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Chemistry

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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


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03-Jan-2022
29-May-2025
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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.

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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.

Pepcid Manufacturers

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

Pepcid Suppliers

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

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

Pepcid USDMF

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

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

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

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

Pepcid KDMF

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

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

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

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

Pepcid CEP

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

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

Pepcid WC

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

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

Pepcid 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 Pepcid as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pepcid GMP

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

Pepcid CoA

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

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

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