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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
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
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GDUFA
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 2013-333 - Rev 03
Issue Date : 2024-03-11
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-0183nA2
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
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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 Fortasec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fortasec, including repackagers and relabelers. The FDA regulates Fortasec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fortasec 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 Fortasec manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fortasec supplier is an individual or a company that provides Fortasec active pharmaceutical ingredient (API) or Fortasec finished formulations upon request. The Fortasec suppliers may include Fortasec API manufacturers, exporters, distributors and traders.
click here to find a list of Fortasec suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fortasec DMF (Drug Master File) is a document detailing the whole manufacturing process of Fortasec active pharmaceutical ingredient (API) in detail. Different forms of Fortasec DMFs exist exist since differing nations have different regulations, such as Fortasec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fortasec DMF submitted to regulatory agencies in the US is known as a USDMF. Fortasec USDMF includes data on Fortasec's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fortasec USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fortasec 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 Fortasec Drug Master File in Japan (Fortasec JDMF) empowers Fortasec 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 Fortasec JDMF during the approval evaluation for pharmaceutical products. At the time of Fortasec 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 Fortasec 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 Fortasec Drug Master File in Korea (Fortasec KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fortasec. The MFDS reviews the Fortasec KDMF as part of the drug registration process and uses the information provided in the Fortasec KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fortasec 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 Fortasec API can apply through the Korea Drug Master File (KDMF).
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A Fortasec CEP of the European Pharmacopoeia monograph is often referred to as a Fortasec Certificate of Suitability (COS). The purpose of a Fortasec CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fortasec EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fortasec to their clients by showing that a Fortasec CEP has been issued for it. The manufacturer submits a Fortasec CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fortasec CEP holder for the record. Additionally, the data presented in the Fortasec CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fortasec DMF.
A Fortasec CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fortasec 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 Fortasec suppliers with CEP (COS) on PharmaCompass.
A Fortasec written confirmation (Fortasec WC) is an official document issued by a regulatory agency to a Fortasec manufacturer, verifying that the manufacturing facility of a Fortasec active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fortasec APIs or Fortasec finished pharmaceutical products to another nation, regulatory agencies frequently require a Fortasec WC (written confirmation) as part of the regulatory process.
click here to find a list of Fortasec 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 Fortasec as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fortasec 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 Fortasec 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 Fortasec and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fortasec NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fortasec suppliers with NDC on PharmaCompass.
Fortasec 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 Fortasec 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 Fortasec GMP manufacturer or Fortasec GMP API supplier for your needs.
A Fortasec CoA (Certificate of Analysis) is a formal document that attests to Fortasec's compliance with Fortasec specifications and serves as a tool for batch-level quality control.
Fortasec CoA mostly includes findings from lab analyses of a specific batch. For each Fortasec 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.
Fortasec may be tested according to a variety of international standards, such as European Pharmacopoeia (Fortasec EP), Fortasec JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fortasec USP).
