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1. Centrophne
2. Dihydrochloride, Trimetazidine
3. Idaptan
4. Trimtazidine Irex
5. Trimetazidine
6. Vasartel
7. Vastarel
1. 13171-25-0
2. 1-(2,3,4-trimethoxybenzyl)piperazine Dihydrochloride
3. Trimetazidine Hydrochloride
4. Kyurinett
5. Trimetazidine Hcl
6. Trimetazidine 2hcl
7. Trimetazidine (dihydrochloride)
8. Yoshimilon
9. Vastarel F
10. 1-[(2,3,4-trimethoxyphenyl)methyl]piperazine Dihydrochloride
11. Trimetazidine Di-hcl
12. Trimetazidine Hydrochloride [jan]
13. Trimetazidine Dihcl
14. Trimethazidine Dihydrochloride
15. Piperazine, 1-[(2,3,4-trimethoxyphenyl)methyl]-, Dihydrochloride
16. Mfcd00243086
17. 48v6723z1p
18. Nsc-759317
19. Trimetajust
20. Lubomail
21. Vastarel
22. Yosimilon
23. Piperazine, 1-((2,3,4-trimethoxyphenyl)methyl)-, Dihydrochloride
24. Dsstox_cid_25407
25. Dsstox_rid_80858
26. Dsstox_gsid_45407
27. 1-[(2,3,4-trimethoxyphenyl)methyl]piperazine;dihydrochloride
28. Adexor
29. Piperazine, 1-((2,3,4-trimethoxyphenyl)methyl)-, Dihydrochloride (9ci)
30. Sr-01000781912
31. Ncgc00016697-01
32. Einecs 236-117-0
33. Cas-13171-25-0
34. Unii-48v6723z1p
35. S 4004
36. Kyurinett (tn)
37. Prestwick_871
38. Schembl580378
39. Chembl3561076
40. Dtxsid1045407
41. Chebi:32262
42. Piperazine, 1-(2,3,4-trimethoxybenzyl)-, Dihydrochloride
43. Hms1569n19
44. Bcp21402
45. Hy-b0968
46. Trimetazidine For System Suitability
47. Trimetazidine Hydrochloride (jp17)
48. Tox21_110568
49. S4543
50. Akos015895369
51. Tox21_110568_1
52. Ab05480
53. Ac-5896
54. Ccg-213960
55. Cs-4453
56. Ks-1125
57. Nsc 759317
58. Ncgc00016697-04
59. Trimetazidine Dihydrochloride [mi]
60. Trimetazidine Hydrochloride [mart.]
61. Trimetazidine Hydrochloride [who-dd]
62. Ft-0630397
63. T2726
64. A25088
65. D01606
66. P10117
67. 2,3,4-trimethoxybenzylpiperazine Dihydrochloride
68. 171t250
69. Sr-01000781912-3
70. Sr-01000781912-4
71. Trimetazidine Dihydrochloride [ep Monograph]
72. W-108326
73. 1-[(2,3,4-trimethoxyphenyl)methyl]piperazine Dihcl
74. Q27259190
75. F2173-1142
76. 1-(2,3,4-trimethoxybenzyl)piperazine Dihydrochloride, 97%
77. Trimetazidine Dihydrochloride 1.0 Mg/ml In Methanol (as Free Base)
78. Trimetazidine For System Suitability, European Pharmacopoeia (ep) Reference Standard
| Molecular Weight | 339.3 g/mol |
|---|---|
| Molecular Formula | C14H24Cl2N2O3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 5 |
| Exact Mass | 338.1163980 g/mol |
| Monoisotopic Mass | 338.1163980 g/mol |
| Topological Polar Surface Area | 43 Ų |
| Heavy Atom Count | 21 |
| Formal Charge | 0 |
| Complexity | 259 |
| 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 | 3 |
Vasodilator Agents
Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35644
Submission : 2021-03-30
Status : Active
Type : II
Certificate Number : CEP 2011-305 - Rev 05
Issue Date : 2023-10-06
Type : Chemical
Substance Number : 1741
Status : Valid
Date of Issue : 2022-06-27
Valid Till : 2025-06-02
Written Confirmation Number : WC-0012
Address of the Firm :
NDC Package Code : 62147-0279
Start Marketing Date : 2020-12-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2021-06-26
Registration Number : 20210626-209-J-1039
Manufacturer Name : USV Private Limited
Manufacturer Address : B-1/8, MIDC Lote Parshuram Industrial Area, Taluka Khed, District Ratnagiri, Maharashtra, India 415 722, India
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20680
Submission : 2007-08-16
Status : Active
Type : II
Certificate Number : R1-CEP 2007-231 - Rev 03
Issue Date : 2022-10-17
Type : Chemical
Substance Number : 1741
Status : Valid
Date of Issue : 2019-06-26
Valid Till : 2019-07-07
Written Confirmation Number : WC-0141
Address of the Firm :
NDC Package Code : 53104-7660
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26437
Submission : 2012-09-12
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-075 - Rev 01
Issue Date : 2020-01-07
Type : Chemical
Substance Number : 1741
Status : Valid
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0153
Address of the Firm :
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-07-23
Registration Number : 20190521-209-J-349(2)
Manufacturer Name : SHARON BIO-MEDICINE LTD
Manufacturer Address : Plot NO-L-6, MIDC, Taloja, Raigad, Maharashtra Raigad 410208 Maharashtra State, India
Certificate Number : R0-CEP 2021-001 - Rev 00
Issue Date : 2023-02-13
Type : Chemical
Substance Number : 1741
Status : Valid
Certificate Number : R1-CEP 2015-206 - Rev 00
Issue Date : 2022-10-13
Type : Chemical
Substance Number : 1741
Status : Valid
Date of Issue : 2022-04-04
Valid Till : 2025-01-13
Written Confirmation Number : WC-0331
Address of the Firm :
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USDMF
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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ABOUT THIS PAGE
A Trimetazidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimetazidine, including repackagers and relabelers. The FDA regulates Trimetazidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimetazidine 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 Trimetazidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trimetazidine supplier is an individual or a company that provides Trimetazidine active pharmaceutical ingredient (API) or Trimetazidine finished formulations upon request. The Trimetazidine suppliers may include Trimetazidine API manufacturers, exporters, distributors and traders.
click here to find a list of Trimetazidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trimetazidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Trimetazidine active pharmaceutical ingredient (API) in detail. Different forms of Trimetazidine DMFs exist exist since differing nations have different regulations, such as Trimetazidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trimetazidine DMF submitted to regulatory agencies in the US is known as a USDMF. Trimetazidine USDMF includes data on Trimetazidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trimetazidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trimetazidine 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 Trimetazidine Drug Master File in Japan (Trimetazidine JDMF) empowers Trimetazidine 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 Trimetazidine JDMF during the approval evaluation for pharmaceutical products. At the time of Trimetazidine 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 Trimetazidine 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 Trimetazidine Drug Master File in Korea (Trimetazidine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trimetazidine. The MFDS reviews the Trimetazidine KDMF as part of the drug registration process and uses the information provided in the Trimetazidine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trimetazidine 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 Trimetazidine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trimetazidine suppliers with KDMF on PharmaCompass.
A Trimetazidine CEP of the European Pharmacopoeia monograph is often referred to as a Trimetazidine Certificate of Suitability (COS). The purpose of a Trimetazidine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trimetazidine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trimetazidine to their clients by showing that a Trimetazidine CEP has been issued for it. The manufacturer submits a Trimetazidine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trimetazidine CEP holder for the record. Additionally, the data presented in the Trimetazidine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trimetazidine DMF.
A Trimetazidine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trimetazidine 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 Trimetazidine suppliers with CEP (COS) on PharmaCompass.
A Trimetazidine written confirmation (Trimetazidine WC) is an official document issued by a regulatory agency to a Trimetazidine manufacturer, verifying that the manufacturing facility of a Trimetazidine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trimetazidine APIs or Trimetazidine finished pharmaceutical products to another nation, regulatory agencies frequently require a Trimetazidine WC (written confirmation) as part of the regulatory process.
click here to find a list of Trimetazidine 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 Trimetazidine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trimetazidine 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 Trimetazidine 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 Trimetazidine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trimetazidine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trimetazidine suppliers with NDC on PharmaCompass.
Trimetazidine 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 Trimetazidine 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 Trimetazidine GMP manufacturer or Trimetazidine GMP API supplier for your needs.
A Trimetazidine CoA (Certificate of Analysis) is a formal document that attests to Trimetazidine's compliance with Trimetazidine specifications and serves as a tool for batch-level quality control.
Trimetazidine CoA mostly includes findings from lab analyses of a specific batch. For each Trimetazidine 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.
Trimetazidine may be tested according to a variety of international standards, such as European Pharmacopoeia (Trimetazidine EP), Trimetazidine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trimetazidine USP).
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