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    Chemistry

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    Also known as: 124750-99-8, Cozaar, Losartan potassium salt, Lorzaar, Losacar, Losaprex
    Molecular Formula
    C22H22ClKN6O
    Molecular Weight
    461.0  g/mol
    InChI Key
    OXCMYAYHXIHQOA-UHFFFAOYSA-N
    FDA UNII
    3ST302B24A
    Losartan Potassium
    An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.
    1 2D Structure

    Losartan Potassium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol
    2.1.2 InChI
    InChI=1S/C22H22ClN6O.K/c1-2-3-8-20-24-21(23)19(14-30)29(20)13-15-9-11-16(12-10-15)17-6-4-5-7-18(17)22-25-27-28-26-22;/h4-7,9-12,30H,2-3,8,13-14H2,1H3;/q-1;+1
    2.1.3 InChI Key
    OXCMYAYHXIHQOA-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCC1=NC(=C(N1CC2=CC=C(C=C2)C3=CC=CC=C3C4=NN=N[N-]4)CO)Cl.[K+]
    2.2 Other Identifiers
    2.2.1 UNII
    3ST302B24A
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-butyl-4-chloro-1-((2'-(1h-etrazol-5-yl) (1,1'-biphenyl)-4-yl)methyl)-1h-imidazole-5-methanol

    2. Cozaar

    3. Dup 753

    4. Dup-753

    5. Dup753

    6. Losartan

    7. Losartan Monopotassium Salt

    8. Mk 954

    9. Mk-954

    10. Mk954

    11. Monopotassium Salt, Losartan

    12. Potassium, Losartan

    13. Salt, Losartan Monopotassium

    2.3.2 Depositor-Supplied Synonyms

    1. 124750-99-8

    2. Cozaar

    3. Losartan Potassium Salt

    4. Lorzaar

    5. Losacar

    6. Losaprex

    7. Hyzaar

    8. Dup 753

    9. Nu-lotan

    10. Mk 954

    11. Lortaan

    12. Losata

    13. Tancin

    14. Mk-0954

    15. Losartanpotassium

    16. Losartan Potassium (dup 753)

    17. Mk0954

    18. L-158086

    19. Losartan Monopotassium Salt

    20. 3st302b24a

    21. Aradois

    22. Zaart

    23. Dup-753

    24. Presartan-50

    25. E-3340

    26. 2-butyl-4-chloro-1-(p-(o-1h-tetrazol-5-ylphenyl)benzyl)imidazole-5-methanol, Monopotassium Salt

    27. 124750-99-8 (ka+)

    28. Potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol

    29. Lifezar

    30. Lorzaan

    31. Losacor

    32. Tenopres

    33. Lotim

    34. Niten

    35. Ocsaar

    36. Du Pont-753

    37. Neo Lotan

    38. 1h-imidazole-5-methanol, 2-butyl-4-chloro-1-((2'-(1h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Monopotassium Salt

    39. 2-butyl-4-chloro-1-[[2'-(1h-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-1h-imidazole-5-methanol, Monopotassium Salt

    40. Mfcd09850721

    41. Mk-954

    42. Du Pont 753

    43. Losartan Potassium [usan]

    44. Covance

    45. Unii-3st302b24a

    46. Losartan Potassium [usan:usp]

    47. Potassium 5-(4'-((2-butyl-4-chloro-5-(hydroxymethyl)-1h-imidazol-1-yl)methyl)biphenyl-2-yl)tetrazol-1-ide

    48. Cozaar (tn)

    49. Dup-753 Potassium

    50. Mk 0954

    51. Losartan Potassium,(s)

    52. Schembl42079

    53. Mls001401407

    54. Ex-89

    55. Dtxsid3044209

    56. Losartan Potassium [jan]

    57. Losartan Potassium (jp17/usp)

    58. Losartan Potassium [hsdb]

    59. Hms2051m12

    60. Hms2090o22

    61. Hms2235f20

    62. Hms3369f08

    63. Hms3393m12

    64. Losartan Potassium [vandf]

    65. Losartan Potassium [mart.]

    66. Act02618

    67. Bcp05332

    68. Bcp29397

    69. Losartan Potassium [usp-rs]

    70. Losartan Potassium [who-dd]

    71. Akos015955543

    72. Akos025310168

    73. Ac-1072

    74. Ccg-100869

    75. Losartan Potassium, Analytical Standard

    76. Nc00119

    77. 2-butyl-4-chloro-1-(2'-(tetrazol-5-yl)biphenyl-4-ylmethyl)-1h-imidazole-5-methanol Potassium

    78. Losartan Monopotassium Salt [mi]

    79. Losartan Potassium [orange Book]

    80. Losartan Potassium [ep Monograph]

    81. 2-butyl-4-chloro-1-[[2'-(1h-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl]imidazole-5-methanol Potassium Salt

    82. Bl164642

    83. Epo

    84. Hyzaar Component Losartan Potassium

    85. Losartan Potassium [usp Monograph]

    86. Smr000469593

    87. Ft-0625705

    88. L-185

    89. L0232

    90. Losartan Potassium Component Of Hyzaar

    91. D00357

    92. Ab01275507-01

    93. 750l998

    94. A805291

    95. Sr-05000001514

    96. Sr-05000001514-1

    97. Q27257991

    98. Losartan Potassium, European Pharmacopoeia (ep) Reference Standard

    99. Losartan Potassium Is Known As A Potent, Synthetic At1 Receptor Antagonist.

    100. Losartan Potassium, United States Pharmacopeia (usp) Reference Standard

    101. Losartan Potassium, Pharmaceutical Secondary Standard; Certified Reference Material

    102. [2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol; Potassium;losartan Potassium

    103. 1h-imidazole-5-methanol, 2-butyl-4-chloro-1-((2-(1h-tetrazol-5-yl)(1,1-biphenyl)-4-yl)methyl)-, Monopotassium Salt

    104. Potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,3-triaza-4-azanidacyclopenta-2,5-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol.

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 461.0 g/mol
    Molecular Formula C22H22ClKN6O
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count8
    Exact Mass460.1180685 g/mol
    Monoisotopic Mass460.1180685 g/mol
    Topological Polar Surface Area77.7 Ų
    Heavy Atom Count31
    Formal Charge0
    Complexity526
    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 NameCozaar
    PubMed HealthLosartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelCOZAAR1(losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.Its...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    2 of 4  
    Drug NameLosartan potassium
    Drug LabelLosartan potassium tablets USP are an angiotensin II receptor (type AT1) antagonist. Losartan potassium, USP a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyUpsher Smith; Teva; Apotex; Alembic Pharms; Aurobindo Pharma; Torrent Pharms; Lupin; Sandoz; Prinston; Roxane; Watson Labs; Macleods Pharms; Ipca Labs; Vivimed Labs; Micro Labs Ltd India; Cadista Pharms; Zydus Pharms Usa; Mylan

    3 of 4  
    Drug NameCozaar
    PubMed HealthLosartan (By mouth)
    Drug ClassesCardiovascular Agent, Renal Protective Agent
    Drug LabelCOZAAR1(losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt.Its...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    4 of 4  
    Drug NameLosartan potassium
    Drug LabelLosartan potassium tablets USP are an angiotensin II receptor (type AT1) antagonist. Losartan potassium, USP a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium...
    Active IngredientLosartan potassium
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyUpsher Smith; Teva; Apotex; Alembic Pharms; Aurobindo Pharma; Torrent Pharms; Lupin; Sandoz; Prinston; Roxane; Watson Labs; Macleods Pharms; Ipca Labs; Vivimed Labs; Micro Labs Ltd India; Cadista Pharms; Zydus Pharms Usa; Mylan

    4.2 Drug Indication

    Indicated in adult and paediatric patients for the: - treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. - treatment of anemia due to zidovudine in patients with HIV-infection. - treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. - reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

    FDA Label

    Proteinuria, Treatment of heart failure, Treatment of hypertension

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Erythropoietin and epoetin alfa are involved in the regulation of erythrocyte differentiation and the maintenance of a physiological level of circulating erythrocyte mass. It is reported to increase the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. Depending on the dose administered, the rate of hemoglobin increase may vary. In patients receiving hemodialysis, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly. Epoetin alfa serves to restore erythropoietin deficiency in pathological and other clinical conditions where normal production of erythropoietin is impaired or compromised. In anemic patients with chronic renal failure (CRF), administration with epoetin alfa stimulated erythropoiesis by increasing the reticulocyte count within 10 days, followed by increases in the red cell count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. Epoetin alfa was shown to be effective in increasing hematocrit in zidovudine-treated HIV-infected patients and anemic cancer patients undergoing chemotherapy.

    5.2 MeSH Pharmacological Classification

    Angiotensin II Type 1 Receptor Blockers

    Agents that antagonize ANGIOTENSIN II TYPE 1 RECEPTOR. Included are ANGIOTENSIN II analogs such as SARALASIN and biphenylimidazoles such as LOSARTAN. Some are used as ANTIHYPERTENSIVE AGENTS. (See all compounds classified as Angiotensin II Type 1 Receptor Blockers.)

    Anti-Arrhythmia Agents

    Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

    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.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Angiotensin 2 Receptor Blocker [EPC]; Angiotensin 2 Receptor Antagonists [MoA]
    5.4 ATC Code

    B - Blood and blood forming organs

    B03 - Antianemic preparations

    B03X - Other antianemic preparations

    B03XA - Other antianemic preparations

    B03XA01 - Erythropoietin

    5.5 Absorption, Distribution and Excretion

    Absorption

    The time to reach peak concentration is slower via the subcutaneous route than the intravenous route which ranges from 20 to 25 hours, and the peak is always well below the peak achieved using the intravenous route (510% of those seen with IV administration). The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenously administered product and is approximately 20-40%. **Adult and paediatric patients with CRF:** Following subcutaneous administration, the peak plasma levels are achieved within 5 to 24 hours. **Cancer patients receiving cyclic chemotherapy:** The average time to reach peak plasma concentration was approximately 13.3 12.4 hours after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing. The Cmax is expected be 3- to 7- fold higher and the Tmax is expected to be 2- to 3-fold longer in patients receiving a 40,000 Units SC weekly dosing regimen.

    Route of Elimination

    Erythropoietin and epoetin alfa are cleared via uptake and degradation via the EPO-R-expressing cells, and may also involve other cellular pathways in the interstitium, probably via cells in the reticuloendothelial scavenging pathway or lymphatic system. Only a small amount of unchanged epoetin alfa is found in the urine.

    Volume of Distribution

    In healthy volunteers, the volume of distribution of intravenous epoetin alfa was generally similar to the plasma volume (range of 4063.80 mL/kg), indicating limited extravascular distribution.

    Clearance

    **Healthy volunteers: *

    In male volunteers receiving intravenous epoetin alfa, the total body clearance was approximately 8.12 1.00 mL/h/kg. **Cancer patients receiving cyclic chemotherapy:*

    The average clearance was approximately 20.2 15.9 mL/h/kg after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing. The patients receiving a 40,000 Units SC weekly dosing regimen display a lower clearance (9.2 4.7 mL/h/kg).

    5.6 Metabolism/Metabolites

    Binding of erythropoietin and epoetin alfa to EPO-R leads to cellular internalization, which involves the degradation of the ligand. Erythropoietin and epoetin alfa may also be degraded by the reticuloendothelial scavenging pathway or lymphatic system.

    5.7 Biological Half-Life

    **Healthy volunteers:*

    The half life is approximately 4 hours in healthy volunteers receiving an intravenous injection. A half-life of approximately 6 hours has been reported in children. **Adult and paediatric patients with CRF:*

    The elimination half life following intravenous administration ranges from 4 to 13 hours, which is about 20% longer in CRF patients than that in healthy subjects. The half life is reported to be similar between adult patients receiving or not receiving dialysis. **Cancer patients receiving cyclic chemotherapy:*

    Following subcutaneous administration, the average half life is 40 hours with range of 16 to 67 hours.

    5.8 Mechanism of Action

    Erythropoietin or exogenous epoetin alfa binds to the erythropoietin receptor (EPO-R) and activates intracellular signal transduction pathways. The affinity (Kd) of EPO for its receptor on human cells is 100 to 200 pM. Upon binding to EPO-R on the surface of erythroid progenitor cells, a conformational change is induced which brings EPO-R-associated Janus family tyrosine protein kinase 2 (JAK2) molecules into close proximity. JAK2 molecules are subsequently activated via phosphorylation, then phosphorylate tyrosine residues in the cytoplasmic domain of the EPO-R that serve as docking sites for Src homology 2-domain-containing intracellular signaling proteins. The signalling proteins include STAT5 that once phosphorylated by JAK2, dissociates from the EPO-R, dimerizes, and translocates to the nucleus where they serve as transcription factors to activate target genes involved in cell division or differentiation, including the apoptosis inhibitor Bcl-x. The inhibition of apoptosis by the EPO-activated JAK2/STAT5/Bcl-x pathway is critical in erythroid differentiation. Via JAK2-mediated tyrosine phosphorylation, erythropoietin and epoetin alfa also activates other intracellular proteins involved in erythroid cell proliferation and survival, such as Shc , phosphatidylinositol 3-kinase (PI3K), and phospholipase C-1.

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    01-Jan-2022
    30-Apr-2025
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    DOSAGE - TABLET;ORAL - 100MG

    USFDA APPLICATION NUMBER - 20386

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    DOSAGE - TABLET;ORAL - 25MG

    USFDA APPLICATION NUMBER - 20386

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    DOSAGE - TABLET;ORAL - 50MG

    USFDA APPLICATION NUMBER - 20386

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    DOSAGE - TABLET;ORAL - 12.5MG;100MG

    USFDA APPLICATION NUMBER - 20387

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    DOSAGE - TABLET;ORAL - 12.5MG;50MG

    USFDA APPLICATION NUMBER - 20387

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    USFDA APPLICATION NUMBER - 20387

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    ABOUT THIS PAGE

    Looking for 124750-99-8 / Losartan Potassium API manufacturers, exporters & distributors?

    Losartan Potassium manufacturers, exporters & distributors 1

    54

    PharmaCompass offers a list of Losartan Potassium 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 Losartan Potassium manufacturer or Losartan Potassium supplier for your needs.

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

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

    API | Excipient name

    Losartan Potassium

    Synonyms

    124750-99-8, Cozaar, Erythropoietin, Losartan potassium salt, Lorzaar, Losacar

    Cas Number

    124750-99-8

    Unique Ingredient Identifier (UNII)

    3ST302B24A

    About Losartan Potassium

    An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.

    Losartan and Hydrochlorothiazide-1 Manufacturers

    A Losartan and Hydrochlorothiazide-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Losartan and Hydrochlorothiazide-1, including repackagers and relabelers. The FDA regulates Losartan and Hydrochlorothiazide-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Losartan and Hydrochlorothiazide-1 Suppliers

    A Losartan and Hydrochlorothiazide-1 supplier is an individual or a company that provides Losartan and Hydrochlorothiazide-1 active pharmaceutical ingredient (API) or Losartan and Hydrochlorothiazide-1 finished formulations upon request. The Losartan and Hydrochlorothiazide-1 suppliers may include Losartan and Hydrochlorothiazide-1 API manufacturers, exporters, distributors and traders.

    click here to find a list of Losartan and Hydrochlorothiazide-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Losartan and Hydrochlorothiazide-1 USDMF

    A Losartan and Hydrochlorothiazide-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Losartan and Hydrochlorothiazide-1 active pharmaceutical ingredient (API) in detail. Different forms of Losartan and Hydrochlorothiazide-1 DMFs exist exist since differing nations have different regulations, such as Losartan and Hydrochlorothiazide-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Losartan and Hydrochlorothiazide-1 DMF submitted to regulatory agencies in the US is known as a USDMF. Losartan and Hydrochlorothiazide-1 USDMF includes data on Losartan and Hydrochlorothiazide-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Losartan and Hydrochlorothiazide-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Losartan and Hydrochlorothiazide-1 suppliers with USDMF on PharmaCompass.

    Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 Drug Master File in Japan (Losartan and Hydrochlorothiazide-1 JDMF) empowers Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 JDMF during the approval evaluation for pharmaceutical products. At the time of Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 suppliers with JDMF on PharmaCompass.

    Losartan and Hydrochlorothiazide-1 KDMF

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

    Pharmaceutical companies submit a Losartan and Hydrochlorothiazide-1 Drug Master File in Korea (Losartan and Hydrochlorothiazide-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Losartan and Hydrochlorothiazide-1. The MFDS reviews the Losartan and Hydrochlorothiazide-1 KDMF as part of the drug registration process and uses the information provided in the Losartan and Hydrochlorothiazide-1 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Losartan and Hydrochlorothiazide-1 suppliers with KDMF on PharmaCompass.

    Losartan and Hydrochlorothiazide-1 CEP

    A Losartan and Hydrochlorothiazide-1 CEP of the European Pharmacopoeia monograph is often referred to as a Losartan and Hydrochlorothiazide-1 Certificate of Suitability (COS). The purpose of a Losartan and Hydrochlorothiazide-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Losartan and Hydrochlorothiazide-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Losartan and Hydrochlorothiazide-1 to their clients by showing that a Losartan and Hydrochlorothiazide-1 CEP has been issued for it. The manufacturer submits a Losartan and Hydrochlorothiazide-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Losartan and Hydrochlorothiazide-1 CEP holder for the record. Additionally, the data presented in the Losartan and Hydrochlorothiazide-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Losartan and Hydrochlorothiazide-1 DMF.

    A Losartan and Hydrochlorothiazide-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 suppliers with CEP (COS) on PharmaCompass.

    Losartan and Hydrochlorothiazide-1 WC

    A Losartan and Hydrochlorothiazide-1 written confirmation (Losartan and Hydrochlorothiazide-1 WC) is an official document issued by a regulatory agency to a Losartan and Hydrochlorothiazide-1 manufacturer, verifying that the manufacturing facility of a Losartan and Hydrochlorothiazide-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Losartan and Hydrochlorothiazide-1 APIs or Losartan and Hydrochlorothiazide-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a Losartan and Hydrochlorothiazide-1 WC (written confirmation) as part of the regulatory process.

    click here to find a list of Losartan and Hydrochlorothiazide-1 suppliers with Written Confirmation (WC) on PharmaCompass.

    Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Losartan and Hydrochlorothiazide-1 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Losartan and Hydrochlorothiazide-1 suppliers with NDC on PharmaCompass.

    Losartan and Hydrochlorothiazide-1 GMP

    Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 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 Losartan and Hydrochlorothiazide-1 GMP manufacturer or Losartan and Hydrochlorothiazide-1 GMP API supplier for your needs.

    Losartan and Hydrochlorothiazide-1 CoA

    A Losartan and Hydrochlorothiazide-1 CoA (Certificate of Analysis) is a formal document that attests to Losartan and Hydrochlorothiazide-1's compliance with Losartan and Hydrochlorothiazide-1 specifications and serves as a tool for batch-level quality control.

    Losartan and Hydrochlorothiazide-1 CoA mostly includes findings from lab analyses of a specific batch. For each Losartan and Hydrochlorothiazide-1 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.

    Losartan and Hydrochlorothiazide-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (Losartan and Hydrochlorothiazide-1 EP), Losartan and Hydrochlorothiazide-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Losartan and Hydrochlorothiazide-1 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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