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1. Hydrochloride, Loperamide
2. Imodium
3. Loperamide
4. Loperamide Monohydrochloride
5. Monohydrochloride, Loperamide
6. R 18553
7. R-18553
8. R18553
1. 34552-83-5
2. Loperamide Hcl
3. Imodium
4. Suprasec
5. Loperamide (hydrochloride)
6. Fortasec
7. Imodium A-d
8. 4-(4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl)-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride
9. Nsc-696356
10. Maalox Anti-diarrheal
11. 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride
12. 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-n,n-dimethyl-2,2-diphenylbutanamide;hydrochloride
13. Mls000069779
14. Chebi:6533
15. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-, Hydrochloride
16. R 18,553
17. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidine Butyramide Hcl
18. 77ti35393c
19. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenylpiperidine-1-butyramide Monohydrochloride
20. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutyramide Monohydrochloride
21. Dissenten
22. Lopemid
23. Lopemin
24. Loperyl
25. Smr000058466
26. Imosec
27. Tebloc
28. R-18553
29. Maalox Antidiarrheal
30. Blox
31. Brek
32. Diamode
33. Loseramin
34. Imotil
35. Anti-diarrheal
36. Kao-paverin
37. Diar-aid
38. Kaopectate 1-d
39. K-pek Ii
40. Pepto Diarrhea Control
41. Imodium A-d Ez Chews
42. Pj185
43. Sr-01000075507
44. Up And Up Anti Diarrheal
45. Einecs 252-082-4
46. C29h33cln2o2.hcl
47. Unii-77ti35393c
48. Loperamide, Hcl
49. R 18553
50. Prestwick_302
51. Imodium (tn)
52. Mfcd00058581
53. Cpd000058466
54. Loperamide Hydrochloride [usan:usp:jan]
55. Loperamidi Hydrochloridum
56. Opera_id_1508
57. 4-(4-(p-chlorophenyl)-4-hydroxy-1-piperidyl)-n,n-dimethyl-2,2-diphenylbutyramide Hcl
58. Chembl1707
59. Loperamidehydrochloride
60. Schembl15048
61. R-18553 (hydrochloride)
62. Mls001148627
63. Mls002222200
64. Spectrum2300241
65. Regid_for_cid_71420
66. Loperamide Hydrochloride ,(s)
67. Hy-b0418a
68. Dtxsid00880006
69. Hms1568m10
70. Hms1922j18
71. Pharmakon1600-02300241
72. Bcp28441
73. Loperamide Hydrochloride (jan/usp)
74. Tox21_500708
75. Ccg-39494
76. Loperamide Hydrochloride [mi]
77. Nsc696356
78. Nsc759568
79. S2480
80. Loperamide Hydrochloride [jan]
81. Akos015846351
82. Ac-8242
83. Adl 2-1294
84. Loperamide Hydrochloride [usan]
85. Lp00708
86. Nc00572
87. Nsc 759568
88. Nsc-759568
89. Loperamide Hydrochloride [mart.]
90. Loperamide Hydrochloride [vandf]
91. Loperamide Hydrochloride [usp-rs]
92. Loperamide Hydrochloride [who-dd]
93. Loperamide Hydrochloride [who-ip]
94. Ncgc00094059-01
95. Ncgc00094059-02
96. Ncgc00094059-03
97. Ncgc00094059-04
98. Ncgc00094059-05
99. Ncgc00180886-01
100. Ncgc00180886-02
101. Ncgc00261393-01
102. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-.alpha.,.alpha.-diphenyl-, Monohydrochloride
103. 1-piperidinebutanamide, 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-, Monohydrochloride
104. 4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl]-n,n-dimethyl-2,2-diphenylbutanamide Hydrochloride
105. As-13181
106. Bl166178
107. B1392
108. Eu-0100708
109. Ft-0627973
110. L0154
111. Sw196602-3
112. Loperamide Hydrochloride [ep Impurity]
113. Loperamide Hydrochloride [orange Book]
114. D00729
115. D78217
116. L 4762
117. Loperamide Hydrochloride [ep Monograph]
118. Loperamide Hydrochloride [usp Monograph]
119. Loperamidi Hydrochloridum [who-ip Latin]
120. 552l835
121. A822272
122. Sr-01000075507-1
123. Sr-01000075507-3
124. Sr-01000075507-8
125. W-106729
126. Q27107231
127. Loperamide Hydrochloride, Vetranal(tm), Analytical Standard
128. Imodium Multi-symptom Relief Component Loperamide Hydrochloride
129. Loperamide Hydrochloride Component Of Imodium Multi-symptom Relief
130. Loperamide Hydrochloride, British Pharmacopoeia (bp) Reference Standard
131. Loperamide Hydrochloride, European Pharmacopoeia (ep) Reference Standard
132. 4-(4-chlorophenyl)-4-hydroxy-n,.alpha.-diphenyl-1-piperidinebutanamide Monohydrochloride
133. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-?,?-diphenyl-1-piperidinebutanamide Hydrochloride
134. Loperamide Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
135. Loperamide Hydrochloride, United States Pharmacopeia (usp) Reference Standard
136. 4-(4-chlorophenyl)-1-[4-(dimethylamino)-4-oxo-3,3-diphenylbutyl]-4-hydroxypiperidin-1-ium Chloride
137. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutanamide Hydrochloride
138. 4-(4-chlorophenyl)-4-hydroxy-n,n-dimethyl-alpha,alpha-diphenyl-1-piperidinebutanamidehydrochloride
139. 4-(p-chlorophenyl)-4-hydroxy-n,n-dimethyl-.alpha.,.alpha.-diphenyl-1-piperidinebutyramide Monohydrochloride
140. 4-[4-(4-chlorophenyl)-4-oxidanyl-piperidin-1-yl]-n,n-dimethyl-2,2-diphenyl-butanamide Hydrochloride
141. Loperamide Hydrochloride For System Suitability, European Pharmacopoeia (ep) Reference Standard
Molecular Weight | 513.5 g/mol |
---|---|
Molecular Formula | C29H34Cl2N2O2 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 3 |
Rotatable Bond Count | 7 |
Exact Mass | 512.1997337 g/mol |
Monoisotopic Mass | 512.1997337 g/mol |
Topological Polar Surface Area | 43.8 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 623 |
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 | 2 |
1 of 8 | |
---|---|
Drug Name | Imodium |
Active Ingredient | Loperamide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | 2mg |
Market Status | Prescription |
Company | Mcneil Cons |
2 of 8 | |
---|---|
Drug Name | Imodium a-d ez chews |
Active Ingredient | Loperamide hydrochloride |
Dosage Form | Tablet, chewable |
Route | Oral |
Strength | 2mg |
Market Status | Over the Counter |
Company | Mcneil |
3 of 8 | |
---|---|
Drug Name | Loperamide hydrochloride |
PubMed Health | Loperamide (By mouth) |
Drug Classes | Antidiarrheal, Gastrointestinal Agent |
Drug Label | Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water.Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-monohydrochloride, is a s... |
Active Ingredient | Loperamide hydrochloride |
Dosage Form | Tablet; Capsule; Suspension; Solution |
Route | Oral |
Strength | 1mg/5ml; 1mg; 2mg; 1mg/7.5ml |
Market Status | Over the Counter; Prescription |
Company | Wockhardt; Ohm Labs; Teva; Lnk; Banner Pharmacaps; Roxane; Perrigo R And D; Hi Tech Pharma; Perrigo; Contract Pharmacal; Mylan |
4 of 8 | |
---|---|
Drug Name | Loperamide hydrochloride and simethicone |
Drug Label | IMODIUM (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.IMODIUM is available in 2mg capsules.The inactive ingredients are: Lact... |
Active Ingredient | simethicone; Loperamide hydrochloride |
Dosage Form | Tablet; Tablet, chewable |
Route | Oral |
Strength | 125mg; 2mg |
Market Status | Over the Counter |
Company | Ranbaxy; Perrigo |
5 of 8 | |
---|---|
Drug Name | Imodium |
Active Ingredient | Loperamide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | 2mg |
Market Status | Prescription |
Company | Mcneil Cons |
6 of 8 | |
---|---|
Drug Name | Imodium a-d ez chews |
Active Ingredient | Loperamide hydrochloride |
Dosage Form | Tablet, chewable |
Route | Oral |
Strength | 2mg |
Market Status | Over the Counter |
Company | Mcneil |
7 of 8 | |
---|---|
Drug Name | Loperamide hydrochloride |
PubMed Health | Loperamide (By mouth) |
Drug Classes | Antidiarrheal, Gastrointestinal Agent |
Drug Label | Loperamide hydrochloride is a white to slightly yellow powder and is freely soluble in methanol, isopropyl alcohol, chloroform and slightly soluble in water.Loperamide hydrochloride, 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-monohydrochloride, is a s... |
Active Ingredient | Loperamide hydrochloride |
Dosage Form | Tablet; Capsule; Suspension; Solution |
Route | Oral |
Strength | 1mg/5ml; 1mg; 2mg; 1mg/7.5ml |
Market Status | Over the Counter; Prescription |
Company | Wockhardt; Ohm Labs; Teva; Lnk; Banner Pharmacaps; Roxane; Perrigo R And D; Hi Tech Pharma; Perrigo; Contract Pharmacal; Mylan |
8 of 8 | |
---|---|
Drug Name | Loperamide hydrochloride and simethicone |
Drug Label | IMODIUM (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.IMODIUM is available in 2mg capsules.The inactive ingredients are: Lact... |
Active Ingredient | simethicone; Loperamide hydrochloride |
Dosage Form | Tablet; Tablet, chewable |
Route | Oral |
Strength | 125mg; 2mg |
Market Status | Over the Counter |
Company | Ranbaxy; Perrigo |
Antidiarrheals
Miscellaneous agents found useful in the symptomatic treatment of diarrhea. They have no effect on the agent(s) that cause diarrhea, but merely alleviate the condition. (See all compounds classified as Antidiarrheals.)
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7453
Submission : 1988-04-28
Status : Active
Type : II
NDC Package Code : 49632-070
Start Marketing Date : 2018-07-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Review : Reviewed
Rev. Date : 2017-01-19
Pay. Date : 2016-11-28
DMF Number : 7340
Submission : 1988-02-17
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-17
Pay. Date : 2019-07-16
DMF Number : 10517
Submission : 1993-09-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-20
Pay. Date : 2013-11-25
DMF Number : 27731
Submission : 2013-12-06
Status : Active
Type : II
Certificate Number : CEP 2021-341 - Rev 02
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 929
Status : Valid
Registration Number : 304MF10091
Registrant's Address : 78/A, Bengalrao Nagar, Hyderabad-500 038, Telangana State, India.
Initial Date of Registration : 2022-06-22
Latest Date of Registration :
Date of Issue : 2022-06-15
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183
Address of the Firm :
NDC Package Code : 66577-015
Start Marketing Date : 2018-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : 아이엠씨디코리아주식회사
Registration Date : 2021-03-10
Registration Number : 20200908-209-J-737(2)
Manufacturer Name : Vasudha Pharma Chem Limited
Manufacturer Address : Unit I, Plot No. 37/A, 38, 39A & B, Phase I IDA, Jeedimetla, Hyderabad-500 055, Telangana, India
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
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DMF Review : N/A
Rev. Date :
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DMF Number : 7453
Submission : 1988-04-28
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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DMF Review : Complete
Rev. Date : 2017-01-19
Pay. Date : 2016-11-28
DMF Number : 7340
Submission : 1988-02-17
Status : Active
Type : II
GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 10942
Submission : 1994-06-17
Status : Inactive
Type : II
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DMF Review : Complete
Rev. Date : 2014-04-23
Pay. Date : 2013-08-07
DMF Number : 10028
Submission : 1992-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8206
Submission : 1989-09-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-17
Pay. Date : 2019-07-16
DMF Number : 10517
Submission : 1993-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7299
Submission : 1988-01-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2013-11-25
DMF Number : 27731
Submission : 2013-12-06
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8314
Submission : 1989-12-01
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8051
Submission : 1989-05-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2016-168 - Rev 03
Status : Valid
Issue Date : 2024-04-19
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 1996-088 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2001-12-03
Type : Chemical
Substance Number : 929
Certificate Number : R2-CEP 1994-020 - Rev 05
Status : Valid
Issue Date : 2019-11-19
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2004-133 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2012-09-13
Type : Chemical
Substance Number : 1729
Certificate Number : R1-CEP 2009-362 - Rev 02
Status : Valid
Issue Date : 2023-02-14
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2003-149 - Rev 05
Status : Valid
Issue Date : 2021-06-15
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2004-132 - Rev 05
Status : Valid
Issue Date : 2020-09-25
Type : Chemical
Substance Number : 929
Certificate Number : R1-CEP 2008-313 - Rev 03
Status : Valid
Issue Date : 2022-01-04
Type : Chemical
Substance Number : 929
Loperamide Hydrochloride, Process-II
Certificate Number : CEP 2021-341 - Rev 02
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 929
Certificate Number : CEP 2013-333 - Rev 03
Status : Valid
Issue Date : 2024-03-11
Type : Chemical
Substance Number : 929
Registration Number : 217MF10757
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2020-10-01
Registration Number : 304MF10091
Registrant's Address : 78/A, Bengalrao Nagar, Hyderabad-500 038, Telangana State, India.
Initial Date of Registration : 2022-06-22
Latest Date of Registration : 2024-04-18
Loperamide Hydrochloride Ph.Eur/BP/USP
Date of Issue : 2022-08-16
Valid Till : 2025-08-13
Written Confirmation Number : WC-0229
Address of the Firm : Survey No. 270, Nawabpet Village, Shivampet Mandai, Medak District, Telangana-50...
Loperamide Hydrochloride Ph.Eur
Date of Issue : 2023-02-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0101
Address of the Firm : No.21M, Attibele Industrial Area, Anekal Taluk, Bangalore-562107, Karnataka, Ind...
Loperamide Hydrochloride USP/Ph. Eur
Date of Issue : 2022-06-15
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183
Address of the Firm : Unit-ll,PlotNo.79,Jawaharlal NehruPharmaCity, Thanam Village, Parawada Mandal, A...
Loperamide Hydrochloride BP/Ph.Eur/USP
Date of Issue : 2022-06-14
Valid Till : 2025-07-04
Written Confirmation Number : WC-0070nA2
Address of the Firm : 37/A, 38, 39 A&B, PHASE-1, IDA, Jeedimetla, Hyderabad, 500 055, Telangana, India
Date of Issue : 2021-02-12
Valid Till : 2022-07-04
Written Confirmation Number : WC-0070Amended
Address of the Firm : Unit-1, 37/A, 38, 39 A&B, PHASE-1, IDA, Jeedimetla, Hyderabad, 500 055, Telangan...
Registrant Name : 아이엠씨디코리아주식회사
Registration Date : 2021-03-10
Registration Number : 20200908-209-J-737(2)
Manufacturer Name : Vasudha Pharma Chem Limited
Manufacturer Address : Unit I, Plot No. 37/A, 38, 39A & B, Phase I IDA, Jeedimetla, Hyderabad-500 055, Telan...
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2020-09-08
Registration Number : 20200908-209-J-737
Manufacturer Name : Vasudha Pharma Chem Limited
Manufacturer Address : Unit I, Plot No. 37/A, 38, 39A & B, Phase I IDA, Jeedimetla, Hyderabad-500 055, Telan...
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2020-11-19
Registration Number : 20200908-209-J-737(1)
Manufacturer Name : Vasudha Pharma Chem Limited
Manufacturer Address : UnitⅠ, Plot No.37/A, 38, 39 A&B, Phase-Ⅰ IDA, Jeedimetla, Hyderabad-500055, Telan...
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
NDC Package Code : 49632-070
Start Marketing Date : 2018-07-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 38779-0446
Start Marketing Date : 2014-04-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 17337-0549
Start Marketing Date : 2024-09-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0526
Start Marketing Date : 2017-02-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0550
Start Marketing Date : 2024-09-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-2357
Start Marketing Date : 2002-07-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-0174
Start Marketing Date : 2014-01-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 48292-0029
Start Marketing Date : 2015-02-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49452-4133
Start Marketing Date : 1997-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66577-015
Start Marketing Date : 2018-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Details:
Generic of Loperamide Hydrochloride and Simethicone Tablets have been approved which is indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.
Lead Product(s): Loperamide Hydrochloride,Simethicone
Therapeutic Area: Infections and Infectious Diseases Brand Name: Imodium Multi-Symptom Relief-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 30, 2022
Lead Product(s) : Loperamide Hydrochloride,Simethicone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Limited Received ANDA Approval for Loperamide HCl and Simethicone Tablets
Details : Generic of Loperamide Hydrochloride and Simethicone Tablets have been approved which is indicated to relieve symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas.
Product Name : Imodium Multi-Symptom Relief-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 30, 2022
Details:
Nerlynx (neratinib) is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2 overexpressed/amplified breast cancer.
Lead Product(s): Neratinib,Capecitabine,Loperamide Hydrochloride
Therapeutic Area: Oncology Brand Name: Nerlynx
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 11, 2025
Lead Product(s) : Neratinib,Capecitabine,Loperamide Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Breast Cancer Therapy Approved in Thailand to Reduce Recurrence Risk
Details : Nerlynx (neratinib) is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2 overexpressed/amplified breast cancer.
Product Name : Nerlynx
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 11, 2025
Details:
Loperamide hydrochloride binds to the opiate receptor in the gut wall and acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel.
Lead Product(s): Loperamide Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: Imodium-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2023
Lead Product(s) : Loperamide Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Receives Final Approval from The USFDA for Loperamide Hydrochloride Capsules USP, 2 mg
Details : Loperamide hydrochloride binds to the opiate receptor in the gut wall and acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel.
Product Name : Imodium-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 28, 2023
Details:
Phase II SUMMIT ‘basket’ trial is an open-label, international multi-histology study to evaluate the safety and efficacy of neratinib, administered daily to patients, across a broad spectrum of cancer types in patients whose tumors harbor activating HER2 somatic mutations.
Lead Product(s): Neratinib,Loperamide Hydrochloride
Therapeutic Area: Oncology Brand Name: Nerlynx
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2020
Lead Product(s) : Neratinib,Loperamide Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Phase II SUMMIT ‘basket’ trial is an open-label, international multi-histology study to evaluate the safety and efficacy of neratinib, administered daily to patients, across a broad spectrum of cancer types in patients whose tumors harbor activating ...
Product Name : Nerlynx
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 27, 2020
4-(4-Chlorophenyl)-4-hydroxypiperidine
CAS Number : 39512-49-7
End Use API : Loperamide Hydrochloride
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
4-(4-Chlorophenyl)-4-Hydroxy Piperidine
CAS Number : 39512-49-7
End Use API : Loperamide Hydrochloride
About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domesti...
4-(4-Chlorophenyl)-4-hydroxy piperidine (PCP)
CAS Number : 39512-49-7
End Use API : Loperamide Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
4-Bromo-2,2-diphenyl butyric acid
CAS Number : 37742-98-6
End Use API : Loperamide Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Dihydro-N,N-dimethyl-3,3-diphenyl-2(3H)-furanimini...
CAS Number : 37743-18-3
End Use API : Loperamide Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
CAS Number : 86--29-3
End Use API : Loperamide Hydrochloride
About The Company : NAM Group of Industries is a prominent manufacturer and exporter of pharmaceutical API’s for both human and veterinary use, along with pharmaceutical intermed...
4-(4-Chlorophenyl)-4-hydroxypiperidine
CAS Number : 39512-49-7
End Use API : Loperamide Hydrochloride
About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...
furyliden ammonium bromide ( Furaniminium Bromide ...
CAS Number : 37743-18-3
End Use API : Loperamide Hydrochloride
About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...
CAS Number : 956-89-8
End Use API : Loperamide Hydrochloride
About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...
4-Bromo-2-2-diphenylbutyricacid
CAS Number : 37742-98-6
End Use API : Loperamide Hydrochloride
About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Sallyso (Croscarmellose Sodium) is a cross-linked polymer of carboxymethylcellulose sodium, used as a superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Sallyso 0.5 to 3.0%
Ingredient(s) : Croscarmellose Sodium
Dosage Form : Capsule
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Solvostar (Sodium Starch Glycolate) is used as a superdisintegrant in oral solid dosage forms such as tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Solvostar 2% to 8%
Ingredient(s) : Sodium Starch Glycolate
Dosage Form : Softgels
Grade : Oral
Dosage Form : Tablet
Grade : Oral
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Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Dosage Form : Tablet
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Excipient Details : Sucrex (Sucralose) is used as a sweetener and a taste masking agent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : NA
Ingredient(s) : Sucralose
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : SweetACE (Acesulfame K) is used as a sweetener and a taste masking agent in oral dosage forms such as tablets.
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Technical Specs : NA
Ingredient(s) : Acesulfame Potassium
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
4-(4-Chlorophenyl)-4-Piperidinol
CAS Number : 39512-49-7
Quantity Per Vial :
Price ($) : 800
Catalog Number : 1A07620
Current Lot : 25 mg
Previous Lot :
NDC Code :
ANALYTICAL
Analyte : Loperamide
Method : LSMS/MS
LLOQ : 50
Units : ng/mL
Details : Human Plasma
ABOUT THIS PAGE
31
PharmaCompass offers a list of Loperamide Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Loperamide Hydrochloride manufacturer or Loperamide Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Loperamide Hydrochloride manufacturer or Loperamide Hydrochloride supplier.
PharmaCompass also assists you with knowing the Loperamide Hydrochloride API Price utilized in the formulation of products. Loperamide Hydrochloride API Price is not always fixed or binding as the Loperamide Hydrochloride Price is obtained through a variety of data sources. The Loperamide Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Loperamide hydrochloride and simethicone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loperamide hydrochloride and simethicone, including repackagers and relabelers. The FDA regulates Loperamide hydrochloride and simethicone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loperamide hydrochloride and simethicone supplier is an individual or a company that provides Loperamide hydrochloride and simethicone active pharmaceutical ingredient (API) or Loperamide hydrochloride and simethicone finished formulations upon request. The Loperamide hydrochloride and simethicone suppliers may include Loperamide hydrochloride and simethicone API manufacturers, exporters, distributors and traders.
click here to find a list of Loperamide hydrochloride and simethicone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Loperamide hydrochloride and simethicone DMF (Drug Master File) is a document detailing the whole manufacturing process of Loperamide hydrochloride and simethicone active pharmaceutical ingredient (API) in detail. Different forms of Loperamide hydrochloride and simethicone DMFs exist exist since differing nations have different regulations, such as Loperamide hydrochloride and simethicone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Loperamide hydrochloride and simethicone DMF submitted to regulatory agencies in the US is known as a USDMF. Loperamide hydrochloride and simethicone USDMF includes data on Loperamide hydrochloride and simethicone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Loperamide hydrochloride and simethicone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone Drug Master File in Japan (Loperamide hydrochloride and simethicone JDMF) empowers Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone JDMF during the approval evaluation for pharmaceutical products. At the time of Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Loperamide hydrochloride and simethicone Drug Master File in Korea (Loperamide hydrochloride and simethicone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Loperamide hydrochloride and simethicone. The MFDS reviews the Loperamide hydrochloride and simethicone KDMF as part of the drug registration process and uses the information provided in the Loperamide hydrochloride and simethicone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Loperamide hydrochloride and simethicone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Loperamide hydrochloride and simethicone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Loperamide hydrochloride and simethicone suppliers with KDMF on PharmaCompass.
A Loperamide hydrochloride and simethicone CEP of the European Pharmacopoeia monograph is often referred to as a Loperamide hydrochloride and simethicone Certificate of Suitability (COS). The purpose of a Loperamide hydrochloride and simethicone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Loperamide hydrochloride and simethicone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Loperamide hydrochloride and simethicone to their clients by showing that a Loperamide hydrochloride and simethicone CEP has been issued for it. The manufacturer submits a Loperamide hydrochloride and simethicone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Loperamide hydrochloride and simethicone CEP holder for the record. Additionally, the data presented in the Loperamide hydrochloride and simethicone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Loperamide hydrochloride and simethicone DMF.
A Loperamide hydrochloride and simethicone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Loperamide hydrochloride and simethicone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Loperamide hydrochloride and simethicone suppliers with CEP (COS) on PharmaCompass.
A Loperamide hydrochloride and simethicone written confirmation (Loperamide hydrochloride and simethicone WC) is an official document issued by a regulatory agency to a Loperamide hydrochloride and simethicone manufacturer, verifying that the manufacturing facility of a Loperamide hydrochloride and simethicone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Loperamide hydrochloride and simethicone APIs or Loperamide hydrochloride and simethicone finished pharmaceutical products to another nation, regulatory agencies frequently require a Loperamide hydrochloride and simethicone WC (written confirmation) as part of the regulatory process.
click here to find a list of Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Loperamide hydrochloride and simethicone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Loperamide hydrochloride and simethicone suppliers with NDC on PharmaCompass.
Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone 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 Loperamide hydrochloride and simethicone GMP manufacturer or Loperamide hydrochloride and simethicone GMP API supplier for your needs.
A Loperamide hydrochloride and simethicone CoA (Certificate of Analysis) is a formal document that attests to Loperamide hydrochloride and simethicone's compliance with Loperamide hydrochloride and simethicone specifications and serves as a tool for batch-level quality control.
Loperamide hydrochloride and simethicone CoA mostly includes findings from lab analyses of a specific batch. For each Loperamide hydrochloride and simethicone 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.
Loperamide hydrochloride and simethicone may be tested according to a variety of international standards, such as European Pharmacopoeia (Loperamide hydrochloride and simethicone EP), Loperamide hydrochloride and simethicone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Loperamide hydrochloride and simethicone USP).