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1. Hsr 803
2. Hsr-803
3. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzmide
1. 122892-31-3
2. Itopride Hcl
3. Ganaton
4. Itopride (hydrochloride)
5. Hsr803
6. Hsr-803
7. Itax
8. Hsr 803
9. Benzamide, N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxy-, Hydrochloride (1:1)
10. 2h9nv66w0i
11. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzamide Hydrochloride
12. N-[4-(2-dimethylaminoethoxy)benzyl]-3,4-dimethoxybenzamide Hcl
13. 122892-31-3 (hcl)
14. Benzamide, N-((4-(2-(dimethylamino)ethoxy)phenyl)methyl)-3,4-dimethoxy-, Monohydrochloride
15. Dsstox_cid_26693
16. Dsstox_rid_81827
17. Dsstox_gsid_46693
18. Itopride Hydrochloride (jan)
19. Itopride Hydrochloride [jan]
20. Cas-122892-31-3
21. Ncgc00167529-01
22. Unii-2h9nv66w0i
23. N-[4-[2-(dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide Hydrochloride
24. Ganaton (tn)
25. Mfcd00881710
26. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxidebenzamide Hydrochloride
27. N-((4-(2-(dimethylamino)ethoxy)phenyl)methyl)-3,4-dimethoxybenzamide Monohydrochloride
28. Mls001401433
29. Schembl554675
30. Chembl2139257
31. Dtxsid5046693
32. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzmide
33. Itopride Hydrochloride [mi]
34. Amy18457
35. Bcp12149
36. Hy-b0732
37. Tox21_112526
38. S4619
39. Akos007930375
40. Itopride Hydrochloride [mart.]
41. N-[4-(2-dimethylaminoethoxy)benzyl]-3,4-dimethoxybenzamide Hydrochloride
42. Tox21_112526_1
43. Ab07646
44. Ccg-101047
45. Itopride Hydrochloride [who-dd]
46. Ks-5067
47. Nc00297
48. Itopride Hydrochloride, >=98% (hplc)
49. Ncgc00167529-02
50. Ac-32564
51. Smr000469143
52. Ft-0631110
53. I0948
54. D02729
55. 892i313
56. A804984
57. Q-201260
58. Q27254746
59. N-{p-[2-(dimethylamino)ethoxy]benzyl}veratramide Hydrochloride
60. N-((4-(2-(dimethylamino)ethoxy)phenyl)methyl)-3,4-dimethoxy-benzamidmonohydrochloride
61. N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxybenzamide;hydrochloride
| Molecular Weight | 394.9 g/mol |
|---|---|
| Molecular Formula | C20H27ClN2O4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 9 |
| Exact Mass | 394.1659350 g/mol |
| Monoisotopic Mass | 394.1659350 g/mol |
| Topological Polar Surface Area | 60 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 411 |
| 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 |
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Jai Radhe Sales is your partner for all your sourcing needs.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2022-08-18
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : JDW Pharmaceutical Co., Ltd.
Registration Date : 2024-12-05
Registration Number : 20210511-209-J-982(2)
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, Gujarat, India
| Available Reg Filing : ASMF, MX, CN |
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Pampia Co., Ltd.
Registration Date : 2021-05-11
Registration Number : 20210511-209-J-982
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, Gujarat, India
| Available Reg Filing : ASMF, MX, CN |
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Huseeed Co., Ltd.
Registration Date : 2023-03-23
Registration Number : 20210511-209-J-982(A)
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road, At & Post: Karakhadi-391450, Taluka: Padra, District: Vadodara, Gujarat, India
| Available Reg Filing : ASMF, MX, CN |
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Hansol Pharma Co., Ltd.
Registration Date : 2021-12-15
Registration Number : 20210511-209-J-982(1)
Manufacturer Name : Ami Lifesciences Pvt. Ltd.
Manufacturer Address : Block No. 82/B, ECP Road, At & Post. Karakhadi-391 450, Taluka:Padra, Dist.Vadodara, Gujarat, India
| Available Reg Filing : ASMF, MX, CN |
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2024-11-06
Registration Number : 20210511-209-J-982(B)
Manufacturer Name : Ami Lifesciences Pvt.Ltd.
Manufacturer Address : Block no 82/B, ECP Road, At & Post-Karakadi-391450 Taluka, Padra, District, Vadodara, Gujarat, India.
| Available Reg Filing : ASMF, MX, CN |
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21190
Submission : 2007-11-28
Status : Inactive
Type : II
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
About the Company : Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable ...
About the Company : Hermes Chemical Company Pvt Ltd is a chemicals company established in 2001 and headquartered in Hyderabad. It is specialized in developing, manufacturing, and selling complex molec...
About the Company : Ravoos Laboratories Limited is one of the fastest growing pharmaceutical company located in Hyderabad, South India. Ravoos Laboratories Limited (RLL) made modest foray in the ye...
About the Company : Spansules started in 2000 & now it is one of the leading pellets manufacturing pharmaceutical company with manufacturing facilities and R&D facilities spearheading landmark researc...
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INTERMEDIATE SUPPLIERS
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Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Regulatory Info :
Registration Country : India
Brand Name : Itopride
Dosage Form : Pellets
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Packaging :
Regulatory Info :
Dosage : Pellets
Dosage Strength :
Brand Name : Itopride
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Esomeprazole Magnesium; Itopride Hydrochloride
Brand Name :
Dosage Form : Capsule
Dosage Strength : 40MG; 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Esomeprazole Magnesium; Itopride Hydrochloride
Dosage : Capsule
Dosage Strength : 40MG; 150MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Rabeprazole; Itopride Hydrochloride
Brand Name :
Dosage Form : Pellet
Dosage Strength : 20MG; 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Rabeprazole; Itopride Hydrochloride
Dosage : Pellet
Dosage Strength : 20MG; 150MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : South Korea
Brand Name :
Dosage Form : TABLET
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Packaging :
Regulatory Info : Generic
Dosage : TABLET
Dosage Strength : 50MG
Brand Name :
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info :
Registration Country : Argentina
Brand Name : Itoplus
Dosage Form : Coated Tablet
Dosage Strength : 50MG
Packaging : 10/30/60 Tabs
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Argentina
Packaging : 10/30/60 Tabs
Regulatory Info :
Dosage : Coated Tablet
Dosage Strength : 50MG
Brand Name : Itoplus
Approval Date :
Application Number :
Registration Country : Argentina
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Coated SR Pellets
Dosage Strength : 50%/W/W
Packaging :
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Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Coated SR Pellets
Dosage Strength : 50%/W/W
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Czech Republic
Brand Name : Itoprid PMCS
Dosage Form : Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Czech Republic
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 50MG
Brand Name : Itoprid PMCS
Approval Date :
Application Number :
Registration Country : Czech Republic
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : SR Pellets
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : SR Pellets
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Esomeprazole; ITOPRIDE HYDROCHLORIDE
Brand Name :
Dosage Form : Capsule
Dosage Strength : 40MG; 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Esomeprazole; ITOPRIDE HYDROCHLORIDE
Dosage : Capsule
Dosage Strength : 40MG; 150MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Registered in Pakistan
Registration Country : India
Brand Name :
Dosage Form : SR Pellets
Dosage Strength : 60% W/W
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in Pakistan
Registration Country : India
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Packaging :
Regulatory Info : Registered in Pakistan
Dosage : SR Pellets
Dosage Strength : 60% W/W
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Itopride 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 Itopride Hydrochloride manufacturer or Itopride Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Itopride Hydrochloride manufacturer or Itopride Hydrochloride supplier.
PharmaCompass also assists you with knowing the Itopride Hydrochloride API Price utilized in the formulation of products. Itopride Hydrochloride API Price is not always fixed or binding as the Itopride Hydrochloride Price is obtained through a variety of data sources. The Itopride Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Itopride Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Itopride Hydrochloride, including repackagers and relabelers. The FDA regulates Itopride Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Itopride Hydrochloride 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 Itopride Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Itopride Hydrochloride supplier is an individual or a company that provides Itopride Hydrochloride active pharmaceutical ingredient (API) or Itopride Hydrochloride finished formulations upon request. The Itopride Hydrochloride suppliers may include Itopride Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Itopride Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Itopride Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Itopride Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Itopride Hydrochloride DMFs exist exist since differing nations have different regulations, such as Itopride Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Itopride Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Itopride Hydrochloride USDMF includes data on Itopride Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Itopride Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Itopride Hydrochloride 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 Itopride Hydrochloride Drug Master File in Japan (Itopride Hydrochloride JDMF) empowers Itopride Hydrochloride 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 Itopride Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Itopride Hydrochloride 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 Itopride Hydrochloride 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 Itopride Hydrochloride Drug Master File in Korea (Itopride Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Itopride Hydrochloride. The MFDS reviews the Itopride Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Itopride Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Itopride Hydrochloride 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 Itopride Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Itopride Hydrochloride suppliers with KDMF on PharmaCompass.
A Itopride Hydrochloride written confirmation (Itopride Hydrochloride WC) is an official document issued by a regulatory agency to a Itopride Hydrochloride manufacturer, verifying that the manufacturing facility of a Itopride Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Itopride Hydrochloride APIs or Itopride Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Itopride Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Itopride Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Itopride Hydrochloride 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 Itopride Hydrochloride 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 Itopride Hydrochloride GMP manufacturer or Itopride Hydrochloride GMP API supplier for your needs.
A Itopride Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Itopride Hydrochloride's compliance with Itopride Hydrochloride specifications and serves as a tool for batch-level quality control.
Itopride Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Itopride Hydrochloride 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.
Itopride Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Itopride Hydrochloride EP), Itopride Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Itopride Hydrochloride USP).
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