62. 576-63-6
63. D-inositol
64. L-myo-inositol
65. Inositol, Allo-
66. Inositol, Muco-
67. Inositol, I-
68. Inositol, Scyllo-
69. Inositol (van)
70. Alloinositol
71. Neoinositol
72. Hexahydroxycyclohexane
73. Scyllo-cyclohexanehexol
74. 1d-myo-inositol
75. 1l-myo-inositol
76. Inositol, Cis-
77. Inositol, Epi-
78. Inositol, Neo-
79. Epi-cyclohexanehexol
80. (+)-inositol
81. 1,2,3,4,5,6-cyclohexanehexol
82. (-)-chiro-inositol
83. Elnd005
84. Rat Antispectacled Eye Factor
85. Levoinositol
86. Ccris 6745
87. 1,2,3,5-trans-4,6-cyclohexanehexol, Cis-
88. Azd 103
89. Chiro-inositol, (-)-
90. Inositol, Myo
91. Mfcd00077932
92. 1,3,5/2,4,6-hexahydroxycyclohexane
93. (1r,2r,3r,4r,5s,6s)-cyclohexane-1,2,3,4,5,6-hexaol
94. (1r,2r,3s,4r,5r,6s)-cyclohexane-1,2,3,4,5,6-hexaol
95. (1r,2r,3s,4s,5s,6s)-cyclohexane-1,2,3,4,5,6-hexol
96. 1-l-chiro-inositol
97. Inositol, D-chiro-
98. (+)-chiro-inositol
99. 38876-99-2
100. Chebi:17268
101. Ai3-16111
102. Nsc8101
103. 1,3,5/2,4,6-cyclohexanehexol
104. 1,2,3,5/4,6-cyclohexanehexol
105. Nsc 8101
106. Nsc-8101
107. Chiro-inositol, (+)-
108. (1r,2r,3r,4r,5r,6r)-cyclohexane-1,2,3,4,5,6-hexol
109. (1r,2r,3r,4s,5s,6s)-cyclohexane-1,2,3,4,5,6-hexaol
110. (1r,2r,3s,4s,5s,6s)-cyclohexane-1,2,3,4,5,6-hexaol
111. 1,2,3,4,5,6-hexahydroxy-cyclohexane
112. Nsc-25142
113. Nsc-55551
114. Nsc404118
115. Myo-inositol;meso-inositol
116. Nsc 404118
117. Nsc-404118
118. J101.890f
119. J101.891d
120. (1s,2s,3s,4s,5s,6s)-cyclohexane-1,2,3,4,5,6-hexol
121. 63gqx5qw03
122. 8lq63p85ic
123. 9o6y5o4p9w
124. Elnd-005
125. R1y9f3n15a
126. (1r,2r,3r,4s,5s,6s)-cyclohexane-1,2,3,4,5,6-hexol
127. (1r,2r,3s,4r,5r,6s)-cyclohexane-1,2,3,4,5,6-hexol
128. (1s,2r,3r,4s,5s,6s)-cyclohexane-1,2,3,4,5,6-hexol
129. Chebi:10642
130. Chebi:23927
131. Chebi:27372
132. Chebi:27987
133. Azd-103
134. 4661d3jp8d
135. 6r79wv4r10
136. M94176hj2f
137. Inositol (van8c
138. Nsc45517
139. Nsc55551
140. Nsc55552
141. Nsc-55552
142. Nsc-55558
143. 1vs4x81277
144. Nsc-103959
145. Nsc-127230
146. Ins
147. Ncgc00159409-02
148. (1r,2r,3r,4r,5s,6s)-cyclohexane-1,2,3,4,5,6-hexol
149. (1r,2r,3s,4r,5s,6s)-cyclohexane-1,2,3,4,5,6-hexaol
150. (1r,2r,3s,4s,5r,6s)-cyclohexane-1,2,3,4,5,6-hexol
151. 4l6452s749
152. 587a93p465
153. Inositol, Myo- (8ci)
154. Dsstox_cid_3146
155. Dsstox_rid_76890
156. Dsstox_gsid_23146
157. 1,3,4,5,6-cyclohexanehexol
158. 1,3,5/4,6-cyclohexanehexol
159. (1r,2r,3s,4r,5s,6s)-cyclohexane-1,2,3,4,5,6-hexol
160. 1,2,4/3,5,6-cyclohexanehexol
161. Rel-(1r,2r,3r,4r,5r,6r)-cyclohexane-1,2,3,4,5,6-hexaol
162. Rel-(1r,2r,3s,4r,5s,6s)-cyclohexane-1,2,3,4,5,6-hexaol
163. Mouse Antialopecia Factor
164. 1,2,3,4,5,6-cyclohexanehexol #
165. Cis-1,2,3,4,5,6-cyclohexanehexol
166. Cas-87-89-8
167. Cis-1,3,5-trans-4,6-cyclohexanehexol
168. Smr000857145
169. Smr000857319
170. Smr000857320
171. Inositol Nf 12
172. Elnd 005
173. Sr-05000001655
174. Einecs 201-781-2
175. Mfcd00065455
176. 1,2,3,4,5,6-hexahydroxycyclohexane
177. Inositols
178. Unii-63gqx5qw03
179. Unii-8lq63p85ic
180. Unii-9o6y5o4p9w
181. Unii-r1y9f3n15a
182. An Inositol
183. Inositol [nonspecific Isomer]
184. Unii-4661d3jp8d
185. Unii-6r79wv4r10
186. Unii-m94176hj2f
187. Muscle Sugar
188. Inositol Myo-
189. D-muco-inositol
190. Unii-1vs4x81277
191. Inositol Fcc
192. 4irx
193. Inositol, Chiro-
194. Rac-chiro-inositol
195. Unii-4l6452s749
196. Unii-587a93p465
197. Inosital (tn)
198. Inositol (nf)
199. Cbu
200. Einecs 207-681-5
201. Einecs 207-682-0
202. Einecs 209-000-7
203. Einecs 211-393-5
204. Einecs 211-394-0
205. Einecs 230-024-9
206. Nsc 25142
207. Epiinositol
208. (+)-epi-inositol
209. Chiro-inositols
210. Epi-inositol, 98%
211. Allo-inositol, 97%
212. Inositol [usan:nf]
213. Inositol, Meso
214. Spectrum_001595
215. 2os9
216. Inositol [inci]
217. Inositol [usan]
218. Inositol [fcc]
219. Inositol [inn]
220. Orthorhombic Myo-inositol
221. D-(+)-chiro Inositol
222. Dl-chiro-inositol
223. Inositol [mi]
224. Inositol (d)
225. Inositol (l)
226. Inositol [vandf]
227. Spectrum3_001053
228. Spectrum4_001193
229. Spectrum5_000961
230. Myo-inositol, >=99%
231. Inositol [mart.]
232. Bmse000102
233. Bmse000103
234. Bmse000113
235. Bmse000901
236. Bmse000922
237. Epitope Id:144993
238. Inositol [usp-rs]
239. Inositol [who-dd]
240. Scyllo-inositol, >=98%
241. Schembl5831
242. Schembl5832
243. Schembl5969
244. Nciopen2_008191
245. Bspbio_002606
246. Kbiogr_001885
247. Kbioss_002075
248. Mls001332377
249. Mls001332378
250. Mls001335965
251. Mls001335966
252. Mls001335967
253. Mls001335968
254. Schembl187278
255. Schembl187397
256. Schembl187796
257. Schembl188106
258. Schembl188237
259. Schembl491333
260. Schembl959404
261. Schembl959405
262. Chembl278373
263. Chembl468154
264. Gtpl4495
265. Gtpl4645
266. Gtpl4648
267. Gtpl4649
268. Megxp0_001817
269. Schembl1055883
270. Schembl4748543
271. Schembl6378921
272. Schembl6468882
273. Schembl6791918
274. Chembl1222251
275. Chembl1231671
276. Chembl1950780
277. Chembl3976780
278. Dtxsid7023146
279. Schembl12371461
280. Schembl12377889
281. Schembl12411898
282. Schembl12711208
283. Schembl12735687
284. Schembl13058696
285. Schembl13114115
286. Schembl13114116
287. Schembl13114128
288. Schembl13207905
289. Schembl13580047
290. Schembl14542470
291. Schembl21388397
292. Acon1_002457
293. Chebi:22357
294. Chebi:23311
295. Chebi:24848
296. Chebi:25492
297. Chebi:27374
298. D-(+)-chiro-inositol, 95%
299. Kbio2_002075
300. Kbio2_004643
301. Kbio2_007211
302. Kbio3_001826
303. L-(-)-chiro-inositol, 95%
304. Dtxsid30110000
305. Dtxsid50905091
306. Myo-inositol, P.a., 98.0%
307. 1,2,3,4,5/6-cyclohexanehexol
308. 1,2,3,4/5,6-cyclohexanehexol
309. 1,2,3/4,5,6-cyclohexanehexol
310. 1,2,4,5/3,6-cyclohexanehexol
311. Dtxsid101028818
312. Dtxsid101028820
313. Dtxsid201028823
314. Dtxsid301028826
315. Dtxsid601028825
316. Dtxsid901028824
317. Hms2091n13
318. Hms2230n03
319. Hms2235h05
320. Hms2235m23
321. Hms3369b06
322. Hms3369f20
323. Hms3373e05
324. Pharmakon1600-01500352
325. D-chiro-inositol [usp-rs]
326. D-chiro-inositol [who-dd]
327. 1,2,3,4,5,6-cyclohexanehexaol
328. Bcp25172
329. Hy-b1411
330. Hy-n3021
331. Myo-inositol [ep Monograph]
332. Nsc25142
333. Nsc55558
334. Zinc1530357
335. D-myo-inositol, Cell Culture Grade
336. Tox21_111642
337. Tox21_302035
338. Ccg-36096
339. Cis-inositol, >=98.0% (tlc)
340. Mfcd00003863
341. Mfcd00272608
342. Mfcd00799555
343. Mfcd00799556
344. Mfcd01321249
345. Nsc 55552
346. Nsc 55558
347. Nsc-45517
348. Nsc103959
349. Nsc127230
350. Nsc757076
351. S4530
352. Stl453612
353. Epi-inositol, >=98.0% (hplc)
354. 1,2,3,4,5,6/0-cyclohexanetetrol
355. Akos006240678
356. Akos006332036
357. Akos015895894
358. Akos015912905
359. Akos015912934
360. Akos015960429
361. Akos015960633
362. Akos015994742
363. Akos024318869
364. Tox21_111642_1
365. Zinc100018867
366. Zinc100019018
367. Zinc100024490
368. Zinc100032893
369. Zinc100035580
370. Zinc100037751
371. Zinc100055570
372. Zinc100073149
373. Zinc100513675
374. Zinc101185827
375. Zinc102201844
376. Zinc103574430
377. Zinc103574467
378. Zinc103574475
379. Zinc250615063
380. Zinc253837650
381. Zinc306121118
382. Cs-4782
383. Cs-w010757
384. Db03106
385. Db13178
386. Db15350
387. Hy-w010041
388. J9.771c
389. Ks-1284
390. Ks-1420
391. Nsc 103959
392. Nsc 127230
393. Nsc-757076
394. Sb44732
395. Sb45039
396. Sb46764
397. Sb46855
398. D-chiro-inositol, >=98.0% (hplc)
399. Ncgc00159409-03
400. Ncgc00159409-04
401. Ncgc00169828-01
402. Ncgc00178580-01
403. Ncgc00178580-03
404. Ncgc00255362-01
405. Ac-11070
406. As-10616
407. As-68396
408. As-68424
409. Cyclohexane-1r,2r,3s,4s,5r,6s-hexol
410. Ls-13189
411. Nci60_041778
412. Sy060836
413. Myo-inositol, Purum, >=98.0% (hplc)
414. Rac-chiro-1,2,3,4,5,6-cyclohexanehexol
415. Sbi-0051369.p003
416. Cis-1,2,4-trans-3,5,6-cyclohexanehexol
417. Db-051583
418. Db-051584
419. Db-054642
420. Hy-121962
421. J101.888d
422. J101.889b
423. J101.892b
424. Myo-inositol, For Microbiology, >=99.0%
425. Cs-0023004
426. Cs-0083766
427. Cs-0369552
428. Ft-0627237
429. Ft-0632208
430. Ft-0632209
431. Ft-0632730
432. Ft-0652045
433. Ft-0670351
434. Ft-0670357
435. Ft-0693444
436. Ft-0693614
437. I0040
438. I0628
439. I0629
440. I0630
441. I0631
442. I0632
443. I0633
444. S6176
445. Myo-inositol, Bioultra, >=99.5% (hplc)
446. Myo-inositol, Saj Special Grade, >=99.0%
447. Myo-inositol, Vetec(tm) Reagent Grade, 99%
448. C00137
449. C06151
450. C06152
451. C06153
452. C19891
453. D08079
454. D78450
455. D91187
456. D91188
457. D91189
458. E78671
459. F19572
460. I-6500
461. M01914
462. T72516
463. Ab00051982_13
464. 643c129
465. A834712
466. A836375
467. A866896
468. Q407997
469. Q743661
470. Q-201583
471. Q2838375
472. Q2974313
473. Q3011024
474. Q3023527
475. Q3205874
476. Q3331426
477. Q3347078
478. Q3589114
479. Sr-05000001655-1
480. Sr-05000001655-5
481. W-202861
482. W-202862
483. W-203081
484. W-203168
485. W-203392
486. 1,2,4/3,5,6-cyclohexane-1,2,3,4,5,6-hexol
487. 7b0cef84-d9ce-4a88-aa7d-ec50c89387a5
488. 1d7a27bf-6060-4fa9-ac46-3bd18dba406e
489. 220128f1-89bf-442d-ad6d-e6d1ea7ba625
490. (1r,2r,3r,4r,5r,6r)-cyclohexane-1,2,3,4,5,6-hexaol
491. (1r,2s,3r,4r,5s,6r)-cyclohexane-1,2,3,4,5,6-hexol
492. (1r,2s,3r,4r,5s,6s)-cyclohexane-1,2,3,4,5,6-hexol
493. D-myo-inositol-1,2,5,6-tetraphosphate Sodium Salt
494. Inositol, United States Pharmacopeia (usp) Reference Standard
495. Myo-inositol, European Pharmacopoeia (ep) Reference Standard
496. (1r,2r,3s,4s,5s,6r)-cyclohexane-1,2,3,4,5,6-hexol
497. 1,2,3,4,5,6-cyclohexanehexol, (cis,cis,cis,trans,cis,trans)- #
498. 1,2,3,4,5,6-cyclohexanehexol, (1alpha,2alpha,3alpha,4beta,5alpha,6beta)
499. Inositol, Pharmaceutical Secondary Standard; Certified Reference Material
500. 1.alpha.,2.alpha.,3.beta.,4.alpha.,5.beta.,6.beta.-cyclohexanehexol
501. 2h3
502. Myo-inositol, Bioreagent, Suitable For Cell Culture, Suitable For Insect Cell Culture, Suitable For Plant Cell Culture
503. Myo-inositol, Pharmagrade, Meets Fcc Testing Specifications, Manufactured Under Appropriate Controls For Use As A Raw Material In Pharma Or Biopharmaceutical Production.
| Molecular Weight | 180.16 g/mol |
|---|---|
| Molecular Formula | C6H12O6 |
| XLogP3 | -3.7 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 0 |
| Exact Mass | 180.06338810 g/mol |
| Monoisotopic Mass | 180.06338810 g/mol |
| Topological Polar Surface Area | 121 Ų |
| Heavy Atom Count | 12 |
| Formal Charge | 0 |
| Complexity | 104 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Inositol may be used in food without any limitation. As a drug, inositol is used as a nutrient supplement in special dietary foods and infant formula. As it presents a relevant role in ensuring oocyte fertility, inositol has been studied for its use in the management of polycystic ovaries. Inositol is also being researched for the treatment of diabetes, prevention of metabolic syndrome, aid agent for weight loss, treatment of depression, psychiatric disorder and anxiety disorder and for prevention of cancer.
Inositol can stimulate glucose uptake in skeletal muscle cells which allows the decrease in blood sugar levels. This effect is later seen as a reduction in urine glucose concentration and indicates a decrease in high blood sugar levels. In PCOS, the administration of inositol has produced the remission of symptoms as well as a reduction in male hormone secretion, a regulation of the cholesterol level, and a more efficient fat breakdown which allow to a significant reduction on body mass and appetite. In the cases of infertility, inositol has been proven to increase sperm count and motility, as well as increase the overall quality of oocytes and embryos. In the brain, inositol has been shown to produce an increase in serotonin receptor sensitivity. This activity produces an increase in GABA release. Some of the effects observed in the brain produced a relief in symptoms of anxiety and obsessive-compulsive disorders. In high doses, it has been shown to even reduce panic attacks. In cancer research, inositol has gained interest as it can act as an antioxidant, anti-inflammatory and it seems to enhance immune properties.
A - Alimentary tract and metabolism
A11 - Vitamins
A11H - Other plain vitamin preparations
A11HA - Other plain vitamin preparations
A11HA07 - Inositol
Absorption
Inositol is absorbed from the small intestine. In patients with inositol deficiency, the maximal plasma concentration after oral administration of inositol is registered to be of 4 hours. Inositol is taken up by the tissues via sodium-dependent inositol co-transporter which also mediates glucose uptake. Oral ingestion of inositol is registered to generate a maximal plasma concentration of 36-45 mcg.
Route of Elimination
Most of the administered dose is excreted in urine.
Volume of Distribution
The pharmacokinetic profile of inositol was studied in preterm infants and the estimated volume of distribution was reported to be 0.5115 L/kg.
Clearance
The pharmacokinetic profile of inositol was studied in preterm infants and the estimated clearance rate was reported to be 0.0679 L.kg/h.
It is thought that inositol is metabolized to phosphoinositol and then converted to phosphatylinositol-4,5-biphosphate which is a precursor of the second-messenger molecules. Inositol can be transformed to D-chiro-inositol via the actions of an epimerase. The normal modifications to inositol structure seem to be between all the different isomers.
The pharmacokinetic profile of inositol was studied in preterm infants and the estimated elimination half-life was reported to be of 5.22 hours.
The mechanism of action of inositol in brain disorders is not fully understood but it is thought that it may be involved in neurotransmitter synthesis and it is a precursor to the phosphatidylinositol cycle. The change that occurs in the cycle simulates when the postsynaptic receptor is activated but without activating the receptor. This activity provokes a fake activation which regulated the activity of monoamines and other neurotransmitters. Reports have shown that insulin resistance plays a key role in the clinical development of PCOS. The presence of hyperinsulinemia can induce an excess in androgen production by stimulating ovaries to produce androgens and by reducing the sex hormone binding globulin serum levels. One of the mechanisms of insulin deficiency is thought to be related to a deficiency in inositol in the inositolphosphoglycans. The administration of inositol allows it to act as a direct messenger of the insulin signaling and improves glucose tissue uptake. This mechanism is extrapolated to its functions in diabetes treatment, metabolic syndrome, and weight loss. In cancer, the mechanism of action of inositol is not fully understood. It is hypothesized that the administration of inositol increases the level of lower-phosphate inositol phosphates why can affect cycle regulation, growth, and differentiation of malignant cells. On the other hand, the formation of inositol hexaphosphate after administration of inositol presents antioxidant characteristics by the chelation of ferric ions and suppression of hydroxyl radicals.
API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12019
Submission : 1996-06-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9021
Submission : 1991-03-08
Status : Inactive
Type : II
Registration Number : 218MF10856
Registrant's Address : 2283 Chonomachi, Katsuragi-cho, Ito-gun, Wakayama Prefecture
Initial Date of Registration : 2006-11-06
Latest Date of Registration : --
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
About the Company : Allastir instituted the services in 2010 with a motive to cater the pharmaceutical industry with niche API's. In Allastir we strongly believe in team work and customer satisfaction...
About the Company : World leading manufacturing facility in accordance with GMP standard. Over 10 years of large scale production experience provide confidence on our product stability and quality con...
About the Company : Jing Jing Pharmaceutical Co., Ltd., founded in October 2007, covers an area of 200 mu, registered capital of 257.28 million yuan, and employees of more than 700 people, is a high-t...
About the Company : Jing Jing Pharmaceutical Co., Ltd., founded in October 2007, covers an area of 200 mu, registered capital of 257.28 million yuan, and employees of more than 700 people, is a high-t...
About the Company : Summit ingredient Co.,Ltd is a leading and rapidly growing company wh ich engages in the production, development, source and sale of botanical extracts . Summit located in Shaanxi ...
About the Company : At Tsuno group, we strive to deliver the limitless benefits of Rice bran to you. The unparalleled quality and safety of our products are at the heart of our research and developmen...
About the Company : Yangzhou Gami Biochem Co., Ltd. is one of the leading exporters of CDCA, UDCA from China. We mainly engaged in sales of biochemical products, API, amino acids, plant extracts, food...
About the Company : The specialist of high quality ingredients for human and animal nutrition.Headquarter in Hangzhou,Zhejiang province,China,Chemvplus is certified from ISO 9000, FAMI-QS. It has expo...
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ABOUT THIS PAGE
A Inositol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Inositol, including repackagers and relabelers. The FDA regulates Inositol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Inositol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Inositol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Inositol supplier is an individual or a company that provides Inositol active pharmaceutical ingredient (API) or Inositol finished formulations upon request. The Inositol suppliers may include Inositol API manufacturers, exporters, distributors and traders.
click here to find a list of Inositol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Inositol DMF (Drug Master File) is a document detailing the whole manufacturing process of Inositol active pharmaceutical ingredient (API) in detail. Different forms of Inositol DMFs exist exist since differing nations have different regulations, such as Inositol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Inositol DMF submitted to regulatory agencies in the US is known as a USDMF. Inositol USDMF includes data on Inositol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Inositol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Inositol suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Inositol Drug Master File in Japan (Inositol JDMF) empowers Inositol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Inositol JDMF during the approval evaluation for pharmaceutical products. At the time of Inositol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Inositol suppliers with JDMF on PharmaCompass.
A Inositol written confirmation (Inositol WC) is an official document issued by a regulatory agency to a Inositol manufacturer, verifying that the manufacturing facility of a Inositol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Inositol APIs or Inositol finished pharmaceutical products to another nation, regulatory agencies frequently require a Inositol WC (written confirmation) as part of the regulatory process.
click here to find a list of Inositol suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Inositol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Inositol API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Inositol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Inositol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Inositol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Inositol suppliers with NDC on PharmaCompass.
Inositol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Inositol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Inositol GMP manufacturer or Inositol GMP API supplier for your needs.
A Inositol CoA (Certificate of Analysis) is a formal document that attests to Inositol's compliance with Inositol specifications and serves as a tool for batch-level quality control.
Inositol CoA mostly includes findings from lab analyses of a specific batch. For each Inositol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Inositol may be tested according to a variety of international standards, such as European Pharmacopoeia (Inositol EP), Inositol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Inositol USP).
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