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Also known as: Prochlorperazine dimaleate, 84-02-6, Prochlorperazine dimaleate salt, Buccastem, Vertigon, I1t8o1jtl6
Molecular Formula
C28H32ClN3O8S
Molecular Weight
606.1  g/mol
InChI Key
DSKIOWHQLUWFLG-SPIKMXEPSA-N
FDA UNII
I1T8O1JTL6

Prochlorperazine Maleate
A phenothiazine antipsychotic used principally in the treatment of NAUSEA; VOMITING; and VERTIGO. It is more likely than CHLORPROMAZINE to cause EXTRAPYRAMIDAL DISORDERS. (From Martindale, The Extra Pharmacopoeia, 30th ed, p612)
1 2D Structure

Prochlorperazine Maleate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(Z)-but-2-enedioic acid;2-chloro-10-[3-(4-methylpiperazin-1-yl)propyl]phenothiazine
2.1.2 InChI
InChI=1S/C20H24ClN3S.2C4H4O4/c1-22-11-13-23(14-12-22)9-4-10-24-17-5-2-3-6-19(17)25-20-8-7-16(21)15-18(20)24;2*5-3(6)1-2-4(7)8/h2-3,5-8,15H,4,9-14H2,1H3;2*1-2H,(H,5,6)(H,7,8)/b;2*2-1-
2.1.3 InChI Key
DSKIOWHQLUWFLG-SPIKMXEPSA-N
2.1.4 Canonical SMILES
CN1CCN(CC1)CCCN2C3=CC=CC=C3SC4=C2C=C(C=C4)Cl.C(=CC(=O)O)C(=O)O.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CN1CCN(CC1)CCCN2C3=C(SC4=CC=CC=C24)C=CC(=C3)Cl.C(=C\C(=O)O)\C(=O)O.C(=C\C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
I1T8O1JTL6
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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)

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 606.1 g/mol
Molecular Formula C28H32ClN3O8S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count12
Rotatable Bond Count8
Exact Mass605.1598639 g/mol
Monoisotopic Mass605.1598639 g/mol
Topological Polar Surface Area184 Ų
Heavy Atom Count41
Formal Charge0
Complexity548
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameProchlorperazine maleate
Active IngredientProchlorperazine maleate
Dosage FormTablet
RouteOral
Strengtheq 5mg base; eq 10mg base
Market StatusPrescription
CompanySandoz; Teva Pharms; Mylan

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Phenothiazines [CS]; Phenothiazine [EPC]

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Certificate Number : R0-CEP 2019-071 - Rev 01

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Type : Chemical

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LIMITED","customerCountry":"INDIA","quantity":"153.00","actualQuantity":"153","unit":"KGS","unitRateFc":"1526.4","totalValueFC":"236535.8","currency":"USD","unitRateINR":"127683","date":"22-Feb-2023","totalValueINR":"19535496","totalValueInUsd":"236535.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29343000","bill_no":"1000788","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679077800,"product":"PROCHLORPERAZINE MALEATE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"M\/S.CHEMESS DWC LLC","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"109.00","actualQuantity":"109","unit":"KGS","unitRateFc":"1525.7","totalValueFC":"169232.2","currency":"USD","unitRateINR":"127701.1","date":"18-Mar-2023","totalValueINR":"13919415","totalValueInUsd":"169232.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29343000","bill_no":"1001157","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679596200,"product":"PROCHLORPERAZINE MALEATE","address":"12\/8 SARASWATHI AMMAL STREET MARUTHI SEVA NAGAR Contact No: 9177","city":"BANGALORE KARNATAKA","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"75.46","actualQuantity":"75.46","unit":"KGS","unitRateFc":"537","totalValueFC":"44019.8","currency":"EUR","unitRateINR":"47981","date":"24-Mar-2023","totalValueINR":"3620642.49","totalValueInUsd":"44019.8","indian_port":"BANGALORE AIR","hs_no":"29420090","bill_no":"5210393","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12\/8 SARASWATHI AMMAL STREET MARUTHI SEVA NAGAR Contact No: 9177"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691692200,"product":"PF5103 PROCHLORPERAZINE MALEATE","address":"201, DEVAVRATA, SECTOR 17,, VASHI, NAVI MUMBAI, NAVI","city":"MUMBAI","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"2.19","actualQuantity":"2.19","unit":"KGS","unitRateFc":"948","totalValueFC":"2303.7","currency":"EUR","unitRateINR":"86265","date":"11-Aug-2023","totalValueINR":"190828.704","totalValueInUsd":"2303.7","indian_port":"BANGALORE AIR","hs_no":"29343000","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"201, DEVAVRATA, SECTOR 17,, VASHI, NAVI MUMBAI, NAVI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696444200,"product":"PROCHLORPERAZINE MALEATE USP (PF5103 PROCHLORPERAZINE MALEATE) CAS NO. 84-02-6","address":"PARIJAT HOUSE,","city":"MUMBAI ,MAHARASHTRA","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"KOPRAN","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"648","totalValueFC":"17527.6","currency":"EUR","unitRateINR":"58352.4","date":"05-Oct-2023","totalValueINR":"1458810","totalValueInUsd":"17527.6","indian_port":"Bombay Air","hs_no":"29211990","bill_no":"8146998","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIA GUIDO GUARINI MATTEUCCI,120162 MILANO (MI) ITALIASDNF IT","customerAddress":"PARIJAT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701801000,"product":"PROCHLORPERAZINE MALEATE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"537","totalValueFC":"44390.8","currency":"EUR","unitRateINR":"49269.8","date":"06-Dec-2023","totalValueINR":"3695231.25","totalValueInUsd":"44390.8","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"9100575","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA GUIDO GUARINI MATTEUCCI, 120162 MILANOSDNF ITALY","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701887400,"product":"PF5103 PROCHLORPERAZINE MALEATE(BATCH NO:PCP-M\/262\/L)","address":"C-4, INDUSTRIAL AREA","city":"HYDERABAD, ANDHRA PRADESH","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"SRI KRISHNA PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"580","totalValueFC":"31963.6","currency":"EUR","unitRateINR":"53215","date":"07-Dec-2023","totalValueINR":"2660750","totalValueInUsd":"31963.6","indian_port":"Hyderabad Air","hs_no":"29211990","bill_no":"9115611","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIA GUIDO GUARINI MATTEUCCI,1 20162MILANO (MI) - ITALIASDNF Italy","customerAddress":"C-4, INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712169000,"product":"PROCHLORPERAZINE MALEATE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"MEDREICH","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"537","totalValueFC":"59482.8","currency":"EUR","unitRateINR":"49672.5","date":"04-Apr-2024","totalValueINR":"4967250","totalValueInUsd":"59482.8","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"2882575","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA GUIDO GUARINI MATTEUCCI, 120162 MILANOSDNF ITALY","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714761000,"product":"PROCHLORPERAZINE MALEATE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"MEDREICH","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"537","totalValueFC":"5862.6","currency":"EUR","unitRateINR":"48867","date":"04-May-2024","totalValueINR":"488670","totalValueInUsd":"5862.6","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"3333853","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA GUIDO GUARINI MATTEUCCI, 120162 MILANOSDNF ITALY","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716316200,"product":"PROCHLORPERAZINE MALEATE PH. EUR PF5103","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"IPCA LABORATORIES","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"553","totalValueFC":"76709.6","currency":"EUR","unitRateINR":"51152.5","date":"22-May-2024","totalValueINR":"6394062.5","totalValueInUsd":"76709.6","indian_port":"Bombay Air","hs_no":"29343000","bill_no":"3611478","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA GUIDO GUARINI MATTEUCCI, 1 20162 MILANO (MI) Milano, , ItalySDNF Italy","customerAddress":"48, KANDIVLI INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"(Z)-BUT-2-ENEDIOIC ACID : 2-CHLORO-10-(3-(4-METHYLPIPERAZIN-1-YL)PROPYL)PHENOTHIAZINE PROCHLORPERAZINE MALEATE","address":"PLOT NOS. B5 (pt) & B6 (pt) SIPCOT INDUSTRIAL PARK, IRUNGATTUKOTTAI","city":"SRIPERUMBUDUR","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"ORBION PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1075","totalValueFC":"118229","currency":"EUR","unitRateINR":"99168.8","date":"03-Aug-2024","totalValueINR":"9916875","totalValueInUsd":"118229","indian_port":"Madras Air","hs_no":"29349990","bill_no":"4850945","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA DELLE INDUSTRIE,620816-CERIANO LAGHETTO (MB)-ITALIASDNF IT","customerAddress":"PLOT NOS. B5 (pt) & B6 (pt) SIPCOT INDUSTRIAL PARK, IRUNGATTUKOTTAI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"PF5103 PROCHLORPERAZINE MALEATE","address":"3RD FLOOR,NARMADA ARCADE,SNEHAPURI","city":"HYDERABAD","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"OPTIMUS PHARMA","customerCountry":"INDIA","quantity":"46.10","actualQuantity":"46.1","unit":"KGS","unitRateFc":"975","totalValueFC":"49134.9","currency":"EUR","unitRateINR":"89943.8","date":"13-Nov-2024","totalValueINR":"4146406.88","totalValueInUsd":"49134.9","indian_port":"Hyderabad Air","hs_no":"29343000","bill_no":"6646552","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA DELLE INDUSTRIE 6 20816- CERIAN O LAGHETTO (MB) SDNF Italy","customerAddress":"3RD FLOOR,NARMADA ARCADE,SNEHAPURI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"PROCHLORPERAZINE MALEATE","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"TRIFARMA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"535","totalValueFC":"8634.7","currency":"EUR","unitRateINR":"48578","date":"19-Nov-2024","totalValueINR":"728670","totalValueInUsd":"8634.7","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"6749478","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA GUIDO GUARINI MATTEUCCI, 1 20162 MILANO SDNF ITALY","customerAddress":"MEDREICH HOUSE, NO12\/8,"}]
12-Feb-2021
19-Nov-2024
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ABOUT THIS PAGE

Prochlorperazine Maleate Manufacturers

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.

Prochlorperazine Maleate Suppliers

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.

Prochlorperazine Maleate USDMF

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.

Prochlorperazine Maleate JDMF

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.

Prochlorperazine Maleate CEP

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.

Prochlorperazine Maleate WC

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.

Prochlorperazine Maleate NDC

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).

Finished drug products

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.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Prochlorperazine Maleate CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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