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    Also known as: Famotidine, 76824-35-6, Gastridin, Famodil, Pepdine, Pepdul
    Molecular Formula
    C8H15N7O2S3
    Molecular Weight
    337.5  g/mol
    InChI Key
    XUFQPHANEAPEMJ-UHFFFAOYSA-N
    FDA UNII
    5QZO15J2Z8
    Famotidine
    A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.
    Famotidine is a Histamine-2 Receptor Antagonist. The mechanism of action of famotidine is as a Histamine H2 Receptor Antagonist.
    1 2D Structure

    Famotidine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-[[2-(diaminomethylideneamino)-1,3-thiazol-4-yl]methylsulfanyl]-N'-sulfamoylpropanimidamide
    2.1.2 InChI
    InChI=1S/C8H15N7O2S3/c9-6(15-20(12,16)17)1-2-18-3-5-4-19-8(13-5)14-7(10)11/h4H,1-3H2,(H2,9,15)(H2,12,16,17)(H4,10,11,13,14)
    2.1.3 InChI Key
    XUFQPHANEAPEMJ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=C(N=C(S1)N=C(N)N)CSCCC(=NS(=O)(=O)N)N
    2.1.5 Isomeric SMILES
    C1=C(N=C(S1)N=C(N)N)CSCC/C(=N/S(=O)(=O)N)/N
    2.2 Other Identifiers
    2.2.1 UNII
    5QZO15J2Z8
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Famotidine

    2. Famotidine Hydrochloride

    3. Mk 208

    4. Mk-208

    5. Mk208

    6. Ym 11170

    7. Ym-11170

    8. Ym11170

    2.3.2 Depositor-Supplied Synonyms

    1. Famotidine

    2. 76824-35-6

    3. Gastridin

    4. Famodil

    5. Pepdine

    6. Pepdul

    7. Pepcidine

    8. Famoxal

    9. Ganor

    10. Pepcidac

    11. Amfamox

    12. Gastropen

    13. Famosan

    14. Fluxid

    15. Gaster

    16. Lecedil

    17. Motiax

    18. Muclox

    19. Pepcid Ac

    20. Quamatel

    21. Ym-11170

    22. Pepcid Rpd

    23. Fadul

    24. Mk-208

    25. Famotidine (pepcid)

    26. 3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-n-sulfamoylpropanimidamide

    27. L 643341

    28. Mk 208

    29. Chebi:4975

    30. Ym 11170

    31. Nsc-757810

    32. 3-(((2-((diaminomethylene)amino)thiazol-4-yl)methyl)thio)-n'-sulfamoylpropanimidamide

    33. Xufqphaneapemj-uhfffaoysa-

    34. 3-(((2-guanidinothiazol-4-yl)methyl)thio)-n-sulfamoylpropanimidamide

    35. (1-amino-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)propylidene)sulfamide

    36. Pepcid Ac Gelcaps

    37. Smr000058961

    38. Pepcid (tn)

    39. Chembl902

    40. 3-[[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-n-(aminosulfonyl)propanimidamide

    41. Sr-05000001440

    42. 5qzo15j2z8

    43. Ncgc00015446-05

    44. Fo9

    45. Propanimidamide, N'-(aminosulfonyl)-3-(((2-((diaminomethylene)amino)-4-thiazolyl)methyl)thio)-

    46. Prestwick_212

    47. Cas-76824-35-6

    48. Fluxid (tn)

    49. Mfcd00079297

    50. Hs-0054

    51. Ym-1170

    52. Famotidine [mi]

    53. 3-(2-guanidinothiazol-4-ylmethylthio)-n1-sulfamoylpropionamide

    54. Famotidine [inn]

    55. Famotidine [jan]

    56. Prestwick2_000104

    57. Prestwick3_000104

    58. Famotidine [hsdb]

    59. Famotidine [usan]

    60. Lopac-f-6889

    61. F0530

    62. Schembl972

    63. Schembl974

    64. Famotidine [vandf]

    65. F 6889

    66. Famotidine [mart.]

    67. Famotidine [usp-rs]

    68. Famotidine [who-dd]

    69. N'-(aminosulfonyl)-3-([2-(diaminomethyleneamino)-4-thiazolyl]methylthio)propanamidine

    70. Lopac0_000497

    71. Bspbio_000088

    72. Mls000028583

    73. Mls000758205

    74. Mls001423994

    75. Bidd:gt0759

    76. Bpbio1_000098

    77. Famotidine (jp17/usp/inn)

    78. Famotidine [orange Book]

    79. Bdbm22891

    80. Cid_5702160

    81. Famotidine [ep Monograph]

    82. Famotidine [usp Impurity]

    83. Famotidine [usp Monograph]

    84. Hms1568e10

    85. Hms2051a07

    86. Hms2089i12

    87. Hms2095e10

    88. Hms2231i22

    89. Hms3261d15

    90. Hms3712e10

    91. Hms3884j03

    92. Hy-b0377

    93. Tox21_500497

    94. Bdbm50103514

    95. Pdsp1_000398

    96. Pdsp2_000396

    97. S2078

    98. Stk527689

    99. Akos005460541

    100. Akos015994617

    101. Ccg-100767

    102. Ccg-220104

    103. Ccg-221801

    104. Nc00017

    105. Sdccgsbi-0050481.p004

    106. 3-[[2-(diaminomethylideneamino)-1,3-thiazol-4-yl]methylsulfanyl]-n'-sulfamoylpro

    107. Propanimidamide, 3-[[[2-[aminoiminomethyl)amino]-4-thiazoyl]methyl]thio]-n-(aminosulfonyl)

    108. Ncgc00015446-01

    109. Ncgc00015446-02

    110. Ncgc00015446-03

    111. Ncgc00015446-04

    112. Ncgc00015446-06

    113. Ncgc00015446-08

    114. Ncgc00018276-01

    115. Ncgc00018276-02

    116. Ncgc00093899-01

    117. Ncgc00093899-02

    118. Ncgc00093899-03

    119. Ncgc00188952-01

    120. Ncgc00261182-01

    121. (1z)-3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-n'-sulfamoylpropanimidamide

    122. (1z)-n'-(aminosulfonyl)-3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)thio]propanimidamide

    123. Ac-11713

    124. Ac-31723

    125. Pepcid Complete Component Famotidine

    126. Sbi-0050481.p003

    127. Eu-0100497

    128. Famotidine Component Of Pepcid Complete

    129. D00318

    130. Ab00383032_11

    131. 824f356

    132. A838850

    133. A899959

    134. L003830

    135. L013386

    136. Sr-01000075883

    137. Sr-01000075883-1

    138. Sr-05000001440-1

    139. Sr-05000001440-2

    140. Famotidine, British Pharmacopoeia (bp) Reference Standard

    141. Famotidine, European Pharmacopoeia (ep) Reference Standard

    142. Famotidine, United States Pharmacopeia (usp) Reference Standard

    143. 3-[(2-guanidinothiazol-4-yl)methylsulfanyl]-n-sulfamoyl-propanamidine

    144. Famotidine, Pharmaceutical Secondary Standard; Certified Reference Material

    145. 3-((((2-(diaminomethylene)amino)-4-thiazolyl)methyl)thio)-n-sulfamoylpropionamidine

    146. 3-(2-(diaminomethyleneamino)-1,3-thiazol-4-yl)methylthio)-n'- Sulfamoylpropionamidine

    147. 3-[2-(diaminomethyleneamino] Thiazol-4-ylmethylthio]-n-sulphamoyl Propionamidine

    148. Famotidine For System Suitability, European Pharmacopoeia (ep) Reference Standard

    149. 3-[({2-[(diaminomethylene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-n'-sulfamoylpropanimidamide

    150. 3-[({2-[(diaminomethylidene)amino]-1,3-thiazol-4-yl}methyl)sulfanyl]-n''-sulfamoylpropanimidamide

    2.4 Create Date
    2006-03-07
    3 Chemical and Physical Properties
    Molecular Weight 337.5 g/mol
    Molecular Formula C8H15N7O2S3
    XLogP3-0.6
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count7
    Exact Mass337.04493627 g/mol
    Monoisotopic Mass337.04493627 g/mol
    Topological Polar Surface Area238 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity469
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 10  
    Drug NameFamotidine
    Active IngredientFamotidine
    Dosage FormInjectable; Tablet; Tablet, chewable; For suspension; Suspension
    Routeinjection; Injection; Oral
    Strength40mg/5ml; 10mg; 10mg/ml; 40mg; 20mg
    Market StatusTentative Approval; Over the Counter; Prescription
    CompanyNavinta; Ranbaxy; Wockhardt; Bedford; Ivax Sub Teva Pharms; Marsam Pharms; Fresenius Kabi Usa; Hi-tech Pharma; Hikma Maple; Teva; Apotex; Perrigo; Alembic Pharms; Lupin; Dr Reddys Labs; Carlsbad; Agila Speclts; Mylan; Novel Labs

    2 of 10  
    Drug NameFamotidine preservative free
    PubMed HealthFamotidine
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in PEPCID (famotidine) is a histamine H2-receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and it..
    Active IngredientFamotidine
    Dosage FormInjectable
    RouteInjection
    Strength10mg/ml
    Market StatusPrescription
    CompanyBedford; Fresenius Kabi Usa; Hikma Maple; Bedford Labs; Agila Speclts

    3 of 10  
    Drug NameFamotidine preservative free in plastic container
    PubMed HealthFamotidine (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Active IngredientFamotidine
    Dosage FormInjectable
    RouteInjection
    Strength0.4mg/ml
    Market StatusPrescription
    CompanyBaxter Hlthcare

    4 of 10  
    Drug NamePepcid
    PubMed HealthFamotidine
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in Famotidine Injection, USP is a histamine H2-receptor antagonist. Famotidine is [1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propylidene] sulfamide. Its structural formula is:C8H15N7O2S3 MW 337.4...
    Active IngredientFamotidine
    Dosage FormTablet; For suspension
    RouteOral
    Strength40mg/5ml; 40mg; 20mg
    Market StatusPrescription
    CompanyMarathon Pharms; Salix Pharms

    5 of 10  
    Drug NamePepcid ac
    Active IngredientFamotidine
    Dosage FormTablet; Tablet, chewable
    RouteOral
    Strength10mg; 20mg
    Market StatusOver the Counter
    CompanyMcneil Cons

    6 of 10  
    Drug NameFamotidine
    Active IngredientFamotidine
    Dosage FormInjectable; Tablet; Tablet, chewable; For suspension; Suspension
    Routeinjection; Injection; Oral
    Strength40mg/5ml; 10mg; 10mg/ml; 40mg; 20mg
    Market StatusTentative Approval; Over the Counter; Prescription
    CompanyNavinta; Ranbaxy; Wockhardt; Bedford; Ivax Sub Teva Pharms; Marsam Pharms; Fresenius Kabi Usa; Hi-tech Pharma; Hikma Maple; Teva; Apotex; Perrigo; Alembic Pharms; Lupin; Dr Reddys Labs; Carlsbad; Agila Speclts; Mylan; Novel Labs

    7 of 10  
    Drug NameFamotidine preservative free
    PubMed HealthFamotidine
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in PEPCID (famotidine) is a histamine H2-receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and it..
    Active IngredientFamotidine
    Dosage FormInjectable
    RouteInjection
    Strength10mg/ml
    Market StatusPrescription
    CompanyBedford; Fresenius Kabi Usa; Hikma Maple; Bedford Labs; Agila Speclts

    8 of 10  
    Drug NameFamotidine preservative free in plastic container
    PubMed HealthFamotidine (By mouth)
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Active IngredientFamotidine
    Dosage FormInjectable
    RouteInjection
    Strength0.4mg/ml
    Market StatusPrescription
    CompanyBaxter Hlthcare

    9 of 10  
    Drug NamePepcid
    PubMed HealthFamotidine
    Drug ClassesAntiulcer, Gastric Acid Secretion Inhibitor
    Drug LabelThe active ingredient in Famotidine Injection, USP is a histamine H2-receptor antagonist. Famotidine is [1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propylidene] sulfamide. Its structural formula is:C8H15N7O2S3 MW 337.4...
    Active IngredientFamotidine
    Dosage FormTablet; For suspension
    RouteOral
    Strength40mg/5ml; 40mg; 20mg
    Market StatusPrescription
    CompanyMarathon Pharms; Salix Pharms

    10 of 10  
    Drug NamePepcid ac
    Active IngredientFamotidine
    Dosage FormTablet; Tablet, chewable
    RouteOral
    Strength10mg; 20mg
    Market StatusOver the Counter
    CompanyMcneil Cons

    4.2 Therapeutic Uses

    Anti-Ulcer Agents; Histamine H2 Antagonists

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    Famotidine is currently the drug of choice for initial treatment and maintenance therapy in most patients with uncomplicated gastric or duodenal ulcer. ... A single bedtime dose of famotidine 40 mg is as efficatious as previously recommended multidose regimens and increases compliance.

    American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 892

    Histamine H2-receptor antagonists are indicated in the short-term treatment of active duodenal ulcer. They are also indicated (at reduce dosage) in the prevention of duodenal ulcer recurrence in selected patients. /Histamine H2-receptor antagonists; Included in US product labeling/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1611

    Famotidine ... /is/ indicated in the short-term treatment of active benign gastric ulcer. /Included in US product labeling/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1611

    For more Therapeutic Uses (Complete) data for FAMOTIDINE (12 total), please visit the HSDB record page.

    4.3 Drug Warning

    Although appropriate studies on the relationship of age to the effects of these medicines /cimetidine, famotidine, and ranitidine/ have not been performed in the geriatric population, no geriatrics-specific problems have been documented to date. However, confusion is more likely to occur in elderly patients with impaired hepatic or renal function.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1613

    Adverse nervous system effects (eg, headache, dizziness) and GI effects (eg, constipation, diarrhea) occur most frequently during famotidine therapy. Although adverse effects of the drug generally are not severe, discontinuance of famotidine therapy has been necessary in up to 14% of patients. Adverse effects generally are similar when famotidine is administered orally or IV.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2151

    Fever, hypertension, flushing, musculoskeletal pain, arthralgia, and tinnitus have been reported in 1% or less of patients receiving famotidine, but a causal relationship to the drug has not been established in many cases. An acute episode of gout occurred in one patient during therapy with the drug.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2151

    Leukocytosis, leukopenia, neutropenia, pancytopenia, agranulocytosis, eosinophilia, prolonged erythrocyte sedimentation rate (ESR), and thrombocytopenia have occurred rarely in patients receiving famotidine. Changes in serum protein or cholesterol concentrations also have occurred.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2151

    For more Drug Warnings (Complete) data for FAMOTIDINE (10 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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.)

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    FAMOTIDINE
    5.2.2 FDA UNII
    5QZO15J2Z8
    5.2.3 Pharmacological Classes
    Histamine-2 Receptor Antagonist [EPC]; Histamine H2 Receptor Antagonists [MoA]
    5.3 ATC Code

    A - Alimentary tract and metabolism

    A02 - Drugs for acid related disorders

    A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

    A02BA - H2-receptor antagonists

    A02BA03 - Famotidine

    5.4 Absorption, Distribution and Excretion

    All H2-receptor antagonists are distributed in breast milk and cerebral spinal fluid. /Histamine H2-receptor antagonists/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1612

    Distribution of famotidine into human body tissues and fluids has not been fully characterized. The apparent volume of distribution of the drug is reported to be 1.1-1.4 l/kg in adults and does not appear to be altered substantially in patients with renal dysfunction. Following oral or IV administration in rats, famotidine is widely distributed, appearing in highest concentrations in the kidney, liver, pancreas, and submandibular gland. The drug is 15-20% protein bound.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2149

    In rats famotidine appears to distribute only minimally into the CNS, and does not cross the placenta. It is not known whether the drug crosses the placenta in humans. Famotidine is distributed into milk in rats; however, it is not known whether the drug is distributed into milk in humans.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2149

    Famotidine is excreted principally in urine via glomerular filtration and tubular secretion. Approximately 25-30 or 65-80% of a dose is excreted unchanged in urine within 24 hours following oral or IV administration, respectively, and approximately 13-49 or 52-82% of a single 40 mg oral or IV dose respectively, is excreted within 72 hours. ... The remainder of an orally administered dose is eliminated in feces.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2149

    For more Absorption, Distribution and Excretion (Complete) data for FAMOTIDINE (7 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Famotidine is metabolized in the liver to famotidine S-oxide (S-famotidine). The metabolite does not appear to inhibit gastric acid secretion. Orally administered famotidine undergoes minimal metabolism on first pass through the liver.

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2149

    5.6 Mechanism of Action

    H2-receptor antagonists inhibit basal and nocturnal gastric acid secretion by competitive inhibition of the action of histamine at the histamine H2-receptors of the parietal cells. They also inhibit gastric acid secretion stimulated by food, betazole, pentagastrin, caffeine, insulin, and physiological vagal reflex. /Histamine H2-receptor antagonists/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1612

    Weak inhibitor of hepatic cytochrome p450 mixed function oxidase system.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 1612

    Famotidine is a competitive H2 receptor antagonist that inhibits basal, overnight, and pentagastrin-stimulated gastric acid secretion. Pharmacologically, it is three times more potent than ranitidine and 20 times more potent than cimetidine.

    American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 902

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 20MG **Federal Registe...DOSAGE - TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19462

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    DOSAGE - TABLET;ORAL - 40MG **Federal Registe...DOSAGE - TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19462

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    DOSAGE - FOR SUSPENSION;ORAL - 40MG/5ML **Fed...DOSAGE - FOR SUSPENSION;ORAL - 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 19527

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    ABOUT THIS PAGE

    Looking for 76824-35-6 / Famotidine API manufacturers, exporters & distributors?

    Famotidine manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Famotidine

    Synonyms

    76824-35-6, Gastridin, Famodil, Pepdine, Pepdul, Pepcidine

    Cas Number

    76824-35-6

    Unique Ingredient Identifier (UNII)

    5QZO15J2Z8

    About Famotidine

    A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion.

    Ulfam Manufacturers

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

    Ulfam Suppliers

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

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

    Ulfam USDMF

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

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

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

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

    Ulfam KDMF

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

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

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

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

    Ulfam CEP

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

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

    Ulfam WC

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

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

    Ulfam 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 Ulfam as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Ulfam GMP

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

    Ulfam CoA

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

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

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