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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-2021
31-Mar-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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DOSAGE - TABLET;ORAL - 25MG;100MG

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 Manufacturers

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

Losartan Suppliers

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

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

Losartan USDMF

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

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

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

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

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

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

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

Losartan CEP

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

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

Losartan WC

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

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

Losartan 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Losartan GMP

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

Losartan CoA

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

Losartan CoA mostly includes findings from lab analyses of a specific batch. For each Losartan 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Losartan EP), Losartan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Losartan 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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