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Chemistry

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Also known as: 7232-21-5, Maxolon, Metoclopramide hcl, Metoclopramide monohydrochloride, Cerucal, Paspertin
Molecular Formula
C14H23Cl2N3O2
Molecular Weight
336.3  g/mol
InChI Key
RVFUNJWWXKCWNS-UHFFFAOYSA-N
FDA UNII
7B1QZY5SWZ

Metoclopramide Hydrochloride
A dopamine D2 antagonist that is used as an antiemetic.
1 2D Structure

Metoclopramide Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide;hydrochloride
2.1.2 InChI
InChI=1S/C14H22ClN3O2.ClH/c1-4-18(5-2)7-6-17-14(19)10-8-11(15)12(16)9-13(10)20-3;/h8-9H,4-7,16H2,1-3H3,(H,17,19);1H
2.1.3 InChI Key
RVFUNJWWXKCWNS-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCN(CC)CCNC(=O)C1=CC(=C(C=C1OC)N)Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
7B1QZY5SWZ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-2-methoxybenzamide

2. Cerucal

3. Dihydrochloride, Metoclopramide

4. Hydrochloride, Metoclopramide

5. Maxolon

6. Metaclopramide

7. Metoclopramide

8. Metoclopramide Dihydrochloride

9. Metoclopramide Monohydrochloride

10. Metoclopramide Monohydrochloride, Monohydrate

11. Monohydrochloride, Metoclopramide

12. Primperan

13. Reglan

14. Rimetin

2.3.2 Depositor-Supplied Synonyms

1. 7232-21-5

2. Maxolon

3. Metoclopramide Hcl

4. Metoclopramide Monohydrochloride

5. Cerucal

6. Paspertin

7. Clopra

8. Reglan

9. 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-2-methoxybenzamide Hydrochloride

10. Metozolv

11. Metozolv Odt

12. Metoclopramide Hydrochloride Anhydrous

13. 7b1qzy5swz

14. Metoclopramide (hydrochloride)

15. Mls000069667

16. 4-amino-5-chloro-n-[2-(diethylamino)ethyl]-2-methoxybenzamide;hydrochloride

17. Benzamide, 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-2-methoxy-, Monohydrochloride

18. Nsc-354467

19. Rimetin

20. Smr000058471

21. 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-o-anisamide Hydrochloride

22. Primperan (tablet)

23. Metoclopramide Hydrochloride 100 Microg/ml In Acetonitrile

24. Metoclopramide Intensol

25. Reglan Odt

26. Ccris 7142

27. Sr-01000000165

28. Einecs 230-634-5

29. Unii-7b1qzy5swz

30. Nsc 354467

31. 4-amino-5-chloro-n-[2-(diethylamino)ethyl]-o-anisamide Hydrochloride

32. Prestwick_332

33. 4-amino-5-chloro-n-(2-diethylaminoethyl)-2-methoxy-benzamide

34. Mfcd00058011

35. Metoclopramidehcl

36. Opera_id_1671

37. Mls001074186

38. Mls002222202

39. O-anisamide, Monohydrochloride

40. Schembl205200

41. Spectrum1500410

42. Chembl1256771

43. Dtxsid10964306

44. Hms1568j19

45. Hms1920n15

46. Metoclopramide Hydrochloride, Solid

47. Pharmakon1600-01500410

48. Bcp28471

49. Tox21_500762

50. Nsc354467

51. Nsc757117

52. 4-amino-5-chloro-n-(2-diethylaminoethyl)-2-methoxybenzamide Hydrochloride

53. Akos015889947

54. O-anisamide, 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-, Monohydrochloride

55. Ccg-212697

56. Hs-0006

57. Lp00762

58. Nc00519

59. 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-2-methoxybenzamide Monohydrochloride

60. Ncgc00094102-01

61. Ncgc00094102-02

62. Ncgc00094102-03

63. Ncgc00094102-04

64. Ncgc00094102-05

65. Ncgc00261447-01

66. Wln: 2n2&2mvr Dz Cg Fo1 &gh

67. Eu-0100762

68. Ft-0657870

69. Ft-0672375

70. S4289

71. Sw196611-3

72. Vu0239518-5

73. A14247

74. M 0763

75. A923754

76. Sr-01000000165-2

77. Sr-01000000165-7

78. Q27267998

79. 4-amino-5-chloro-n-(2-diethylaminoethyl)-2-methoxybenzamide Hcl

80. 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-o-anisamidmonohydrochloride

81. 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-o-anisamide Monohydrochloride

82. Benzamide, 4-amino-5-chloro-n-(2-(diethylamino)ethyl)-2-methoxy-, Monohydrochloride (9ci)

83. Benzamide, 4-amino-5-chloro-n-[2-(diethylamino)ethyl]-2-methoxy-, Hydrochloride (1:1)

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 336.3 g/mol
Molecular Formula C14H23Cl2N3O2
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count7
Exact Mass335.1167324 g/mol
Monoisotopic Mass335.1167324 g/mol
Topological Polar Surface Area67.6 Ų
Heavy Atom Count21
Formal Charge0
Complexity300
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameMetoclopramide hydrochloride
Drug LabelMetoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically it...
Active IngredientMetoclopramide hydrochloride
Dosage FormTablet; Injectable; Tablet, orally disintegrating; Solution
RouteInjection; Oral
Strengtheq 5mg base; eq 5mg base/5ml; eq 5mg base/ml; eq 10mg base
Market StatusPrescription
CompanyVintage Pharms; Wockhardt; Silarx; Ani Pharms; Hospira; Teva; Pharm Assoc; Teva Pharms Usa; Northstar Hlthcare; Par Pharm; Novel Labs; Watson Labs; Vistapharm; Ipca Labs; Mutual Pharm; Bd Rx

2 of 4  
Drug NameMetozolv odt
PubMed HealthMetoclopramide
Drug ClassesAntiemetic, Diagnostic Agent, Stimulant, Gastrointestinal
Drug LabelMETOZOLV ODT is an orally disintegrating tablet formulation of metoclopramide hydrochloride. The 5 mg strength is a round white tablet debossed on one side with a 5 and plain on the other side; it is comprised of 5 mg metoclopramide (as 5.91...
Active IngredientMetoclopramide hydrochloride
Dosage FormTablet, orally disintegrating
RouteOral
Strengtheq 5mg base
Market StatusPrescription
CompanySalix Pharms

3 of 4  
Drug NameMetoclopramide hydrochloride
Drug LabelMetoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform, practically insoluble in ether. Chemically it...
Active IngredientMetoclopramide hydrochloride
Dosage FormTablet; Injectable; Tablet, orally disintegrating; Solution
RouteInjection; Oral
Strengtheq 5mg base; eq 5mg base/5ml; eq 5mg base/ml; eq 10mg base
Market StatusPrescription
CompanyVintage Pharms; Wockhardt; Silarx; Ani Pharms; Hospira; Teva; Pharm Assoc; Teva Pharms Usa; Northstar Hlthcare; Par Pharm; Novel Labs; Watson Labs; Vistapharm; Ipca Labs; Mutual Pharm; Bd Rx

4 of 4  
Drug NameMetozolv odt
PubMed HealthMetoclopramide
Drug ClassesAntiemetic, Diagnostic Agent, Stimulant, Gastrointestinal
Drug LabelMETOZOLV ODT is an orally disintegrating tablet formulation of metoclopramide hydrochloride. The 5 mg strength is a round white tablet debossed on one side with a 5 and plain on the other side; it is comprised of 5 mg metoclopramide (as 5.91...
Active IngredientMetoclopramide hydrochloride
Dosage FormTablet, orally disintegrating
RouteOral
Strengtheq 5mg base
Market StatusPrescription
CompanySalix Pharms

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Dopamine D2 Receptor Antagonists

Compounds and drugs that bind to and inhibit or block the activation of DOPAMINE D2 RECEPTORS. (See all compounds classified as Dopamine D2 Receptor Antagonists.)


Antiemetics

Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Dopamine-2 Receptor Antagonist [EPC]; Dopamine D2 Antagonists [MoA]

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LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"240","totalValueFC":"12270.6","currency":"USD","unitRateINR":"18516","date":"26-Apr-2022","totalValueINR":"925800","totalValueInUsd":"12270.6","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29242990","bill_no":"1000634","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654453800,"product":"METOCLOPRAMIDE HCL, USP (MONOHYDRATE) RAPV00049","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"LUNDBECK PHARMACEUTICALS ITALY SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"PFIZER HEALTHCARE INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"240","totalValueFC":"18111.8","currency":"USD","unitRateINR":"18840","date":"06-Jun-2022","totalValueINR":"1413000","totalValueInUsd":"18111.8","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29242990","bill_no":"1000890","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1655145000,"product":"( TEST PURPOSE FOC )I-PF-0010 METOCLOPRAMIDE HCL MICRONIZED(BATCHNO.20004,21004,22004)(LICNO.TL\/SZ\/22\/000181)","address":"NO.18,DR NAIR ROAD, T NAGAR,","city":"CHENNAI","supplier":"ICROM SRL","supplierCountry":"ITALY","foreign_port":"NA","customer":"STERIL-GENE LIFE SCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.12","actualQuantity":"0.12","unit":"KGS","unitRateFc":"18333.3","totalValueFC":"2375.8","currency":"EURO","unitRateINR":"1544583.3","date":"14-Jun-2022","totalValueINR":"185350","totalValueInUsd":"2375.8","indian_port":"BANGALORE AIR","hs_no":"29420090","bill_no":"9111086","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"NO.18,DR NAIR ROAD, T NAGAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1660156200,"product":"METOCLOPRAMIDE HYDROCHLORIDE","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"LUNDBECK PHARMACEUTICALS ITALY SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"PFIZER HEALTHCARE INDIA PRIVATE 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LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"280","totalValueFC":"14274.9","currency":"USD","unitRateINR":"23492","date":"31-Oct-2022","totalValueINR":"1174600","totalValueInUsd":"14274.9","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29242990","bill_no":"1001807","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694370600,"product":"METOCLOPRAMIDE HYDROCHLORIDE","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"LUNDBECK PHARMACEUTICALS ITALY SPA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"PFIZER HEALTHCARE INDIA PRIVATE 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LIMITED","customerCountry":"INDIA","quantity":"175.00","actualQuantity":"175","unit":"KGS","unitRateFc":"112.5","totalValueFC":"21390.7","currency":"USD","unitRateINR":"10159","date":"12-Jan-2024","totalValueINR":"1777819.54","totalValueInUsd":"21390.7","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"9638760","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LIMA -","supplierAddress":"AV. PEDRO RUIZ GALLO NO 935, ATE-LIMA, PERU Lima, Lima, PERUSDNF PERU","customerAddress":"20 C HAZRA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708885800,"product":"METOCLOPRAMIDE HYDROCLORIDE USP [METOCLOPRAMIDE HCL USP]","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"COSMA SPA","supplierCountry":"ITALY","foreign_port":"SEGRATE AIRPRT MILAN","customer":"EMCURE PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"9.80","actualQuantity":"9.8","unit":"KGS","unitRateFc":"1650","totalValueFC":"16350.5","currency":"USD","unitRateINR":"138435","date":"26-Feb-2024","totalValueINR":"1356663","totalValueInUsd":"16350.5","indian_port":"Bombay Air","hs_no":"29242990","bill_no":"2310145","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SEGRATE AIRPRT MILAN","supplierAddress":"VIA COLLEONI, 15\/17-24040, CISERANO(BG) , ITALY , , ItalySDNF Italy","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"METOCLOPRAMIDE HCL USP DMF (B.NO: 118123001)ITEM NUMBER: 100002221","address":"CLARIS CORPORATE HEAD QUARTERS,","city":"ELLISBRIDGE,AHMEDABD,GUJARAT,INDIA","supplier":"COSMA SPA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"5000","totalValueFC":"25260.7","currency":"USD","unitRateINR":"421750","date":"06-Jun-2024","totalValueINR":"2108750","totalValueInUsd":"25260.7","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"3860227","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"SOCIETA CON SOCIO UNICO VIA COLLEONI, 15\/17 - 24040 CISERANO (BG), ITALY ITALY","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721845800,"product":"METOCLOPRAMIDE HYDROCHLORIDE USP DMF(B.NO: 118123001)ITEM NUMBER: 100002221","address":"CLARIS CORPORATE HEAD QUARTERS,","city":"ELLISBRIDGE,AHMEDABD,GUJARAT,INDIA","supplier":"COSMA SPA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"5000","totalValueFC":"25286.8","currency":"USD","unitRateINR":"422750","date":"25-Jul-2024","totalValueINR":"2113750","totalValueInUsd":"25286.8","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"4692492","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"SOCIETA CON SOCIO UNICO VIA COLLEONI, 15\/17 - 24040 CISERANO (BG), ITALY ITALY","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"METOCLOPRAMIDE HYDROCHLORIDE USP DMF(B.NO: 118123001)ITEM NUMBER: 100002221","address":"CLARIS CORPORATE HEAD QUARTERS,","city":"ELLISBRIDGE,AHMEDABD,GUJARAT,INDIA","supplier":"COSMA SPA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"5000","totalValueFC":"25240.5","currency":"USD","unitRateINR":"426000","date":"13-Nov-2024","totalValueINR":"2130000","totalValueInUsd":"25240.5","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"6645606","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"SOCIETA CON SOCIO UNICO VIA COLLEON I, 15\/17 - 24040 CISERANO (BG), ITA LY ITALY","customerAddress":"CLARIS CORPORATE HEAD QUARTERS,"}]
06-Jan-2022
28-Apr-2025
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DOSAGE - INJECTABLE;INJECTION - EQ 5MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 17862

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22246

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22246

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ABOUT THIS PAGE

Looking for 7232-21-5 / Metoclopramide Hydrochloride API manufacturers, exporters & distributors?

Metoclopramide Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Metoclopramide 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 Metoclopramide Hydrochloride manufacturer or Metoclopramide Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Metoclopramide Hydrochloride manufacturer or Metoclopramide Hydrochloride supplier.

PharmaCompass also assists you with knowing the Metoclopramide Hydrochloride API Price utilized in the formulation of products. Metoclopramide Hydrochloride API Price is not always fixed or binding as the Metoclopramide Hydrochloride Price is obtained through a variety of data sources. The Metoclopramide Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Metoclopramide Hydrochloride

Synonyms

7232-21-5, Maxolon, Metoclopramide hcl, Metoclopramide monohydrochloride, Cerucal, Paspertin

Cas Number

7232-21-5

Unique Ingredient Identifier (UNII)

7B1QZY5SWZ

About Metoclopramide Hydrochloride

A dopamine D2 antagonist that is used as an antiemetic.

Metoclopramide Hydrochloride Manufacturers

A Metoclopramide Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metoclopramide Hydrochloride, including repackagers and relabelers. The FDA regulates Metoclopramide Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metoclopramide 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 Metoclopramide Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Metoclopramide Hydrochloride Suppliers

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

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

Metoclopramide Hydrochloride USDMF

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

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

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

Metoclopramide Hydrochloride 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 Metoclopramide Hydrochloride Drug Master File in Japan (Metoclopramide Hydrochloride JDMF) empowers Metoclopramide 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 Metoclopramide Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Metoclopramide 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 Metoclopramide Hydrochloride suppliers with JDMF on PharmaCompass.

Metoclopramide Hydrochloride CEP

A Metoclopramide Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Metoclopramide Hydrochloride Certificate of Suitability (COS). The purpose of a Metoclopramide Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Metoclopramide Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Metoclopramide Hydrochloride to their clients by showing that a Metoclopramide Hydrochloride CEP has been issued for it. The manufacturer submits a Metoclopramide Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Metoclopramide Hydrochloride CEP holder for the record. Additionally, the data presented in the Metoclopramide Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Metoclopramide Hydrochloride DMF.

A Metoclopramide Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Metoclopramide Hydrochloride 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 Metoclopramide Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Metoclopramide Hydrochloride WC

A Metoclopramide Hydrochloride written confirmation (Metoclopramide Hydrochloride WC) is an official document issued by a regulatory agency to a Metoclopramide Hydrochloride manufacturer, verifying that the manufacturing facility of a Metoclopramide Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Metoclopramide Hydrochloride APIs or Metoclopramide Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Metoclopramide Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Metoclopramide Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Metoclopramide Hydrochloride 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 Metoclopramide Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Metoclopramide Hydrochloride GMP

Metoclopramide 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 Metoclopramide 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 Metoclopramide Hydrochloride GMP manufacturer or Metoclopramide Hydrochloride GMP API supplier for your needs.

Metoclopramide Hydrochloride CoA

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

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

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