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Chemistry

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Also known as: 122892-31-3, Itopride hcl, Ganaton, Itopride (hydrochloride), Hsr803, Hsr-803
Molecular Formula
C20H27ClN2O4
Molecular Weight
394.9  g/mol
InChI Key
ZTOUXLLIPWWHSR-UHFFFAOYSA-N
FDA UNII
2H9NV66W0I

Itopride Hydrochloride
1 2D Structure

Itopride Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxybenzamide;hydrochloride
2.1.2 InChI
InChI=1S/C20H26N2O4.ClH/c1-22(2)11-12-26-17-8-5-15(6-9-17)14-21-20(23)16-7-10-18(24-3)19(13-16)25-4;/h5-10,13H,11-12,14H2,1-4H3,(H,21,23);1H
2.1.3 InChI Key
ZTOUXLLIPWWHSR-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(C)CCOC1=CC=C(C=C1)CNC(=O)C2=CC(=C(C=C2)OC)OC.Cl
2.2 Other Identifiers
2.2.1 UNII
2H9NV66W0I
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Hsr 803

2. Hsr-803

3. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzmide

2.3.2 Depositor-Supplied Synonyms

1. 122892-31-3

2. Itopride Hcl

3. Ganaton

4. Itopride (hydrochloride)

5. Hsr803

6. Hsr-803

7. Itax

8. Hsr 803

9. Benzamide, N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxy-, Hydrochloride (1:1)

10. 2h9nv66w0i

11. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzamide Hydrochloride

12. N-[4-(2-dimethylaminoethoxy)benzyl]-3,4-dimethoxybenzamide Hcl

13. 122892-31-3 (hcl)

14. Benzamide, N-((4-(2-(dimethylamino)ethoxy)phenyl)methyl)-3,4-dimethoxy-, Monohydrochloride

15. Dsstox_cid_26693

16. Dsstox_rid_81827

17. Dsstox_gsid_46693

18. Itopride Hydrochloride (jan)

19. Itopride Hydrochloride [jan]

20. Cas-122892-31-3

21. Ncgc00167529-01

22. Unii-2h9nv66w0i

23. N-[4-[2-(dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide Hydrochloride

24. Ganaton (tn)

25. Mfcd00881710

26. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxidebenzamide Hydrochloride

27. N-((4-(2-(dimethylamino)ethoxy)phenyl)methyl)-3,4-dimethoxybenzamide Monohydrochloride

28. Mls001401433

29. Schembl554675

30. Chembl2139257

31. Dtxsid5046693

32. N-(4-(2-(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzmide

33. Itopride Hydrochloride [mi]

34. Amy18457

35. Bcp12149

36. Hy-b0732

37. Tox21_112526

38. S4619

39. Akos007930375

40. Itopride Hydrochloride [mart.]

41. N-[4-(2-dimethylaminoethoxy)benzyl]-3,4-dimethoxybenzamide Hydrochloride

42. Tox21_112526_1

43. Ab07646

44. Ccg-101047

45. Itopride Hydrochloride [who-dd]

46. Ks-5067

47. Nc00297

48. Itopride Hydrochloride, >=98% (hplc)

49. Ncgc00167529-02

50. Ac-32564

51. Smr000469143

52. Ft-0631110

53. I0948

54. D02729

55. 892i313

56. A804984

57. Q-201260

58. Q27254746

59. N-{p-[2-(dimethylamino)ethoxy]benzyl}veratramide Hydrochloride

60. N-((4-(2-(dimethylamino)ethoxy)phenyl)methyl)-3,4-dimethoxy-benzamidmonohydrochloride

61. N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4-dimethoxybenzamide;hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 394.9 g/mol
Molecular Formula C20H27ClN2O4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count9
Exact Mass394.1659350 g/mol
Monoisotopic Mass394.1659350 g/mol
Topological Polar Surface Area60 Ų
Heavy Atom Count27
Formal Charge0
Complexity411
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

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REDDY COLONY, BANJARA HILLS,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690914600,"product":"ITOPRIDE HYDROCHLORIDE BATCH NO. 22IP025 REJECTED QTY -REIMPORT","address":"CADILA CORPORATE CAMPUS,SARKHEJ DH OLKA ROAD, BHAT","city":"AHMEDABAD","supplier":"PHARMAGEN GMBH","supplierCountry":"INDIA","foreign_port":"NA","customer":"CADILA PHARMACEUTICALS","customerCountry":"INDIA","quantity":"332.00","actualQuantity":"332","unit":"KGS","unitRateFc":"250","totalValueFC":"96353.8","currency":"EUR","unitRateINR":"23800.5","date":"02-Aug-2023","totalValueINR":"7981590.452","totalValueInUsd":"96353.8","indian_port":"AHEMDABAD AIR","hs_no":"29420090","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CADILA CORPORATE CAMPUS,SARKHEJ DH OLKA ROAD, BHAT"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709663400,"product":"ITOPRIDE HYDROCHLORIDE ((REJECTED RETURN CARGO VIDE SB NO.8292628 DT.06-MAR-23)","address":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE","city":"HYDERABAD-AP","supplier":"ZENTIVA","supplierCountry":"INDIA","foreign_port":"PRAGUE - RUZYNE","customer":"SYMED LABS","customerCountry":"INDIA","quantity":"41.50","actualQuantity":"41.504","unit":"KGS","unitRateFc":"205","totalValueFC":"9288.5","currency":"EUR","unitRateINR":"18583.3","date":"06-Mar-2024","totalValueINR":"771279.21","totalValueInUsd":"9288.5","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"2454438","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"U KABELOVNY 130 102 37 PRAHA 10DOLNI MECHOLUPYCZECH REPUBLIC CZ","customerAddress":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709663400,"product":"ITOPRIDE HYDROCHLORIDE ((REJECTED RETURN CARGO VIDE SB NO.8292628 DT.06-MAR-23)","address":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE","city":"HYDERABAD-AP","supplier":"ZENTIVA","supplierCountry":"INDIA","foreign_port":"PRAGUE - RUZYNE","customer":"SYMED LABS","customerCountry":"INDIA","quantity":"126.20","actualQuantity":"126.202","unit":"KGS","unitRateFc":"205","totalValueFC":"28243.8","currency":"EUR","unitRateINR":"18583.3","date":"06-Mar-2024","totalValueINR":"2345243.32","totalValueInUsd":"28243.8","indian_port":"Hyderabad Air","hs_no":"29241900","bill_no":"2454438","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"U KABELOVNY 130 102 37 PRAHA 10DOLNI MECHOLUPYCZECH REPUBLIC CZ","customerAddress":"8-3-166\/6 7, IIND FLOOR,SREE ARCADE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718562600,"product":"ITOPRIDE HYDROCHLORIDE IH BATCH NO : ITR\/90080623 (SB NO : 5546079 DT : 24.11.23 )","address":"2 FLR.PRESTIGE PLAZA","city":"AKOTA BARODA","supplier":"PRO.MED.CS PRAHA A.S","supplierCountry":"INDIA","foreign_port":"PRAGUE - RUZYNE","customer":"AMI LIFESCIENCES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"275.00","actualQuantity":"275","unit":"KGS","unitRateFc":"140","totalValueFC":"47091.5","currency":"USD","unitRateINR":"14295.2","date":"17-Jun-2024","totalValueINR":"3931172.44","totalValueInUsd":"47091.5","indian_port":"Ahmedabad Air","hs_no":"29242990","bill_no":"4036572","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"PRAGUE - RUZYNE","supplierAddress":"P&P DEPARTMENT TELCSKA377\/1, 140 00 PRAHA 4SDNF CZ","customerAddress":"2 FLR.PRESTIGE PLAZA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724956200,"product":"ESOMEPRAZOLE EC 20 MG+ITOPRIDE SR 150 MG (BATCH:JP\/FR\/EI\/23001)","address":"SHOP 2004 2ND FLOOR NORTH,EXTENSIO","city":"SAHARA DARWAJA SURAT,GUJARAT","supplier":"QUESTA CARE LIMITED","supplierCountry":"INDIA","foreign_port":"MOMBASA","customer":"TRIDENT LIFELINE LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"24.3","totalValueFC":"7368.8","currency":"USD","unitRateINR":"2060.3","date":"30-Aug-2024","totalValueINR":"618080.49","totalValueInUsd":"7368.8","indian_port":"JNPT","hs_no":"29334900","bill_no":"5322203","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MOMBASA","supplierAddress":"PLOT NO. 209\/7184,HOMABAY ROAD, INDUSTRIAL AREA, P.O.BOX 172-00623 PARKLANDS, NAIROBI-KENYA Nairobi, , Ke Kenya","customerAddress":"SHOP 2004 2ND FLOOR NORTH,EXTENSIO"}]
04-Jan-2021
29-Mar-2025
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INTERMEDIATE SUPPLIERS

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01

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CAS Number : 20059-73-8

End Use API : Itopride Hydrochloride

About The Company : VASUDHA PHARMA CHEM LIMITED was incorporated, as a public limited company under the Companies Act, 1956 in 1994-95 at Hyderabad in the state of Telangana, India...

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FDF Dossiers

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01

Anwita Drugs

India
AACR Annual meeting
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Anwita Drugs

India
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AACR Annual meeting
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Esomeprazole Magnesium; Itopride Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 40MG; 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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02

Anwita Drugs

India
AACR Annual meeting
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Anwita Drugs

India
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AACR Annual meeting
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Rabeprazole Sodium; Itopride Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 20MG; 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

AACR Annual meeting
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AACR Annual meeting
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Itopride

Brand Name :

Dosage Form : Pellets

Dosage Strength : 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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04

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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Rabeprazole; Itopride Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 20MG; 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

Bio Labs

Pakistan
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Bio Labs

Pakistan
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Ganaton

Brand Name : Biopride

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging : 1x10's 3x10's

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Pakistan

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06

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

Esomeprazole Magnesium; Itopride Hydrochloride

Brand Name :

Dosage Form : Pellet

Dosage Strength : 40MG; 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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07

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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Pantoprazole; Itopride Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 40MG; 150MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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08

Hiral Labs

India
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Hiral Labs

India
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ITOPRIDE HCl

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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09

AACR Annual meeting
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Itopride Hydrochloride

Brand Name :

Dosage Form : Coated SR Pellets

Dosage Strength : 60%/W/W

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

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Itopride

Brand Name :

Dosage Form : SR Pellets

Dosage Strength : 60% W/W

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in Pakistan

Registration Country : India

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ABOUT THIS PAGE

Looking for 122892-31-3 / Itopride Hydrochloride API manufacturers, exporters & distributors?

Itopride Hydrochloride manufacturers, exporters & distributors 1

10

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

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

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

API | Excipient name

Itopride Hydrochloride

Synonyms

122892-31-3, Itopride hcl, Ganaton, Itopride (hydrochloride), Hsr803, Hsr-803

Cas Number

122892-31-3

Unique Ingredient Identifier (UNII)

2H9NV66W0I

Itopride Hydrochloride Manufacturers

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

Itopride Hydrochloride Suppliers

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

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

Itopride Hydrochloride USDMF

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

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

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

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

Itopride Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Itopride Hydrochloride Drug Master File in Korea (Itopride Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Itopride Hydrochloride. The MFDS reviews the Itopride Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Itopride Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Itopride Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Itopride Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Itopride Hydrochloride suppliers with KDMF on PharmaCompass.

Itopride Hydrochloride WC

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

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

Itopride Hydrochloride GMP

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

Itopride Hydrochloride CoA

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

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

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