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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

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EU WC

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API REF. PRICE (USD/KG)

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Europe

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GLOBAL SALES INFORMATION

US Medicaid

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Annual Reports

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5 RELATED EXCIPIENT COMPANIES

6EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 3598-37-6, Anatran, Sedalin, Soprontin, Acetopromazine maleate salt, Acepromazine monomaleate
Molecular Formula
C23H26N2O5S
Molecular Weight
442.5  g/mol
InChI Key
FQRHOOHLUYHMGG-BTJKTKAUSA-N
FDA UNII
37862HP2OM

Acepromazine
A phenothiazine that is used in the treatment of PSYCHOSES.
1 2D Structure

Acepromazine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(Z)-but-2-enedioic acid;1-[10-[3-(dimethylamino)propyl]phenothiazin-2-yl]ethanone
2.1.2 InChI
InChI=1S/C19H22N2OS.C4H4O4/c1-14(22)15-9-10-19-17(13-15)21(12-6-11-20(2)3)16-7-4-5-8-18(16)23-19;5-3(6)1-2-4(7)8/h4-5,7-10,13H,6,11-12H2,1-3H3;1-2H,(H,5,6)(H,7,8)/b;2-1-
2.1.3 InChI Key
FQRHOOHLUYHMGG-BTJKTKAUSA-N
2.1.4 Canonical SMILES
CC(=O)C1=CC2=C(C=C1)SC3=CC=CC=C3N2CCCN(C)C.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CC(=O)C1=CC2=C(C=C1)SC3=CC=CC=C3N2CCCN(C)C.C(=C\C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
37862HP2OM
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Acepromazine

2. Acetazine

3. Acetopromazine

4. Acetylpromazine

5. Calmivet

6. Maleate, Acepromazine

7. Plegicil

8. Vetranquil

2.3.2 Depositor-Supplied Synonyms

1. 3598-37-6

2. Anatran

3. Sedalin

4. Soprontin

5. Acetopromazine Maleate Salt

6. Acepromazine Monomaleate

7. Acetopromazine Maleate

8. 37862hp2om

9. Acepromazine Hydrogen Maleate

10. Nsc-264522

11. Acetylpromazine Maleate (1:1)

12. 2-acetyl-10-(3-(dimethylamino)propyl)phenothiazine, Maleate

13. Acepromazine D6 Maleate

14. 10-(3-(dimethylamino)propyl)phenothiazin-2-yl Methyl Ketone Maleate (1:1)

15. Dsstox_cid_27763

16. Dsstox_rid_82540

17. Ethanone, 1-(10-(3-(dimethylamino)propyl)-10h-phenothiazin-2-yl)-, (z)-2-butenedioate (1:1)

18. Dsstox_gsid_47783

19. A 23051

20. Notensil Maleate

21. Maleate Acide De L'acetyl 3-dimethylamino 3-propyl-10-phenothiazine

22. Sr-05000001648

23. Ncgc00016634-01

24. Cas-3598-37-6

25. Nsc 264522

26. Acepromazine Maleate [usan]

27. Unii-37862hp2om

28. Acepromazine Maleate [usan:usp]

29. Prestwick_888

30. Einecs 222-748-9

31. Mfcd00082473

32. 1-(10-(3-(dimethylamino)propyl)-10h-phenothiazin-2-yl)ethanone Maleate

33. (z)-but-2-enedioic Acid;1-[10-[3-(dimethylamino)propyl]phenothiazin-2-yl]ethanone

34. Acepromazinemaleate

35. Acepromazine Hydrogenmaleate

36. Acepromazine Maleate (usp)

37. Schembl204733

38. Chembl1883146

39. Dtxsid6047783

40. Acepromazine Maleate [mi]

41. 2-acetyl-10-(3-dimethylaminopropyl)phenothiazine Maleate Salt

42. Hms1569d14

43. Hms2093n15

44. Hms2096d14

45. Hms3263n18

46. Hms3713d14

47. Pharmakon1600-01505498

48. Phenothiazine, 2-acetyl-10-(3-(dimethylamino)propyl)-, Maleate

49. Tox21_110536

50. Tox21_501268

51. Acepromazine Maleate [mart.]

52. Nsc760058

53. Acepromazine Maleate [usp-rs]

54. Acepromazine Maleate [who-dd]

55. Akos015855868

56. Maleate Acide De L'acetyl 3-dimethylamino 3-propyl-10-phenothiazine [french]

57. Tox21_110536_1

58. Acepromazine Maleate, >=98% (hplc)

59. Ccg-213470

60. Ds-9727

61. Nsc-760058

62. Acepromazine Maleate [green Book]

63. Ncgc00016634-04

64. Ncgc00261953-01

65. Acepromazine Maleate [usp Monograph]

66. Cs-0013292

67. Acepromazine Maleate 100 Microg/ml In Ethanol

68. D02604

69. 9-oxo-9h-thioxanthene-3-carboxylicacid&

70. A874474

71. A935720

72. Sr-05000001648-1

73. Sr-05000001648-2

74. Q27256656

75. Acepromazine Maleate, United States Pharmacopeia (usp) Reference Standard

76. Ketone, 10-(3-(dimethylamino)propyl)phenothiazin-2-yl Methyl, Maleate (1:1)

77. (2z)-but-2-enedioic Acid; 1-{10-[3-(dimethylamino)propyl]-10h-phenothiazin-2-yl}ethan-1-one

78. 115120-92-8

2.4 Create Date
2006-04-14
3 Chemical and Physical Properties
Molecular Weight 442.5 g/mol
Molecular Formula C23H26N2O5S
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count7
Exact Mass442.15624311 g/mol
Monoisotopic Mass442.15624311 g/mol
Topological Polar Surface Area123 Ų
Heavy Atom Count31
Formal Charge0
Complexity533
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

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.)


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.)


API SUPPLIERS

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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF

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Iropharm Ltd

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USDMF

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Iropharm Ltd

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7803

Submission : 1988-11-28

Status : Inactive

Type : II

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Sibefat Spa

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USDMF

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Sibefat Spa

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5177

Submission : 1983-11-04

Status : Inactive

Type : II

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NDC API

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ACEPROMAZINE MALEATE

NDC Package Code : 60592-430

Start Marketing Date : 2020-01-03

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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ACEPROMAZINE MALEATE

NDC Package Code : 54154-019

Start Marketing Date : 2010-03-29

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT

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ACEPROMAZINE MALEATE

NDC Package Code : 54154-028

Start Marketing Date : 2024-10-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT

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VMF

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API Reference Price

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23-Jul-2022
27-Feb-2024
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INTERMEDIATES SUPPLIERS

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Pharma, Lab & Chemical Expo
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CAS Number : 6631-94-3

End Use API : Acepromazine

About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...

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Atom Pharma

India
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Atom Pharma

India
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CAS Number : 5407-04-5

End Use API : Acepromazine

About The Company : Atom pharma is ISO 9001:2015 integrated, fastest growing and reputed Pharmaceutical bulk drugs [API] and pharmaceutical Intermediates exporting company. We have...

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CAS Number : 6631-94-3

End Use API : Acepromazine

About The Company : With nearly seven decades of manufacturing expertise, Speichim Processing actively formulates circular economy strategies by reclaiming waste and chemical produ...

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Canada

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ACEPROMAZINE MALEATE

Brand Name : ATRAVET 10 MG INJECTABLE

Dosage Form : SOLUTION

Dosage Strength : 10MG/ML

Packaging : 50 ML

Approval Date :

Application Number : 53023

Regulatory Info :

Registration Country : Canada

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ACEPROMAZINE MALEATE

Brand Name : ACEVET 25 INJECTABLE

Dosage Form : SOLUTION

Dosage Strength : 25MG/ML

Packaging : 100ML

Approval Date :

Application Number : 526061

Regulatory Info :

Registration Country : Canada

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Listed Dossiers

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Pharma, Lab & Chemical Expo
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Acepromazine

Brand Name : Equipromazina

Dosage Form :

Dosage Strength : 5MG/ML

Packaging : 25 & 100 ML Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country :

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Acepromazine

Dosage :

Dosage Strength : 5MG/ML

Brand Name : Equipromazina

Approval Date :

Application Number :

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ABOUT THIS PAGE

Acepromazine Manufacturers

A Acepromazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acepromazine, including repackagers and relabelers. The FDA regulates Acepromazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acepromazine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Acepromazine Suppliers

A Acepromazine supplier is an individual or a company that provides Acepromazine active pharmaceutical ingredient (API) or Acepromazine finished formulations upon request. The Acepromazine suppliers may include Acepromazine API manufacturers, exporters, distributors and traders.

click here to find a list of Acepromazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Acepromazine USDMF

A Acepromazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Acepromazine active pharmaceutical ingredient (API) in detail. Different forms of Acepromazine DMFs exist exist since differing nations have different regulations, such as Acepromazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Acepromazine DMF submitted to regulatory agencies in the US is known as a USDMF. Acepromazine USDMF includes data on Acepromazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acepromazine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Acepromazine suppliers with USDMF on PharmaCompass.

Acepromazine 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 Acepromazine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Acepromazine 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 Acepromazine 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 Acepromazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acepromazine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Acepromazine suppliers with NDC on PharmaCompass.

Acepromazine GMP

Acepromazine 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 Acepromazine 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 Acepromazine GMP manufacturer or Acepromazine GMP API supplier for your needs.

Acepromazine CoA

A Acepromazine CoA (Certificate of Analysis) is a formal document that attests to Acepromazine's compliance with Acepromazine specifications and serves as a tool for batch-level quality control.

Acepromazine CoA mostly includes findings from lab analyses of a specific batch. For each Acepromazine 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.

Acepromazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Acepromazine EP), Acepromazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acepromazine 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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