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1. Acidin Pepsin
2. Acidin-pepsin
3. Acidinpepsin
4. Betaine Hydrochloride
5. Betaine, Glycine
6. C.b.b.
7. Citrate De Btane Beaufour
8. Citrate De Btane Upsa
9. Cystadane
10. Glycine Betaine
11. Hepastyl
12. Hydrochloride, Betaine
13. Lycine
14. Novobetaine
15. Oxyneurine
16. Scorbo Btane
17. Scorbo-btane
18. Scorbobtane
19. Stea 16
20. Stea-16
21. Stea16
1. 107-43-7
2. Glycine Betaine
3. Oxyneurine
4. Trimethylglycine
5. Lycine
6. Abromine
7. Trimethylglycocoll
8. Glycocoll Betaine
9. Glycylbetaine
10. 2-(trimethylazaniumyl)acetate
11. Acidin-pepsin
12. Rubrine C
13. Betaine, Anhydrous
14. Jortaine
15. Alpha-earleine
16. Trimethylammonioacetate
17. 2-(trimethylammonio)acetate
18. N,n,n-trimethylglycine
19. Trimethylaminoacetic Acid
20. Glycine, Trimethylbetaine
21. Loramine Amb 13
22. (trimethylammonio)acetate
23. Glykokollbetain [german]
24. Trimethylaminoacetate
25. Acidol
26. Methanaminium, 1-carboxy-n,n,n-trimethyl-, Inner Salt
27. Methanaminium, 1-carboxy-n,n,n-trimethyl-, Hydroxide, Inner Salt
28. Betaine Anhydrous
29. 2-trimethylammonioacetate
30. Ai3-24187
31. Ai3-52598
32. Mfcd00012123
33. N,n,n-trimethylammonioacetate
34. Betafin
35. Brn 3537113
36. Glycinebetaine
37. Chebi:17750
38. (carboxymethyl)trimethylammonium Hydroxide, Inner Salt
39. 2-(trimethylammonio)ethanoic Acid, Hydroxide, Inner Salt
40. 2-(trimethylamino)acetic Acid
41. 3scv180c9w
42. 1-carboxy-n,n,n-trimethylmethanaminium Hydroxide, Inner Salt
43. 2-n,n,n-trimethylammonio Acetate
44. Aminocoat
45. Betaine (jan)
46. Greenstim
47. Finnstim
48. Nsc-166511
49. Betafin Bp
50. Betafin Bcr
51. Novobetaine
52. .alpha.-earleine
53. Hepastyl
54. Betaine [jan]
55. Dsstox_cid_2666
56. (carboxymethyl)trimethylammonium Hydroxide Inner Salt
57. Dsstox_rid_76680
58. Dsstox_gsid_22666
59. Glykokollbetain
60. 1-carboxy-n,n,n-trimethylmethanaminium Inner Salt
61. Fema No. 4223
62. Cas-107-43-7
63. Hsdb 7467
64. Ncgc00015150-03
65. Einecs 203-490-6
66. Trimethylglycocoll Anhydride
67. Nsc 166511
68. Unii-3scv180c9w
69. Glycine-betaine
70. .beta.ine
71. 3mam
72. 3ppp
73. Cystadane (tn)
74. Betaine,(s)
75. Betaine (8ci)
76. Aquadew An 100
77. 3l6h
78. Betaine [vandf]
79. Betaine [fhfi]
80. Betaine [hsdb]
81. Betaine [inci]
82. Betaine [fcc]
83. Betaine [mi]
84. Bet
85. Betaine [mart.]
86. Betaine [usp-rs]
87. Betaine [who-dd]
88. Bmse000069
89. Bmse000948
90. Bmse000997
91. (trimethylammoniumyl)acetate
92. Caprylic Amidopropyl Betaine
93. Ec 203-490-6
94. Schembl7739
95. Chembl1182
96. 4-04-00-02369 (beilstein Handbook Reference)
97. Betaine [orange Book]
98. (carboxymethyl)trimethylammonium
99. Gtpl4550
100. Dtxsid8022666
101. Bcp21888
102. Hy-b0710
103. Tox21_113511
104. Tox21_301159
105. Bdbm50103520
106. Betaine Anhydrous [ema Epar]
107. Nsc166511
108. Stk372904
109. Akos005206774
110. Am90357
111. Ccg-266068
112. Db06756
113. Sdccgmls-0066923.p001
114. Ncgc00178605-01
115. Ncgc00178605-02
116. Ncgc00178605-03
117. Ncgc00178605-08
118. Ncgc00255057-01
119. Abromine; Lycine; Trimethylglycine (tmg)
120. As-12941
121. Sy011295
122. Methanaminium, 1-carboxy-n,n,n-trimethyl-
123. B0455
124. Ft-0622917
125. N1709
126. Wln: Qv1k1 & 1 & 1 & Q
127. C00719
128. D07523
129. Ab00053634_03
130. A801696
131. Methanaminium, Carboxy-n,n,n-trimethyl-, Inner Salt
132. Methanaminium,n,n-trimethyl-, Hydroxide, Inner Salt
133. Q-200708
134. Q10860583
135. Z2756787719
136. Methanaminium, 1-carboxy-n,n,n-trimethyl-, Inner Salt (9ci)
137. Ammonium Compounds, Substituted, (carboxymethyl)trimethyl-, Hydroxide, Inner Salt (7ci)
1. Betaine Salicylate
2. Betaine Nitrate
Molecular Weight | 117.15 g/mol |
---|---|
Molecular Formula | C5H11NO2 |
XLogP3 | 0.5 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 1 |
Exact Mass | 117.078978594 g/mol |
Monoisotopic Mass | 117.078978594 g/mol |
Topological Polar Surface Area | 40.1 Ų |
Heavy Atom Count | 8 |
Formal Charge | 0 |
Complexity | 87.6 |
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 |
1 of 2 | |
---|---|
Drug Name | Cystadane |
PubMed Health | Betaine (Oral route) |
Drug Classes | Digestant |
Drug Label | Cystadane (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. It contains no ingredients other than anhydrous betaine. Cystadane is a white, granular, hygroscopic powder, which is diluted in water and administered... |
Active Ingredient | Betaine hydrochloride |
Dosage Form | For solution |
Route | Oral |
Strength | 1gm/scoopful |
Market Status | Prescription |
Company | Rare Dis Therap |
2 of 2 | |
---|---|
Drug Name | Cystadane |
PubMed Health | Betaine (Oral route) |
Drug Classes | Digestant |
Drug Label | Cystadane (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. It contains no ingredients other than anhydrous betaine. Cystadane is a white, granular, hygroscopic powder, which is diluted in water and administered... |
Active Ingredient | Betaine hydrochloride |
Dosage Form | For solution |
Route | Oral |
Strength | 1gm/scoopful |
Market Status | Prescription |
Company | Rare Dis Therap |
... /The authors/ measured blood lipids in four placebo-controlled, randomised intervention studies that examined the effect of betaine (three studies, n = 151), folic acid (two studies, n = 75), and phosphatidylcholine (one study, n = 26) on plasma homocysteine concentrations ... /They/ combined blood lipid data from the individual studies and calculated a weighted mean change in blood lipid concentrations relative to placebo. Betaine supplementation (6 g/day) for 6 wk increased blood LDL cholesterol concentrations by 0.36 mmol/L (95% confidence interval: 0.25 to 0.46), and triacylglycerol concentrations by 0.14 mmol/L (0.04 to 0.23) relative to placebo. The ratio of total to HDL cholesterol increased by 0.23 (0.14 to 0.32). Concentrations of HDL cholesterol were not affected. Doses of betaine lower than 6 g/day also raised LDL cholesterol, but these changes were not statistically significant. Further, the effect of betaine on LDL cholesterol was already evident after 2 wk of intervention. Phosphatidylcholine supplementation (providing approximately 2.6 g/day of choline) for 2 wk increased triacylglycerol concentrations by 0.14 mmol/L (0.06 to 0.21), but did not affect cholesterol concentrations. Folic acid supplementation (0.8 mg/day) had no effect on lipid concentrations.
Olthof MR et al; PLoS Med 2(5):e135 (2005)
Anhydrous betaine has been useful in the treatment of homocystinuria and betaine may be helpful in other conditions characterized by elevated plasma homocysteine levels. Betaine hydrochloride is used as a digestive aid in some. There is some suggestion in animal research that betaine may be hepatoprotective in some circumstances.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ (2001) p.47
Cystadane (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are deficiencies or defects in: cystathionine beta-synthase (CBS), 5,10-methylenetetrahydrofolate reductase (MTHFR), and cobalamin cofactor metabolism (cbl).
US FDA; Center for Drug Evaluation and Research; Revised Label Cystadane (Betaine anhydrous for oral solution) (Approved 2/17/2006). Available from, as of August 28, 2006: https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
VET: Betaine glucuronate is, together with 2-aminoethanol glucuronate, used as active principle in a product for symptomatic treatment of acute or chronic disorders of the liver, such as endogenous metabolic disorders, cases of exogenous intoxication or disorders related to parasite infestations. It is administered by injection in cattle, horses, sheep, goats and pigs ... . /Betaine glucuronate/
European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, Veterinary Medicines Evaluation Unit, Committee for Veterinary Medicinal Products; Betaine Glucuronate, Summary Report. EMEA/MRL/568/99-Final (February 1999). Available from, as of November 6, 2006: https://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/document_library_search.jsp&murl=menus/document_library/document_library.jsp&mid
For more Therapeutic Uses (Complete) data for BETAINE (14 total), please visit the HSDB record page.
It is not known whether betaine is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk). Because many drugs are excreted in human milk, caution should be exercised when Cystadane is administered to a nursing woman.
US FDA; Center for Drug Evaluation and Research; Revised Label Cystadane (Betaine anhydrous for oral solution) (Approved 2/17/2006). Available from, as of August 28, 2006: https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
Therapy with Cystadane should be directed by physicians knowledgeable in the management of patients with homocystinuria.
US FDA; Center for Drug Evaluation and Research; Revised Label Cystadane (Betaine anhydrous for oral solution) (Approved 2/17/2006). Available from, as of August 28, 2006: https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations. Treatment with Cystadane may further increase methionine concentrations due to the remethylation of homocysteine to methionine. Cerebral edema has been reported in patients with hypermethioninemia, including a few patients treated with Cystadane. Plasma methionine concentrations should be monitored in patients with CBS deficiency. Plasma methionine concentrations should be kept below 1,000 umol/L through dietary modification and, if necessary, a reduction of Cystadane dose.
US FDA; Center for Drug Evaluation and Research; Revised Label Cystadane (Betaine anhydrous for oral solution) (Approved 2/17/2006). Available from, as of August 28, 2006: https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
For more Drug Warnings (Complete) data for BETAINE (11 total), please visit the HSDB record page.
Betaine is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are deficiencies or defects in: 1. cystathionine beta-synthase (CBS), 2. 5,10-methylenetetrahydrofolate reductase (MTHFR), 3. cobalamin cofactor metabolism (cbl).
FDA Label
Amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:
cystathionine beta-synthase (CBS),
5,10 methylene tetrahydrofolate reductase (MTHFR),
cobalamin cofactor metabolism (cbl).
Lipotropic Agents
Endogenous factors or drugs that increase the transport and metabolism of LIPIDS including the synthesis of LIPOPROTEINS by the LIVER and their uptake by extrahepatic tissues. (See all compounds classified as Lipotropic Agents.)
Gastrointestinal Agents
Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)
A16AA06
A - Alimentary tract and metabolism
A16 - Other alimentary tract and metabolism products
A16A - Other alimentary tract and metabolism products
A16AA - Amino acids and derivatives
A16AA06 - Betaine
Absorption
After a single oral dose of betaine (50 mg/kg), absorption was rapid (tmax = 0.9 0.3 hours and a Cmax = 0.9 0.2 mM).
Volume of Distribution
V/F = 1.3 l/kg
Clearance
84 ml/h/kg
Betaine is absorbed from the small intestines into the enterocytes. It is released by the enterocytes into the portal circulation which carries it to the liver where there is significant first-pass extraction and first-pass metabolism of betaine. The principal metabolic reaction is the transfer of a methyl group from betaine to homocysteine via the enzyme betaine-homocysteine methyltransferase. The products of the reaction are L-methionine and dimethylglycine. Betaine hydrochloride is converted to betaine in the alkaline environment of the small intestine.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ (2001) p.47
It is not known whether betaine is distributed into breast milk. However, its metabolic precursor, choline, is found in human breast milk in high concentrations .
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
... /The authors/ measured homocysteine, betaine, folate, vitamin B(6), and related compounds in serum/plasma from 500 healthy men and women aged 34 to 69 years before (fasting levels) and 6 hours after a standard methionine loading test. Choline, dimethylglycine, and folate were determinants of plasma betaine in a multiple regression model adjusting for age and sex. The increase in homocysteine after loading showed a strong inverse association with plasma betaine and a weaker inverse association with folate and vitamin B6. Fasting homocysteine showed a strong inverse relation to folate, a weak relation to plasma betaine, and no relation to vitamin B6. Notably, adjusted (for age and sex) dose-response curves for the postmethionine increase in homocysteine or fasting homocysteine versus betaine showed that the inverse associations were most pronounced at low serum folate, an observation that was confirmed by analyses of interaction ... Collectively, these results show that plasma betaine is a strong determinant of increase in homocysteine after methionine loading, particularly in subjects with low folate status. In 500 healthy subjects, postmethionine load increase in tHcy showed a stronger inverse relation to betaine than to folate and vitamin B6, whereas for fasting total homocysteine (tHcy) betaine was a weaker determinant than folate. For both tHcy modalities, the association with betaine was most pronounced in subjects with low folate status.
PMID:15550695 Holm PI et al; Arterioscler Thromb Vasc Biol 25(2):379-85 (2005)
Thirty-four healthy men and women were supplied with doses of 1, 3 and 6 g betaine and then with 6 g betaine +1 mg folic acid for four consecutive 1-week periods. The mean plasma total homocysteine (tHcy) concentration decreased by 1.1 (NS), 10.0 and 14.0 % (P<0.001) after supplementation with 1, 3 and 6 g betaine respectively. A further decrease in plasma tHcy by 5 % (P<0.01) was achieved by combining 1 mg folic acid with the 6 g betaine dose. Plasma betaine increased from 31 (sd 13) to 255 (sd 136) umol/L in a dose-dependent manner (R(2) 0.97) ... /The authors/ conclude that plasma tHcy is lowered rapidly and significantly by 3 or 6 g betaine/d in healthy men and women.
PMID:15522136 Alfthan G et al; Br J Nutr 92(4):665-9 (2004)
... /The authors/ investigated the courses of plasma choline and betaine during normal human pregnancy and their relations to plasma total homocysteine (tHcy) ... Blood samples were obtained monthly; the initial samples were taken at gestational week (GW) 9, and the last samples were taken approximately 3 mo postpartum. The study population comprised 50 women of West African descent. Most of the subjects took folic acid irregularly ... Plasma choline (geometric x; 95% reference interval) increased continuously during pregnancy, from 6.6 (4.5, 9.7) umol/L at GW 9 to 10.8 (7.4, 15.6) umol/L at GW 36. Plasma betaine decreased in the first half of pregnancy, from 16.3 (8.6, 30.8) umol/L at GW 9 to 10.3 (6.6, 16.2) umol/L at GW 20 and remained constant thereafter ... /The authors/ confirmed a reduction in plasma tHcy, and the lowest concentration was found in the second trimester. From GW 16 onward, an inverse relation between plasma tHcy and betaine was observed. Multiple regression analysis showed that plasma betaine was a strong predictor of plasma tHcy from GW 20 onward ... The steady increase in choline throughout gestation may ensure choline availability for placental transfer with subsequent use by the growing fetus. Betaine becomes a strong predictor of tHcy during the course of pregnancy.
PMID:15941891 Velzing-Aarts FV et al; Am J Clin Nutr 81(6):1383-9 (2005)
Betaine is absorbed from the small intestines into the enterocytes. It is released by the enterocytes into the portal circulation which carries it to the liver where there is significant first-pass extraction and first-pass metabolism of betaine. The principal metabolic reaction is the transfer of a methyl group from betaine to homocysteine via the enzyme betaine-homocysteine methyltransferase. The products of the reaction are L-methionine and dimethylglycine. Betaine hydrochloride is converted to betaine in the alkaline environment of the small intestine.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ (2001) p.47
/Betaine/ is a metabolite of choline ...
US FDA; Center for Drug Evaluation and Research; Revised Label Cystadane (Betaine anhydrous for oral solution) (Approved 2/17/2006). Available from, as of August 28, 2006: https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory
14 hours
Betaine acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria.
Betaine acts as metabolic intermediate in transmethylating processes (creatine and methionine synthesis).
European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, Veterinary Medicines Evaluation Unit, Committee for Veterinary Medicinal Products; Betaine, Summary Report. EMEA/MRL/261/97-Final (September 1997). Available from, as of November 6, 2006: https://www.ema.europa.eu/ema/index.jsp?curl=pages/document_library/landing/document_library_search.jsp&murl=menus/document_library/document_library.jsp&mid
Betaine acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria. This reduces toxic concentrations of homocysteine, usually to 20 to 30% or less of pretreatment concentrations.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
Betaine or trimethylglycine is a quarternary ammonium compound that was first discovered in the juice of sugar beets (Beta vulgaris). Betaine is a metabolite of choline ... and is a substrate in one of the two recycling pathways that convert homocysteine to L-methionine. The other and principal recycling reaction is catalyzed by the enzyme methionine synthase and uses methylcobalamin as a cofactor and 5-methyltetrahydrofolate as a cosubstrate.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.46 (2001)
Betaine-homocysteine methyltransferase (BHMT) is a zinc metalloenzyme which catalyzes the transfer of a methyl group from betaine to homocysteine in the formation of methionine. BHMT is found in the liver and kidneys and may also exist in brain tissue. Betaine acts to lower homocysteine levels in some with primary hyperhomocysteinemia/homocystinuria via this enzyme.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.47 (2001)
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-04-24
Pay. Date : 2020-03-10
DMF Number : 34404
Submission : 2020-03-12
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-076
Start Marketing Date : 2019-11-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 11079
Submission : 1994-09-08
Status : Active
Type : II
NDC Package Code : 46052-0196
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-01
Pay. Date : 2017-10-27
DMF Number : 31655
Submission : 2017-03-28
Status : Active
Type : II
NDC Package Code : 46052-0196
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15348
Submission : 2001-03-23
Status : Active
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 5082
Submission : 1983-09-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11069
Submission : 1994-09-08
Status : Inactive
Type : II
Registration Number : 225MF10183
Registrant's Address : An der Zucker-Raffinerie 9, 38373 Frellstedt, Germany
Initial Date of Registration : 2013-09-25
Latest Date of Registration : --
NDC Package Code : 46052-0196
Start Marketing Date : 1997-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-24
Pay. Date : 2020-03-10
DMF Number : 34404
Submission : 2020-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15348
Submission : 2001-03-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-01
Pay. Date : 2017-10-27
DMF Number : 31655
Submission : 2017-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11079
Submission : 1994-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11069
Submission : 1994-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5082
Submission : 1983-09-30
Status : Inactive
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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Details:
Betaine anhydrous for oral solution is indicated in children and adults for the treatment of homocystinuria to decrease high homocysteine blood levels. The program will provide prescription fulfillment, insurance benefits investigation, educational support.
Lead Product(s): Betaine
Therapeutic Area: Genetic Disease Brand Name: Cystadane-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Lead Product(s) : Betaine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Betaine anhydrous for oral solution is indicated in children and adults for the treatment of homocystinuria to decrease high homocysteine blood levels. The program will provide prescription fulfillment, insurance benefits investigation, educational suppo...
Brand Name : Cystadane-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 10, 2023
Details:
Cystadane (betaine anhydrous) transfers a methyl group via the enzyme betaine homocysteine methyl transferase, converting homocysteine back into methionine and dimethylglycine. In patients with homocystinuria, betaine reduces homocysteine levels and improves health outcomes.
Lead Product(s): Betaine
Therapeutic Area: Genetic Disease Brand Name: Cystadane
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2023
Lead Product(s) : Betaine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Cosette Pharmaceuticals Launches Betaine Anhydrous Powder, AB-rated to Cystadane® (Betaine Anhydr...
Details : Cystadane (betaine anhydrous) transfers a methyl group via the enzyme betaine homocysteine methyl transferase, converting homocysteine back into methionine and dimethylglycine. In patients with homocystinuria, betaine reduces homocysteine levels and impr...
Brand Name : Cystadane
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 02, 2023
Details:
Betaine shares the same prescriber base as the carglumic acid tablets, so it is an attractive opportunity to leverage the existing commercial infrastructure.
Lead Product(s): Betaine
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Eton Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 13, 2022
Lead Product(s) : Betaine
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Eton Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Details : Betaine shares the same prescriber base as the carglumic acid tablets, so it is an attractive opportunity to leverage the existing commercial infrastructure.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 13, 2022
Details:
Company’s patented hydrogel-forming microneedle patch, PHARMAPATCH™, to deliver ketamine and KETABET™ (ketamine and betaine anhydrous), which aims to prevent the potential side effects of repeated ketamine treatment for depression and other indications.
Lead Product(s): Ketamine Hydrochloride,Betaine
Therapeutic Area: Psychiatry/Psychology Brand Name: Ketabet
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2022
Lead Product(s) : Ketamine Hydrochloride,Betaine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch
Details : Company’s patented hydrogel-forming microneedle patch, PHARMAPATCH™, to deliver ketamine and KETABET™ (ketamine and betaine anhydrous), which aims to prevent the potential side effects of repeated ketamine treatment for depression and other indicat...
Brand Name : Ketabet
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 29, 2022
Details:
KETABET (Ketamine and Betaine) aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.
Lead Product(s): Ketamine Hydrochloride,Betaine
Therapeutic Area: Psychiatry/Psychology Brand Name: Ketabet
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2022
Lead Product(s) : Ketamine Hydrochloride,Betaine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
PharmaTher Announces Positive Results from Study of KETABET for Depression
Details : KETABET (Ketamine and Betaine) aims to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain.
Brand Name : Ketabet
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 07, 2022
Details:
Patent granted strengthen the Company’s global patent portfolio and it provides for broad potential of KETABET™(Ketamine) for uses in various mental health, neurological and pain disorders, as well as novel delivery forms.
Lead Product(s): Ketamine Hydrochloride,Betaine
Therapeutic Area: Psychiatry/Psychology Brand Name: Ketabet MN
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2021
Lead Product(s) : Ketamine Hydrochloride,Betaine
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
PharmaTher Granted New Japanese Patent for KETABET™ (Ketamine Combination Formulation), Strength...
Details : Patent granted strengthen the Company’s global patent portfolio and it provides for broad potential of KETABET™(Ketamine) for uses in various mental health, neurological and pain disorders, as well as novel delivery forms.
Brand Name : Ketabet MN
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 30, 2021
RLD : No
TE Code : AB
Brand Name : BETAINE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 1GM/SCOOPFUL
Approval Date : 2022-01-28
Application Number : 210508
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : BETAINE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 1GM/SCOOPFUL
Approval Date : 2021-11-23
Application Number : 214864
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : CYSTADANE
Dosage Form : FOR SOLUTION;ORAL
Dosage Strength : 1GM/SCOOPFUL
Approval Date : 1996-10-25
Application Number : 20576
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
Related Excipient Companies
Dosage Form : Tablet
Grade : Not Available
Application : Rheology Modifiers
Excipient Details : Tablet Coating, Rheology Modifier
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Carboxymethyl cellulose sodium
Excipients by Applications
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Suspension, Tablet
Grade : Topical, Oral
Category : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : Carboxymethyl Cellulose
Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Carboxymethylcellulose serves as a disintegrant, binder, coating agent & thickener in oral formulations, also as a stabilizer in topical formulations.
Application : Thickeners and Stabilizers
Excipient Details : SPI® VAC Gels are based on highly engineered pseudo-boehmite and are used as vaccine adjuvants.
Application : Rheology Modifiers, Thickeners and Stabilizers
Excipient Details : Blanose CMC 7MF is used as a thickener and viscosity modifier in liquid formulations such as suspensions.
Pharmacopoeia Ref : EP, USP/NF
Technical Specs : N/A
Ingredient(s) : Sodium Carboxymethyl Cellulose Excipient
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Grade : Oral
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Brand Name : Carboxymethyl Cellulose
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Excipient Details : Carboxy Methyl Cellulose is used as a binder, disintegrant, film-former, and rheology modifier in the production of tablets and capsules.
Dosage Form : Emulsion, Suspension, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Rheology Modifiers, Thickeners and Stabilizers
Application : Fillers, Diluents & Binders, Rheology Modifiers, Thickeners and Stabilizers
Excipient Details : HiCel MCG is use in oral suspensions as a stabilizer & emulsion prepared with high shear forces. It is a good binder for tablets & excellent stabilizer as well as thickener.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Carboxymethyl cellulose sodium
Application : Solubilizers, Thickeners and Stabilizers
Excipient Details : It provides solubility and viscosity stability on medium viscosity.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Medium Viscosity
Ingredient(s) : Carboxymethyl cellulose sodium
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Suspension, Tablet
Grade : Topical, Oral
Category : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : Carboxymethyl Cellulose
Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Carboxymethylcellulose serves as a disintegrant, binder, coating agent & thickener in oral formulations, also as a stabilizer in topical formulations.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Grade : Oral
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Brand Name : Carboxymethyl Cellulose
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Excipient Details : Carboxy Methyl Cellulose is used as a binder, disintegrant, film-former, and rheology modifier in the production of tablets and capsules.
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Rheology Modifiers
Application : Coating Systems & Additives, Rheology Modifiers
Excipient Details : Tablet Coating, Rheology Modifier
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Carboxymethyl cellulose sodium
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Customized per requirements
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Grade : Oral
Category : Coating Systems & Additives, Film Formers & Plasticizers
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : Ready mix Film coating system for moisture sensitive APIs
Pharmacopoeia Ref : USP, EP, JP; Having US-DMF
Technical Specs : Moisture barrier film coating system
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Application : Empty Capsules
Excipient Details : ACGCAPS™ GL / HL is available in gelatin and cellulose (HPMC) material options and can be used for liquids, semi-liquids, hot-melts and combination fills.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : ACGCAPS™ GR can fulfill immediate release needs and is available in 15 sizes (from # 000 to # 5).
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : Quali-G™ is first preservative-free gelatin capsule, the market standard solid dosage form designed to meet the demanding requirements of the pharmaceutical industry.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : ACGCAPS™ GI / HI is available in gelatin and cellulose (HPMC) material options and is designed for optimal performance with DPI formulations and various inhalation devices.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : ACGCAPS™ GC is specially designed for use in clinical trials and comes in the available sizes: AA, A & B.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : DBcaps® capsules are developed with a tamper-evident design to specifically address the clinical trial challenges of testing without bias.
Pharmacopoeia Ref : Not Available
Technical Specs : Size # AAA- E
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Pharmacopoeia Ref : Certified Vegan, Non-GMO, Vege...
Technical Specs : Size # 00el - 4
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Suspension, Tablet
Grade : Topical, Oral
Category : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : Carboxymethyl Cellulose
Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Carboxymethylcellulose serves as a disintegrant, binder, coating agent & thickener in oral formulations, also as a stabilizer in topical formulations.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Thickeners and Stabilizers
Grade : Oral
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Brand Name : Carboxymethyl Cellulose
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Excipient Details : Carboxy Methyl Cellulose is used as a binder, disintegrant, film-former, and rheology modifier in the production of tablets and capsules.
Dosage Form : Emulsion, Suspension, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Rheology Modifiers, Thickeners and Stabilizers
Application : Fillers, Diluents & Binders, Rheology Modifiers, Thickeners and Stabilizers
Excipient Details : HiCel MCG is use in oral suspensions as a stabilizer & emulsion prepared with high shear forces. It is a good binder for tablets & excellent stabilizer as well as thickener.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Carboxymethyl cellulose sodium
Dosage Form : Tablet
Grade : Topical, Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Dosage Form : Tablet
Grade : Topical, Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : Stearic acid is a saturated, wax-like, fatty acid commonly used in the production of pharmaceutical tablets and capsules.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Suspension, Tablet
Grade : Topical, Oral
Category : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Brand Name : Carboxymethyl Cellulose
Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Carboxymethylcellulose serves as a disintegrant, binder, coating agent & thickener in oral formulations, also as a stabilizer in topical formulations.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Softgels, Tablet
Grade : Oral, Topical, Parenteral
Category : Film Formers & Plasticizers, Parenteral, Topical
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Grade : Oral
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Brand Name : Carboxymethyl Cellulose
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Film Formers & Plasticizers, Rheology Modifiers
Excipient Details : Carboxy Methyl Cellulose is used as a binder, disintegrant, film-former, and rheology modifier in the production of tablets and capsules.
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Grade : Oral
Category : Coating Systems & Additives, Film Formers & Plasticizers
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : Ready mix Film coating system for moisture sensitive APIs
Pharmacopoeia Ref : USP, EP, JP; Having US-DMF
Technical Specs : Moisture barrier film coating system
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Application : Topical
Excipient Details : Triethanolamine is widely used in topical pharmaceutical formulations primarily in the formation of emulsions and sunscreen.
Dosage Form : Cream / Lotion / Ointment, Gel, Tablet
Grade : Oral, Topical
Category : Solubilizers, Topical
Brand Name : Polyoxyl 60 Hydrogenated Castor Oil
Application : Solubilizers, Topical
Excipient Details : Polyoxyl (60) hydrogenated castor oil is used as a wetting agent in OSDs such as tablets. It is also used as a solubilizer in topical dosage forms.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : NA
Ingredient(s) : Polyoxyl 60 Hydrogenated Castor Oil
Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Softgels, Tablet
Grade : Oral, Topical, Parenteral
Category : Film Formers & Plasticizers, Parenteral, Topical
Brand Name : 2-Phenoxyethanol PhEur
Application : Topical
Excipient Details : A & C's 2-Phenoxyethanol is used as an excipient and meets the EP monograph
Pharmacopoeia Ref : PhEur
Technical Specs : Not Available
Ingredient(s) : 2-Phenoxyethanol Excipient
Brand Name : 2-Phenoxyethanol Multi-Compendial Grade
Application : Topical
Excipient Details : A&C's 2-Phenoxyethanol is used as a preservative.
Pharmacopoeia Ref : Multi-Compendial Grade
Technical Specs : Not Available
Ingredient(s) : 2-Phenoxyethanol Excipient
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Softgel Capsule
Grade : Not Available
Category : Thickeners and Stabilizers, Topical
Application : Thickeners and Stabilizers, Topical
Excipient Details : Structure-building consistency factor with dry feel, forms crystalline barrier on skin
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP: Stearic ...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
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29 May 2024
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