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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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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU, MX arrow-down AUDIT
HRV Global Life Sciences

10

Octavius Pharma Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Octavius Pharma
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USDMF

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01

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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GDUFA

DMF Review : Complete

Rev. Date : 2014-01-03

Pay. Date : 2013-11-25

DMF Number : 14309

Submission : 1999-07-22

Status : Active

Type : II

Dr Reddy Company Banner

02

Apotex Pharmachem Inc

Canada

USDMF

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Fi Europe 2024
Not Confirmed

03

Fi Europe 2024
Not Confirmed

03

Fi Europe 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7356

Submission : 1988-02-29

Status : Active

Type : II

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04

Astellas Pharma Inc

Japan

USDMF

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Fi Europe 2024
Not Confirmed

04

Fi Europe 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5746

Submission : 1985-03-20

Status : Inactive

Type : II

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05

Ercros Sa

Spain

USDMF

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Fi Europe 2024
Not Confirmed

05

Ercros Sa

Spain
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Fi Europe 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13086

Submission : 1998-07-21

Status : Active

Type : II

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06

Gedeon Richter Plc

Hungary

USDMF

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Fi Europe 2024
Not Confirmed

06

Fi Europe 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11537

Submission : 1995-06-05

Status : Active

Type : II

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07

Quimica Sintetica Sa

Spain

USDMF

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Fi Europe 2024
Not Confirmed

07

Fi Europe 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2022-03-07

Pay. Date : 2022-03-02

DMF Number : 13036

Submission : 1998-06-17

Status : Active

Type : II

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08

Quimica Sintetica Sa

Spain

USDMF

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Fi Europe 2024
Not Confirmed

08

Fi Europe 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9084

Submission : 1991-03-25

Status : Inactive

Type : II

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09

Fi Europe 2024
Not Confirmed

09

Fi Europe 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15246

Submission : 2001-01-17

Status : Inactive

Type : II

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10

Wockhardt Ltd

India

USDMF

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Fi Europe 2024
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Listed Suppliers

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01

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Not Confirmed
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Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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Famotidine

About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...

Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritional supplement, and food industries. The company maintains an exceptionally selective approach to its suppliers, personally visiting manufacturers overseas to ensure the highest standards. The sustained growth of Pharm-Rx can be attributed to its steadfast commitment to three core values: quality ingredients, competitive pricing, and unparalleled customer service.
Pharm RX

02

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Fi Europe 2024
Not Confirmed
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Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

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Famotidine

About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...

Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our employees operate a regularly inspected cGMP facility equipped with reactors ranging from 40 to 7,600 litres. Located in Montreal, Canada, we have contributed to the success of our North-American and international clients since 1964.
Minakem Delmar

03

LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Famotidine

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

04

Suanfarma

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSuanfarma, at the Core of a Better Life.

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Famotidine

About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...

Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
Suanfarma

05

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  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Famotidine

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
Dr Reddy Company Banner

06

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Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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Famotidine

About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
Gonane Pharma

07

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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Famotidine

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
Jai Radhe Sales

08

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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Famotidine

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
Faran Shimi Pharmaceutical

09

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  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Famotidine

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

10

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Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Famotidine

About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...

Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a wide range of products such as tablets, capsules, syrups and ointments. Its portfolio includes finished dosage formulations, herbal/food supplements and APIs. It exports bulk drugs, finished formulations and APIs, while maintaining quality in compliance with WHO GMP norms. With an experienced team, Octavius Pharma provides consulting services for formulation development and marketing. Octavius exports to LATAM, Middle East, African, Asian and CIS countries.
Octavius Pharma
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API Reference Price

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PLC.","supplierCountry":"INDIA","foreign_port":"AQABA FREE ZONE","customer":"ORCHEV PHARMA PVT LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"49.5","totalValueFC":"25718.4","currency":"USD","unitRateINR":"4271.1","date":"30-Mar-2024","totalValueINR":"2135545.13","totalValueInUsd":"25718.4","indian_port":"Ahmedabad ICD","hs_no":"29420034","bill_no":"2811344","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AQABA FREE ZONE","supplierAddress":"NILE STREET, AL-RAJEEB, P.O. 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05-Jan-2021
30-Oct-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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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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01

Brand Name : Pepcid

Famotidine

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euroPLX 86 Munich
Not Confirmed

Brand Name : Pepcid

Canada
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euroPLX 86 Munich
Not Confirmed

Famotidine

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2020 Revenue in Millions : 31

2019 Revenue in Millions : 2

Growth (%) : 1,450

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02

Brand Name : Gaster

Famotidine

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euroPLX 86 Munich
Not Confirmed

Brand Name : Gaster

Japan
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euroPLX 86 Munich
Not Confirmed

Famotidine

Main Therapeutic Indication : Gastrointestinal Disorders

Currency : USD

2016 Revenue in Millions : 103

2015 Revenue in Millions : 140

Growth (%) : -27

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03

Brand Name : Gaster

Famotidine

arrow
euroPLX 86 Munich
Not Confirmed

Brand Name : Gaster

Japan
arrow
euroPLX 86 Munich
Not Confirmed

Famotidine

Main Therapeutic Indication : Gastrointestinal Disorders

Currency : USD

2017 Revenue in Millions : 21

2016 Revenue in Millions : 109

Growth (%) : -81

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