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    Chemistry

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    Also known as: Ranitidine hydrochloride, 66357-59-3, 71130-06-8, Fendibina, Gastridina, Gastrolav
    Molecular Formula
    C13H23ClN4O3S
    Molecular Weight
    350.87  g/mol
    InChI Key
    GGWBHVILAJZWKJ-KJEVSKRMSA-N
    Ranitidine Hydrochloride
    A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.
    1 2D Structure

    Ranitidine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-1-N'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-1-N-methyl-2-nitroethene-1,1-diamine;hydrochloride
    2.1.2 InChI
    InChI=1S/C13H22N4O3S.ClH/c1-14-13(9-17(18)19)15-6-7-21-10-12-5-4-11(20-12)8-16(2)3;/h4-5,9,14-15H,6-8,10H2,1-3H3;1H/b13-9+;
    2.1.3 InChI Key
    GGWBHVILAJZWKJ-KJEVSKRMSA-N
    2.1.4 Canonical SMILES
    CNC(=C[N+](=O)[O-])NCCSCC1=CC=C(O1)CN(C)C.Cl
    2.1.5 Isomeric SMILES
    CN/C(=C\[N+](=O)[O-])/NCCSCC1=CC=C(O1)CN(C)C.Cl
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Ah 19065

    2. Ah-19065

    3. Ah19065

    4. Biotidin

    5. Hydrochloride, Ranitidine

    6. N (2-(((5-((dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-n'-methyl-2-nitro-1,1-ethenediamine

    7. Ranisen

    8. Ranitidin

    9. Ranitidine

    10. Ranitidine Hydrochloride

    11. Sostril

    12. Zantac

    13. Zantic

    2.2.2 Depositor-Supplied Synonyms

    1. Ranitidine Hydrochloride

    2. 66357-59-3

    3. 71130-06-8

    4. Fendibina

    5. Gastridina

    6. Gastrolav

    7. Kuracid

    8. Raniberl

    9. Ranibloc

    10. Alquen

    11. Rani-nerton

    12. Zantac

    13. Nu-ranit

    14. Rani-q

    15. Ranitidine (hydrochloride)

    16. Santanol

    17. Tanidina

    18. Toriol

    19. Coralen

    20. Quantor

    21. Radin

    22. Chebi:8777

    23. Gastrial

    24. Raniben

    25. Ranibeta

    26. Azantac

    27. Zantac (tn)

    28. (e)-1-n'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-1-n-methyl-2-nitroethene-1,1-diamine;hydrochloride

    29. Mfcd00941509

    30. {2-[({5-[(dimethylamino)methyl]furan-2-yl}methyl)sulfanyl]ethyl}[(z)-1-(methylamino)-2-nitroethenyl]amine Hydrochloride

    31. Smr000653467

    32. (e)-n-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n-methyl-2-nitroethene-1,1-diamine

    33. N-(2-((5-((dimethylamino)methyl)furfuryl)thio)ethyl)-n'-methyl-2-nitrovinylidenediamine Monohydrochloride

    34. C13h22n4o3s.hcl

    35. Zantic

    36. Zantac;noctone

    37. Sr-01000075288

    38. Ah19065

    39. Ah-19065

    40. Prestwick_635

    41. Einecs 275-207-4

    42. Ranitidine (zantac)

    43. Ranitidine Hydrochloride 100 Microg/ml In Acetonitrile

    44. Epitope Id:127516

    45. Mls001146938

    46. Mls002548856

    47. Chembl1092473

    48. Hy-b0281a

    49. Hms1568j03

    50. Amy24712

    51. Bcp28420

    52. N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-n'-methyl-2-nitro-1,1-ethenediamine Hydrochloride

    53. N-[2-[5-[(dimethylamino)methyl]furfurylthio]ethyl]-n'-methyl-2-nitro-1,1-ethenediamine Hydrochloride

    54. Tox21_501073

    55. S1801

    56. Ranitidine Hydrochloride (jp17/usp)

    57. Akos015895250

    58. Ccg-212946

    59. Lp01073

    60. Nc00479

    61. Ranitidine For Impurity A Identification

    62. Ncgc00094351-01

    63. Ncgc00261758-01

    64. Ac-12743

    65. N-[2-[[5-(dimethylaminomethyl)furan-2-yl]methylsulfanyl]ethyl]-n'-methyl-2-nitroethene-1,1-diamine Hydrochloride

    66. Eu-0101073

    67. R-101

    68. R0073

    69. Sw196800-3

    70. Bim-0051043.0001

    71. D00673

    72. 357n593

    73. A835435

    74. Sr-01000075288-2

    75. W-104534

    76. (e)-n-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n'-methyl-2-nitroethene-1,1-diamine Hydrochloride

    77. (e)-n1'-[2-[[5-[(dimethylamino)methyl]-2-furanyl]methylthio]ethyl]-n1-methyl-2-nitroethene-1,1-diamine Hydrochloride

    78. (e)-n1'-[2-[[5-[(dimethylamino)methyl]furan-2-yl]methylsulfanyl]ethyl]-n1-methyl-2-nitro-ethene-1,1-diamine Hydrochloride

    79. 1,1-ethenediamine, N-(2-(((5-((dimethylamino)methyl)-2-furanyl)methyl)thio)ethyl)-n'-methyl-2-nitro-, Hydrochloride

    80. N-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n'-methyl-2-nitroethene-1,1-diamine Hydrochloride

    81. N-(2-(((5-((dimethylamino)methyl)furan-2-yl)methyl)thio)ethyl)-n-methyl-2-nitroethene-1,1-diaminehydrochloride

    82. N-(2-((5-(dimethylaminomethyl)furan-2-yl)methylsulfanyl)ethyl)-n'-methyl-2-nitroethene-1,1-diamine Hcl

    83. N-[2-[[[5-[(dimethylamino)methyl]-2 -furanyl]methyl]thio]ethyl]-n'-methyl-2-nitro-1,1-e Thanediamine Hydrochloride

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 350.87 g/mol
    Molecular Formula C13H23ClN4O3S
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count9
    Exact Mass350.1179395 g/mol
    Monoisotopic Mass350.1179395 g/mol
    Topological Polar Surface Area112 Ų
    Heavy Atom Count22
    Formal Charge0
    Complexity347
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 10  
    Drug NameRanitidine hydrochloride
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet; Syrup; Capsule; Injectable
    RouteInjection; Oral
    Strengtheq 150mg base; eq 15mg base/ml; eq 75mg base; 25mg/ml; eq 300mg base; eq 25mg base/ml
    Market StatusOver the Counter; Prescription
    CompanyVintage Pharms; Amneal Pharms; Wockhardt; Silarx; Breckenridge Pharm; Teva; Pharm Assoc; Apotex; Torpharm; Shasun Chems; Taro; Sandoz; Par Pharm; Perrigo R And D; Svads Holdings Sa; Glenmark Generics; Amneal Pharms Ny; Ivax Sub Teva Pharms; Hi Tech Pharma

    2 of 10  
    Drug NameZantac
    PubMed HealthRanitidine (Injection)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
    Active IngredientRanitidine hydrochloride
    Dosage FormSyrup; Injectable
    RouteInjection; Oral
    Strengtheq 15mg base/ml; eq 25mg base/ml
    Market StatusPrescription
    CompanyCovis Injectables; Glaxo Grp

    3 of 10  
    Drug NameZantac 150
    PubMed HealthRanitidine
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 150mg base
    Market StatusOver the Counter; Prescription
    CompanyBoehringer Ingelheim; Glaxo Grp

    4 of 10  
    Drug NameZantac 300
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 300mg base
    Market StatusPrescription
    CompanyGlaxo Grp

    5 of 10  
    Drug NameZantac 75
    Drug LabelThe active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 75mg base
    Market StatusOver the Counter
    CompanyBoehringer Ingelheim

    6 of 10  
    Drug NameRanitidine hydrochloride
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet; Syrup; Capsule; Injectable
    RouteInjection; Oral
    Strengtheq 150mg base; eq 15mg base/ml; eq 75mg base; 25mg/ml; eq 300mg base; eq 25mg base/ml
    Market StatusOver the Counter; Prescription
    CompanyVintage Pharms; Amneal Pharms; Wockhardt; Silarx; Breckenridge Pharm; Teva; Pharm Assoc; Apotex; Torpharm; Shasun Chems; Taro; Sandoz; Par Pharm; Perrigo R And D; Svads Holdings Sa; Glenmark Generics; Amneal Pharms Ny; Ivax Sub Teva Pharms; Hi Tech Pharma

    7 of 10  
    Drug NameZantac
    PubMed HealthRanitidine (Injection)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
    Active IngredientRanitidine hydrochloride
    Dosage FormSyrup; Injectable
    RouteInjection; Oral
    Strengtheq 15mg base/ml; eq 25mg base/ml
    Market StatusPrescription
    CompanyCovis Injectables; Glaxo Grp

    8 of 10  
    Drug NameZantac 150
    PubMed HealthRanitidine
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 150mg base
    Market StatusOver the Counter; Prescription
    CompanyBoehringer Ingelheim; Glaxo Grp

    9 of 10  
    Drug NameZantac 300
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 300mg base
    Market StatusPrescription
    CompanyGlaxo Grp

    10 of 10  
    Drug NameZantac 75
    Drug LabelThe active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2...
    Active IngredientRanitidine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 75mg base
    Market StatusOver the Counter
    CompanyBoehringer Ingelheim

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Histamine H2 Antagonists

    Drugs that selectively bind to but do not activate histamine H2 receptors, thereby blocking the actions of histamine. Their clinically most important action is the inhibition of acid secretion in the treatment of gastrointestinal ulcers. Smooth muscle may also be affected. Some drugs in this class have strong effects in the central nervous system, but these actions are not well understood. (See all compounds classified as Histamine H2 Antagonists.)

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Histamine-2 Receptor Antagonist [EPC]; Histamine H2 Receptor Antagonists [MoA]

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","customerCountry":"MEXICO","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"48","totalValueFC":"2870.4","currency":"USD","unitRateINR":3314.9733333333334,"date":"12-Mar-2025","totalValueINR":"248623","totalValueInUsd":"2870.4","indian_port":"Hyderabad Air","hs_no":"29420014","bill_no":"8927885","productDescription":"API","marketType":"","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO 19-111 ROAD NO 71,OPP BHAR, JUBILEE HILLS HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741804200,"product":"RANITIDINE HYDROCHLORIDE USP (INJECTABLEUSE)","address":"PLOT NO 19-111 ROAD NO 71,OPP BHAR","city":"JUBILEE HILLS HYDERABAD,TELANGANA","supplier":"SMS LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"KIND ATTN.: LIZA 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MALPENSA","customer":"M\/S","customerCountry":"ITALY","quantity":"49.90","actualQuantity":"49.9","unit":"KGS","unitRateFc":"155","totalValueFC":"7199.9","currency":"EUR","unitRateINR":12497.696793587174,"date":"27-Mar-2025","totalValueINR":"623635.07","totalValueInUsd":"7199.9","indian_port":"Bangalore Air","hs_no":"29420014","bill_no":"9417221","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI, NAVI MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"RANITIDINE HYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1612549800,"product":"(RE-IMPORT OF REJECTED GOODS) RANITIDINE HYDROCHLORIDE(SB NO.4837918 DT.13.06.2019 & 5066734 DT.22.06.2019)(AS INV PKL)","address":"8-2-348\/2,COC BUILDING,BESIDE-ADMN.TIVE STAFF COLLEGE,ROAD NO.3,","city":"BANJARA HILLS, HYDERABAD.AP","supplier":"HEMOFARM A.D.","supplierCountry":"INDIA","foreign_port":"","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"5912.06","actualQuantity":"5912.06","unit":"KGS","unitRateFc":"21","totalValueFC":"125847.1","currency":"USD","unitRateINR":"1549.8","date":"06-Feb-2021","totalValueINR":"9162510.59","totalValueInUsd":"125847.1","indian_port":"HYDERABAD ICD","hs_no":"29420014","bill_no":"2645674","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"8-2-348\/2,COC BUILDING,BESIDE-ADMN.TIVE STAFF COLLEGE,ROAD NO.3,"},{"dataSource":"API Import","activeIngredients":"RANITIDINE HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1618597800,"product":"RE-IMPORT OF INDIAN ORIGIN EXPORTED GOODS REJECTED AND RETURNED(RANITIDINE HYDROCHLORIDE USP) (COMPACTED)","address":"PLOT NO 19-111 ROAD NO 71,OPP BHAR ATIYA VIDYA BHAVAN PUBLIC SCHOOL","city":"JUBILEE HILLS HYDERABAD,TELANGANA","supplier":"SAVANT PHARMA S.A.","supplierCountry":"INDIA","foreign_port":"","customer":"SMS LIFESCIENCES","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"16.5","totalValueFC":"30663.3","currency":"USD","unitRateINR":"1521.9","date":"17-Apr-2021","totalValueINR":"2282858.02","totalValueInUsd":"30663.3","indian_port":"JNPT","hs_no":"29420014","bill_no":"3598678","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"PLOT NO 19-111 ROAD NO 71,OPP BHAR ATIYA VIDYA BHAVAN PUBLIC SCHOOL"}]
    27-Jan-2021
    27-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 18703

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    DOSAGE - TABLET;ORAL - EQ 300MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 18703

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    DOSAGE - INJECTABLE;INJECTION - EQ 25MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 25MG BASE/ML

    USFDA APPLICATION NUMBER - 19090

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    DOSAGE - TABLET;ORAL - EQ 75MG BASE

    USFDA APPLICATION NUMBER - 20520

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    DOSAGE - TABLET;ORAL - EQ 150MG BASE

    USFDA APPLICATION NUMBER - 21698

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    ABOUT THIS PAGE

    Looking for 71130-06-8 / Ranitidine Hydrochloride API manufacturers, exporters & distributors?

    Ranitidine Hydrochloride manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Ranitidine Hydrochloride

    Synonyms

    66357-59-3, 71130-06-8, Fendibina, Gastridina, Gastrolav, Kuracid

    Cas Number

    71130-06-8

    About Ranitidine Hydrochloride

    A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.

    Logat Manufacturers

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

    Logat Suppliers

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

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

    Logat USDMF

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

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

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

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

    Logat KDMF

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

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

    After submitting a Logat 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 Logat API can apply through the Korea Drug Master File (KDMF).

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

    Logat CEP

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

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

    Logat WC

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

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

    Logat 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 Logat as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Logat GMP

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

    Logat CoA

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

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

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