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    Chemistry

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    Also known as: 107133-36-8, Aceon, Perindopril tert-butylamine, Mcn-a-2833-109, Perindopril erbumine [usan], Perindopril (erbumine)
    Molecular Formula
    C23H43N3O5
    Molecular Weight
    441.6  g/mol
    InChI Key
    IYNMDWMQHSMDDE-MHXJNQAMSA-N
    FDA UNII
    1964X464OJ
    Perindopril Erbumine
    An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.
    1 2D Structure

    Perindopril Erbumine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S,3aS,7aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acid;2-methylpropan-2-amine
    2.1.2 InChI
    InChI=1S/C19H32N2O5.C4H11N/c1-4-8-14(19(25)26-5-2)20-12(3)17(22)21-15-10-7-6-9-13(15)11-16(21)18(23)24;1-4(2,3)5/h12-16,20H,4-11H2,1-3H3,(H,23,24);5H2,1-3H3/t12-,13-,14-,15-,16-;/m0./s1
    2.1.3 InChI Key
    IYNMDWMQHSMDDE-MHXJNQAMSA-N
    2.1.4 Canonical SMILES
    CCCC(C(=O)OCC)NC(C)C(=O)N1C2CCCCC2CC1C(=O)O.CC(C)(C)N
    2.1.5 Isomeric SMILES
    CCC[C@@H](C(=O)OCC)N[C@@H](C)C(=O)N1[C@H]2CCCC[C@H]2C[C@H]1C(=O)O.CC(C)(C)N
    2.2 Other Identifiers
    2.2.1 UNII
    1964X464OJ
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Erbumine, Perindopril

    2. Perindopril

    3. Perstarium

    4. Pirindopril

    5. S 9490

    6. S 9490 3

    7. S 9490-3

    8. S 94903

    9. S-9490

    10. S9490

    2.3.2 Depositor-Supplied Synonyms

    1. 107133-36-8

    2. Aceon

    3. Perindopril Tert-butylamine

    4. Mcn-a-2833-109

    5. Perindopril Erbumine [usan]

    6. Perindopril (erbumine)

    7. Pederindopril

    8. S-9490-3

    9. Chebi:8025

    10. Nsc-758929

    11. Perindopril T-butylamine Salt

    12. (2s,3as,7as)-1-((s)-n-((s)-1-carboxybutyl)alanyl)hexahydro-2-indolinecarboxylic Acid, 1-ethyl Ester, Compound With Tert-butylamine (1:1)

    13. 1964x464oj

    14. (2s,3as,7as)-1-[(2s)-2-[[(2s)-1-ethoxy-1-oxopentan-2-yl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic Acid;2-methylpropan-2-amine

    15. S9490-3

    16. Covapril

    17. Coversyl

    18. Unii-1964x464oj

    19. Mfcd02313824

    20. Aceon (tn)

    21. Perindoprilerbumine

    22. Dsstox_cid_24198

    23. Dsstox_gsid_44198

    24. Schembl41679

    25. Spectrum1505212

    26. Perindopril T-butylamine

    27. Chembl1200343

    28. Dtxsid1044198

    29. Hy-b0130a

    30. Perindopril Erbumine (jan/usp)

    31. Amy3408

    32. Hms1922n07

    33. Hms2093m06

    34. Perindopril Erbumine [jan]

    35. Pharmakon1600-01505212

    36. Perindopril Erbumine [vandf]

    37. Tox21_303915

    38. Bdbm50248096

    39. Ccg-39035

    40. Nsc758929

    41. Perindopril Erbumine [mart.]

    42. Perindopril Erbumine [usp-rs]

    43. Perindopril Erbumine [who-dd]

    44. Perindopril T-butylamine Salt- Bio-x

    45. Akos015841351

    46. Akos015961912

    47. Cs-1904

    48. Ks-1243

    49. Nsc 758929

    50. Perindopril Tert-butylamine [mi]

    51. Ncgc00178276-01

    52. Ncgc00357164-01

    53. 1h-indole-2-carboxylic Acid, 1-(2-((1-(ethoxycarbonyl)butyl)amino)-1-oxopropyl)octahydro-, (2s-(1(r*(r*)),2alpha,3abeta,7abeta))-, Compd. With 2-methyl-2-propanamine (1:1)

    54. 2-methylpropan-2-amine (2s,3as,7as)-1-(((s)-1-ethoxy-1-oxopentan-2-yl)-l-alanyl)octahydro-1h-indole-2-carboxylate

    55. Ac-19078

    56. Bp164255

    57. Perindopril Erbumine [orange Book]

    58. Perindopril Erbumine [usp Monograph]

    59. Amlessa Component Perindopril Erbumine

    60. Cas-107133-36-8

    61. S9490

    62. C07707

    63. D00624

    64. 133p368

    65. Perindopril Tert-butylamine [ep Monograph]

    66. Sr-05000001835

    67. Sr-05000001835-1

    68. Q27107642

    69. Perindopril Erbumine, United States Pharmacopeia (usp) Reference Standard

    70. Perindopril Tert-butylamine, European Pharmacopoeia (ep) Reference Standard

    71. Perindopril Erbumine, Pharmaceutical Secondary Standard; Certified Reference Material

    72. Perindopril For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    73. Perindopril For Stereochemical Purity, European Pharmacopoeia (ep) Reference Standard

    74. (2s,3as,7as)-1-{(2s)-2-[(1s)-1-(ethoxycarbonyl)butylamino]propanoyl}octahydro-1h-indole-2-carboxylic Acid--2-methylpropan-2-amine (1/1)

    75. (2s,3as,7as)-1-{(s)-2-[(s)-1-(ethoxycarbonyl)butylamino]propanoyl}octahydroindole-2-carboxylic Acid--1,1-dimethylethanamine (1/1)

    76. 1h-indole-2-carboxylic Acid, 1-(2-((1-(ethoxycarbonyl)butyl)amino)-1-oxopropyl)octahydro-, (2s-(1(r*(r*)),2.alpha.,3a.beta.,7a.beta.))-, Compd. With 2-methyl-2-propanamine (1:1)

    77. 1h-indole-2-carboxylic Acid,1-[(2s)-2-[[(1s)-1-(ethoxycarbonyl)butyl]amino]-1-oxopropyl]octahydro-,(2s,3as,7as)-, Compd. With 2-methyl-2-propanamine (1:1)other Ca Index Names:2-propanamine, 2-methyl-,(2s,3as,7as)-1-[(2s)-2-[[(1s)-1-(ethoxycarbonyl)butyl]amino]-1-oxopropyl]octahydro-1h-indole-2-carboxylate

    78. 2-methylpropan-2-amine (2s,3as,7as)-1-((s)-2-(((s)-1-ethoxy-1-oxopentan-2-yl)amino)propanoyl)octahydro-1h-indole-2-carboxylate

    79. 2-methylpropan-2-amine (2s,3as,7as)-1-((s)-2-((s)-1-ethoxy-1-oxopentan-2-ylamino)propanoyl)octahydro-1h-indole-2-carboxylate

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 441.6 g/mol
    Molecular Formula C23H43N3O5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count9
    Exact Mass441.32027148 g/mol
    Monoisotopic Mass441.32027148 g/mol
    Topological Polar Surface Area122 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity549
    Isotope Atom Count0
    Defined Atom Stereocenter Count5
    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 NameAceon
    PubMed HealthPerindopril (By mouth)
    Drug ClassesAntihypertensive, Cardiovascular Agent, Renal Protective Agent
    Drug LabelACEON (perindopril erbumine) Tablets contain the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine is chemically described as (2S,3S,7S)-1-[(S)-N-[(S)-...
    Active IngredientPerindopril erbumine
    Dosage FormTablet
    RouteOral
    Strength4mg; 2mg; 8mg
    Market StatusPrescription
    CompanySymplmed Pharms

    2 of 4  
    Drug NamePerindopril erbumine
    Drug LabelPerindopril erbumine tablets contain the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine is chemically described as (2S,3S,7S)-1-[(S)-N-[(S)-1-Carboxy-bu...
    Active IngredientPerindopril erbumine
    Dosage FormTablet
    RouteOral
    Strength8mg; 4mg; 2mg
    Market StatusPrescription
    CompanyAni Pharms; Apotex; Aurobindo Pharma; Lupin; Roxane

    3 of 4  
    Drug NameAceon
    PubMed HealthPerindopril (By mouth)
    Drug ClassesAntihypertensive, Cardiovascular Agent, Renal Protective Agent
    Drug LabelACEON (perindopril erbumine) Tablets contain the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine is chemically described as (2S,3S,7S)-1-[(S)-N-[(S)-...
    Active IngredientPerindopril erbumine
    Dosage FormTablet
    RouteOral
    Strength4mg; 2mg; 8mg
    Market StatusPrescription
    CompanySymplmed Pharms

    4 of 4  
    Drug NamePerindopril erbumine
    Drug LabelPerindopril erbumine tablets contain the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine is chemically described as (2S,3S,7S)-1-[(S)-N-[(S)-1-Carboxy-bu...
    Active IngredientPerindopril erbumine
    Dosage FormTablet
    RouteOral
    Strength8mg; 4mg; 2mg
    Market StatusPrescription
    CompanyAni Pharms; Apotex; Aurobindo Pharma; Lupin; Roxane

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Angiotensin-Converting Enzyme Inhibitors

    A class of drugs whose main indications are the treatment of hypertension and heart failure. They exert their hemodynamic effect mainly by inhibiting the renin-angiotensin system. They also modulate sympathetic nervous system activity and increase prostaglandin synthesis. They cause mainly vasodilation and mild natriuresis without affecting heart rate and contractility. (See all compounds classified as Angiotensin-Converting Enzyme Inhibitors.)

    Antihypertensive Agents

    Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Angiotensin-converting Enzyme Inhibitors [MoA]; Angiotensin Converting Enzyme Inhibitor [EPC]

    API Reference Price

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LTD","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"20276.5","totalValueFC":"121849.3","currency":"EURO","unitRateINR":"1766085.5","date":"06-Feb-2025","totalValueINR":"10596513","totalValueInUsd":"121849.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8203246","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738780200,"product":"PERINDOPRIL ERBUMINE (BULK DRUG) PERINDOPRIL ERBUMINE (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"LES LABORATOIRES SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"20276.5","totalValueFC":"243698.6","currency":"EURO","unitRateINR":"1766085.5","date":"06-Feb-2025","totalValueINR":"21193026","totalValueInUsd":"243698.6","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8203170","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738953000,"product":"PERINDOPRIL ERBUMINE (BULK DRUG) PERINDOPRIL ERBUMINE (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"LES LABORATOIRES SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"20600.6","totalValueFC":"251288.8","currency":"EURO","unitRateINR":"1821091.5","date":"08-Feb-2025","totalValueINR":"21853098","totalValueInUsd":"251288.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8255393","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741372200,"product":"PERINDOPRIL ERBUMINE (BULK DRUG) PERINDOPRIL ERBUMINE (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"LES LABORATOIRES SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER INDIA PRIVATE 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LTD","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"21390.2","totalValueFC":"130093.4","currency":"USD","unitRateINR":"1878062","date":"17-Mar-2025","totalValueINR":"11268372","totalValueInUsd":"130093.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8927664","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742322600,"product":"PERINDOPRIL ERBUMINE (BULK DRUG) PERINDOPRIL ERBUMINE (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"LES LABORATOIRES SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"21390.2","totalValueFC":"260186.7","currency":"EURO","unitRateINR":"1878062","date":"19-Mar-2025","totalValueINR":"22536744","totalValueInUsd":"260186.7","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8978109","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744223400,"product":"PERINDOPRIL ERBUMINE (BULK DRUG) PERINDOPRIL ERBUMINE (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"LES LABORATOIRES SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"21629.9","totalValueFC":"262585.8","currency":"EURO","unitRateINR":"1873150.8","date":"10-Apr-2025","totalValueINR":"22477809","totalValueInUsd":"262585.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"9413290","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746642600,"product":"PERINDOPRIL ERBUMINE (BULK DRUG) PERINDOPRIL ERBUMINE (BULK DRUG)","address":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"LES LABORATOIRES SERVIER","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"SERVIER INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"22389.1","totalValueFC":"134885.4","currency":"EUR","unitRateINR":"1915387.5","date":"08-May-2025","totalValueINR":"11492325","totalValueInUsd":"134885.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"9947002","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"50 RUE CARNOT SURESNES CEDEX FR","customerAddress":"SERDIA HOUSE ,OFF.DR.S.S.RAO ROAD,"}]
    06-Jan-2022
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 2MG

    USFDA APPLICATION NUMBER - 20184

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    DOSAGE - TABLET;ORAL - 4MG

    USFDA APPLICATION NUMBER - 20184

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    DOSAGE - TABLET;ORAL - 8MG

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    ABOUT THIS PAGE

    Looking for 107133-36-8 / Perindopril Erbumine API manufacturers, exporters & distributors?

    Perindopril Erbumine manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Perindopril Erbumine 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 Perindopril Erbumine manufacturer or Perindopril Erbumine supplier for your needs.

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

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

    API | Excipient name

    Perindopril Erbumine

    Synonyms

    107133-36-8, Aceon, Perindopril tert-butylamine, Mcn-a-2833-109, Perindopril erbumine [usan], Perindopril (erbumine)

    Cas Number

    107133-36-8

    Unique Ingredient Identifier (UNII)

    1964X464OJ

    About Perindopril Erbumine

    An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) Manufacturers

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

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) Suppliers

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

    click here to find a list of PERINDOPRIL TERT-BUTYLAMINE (ESUB) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) USDMF

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

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

    click here to find a list of PERINDOPRIL TERT-BUTYLAMINE (ESUB) suppliers with USDMF on PharmaCompass.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) Drug Master File in Japan (PERINDOPRIL TERT-BUTYLAMINE (ESUB) JDMF) empowers PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) JDMF during the approval evaluation for pharmaceutical products. At the time of PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) suppliers with JDMF on PharmaCompass.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) KDMF

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

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

    After submitting a PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of PERINDOPRIL TERT-BUTYLAMINE (ESUB) suppliers with KDMF on PharmaCompass.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) CEP

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

    A PERINDOPRIL TERT-BUTYLAMINE (ESUB) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) suppliers with CEP (COS) on PharmaCompass.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) WC

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

    click here to find a list of PERINDOPRIL TERT-BUTYLAMINE (ESUB) suppliers with Written Confirmation (WC) on PharmaCompass.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of PERINDOPRIL TERT-BUTYLAMINE (ESUB) suppliers with NDC on PharmaCompass.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) GMP

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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 PERINDOPRIL TERT-BUTYLAMINE (ESUB) GMP manufacturer or PERINDOPRIL TERT-BUTYLAMINE (ESUB) GMP API supplier for your needs.

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) CoA

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

    PERINDOPRIL TERT-BUTYLAMINE (ESUB) CoA mostly includes findings from lab analyses of a specific batch. For each PERINDOPRIL TERT-BUTYLAMINE (ESUB) 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.

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