Synopsis
Synopsis
0
KDMF
0
VMF
0
FDF
0
Europe
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
Annual Reports
NA
1. Compazine
2. Edisylate Salt, Prochlorperazine
3. Edisylate, Prochlorperazine
4. Maleate, Prochlorperazine
5. Prochlorperazine
6. Prochlorperazine Edisylate
7. Prochlorperazine Edisylate Salt
8. Salt, Prochlorperazine Edisylate
1. Prochlorperazine Dimaleate
2. 84-02-6
3. Prochlorperazine Dimaleate Salt
4. Buccastem
5. Vertigon
6. I1t8o1jtl6
7. Proclorperazine Maleate
8. Prochlorperazinu Dimaleat
9. Prochlorperazine Bimaleate
10. Prochlorperazine Hydrogen Maleate
11. Prochloroproazine Hydrogen Maleate
12. 10h-phenothiazine, 2-chloro-10-(3-(4-methyl-1-piperazinyl)propyl)-, (z)-2-butenedioate (1:2)
13. Dsstox_cid_28941
14. Dsstox_rid_83206
15. Dsstox_gsid_49015
16. Emetiral
17. Pasotomin
18. Nibromin A
19. Meterazin Maleate
20. 2-chloro-10-[3[(4-methyl-1-piperazinyl)propyl]-10h-phenothiazine Dimaleate
21. Chebi:8436
22. Stemetil Dimaleate
23. 2-chloro-10-(3-(4-methyl-1-piperazinyl)propyl)phenothiazine Dimaleate
24. 2-chloro-10-(3-(1-methyl-4-piperazinyl)propyl)phenothiazine, Dimaleate
25. 2-chloro-10-(3-(4-methyl-1-piperazinyl)propyl)phenothiazine Maleate (1:2)
26. Cas-84-02-6
27. Sr-01000000260
28. Ncgc00015856-08
29. Mfcd00069330
30. Unii-i1t8o1jtl6
31. Prochlorperazine Maleate [jan]
32. Prochlorperazinu Dimaleat [czech]
33. Compazine (tn)
34. C20h24cln3s.2c4h4o4
35. Prestwick_410
36. Einecs 201-511-3
37. Prochlorperazine Maleate [usp:jan]
38. Prochlorperazin-dimaleat
39. Prochlorperazinedimaleate
40. 2-chloro-10-(3-(4-methylpiperazin-1-yl)propyl)-10h-phenothiazine Dimaleate
41. Prochlorperazine, Dimaleate
42. Schembl40755
43. Chembl1314751
44. Dtxsid1049015
45. Hms1569o19
46. Hms2096o19
47. Hms3263o09
48. Hms3713o19
49. Hms3885j12
50. Tox21_113522
51. Tox21_501034
52. S4631
53. Prochlorperazine Maleate (jp17/usp)
54. Akos024457528
55. Tox21_113522_1
56. Ccg-220399
57. Ccg-222338
58. Lp01034
59. Nsc 748866
60. Prochlorperazine Dimaleate [mi]
61. Prochlorperazine Maleate [mart.]
62. Prochlorperazine Maleate [vandf]
63. Ncgc00015856-10
64. Ncgc00094323-01
65. Ncgc00261719-01
66. Prochlorperazine Maleate [usp-rs]
67. Prochlorperazine Maleate [who-dd]
68. As-13744
69. Bp165885
70. Eu-0101034
71. P2368
72. Prochlorperazine Maleate [green Book]
73. Prochlorperazine Maleate [orange Book]
74. D00479
75. P 9178
76. Prochlorperazine Dimaleate [green Book]
77. Prochlorperazine Maleate [ep Monograph]
78. Prochlorperazine Maleate [usp Impurity]
79. Prochlorperazine Maleate [usp Monograph]
80. Sr-01000000260-2
81. Sr-01000000260-9
82. Q27108082
83. 2-chloro-10-[3-(4-methylpiperazin-1-yl)propyl]phenothiazine Dimaleate
84. Prochlorperazine Maleate, British Pharmacopoeia (bp) Reference Standard
85. Prochlorperazine Maleate, European Pharmacopoeia (ep) Reference Standard
86. 2-chloro-10-(3-(4-methyl-1-piperazinyl)propyl)phenothiazine Maleate (1:2).
87. 2-chloro-10-[3[(4-methyl-1-piperazi Nyl)propyl]-10h-phenothiazine Dimaleate
88. Phenothiazine, 2-chloro-10-(3-(4-methyl-1-piperazinyl)propyl)-, Maleate (1:2)
89. Prochlorperazine Maleate, United States Pharmacopeia (usp) Reference Standard
90. 10h-phenothiazine, 2-chloro-10-(3-(4-methyl-1-piperazinyl)propyl)-, (2z)-2-butenedioate (1:2)
Molecular Weight | 606.1 g/mol |
---|---|
Molecular Formula | C28H32ClN3O8S |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 8 |
Exact Mass | 605.1598639 g/mol |
Monoisotopic Mass | 605.1598639 g/mol |
Topological Polar Surface Area | 184 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 548 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 2 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
1 of 1 | |
---|---|
Drug Name | Prochlorperazine maleate |
Active Ingredient | Prochlorperazine maleate |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 5mg base; eq 10mg base |
Market Status | Prescription |
Company | Sandoz; Teva Pharms; Mylan |
Antiemetics
Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)
Dopamine Antagonists
Drugs that bind to but do not activate DOPAMINE RECEPTORS, thereby blocking the actions of dopamine or exogenous agonists. Many drugs used in the treatment of psychotic disorders (ANTIPSYCHOTIC AGENTS) are dopamine antagonists, although their therapeutic effects may be due to long-term adjustments of the brain rather than to the acute effects of blocking dopamine receptors. Dopamine antagonists have been used for several other clinical purposes including as ANTIEMETICS, in the treatment of Tourette syndrome, and for hiccup. Dopamine receptor blockade is associated with NEUROLEPTIC MALIGNANT SYNDROME. (See all compounds classified as Dopamine Antagonists.)
Antipsychotic Agents
Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-27
Pay. Date : 2020-09-21
DMF Number : 31842
Submission : 2017-09-25
Status : Active
Type : II
Certificate Number : R0-CEP 2019-071 - Rev 01
Issue Date : 2023-05-15
Type : Chemical
Substance Number : 244
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-21
Pay. Date : 2021-08-17
DMF Number : 36173
Submission : 2021-08-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-13
Pay. Date : 2021-05-10
DMF Number : 2368
Submission : 1974-12-10
Status : Active
Type : II
NDC Package Code : 46204-0106
Start Marketing Date : 2012-03-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4335
Submission : 1981-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 468
Submission : 1962-02-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3078
Submission : 1977-12-06
Status : Inactive
Type : II
Date of Issue : 2013-12-19
Valid Till : 2016-11-21
Written Confirmation Number : WC-258
Address of the Firm :
Date of Issue : 2020-02-14
Valid Till : 2022-07-02
Written Confirmation Number : WC-0214
Address of the Firm :
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-27
Pay. Date : 2020-09-21
DMF Number : 31842
Submission : 2017-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4335
Submission : 1981-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3078
Submission : 1977-12-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 468
Submission : 1962-02-13
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-21
Pay. Date : 2021-08-17
DMF Number : 36173
Submission : 2021-08-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-13
Pay. Date : 2021-05-10
DMF Number : 2368
Submission : 1974-12-10
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3185
Submission : 1978-03-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : R0-CEP 2019-071 - Rev 01
Status : Valid
Issue Date : 2023-05-15
Type : Chemical
Substance Number : 244
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Related Excipient Companies
Dosage Form : Granule / Pellet
Grade : Not Available
Brand Name : Kollicoat SR 30 D
Application : Taste Masking
Excipient Details : pH-independent sustained release coating for small particles, pellets, granules and tablets. Sprayable polymeric film former. Flexible. Wash resistant.
Pharmacopoeia Ref : Ph. Eur.: Poly(vinyl acetate) ...
Technical Specs : Not Available
Ingredient(s) : Sodium Lauryl Sulfate
Dosage Form : Emulsion
Grade : Not Available
Application : Topical
Excipient Details : Self-emulsifying and consistency building, easy-to-use base for dermatological creams
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Sodium Lauryl Sulfate
Dosage Form : Softgel Capsule
Grade : Not Available
Application : Solubilizers
Excipient Details : Nonionic solubilizer, emulsifier and co-emulsifier
Dosage Form : Tablet
Grade : Not Available
Application : Granulation
Excipient Details : Wetting agent, reduces disintegration time, Ionic solubilizer, high HLB anionic emulsifier for semi-solids and foams.
Pharmacopoeia Ref : Ph. Eur.: Sodium Laurilsulfate...
Technical Specs : Not Available
Ingredient(s) : Sodium Lauryl Sulfate
Dosage Form : Capsule
Grade : Not Available
Dosage Form : Emulsion
Grade : Not Available
Brand Name : Kollisolv PEG 300
Application : Solubilizers
Excipient Details : Liquid plasticizer, solvent for oral and topical applications, hydrophilic fill for solubilization of hydrophilic APIs.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 300
Dosage Form : Tablet
Grade : Not Available
Brand Name : Kollisolv PEG 400
Application : Solubilizers
Excipient Details : Liquid plasticizer, Solvent for oral and topical applications, Hydrophilic fill for solubilization of hydrophilic APIs.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 400
Dosage Form : Softgel Capsule
Grade : Not Available
Brand Name : Kollisolv PEG 600
Application : Solubilizers
Excipient Details : Hydrophilic fill for solubilization of hydrophilic APIs.
Pharmacopoeia Ref : Ph. Eur., JP, FCC, USP
Technical Specs : Not Available
Ingredient(s) : Polyethylene Glycol 600
Dosage Form : Softgel Capsule
Grade : Not Available
Application : Thickeners and Stabilizers
Excipient Details : Structure-building consistency factor with dry feel, forms crystalline barrier on skin
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP: Stearic ...
Technical Specs : Not Available
Ingredient(s) : Stearic Acid
Dosage Form : Tablet
Grade : Not Available
Application : Granulation
Excipients by Applications
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Prochlorperazine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prochlorperazine Maleate, including repackagers and relabelers. The FDA regulates Prochlorperazine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prochlorperazine Maleate 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 Prochlorperazine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prochlorperazine Maleate supplier is an individual or a company that provides Prochlorperazine Maleate active pharmaceutical ingredient (API) or Prochlorperazine Maleate finished formulations upon request. The Prochlorperazine Maleate suppliers may include Prochlorperazine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Prochlorperazine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prochlorperazine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prochlorperazine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Prochlorperazine Maleate DMFs exist exist since differing nations have different regulations, such as Prochlorperazine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prochlorperazine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Prochlorperazine Maleate USDMF includes data on Prochlorperazine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prochlorperazine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prochlorperazine Maleate 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 Prochlorperazine Maleate Drug Master File in Japan (Prochlorperazine Maleate JDMF) empowers Prochlorperazine Maleate 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 Prochlorperazine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Prochlorperazine Maleate 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 Prochlorperazine Maleate suppliers with JDMF on PharmaCompass.
A Prochlorperazine Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Prochlorperazine Maleate Certificate of Suitability (COS). The purpose of a Prochlorperazine Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prochlorperazine Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prochlorperazine Maleate to their clients by showing that a Prochlorperazine Maleate CEP has been issued for it. The manufacturer submits a Prochlorperazine Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prochlorperazine Maleate CEP holder for the record. Additionally, the data presented in the Prochlorperazine Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prochlorperazine Maleate DMF.
A Prochlorperazine Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prochlorperazine Maleate 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 Prochlorperazine Maleate suppliers with CEP (COS) on PharmaCompass.
A Prochlorperazine Maleate written confirmation (Prochlorperazine Maleate WC) is an official document issued by a regulatory agency to a Prochlorperazine Maleate manufacturer, verifying that the manufacturing facility of a Prochlorperazine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prochlorperazine Maleate APIs or Prochlorperazine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Prochlorperazine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Prochlorperazine Maleate 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 Prochlorperazine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prochlorperazine Maleate 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 Prochlorperazine Maleate 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 Prochlorperazine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prochlorperazine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prochlorperazine Maleate suppliers with NDC on PharmaCompass.
Prochlorperazine Maleate 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 Prochlorperazine Maleate 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 Prochlorperazine Maleate GMP manufacturer or Prochlorperazine Maleate GMP API supplier for your needs.
A Prochlorperazine Maleate CoA (Certificate of Analysis) is a formal document that attests to Prochlorperazine Maleate's compliance with Prochlorperazine Maleate specifications and serves as a tool for batch-level quality control.
Prochlorperazine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Prochlorperazine Maleate 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.
Prochlorperazine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prochlorperazine Maleate EP), Prochlorperazine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prochlorperazine Maleate USP).
LOOKING FOR A SUPPLIER?