Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.)
API SUPPLIERS
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42591
Submission : 2025-09-16
Status : Active
Type : II
NDC Package Code : 66412-0362
Start Marketing Date : 2025-06-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
Certificate Number : CEP 2008-313 - Rev 04
Issue Date : 2025-07-08
Type : Chemical
Substance Number : 929
Status : Valid
| Available Reg Filing : CA, ASMF |
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
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 : 2025-08-01
Valid Till : 2028-07-14
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 : IMCD Korea Co., Ltd.
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 19860
DOSAGE - CAPSULE;ORAL - 1MG
USFDA APPLICATION NUMBER - 21855
DOSAGE - CAPSULE;ORAL - 2MG
USFDA APPLICATION NUMBER - 21855
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Disintegrants & Superdisintegrants
Direct Compression
Thickeners and Stabilizers
Granulation
Taste Masking
Controlled & Modified Release
Film Formers & Plasticizers
Solubilizers
Topical
Lubricants & Glidants
Chewable & Orodispersible Aids
Co-Processed Excipients
Parenteral
Empty Capsules
Emulsifying Agents
API Stability Enhancers
Rheology Modifiers
Vegetarian Capsules
Surfactant & Foaming Agents
Coloring Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
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 Lopemid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lopemid, including repackagers and relabelers. The FDA regulates Lopemid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lopemid 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 Lopemid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lopemid supplier is an individual or a company that provides Lopemid active pharmaceutical ingredient (API) or Lopemid finished formulations upon request. The Lopemid suppliers may include Lopemid API manufacturers, exporters, distributors and traders.
click here to find a list of Lopemid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lopemid DMF (Drug Master File) is a document detailing the whole manufacturing process of Lopemid active pharmaceutical ingredient (API) in detail. Different forms of Lopemid DMFs exist exist since differing nations have different regulations, such as Lopemid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lopemid DMF submitted to regulatory agencies in the US is known as a USDMF. Lopemid USDMF includes data on Lopemid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lopemid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lopemid 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 Lopemid Drug Master File in Japan (Lopemid JDMF) empowers Lopemid 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 Lopemid JDMF during the approval evaluation for pharmaceutical products. At the time of Lopemid 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 Lopemid 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 Lopemid Drug Master File in Korea (Lopemid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lopemid. The MFDS reviews the Lopemid KDMF as part of the drug registration process and uses the information provided in the Lopemid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lopemid 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 Lopemid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lopemid suppliers with KDMF on PharmaCompass.
A Lopemid CEP of the European Pharmacopoeia monograph is often referred to as a Lopemid Certificate of Suitability (COS). The purpose of a Lopemid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lopemid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lopemid to their clients by showing that a Lopemid CEP has been issued for it. The manufacturer submits a Lopemid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lopemid CEP holder for the record. Additionally, the data presented in the Lopemid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lopemid DMF.
A Lopemid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lopemid 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 Lopemid suppliers with CEP (COS) on PharmaCompass.
A Lopemid written confirmation (Lopemid WC) is an official document issued by a regulatory agency to a Lopemid manufacturer, verifying that the manufacturing facility of a Lopemid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lopemid APIs or Lopemid finished pharmaceutical products to another nation, regulatory agencies frequently require a Lopemid WC (written confirmation) as part of the regulatory process.
click here to find a list of Lopemid 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 Lopemid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lopemid 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 Lopemid 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 Lopemid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lopemid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lopemid suppliers with NDC on PharmaCompass.
Lopemid 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 Lopemid 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 Lopemid GMP manufacturer or Lopemid GMP API supplier for your needs.
A Lopemid CoA (Certificate of Analysis) is a formal document that attests to Lopemid's compliance with Lopemid specifications and serves as a tool for batch-level quality control.
Lopemid CoA mostly includes findings from lab analyses of a specific batch. For each Lopemid 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.
Lopemid may be tested according to a variety of international standards, such as European Pharmacopoeia (Lopemid EP), Lopemid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lopemid USP).
