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Chemistry

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Also known as: 657-24-9, 1,1-dimethylbiguanide, N,n-dimethylimidodicarbonimidic diamide, Fluamine, Metformine, Metiguanide
Molecular Formula
C4H11N5
Molecular Weight
129.16  g/mol
InChI Key
XZWYZXLIPXDOLR-UHFFFAOYSA-N
FDA UNII
9100L32L2N

Metformin
A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
Metformin is a Biguanide.
1 2D Structure

Metformin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-(diaminomethylidene)-1,1-dimethylguanidine
2.1.2 InChI
InChI=1S/C4H11N5/c1-9(2)4(7)8-3(5)6/h1-2H3,(H5,5,6,7,8)
2.1.3 InChI Key
XZWYZXLIPXDOLR-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(C)C(=N)N=C(N)N
2.2 Other Identifiers
2.2.1 UNII
9100L32L2N
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dimethylbiguanidine

2. Dimethylguanylguanidine

3. Glucophage

4. Hcl, Metformin

5. Hydrochloride, Metformin

6. Metformin Hcl

7. Metformin Hydrochloride

2.3.2 Depositor-Supplied Synonyms

1. 657-24-9

2. 1,1-dimethylbiguanide

3. N,n-dimethylimidodicarbonimidic Diamide

4. Fluamine

5. Metformine

6. Metiguanide

7. Dimethylbiguanide

8. Haurymelin

9. Flumamine

10. Gliguanid

11. Melbin

12. Imidodicarbonimidic Diamide, N,n-dimethyl-

13. N,n-dimethylbiguanide

14. N1,n1-dimethylbiguanide

15. Dmgg

16. Nndg

17. N,n-dimethyldiguanide

18. 3-(diaminomethylidene)-1,1-dimethylguanidine

19. 1,1-dimethyl Biguanide

20. Biguanide, 1,1-dimethyl-

21. La-6023

22. Metformin Extended Release

23. Chembl1431

24. Chebi:6801

25. Glifage

26. Islotin

27. Siofor

28. Dimethyldiguanide

29. Diaformin

30. 9100l32l2n

31. Metformina [dcit]

32. Metforminum

33. Metformina

34. Metformina [spanish]

35. Metformine [inn-french]

36. Metforminum [inn-latin]

37. Metformin [usan:inn:ban]

38. Mls000028493

39. [14c]metformin

40. [14c]-metformin

41. 657m249

42. Metformin (usan/inn)

43. Ncgc00016564-01

44. Smr000058277

45. Einecs 211-517-8

46. Cas-1115-70-4

47. Dianben

48. Obimet

49. Dimethylbiguanid

50. Ccris 9321

51. Unii-9100l32l2n

52. N-dimethylbiguanide

53. Dmbg

54. Glucophage (salt/mix)

55. Metformin [inn]

56. N',n'-dimethylbiguanide

57. Metformin [mi]

58. Metformin [usan]

59. Imidodicarbonimidic Diamide-, N,n-dimethyl-

60. Prestwick0_000004

61. Prestwick1_000004

62. Prestwick2_000004

63. Prestwick3_000004

64. Metformin [vandf]

65. Dsstox_cid_3270

66. N,n-dimethylguanylguanidin

67. Metformin [who-dd]

68. Schembl8944

69. Dsstox_rid_76950

70. Dsstox_gsid_23270

71. Bspbio_000007

72. Bspbio_002314

73. Kbiogr_002310

74. Kbioss_002312

75. Cid_14219

76. La 6023 (salt/mix)

77. Bidd:gt0697

78. Spbio_001928

79. Bpbio1_000009

80. Gtpl4503

81. Gtpl4779

82. Schembl9913821

83. Dtxsid2023270

84. Schembl10276396

85. Bdbm57047

86. Kbio2_002310

87. Kbio2_004878

88. Kbio2_007446

89. Kbio3_002790

90. Cmap_000016

91. Hms2089d19

92. Hy-b0627

93. Tox21_302370

94. Bbl012337

95. Bdbm50229665

96. Hsci1_000295

97. Mfcd00242652

98. Nsc813213

99. S5958

100. Stk011633

101. Stl483693

102. Stl484070

103. Zinc12859773

104. Akos000121065

105. Akos005206848

106. Akos015966566

107. Ccg-102605

108. Db00331

109. Nsc-813213

110. 3-carbamimidoyl-1,1-dimethyl-guanidine

111. Ncgc00016564-02

112. Ncgc00016564-03

113. Ncgc00016564-05

114. Ncgc00016564-07

115. Ncgc00188959-01

116. Ncgc00255255-01

117. Ac-32484

118. As-65365

119. Cas-657-24-9

120. Sbi-0206876.p001

121. 1-carbamimidamido-n,n-dimethylmethanimidamide

122. Cs-0009563

123. Ft-0628266

124. A19551

125. C07151

126. D04966

127. D72476

128. Q19484

129. (e)-3-[amino(dimethylamino)methylidene]guanidine

130. 1-[(e)-amino(dimethylamino)methylidene]guanidine

131. W-109589

132. Brd-k79602928-003-04-1

133. Brd-k79602928-003-08-2

134. 3-(diaminomethylene)-1,1-dimethyl-guanidine;hydrochloride

135. 3-[bis(azanyl)methylidene]-1,1-dimethyl-guanidine;hydrochloride

136. Mf8

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 129.16 g/mol
Molecular Formula C4H11N5
XLogP3-1.3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count1
Rotatable Bond Count2
Exact Mass129.10144537 g/mol
Monoisotopic Mass129.10144537 g/mol
Topological Polar Surface Area91.5 Ų
Heavy Atom Count9
Formal Charge0
Complexity132
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 10  
Drug NameFortamet
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Active IngredientMetformin hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength500mg; 1gm
Market StatusPrescription
CompanyAndrx Labs

2 of 10  
Drug NameGlucophage
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Drug LabelGLUCOPHAGE (metformin hydrochloride) Tablets and GLUCOPHAGE XR (metformin hydrochloride) Extended-Release Tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic...
Active IngredientMetformin hydrochloride
Dosage FormTablet
RouteOral
Strength850mg; 500mg; 1gm
Market StatusPrescription
CompanyBristol Myers Squibb

3 of 10  
Drug NameGlucophage xr
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Drug LabelGLUCOPHAGE (metformin hydrochloride) Tablets and GLUCOPHAGE XR (metformin hydrochloride) Extended-Release Tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic...
Active IngredientMetformin hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength500mg; 750mg
Market StatusPrescription
CompanyBristol Myers Squibb

4 of 10  
Drug NameGlumetza
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Active IngredientMetformin hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength500mg; 1gm
Market StatusPrescription
CompanySantarus

5 of 10  
Drug NameRiomet
Active IngredientMetformin hydrochloride
Dosage FormSolution
RouteOral
Strength500mg/5ml
Market StatusPrescription
CompanyRanbaxy

6 of 10  
Drug NameFortamet
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Active IngredientMetformin hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength500mg; 1gm
Market StatusPrescription
CompanyAndrx Labs

7 of 10  
Drug NameGlucophage
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Drug LabelGLUCOPHAGE (metformin hydrochloride) Tablets and GLUCOPHAGE XR (metformin hydrochloride) Extended-Release Tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic...
Active IngredientMetformin hydrochloride
Dosage FormTablet
RouteOral
Strength850mg; 500mg; 1gm
Market StatusPrescription
CompanyBristol Myers Squibb

8 of 10  
Drug NameGlucophage xr
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Drug LabelGLUCOPHAGE (metformin hydrochloride) Tablets and GLUCOPHAGE XR (metformin hydrochloride) Extended-Release Tablets are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic...
Active IngredientMetformin hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength500mg; 750mg
Market StatusPrescription
CompanyBristol Myers Squibb

9 of 10  
Drug NameGlumetza
PubMed HealthMetformin (By mouth)
Drug ClassesHypoglycemic
Active IngredientMetformin hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength500mg; 1gm
Market StatusPrescription
CompanySantarus

10 of 10  
Drug NameRiomet
Active IngredientMetformin hydrochloride
Dosage FormSolution
RouteOral
Strength500mg/5ml
Market StatusPrescription
CompanyRanbaxy

4.2 Therapeutic Uses

Hypoglycemic Agents

National Library of Medicine's Medical Subject Headings. Metformin. Online file (MeSH, 2016). Available from, as of October 28, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html


Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. /Included in US product label/

NIH; DailyMed. Current Medication Information for Metformin Hydrochloride Tablet (Updated: December 2015). Available from, as of November 23, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da99b8c4-f85e-409f-93a8-0e4758d74552


Metformin has been used in the management of metabolic and reproductive abnormalities associated with polycystic ovary syndrome. However, adequate and well-controlled clinical trials evaluating metformin therapy for polycystic ovary syndrome remain limited, particularly regarding long-term efficacy, and available data are conflicting regarding the benefits of the drug in ameliorating various manifestations of the condition. /NOT included in US product label/

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3194


Metformin is commercially available in fixed combination with glyburide or glipizide for use as an adjunct to diet and exercise to improve glycemic control in adults with diabetes mellitus; such fixed-combination preparations may be used as initial therapy in patients whose hyperglycemia cannot be controlled by diet and exercise alone, or as second-line therapy in patients who do not achieve adequate control of hyperglycemia with metformin or sulfonylurea monotherapy. A thiazolidinedione may be added to metformin in fixed combination with glyburide in patients who have inadequate glycemic control with fixed-combination therapy.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3191


For more Therapeutic Uses (Complete) data for METFORMIN (18 total), please visit the HSDB record page.


4.3 Drug Warning

/BOXED WARNING/ Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with metformin; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels > 5 ug/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride tablets, USP is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin hydrochloride tablets, USP treatment should not be initiated in patients = 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking metformin hydrochloride tablets, USP since alcohol potentiates the effects of metformin hydrochloride tablets, USP on lactate metabolism. In addition, metformin should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure. The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence and nonspecific abdominal distress. There may be associated hypothermia, hypotension and resistant bradyarrhythmias with more marked acidosis. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur. Metformin hydrochloride tablets, USP should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose and, if indicated, blood pH, lactate levels and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of metformin, gastrointestinal symptoms, which are common during initiation of therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms, could be due to lactic acidosis or other serious disease. Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking metformin do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity or technical problems in sample handling. Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia). Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking metformin, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride tablets, USP are dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery.

NIH; DailyMed. Current Medication Information for Metformin Hydrochloride Tablet (Updated: December 2015). Available from, as of November 23, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da99b8c4-f85e-409f-93a8-0e4758d74552


Accumulation of metformin may occur in patients with renal impairment, and such accumulation rarely can result in lactic acidosis, a serious, potentially fatal metabolic disease. The risk of developing lactic acidosis is much lower (e.g., 10-fold lower) with metformin than with phenformin (no longer commercially available in the US). However, lactic acidosis constitutes a medical emergency requiring immediate hospitalization and treatment; in such cases, metformin should be discontinued and general supportive therapy (e.g., volume expansion, diuresis) should be initiated immediately. Prompt hemodialysis also is recommended. Lactic acidosis is characterized by elevated blood lactate concentrations (exceeding 45 mg/dL), decreased blood pH (less than 7.35), electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. Lactic acidosis also may occur in association with a variety of pathophysiologic conditions, including diabetes mellitus, and whenever substantial tissue hypoperfusion and hypoxemia exist. Approximately 50% of cases of metformin-associated lactic acidosis have been reported to be fatal. However, it has been suggested that in such cases of lactic acidosis not accompanied by conditions predisposing to tissue anoxia (e.g., heart failure, renal or pulmonary disease), techniques for the elimination of metformin from the body may allow recovery rates exceeding 80%.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3197-8


Urinary tract infection has been reported in 8 or 1.1% of patients receiving metformin alone or in fixed combination with glipizide, respectively. Hypertension has been reported in 5.6 or 2.9-3.5% of patients receiving metformin alone or in fixed combination with glipizide, respectively. Musculoskeletal pain has been reported in 6.7 or 8% of patients receiving metformin alone or in fixed combination with glipizide, respectively. Severe acute hepatitis associated with marked elevations in serum hepatic aminotransferase values and cholestasis has been reported following initiation of metformin therapy in a patient receiving glipizide and enalapril. Accidental injury was reported in 7.3 or 5.6% of patients receiving metformin as an extended-release tablet preparation (Fortamet) or as conventional tablets, respectively.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3199


Pneumonitis with vasculitis has been reported rarely with concomitant metformin and oral sulfonylurea (e.g., glyburide) therapy. Upper respiratory tract infection was reported in 16.3 or 17.3% of patients receiving metformin or metformin in fixed combination with glyburide, respectively. Upper respiratory tract infection was reported in 8.5 or 8.1-9.9% of patients receiving metformin or metformin in fixed combination with glipizide, respectively, as initial therapy for type 2 diabetes mellitus. Upper respiratory tract infection was reported in 10.7 or 10.3% of patients receiving metformin or metformin in fixed combination with glipizide, respectively, as second-line therapy for type 2 diabetes mellitus. Upper respiratory tract infection was reported in 5.2 or 6.2% of patients receiving metformin or metformin combined with sitagliptin, respectively, in clinical trials. Rhinitis was reported in 4.2 or 5.6% of patients receiving metformin as an extended-release tablet preparation (Fortamet) or as conventional tablets, respectively. Infection was reported in 20.5 or 20.9% of patients receiving an extended-release tablet preparation (Fortamet) or conventional tablets, respectively.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3199


For more Drug Warnings (Complete) data for METFORMIN (23 total), please visit the HSDB record page.


4.4 Drug Indication

**Metformin tablet** Metformin is indicated as an adjunct to diet and exercise to increase glycemic control in _adults and pediatric patients_ 10 years of age and older diagnosed with type 2 diabetes mellitus. **Metformin extended-release tablet (XR)** The extended-release form is indicated as an adjunct to diet and exercise to improve glycemic control in only _adults_ with type 2 diabetes mellitus. Safety in children has not been determined to this date. An extended-release combination product containing empagliflozin, linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

**General effects** Insulin is an important hormone that regulates blood glucose levels. Type II diabetes is characterized by a decrease in sensitivity to insulin, resulting in eventual elevations in blood glucose when the pancreas can no longer compensate. In patients diagnosed with type 2 diabetes, insulin no longer exerts adequate effects on tissues and cells (called insulin resistance) and insulin deficiency may also be present. Metformin reduces liver (hepatic) production of glucose, decreases the intestinal absorption of glucose, and enhances insulin sensitivity by increasing both peripheral glucose uptake and utilization. In contrast with drugs of the _sulfonylurea_ class, which lead to hyperinsulinemia, the secretion of insulin is unchanged with metformin use. **Effect on fasting plasma glucose (FPG) and Glycosylated hemoglobin (HbA1c)** HbA1c is an important periodic measure of glycemic control that is used to monitor diabetic patients. Fasting plasma glucose is also a useful and important measure of glycemic control. In a 29-week clinical trial of subjects diagnosed with type II diabetes, metformin decreased the fasting plasma glucose levels by an average of 59 mg/dL from baseline, compared to an average increase of 6.3 mg/dL from baseline in subjects taking a placebo. Glycosylated hemoglobin (HbA1c) was decreased by about 1.4% in subjects receiving metformin, and increased by 0.4% in subjects receiving placebo only.


5.2 MeSH Pharmacological Classification

Hypoglycemic Agents

Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
METFORMIN
5.3.2 FDA UNII
9100L32L2N
5.3.3 Pharmacological Classes
Biguanides [CS]; Biguanide [EPC]
5.4 ATC Code

A10BA02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


A10BA02

S66 | EAWAGTPS | Parent-Transformation Product Pairs from Eawag | DOI:10.5281/zenodo.3754448


A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10B - Blood glucose lowering drugs, excl. insulins

A10BA - Biguanides

A10BA02 - Metformin


5.5 Absorption, Distribution and Excretion

Absorption

**Regular tablet absorption** The absolute bioavailability of a metformin 500 mg tablet administered in the fasting state is about 50%-60%. Single-dose clinical studies using oral doses of metformin 500 to 1500 mg and 850 to 2550 mg show that there is a lack of dose proportionality with an increase in metformin dose, attributed to decreased absorption rather than changes in elimination. At usual clinical doses and dosing schedules of metformin, steady-state plasma concentrations of metformin are achieved within 24-48 hours and are normally measured at <1 g/mL. **Extended-release tablet absorption** After a single oral dose of metformin extended-release, Cmax is reached with a median value of 7 hours and a range of between 4 and 8 hours. Peak plasma levels are measured to be about 20% lower compared to the same dose of regular metformin, however, the extent of absorption of both forms (as measured by area under the curve - AUC), are similar. **Effect of food** Food reduces the absorption of metformin, as demonstrated by about a 40% lower mean peak plasma concentration (Cmax), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute increase in time to peak plasma concentration (Tmax) after ingestion of an 850 mg tablet of metformin taken with food, compared to the same dose administered during fasting. Though the extent of metformin absorption (measured by the area under the curve - AUC) from the metformin extended-release tablet is increased by about 50% when given with food, no effect of food on Cmax and Tmax of metformin is observed. High and low-fat meals exert similar effects on the pharmacokinetics of extended-release metformin.


Route of Elimination

This drug is substantially excreted by the kidney. Renal clearance of metformin is about 3.5 times higher than creatinine clearance, which shows that renal tubular secretion is the major route of metformin elimination. After oral administration, about 90% of absorbed metformin is eliminated by the kidneys within the first 24 hours post-ingestion.


Volume of Distribution

The apparent volume of distribution (V/F) of metformin after one oral dose of metformin 850 mg averaged at 654 358 L.


Clearance

Renal clearance is about 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours.


Metformin is slowly and incompletely absorbed from the GI tract, mainly from the small intestine; absorption is complete within 6 hours. The absolute oral bioavailability of the drug under fasting conditions is reported to be approximately 50-60% with metformin hydrochloride doses of 0.5-1.5 g; binding of the drug to the intestinal wall may explain the difference between the amount of drug absorbed (as determined by the urinary and fecal excretion of unchanged drug) and the amount bioavailable in some studies. In single-dose studies with metformin hydrochloride conventional tablets doses of 0.5-1.5 g or 0.85-2.55 g, plasma metformin concentrations did not increase in proportion to increasing doses, suggesting an active saturable absorption process. Similarly, in single-dose studies with an extended-release tablet preparation (Glumetza) at doses of 0.5-2.5 g, plasma metformin concentrations did not increase in proportion to increasing doses. At steady state after administration of a metformin hydrochloride extended-release tablet preparation (Glucophage XR), the AUC and peak plasma concentrations were not dose proportional within the range of 0.5-2 g. However, limited data from studies in animals and in human intestinal cell cultures suggest that transepithelial transfer of metformin in the intestine may occur through a passive, nonsaturable mechanism, possibly involving a paracellular route. In several studies with another metformin hydrochloride extended-release tablet preparation (Fortamet) using doses of 1-2.5 g, metformin exposure was dose-related.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3202-3


Following oral administration of metformin hydrochloride (0.5-1.5 g) as conventional tablets in healthy individuals or in patients with type 2 diabetes mellitus, plasma concentrations decline in a triphasic manner. Following multiple-dose administration of metformin hydrochloride (500 mg twice daily for 7-14 days) as conventional tablets in a limited number of patients with type 2 diabetes mellitus, peak plasma concentrations remained unchanged, but trough drug concentrations were higher than with single-dose administration, suggesting some drug accumulation in a peripheral tissue compartment. No accumulation of metformin appears to occur following repeated oral doses of the drug as extended-release tablets. The principal plasma elimination half-life of metformin averages approximately 6.2 hours; 90% of the drug is cleared within 24 hours in patients with normal renal function. The decline in plasma metformin concentrations is slower after oral than after IV administration of the drug, indicating that elimination is absorption rate-limited. Urinary excretion data and data from whole blood indicate a slower terminal-elimination phase half-life of 8-20 hours (e.g., 17.6 hours)1 suggesting that the erythrocyte mass may be a compartment of distribution.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3203


Metformin is distributed rapidly in animals and humans into peripheral body tissues and fluids, particularly the GI tract; the drug also appears to distribute slowly into erythrocytes and into a deep tissue compartment (probably GI tissues). The highest tissue concentrations of metformin (at least 10 times the plasma concentration) occur in the GI tract (e.g., esophagus, stomach, duodenum, jejunum, ileum), with lower concentrations (twice the plasma concentration) occurring in kidney, liver, and salivary gland tissue. The drug distributes into salivary glands with a half-life of about 9 hours. Metformin concentrations in saliva are tenfold lower than those in plasma and may be responsible for the metallic taste reported in some patients receiving the drug. Any local effect of metformin on glucose absorption in the GI tract may be associated with the relatively high GI concentrations of the drug compared with those in other tissues. It is not known whether metformin crosses the blood-brain barrier or the placenta in humans or if the drug is distributed into human milk; however, in lactating rats, metformin is distributed into breast milk at levels comparable to those in plasma.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3203


Renal clearance is approximately 3.5 times greater than creatinine clearance, indicating that tubular secretion is the principal route of metformin elimination. Following a single 850-mg oral dose of metformin hydrochloride, renal clearance averaged 552, 491, or 412 mL/minute in nondiabetic adults, diabetic adults, or healthy geriatric individuals, respectively. Renal impairment results in increased peak plasma concentrations of metformin, a prolonged time to peak plasma concentration, and a decreased volume of distribution. Renal clearance is decreased in patients with renal impairment (as measured by decreases in creatinine clearance) and, apparently because of reduced renal function with age, in geriatric individuals. In geriatric individuals, decreased renal and plasma clearance of metformin also results in increased plasma concentrations of the drug; volume of distribution remains unaffected.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3203


For more Absorption, Distribution and Excretion (Complete) data for METFORMIN (12 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Intravenous studies using a single dose of metformin in normal subjects show that metformin is excreted as unchanged drug in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) or biliary excretion.


Metformin is not metabolized in the liver or GI tract and is not excreted in bile; no metabolites of the drug have been identified in humans.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3203


5.7 Biological Half-Life

Approximately 6.2 hours in the plasma and in the blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution.


The principal plasma elimination half-life of metformin averages approximately 6.2 hours ... .

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3203


The drug distributes into salivary glands with a half-life of about 9 hours.

American Society of Health-System Pharmacists 2016; Drug Information 2016. Bethesda, MD. 2016, p. 3203


5.8 Mechanism of Action

Metformin's mechanisms of action are unique from other classes of oral antihyperglycemic drugs. Metformin decreases blood glucose levels by decreasing hepatic glucose production (gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization. It is well established that metformin inhibits mitochondrial complex I activity, and it has since been generally postulated that its potent antidiabetic effects occur through this mechanism. The above processes lead to a decrease in blood glucose, managing type II diabetes and exerting positive effects on glycemic control. After ingestion, the organic cation transporter-1 (OCT1) is responsible for the uptake of metformin into hepatocytes (liver cells). As this drug is positively charged, it accumulates in cells and in the mitochondria because of the membrane potentials across the plasma membrane as well as the mitochondrial inner membrane. Metformin inhibits mitochondrial complex I, preventing the production of mitochondrial ATP leading to increased cytoplasmic ADP:ATP and AMP:ATP ratios. These changes activate AMP-activated protein kinase (AMPK), an enzyme that plays an important role in the regulation of glucose metabolism. Aside from this mechanism, AMPK can be activated by a lysosomal mechanism involving other activators. Following this process, increases in AMP:ATP ratio also inhibit _fructose-1,6-bisphosphatase_ enzyme, resulting in the inhibition of gluconeogenesis, while also inhibiting _adenylate cyclase_ and decreasing the production of cyclic adenosine monophosphate (cAMP), a derivative of ATP used for cell signaling. Activated AMPK phosphorylates two isoforms of acetyl-CoA carboxylase enzyme, thereby inhibiting fat synthesis and leading to fat oxidation, reducing hepatic lipid stores and increasing liver sensitivity to insulin. In the intestines, metformin increases anaerobic glucose metabolism in enterocytes (intestinal cells), leading to reduced net glucose uptake and increased delivery of lactate to the liver. Recent studies have also implicated the gut as a primary site of action of metformin and suggest that the liver may not be as important for metformin action in patients with type 2 diabetes. Some of the ways metformin may play a role on the intestines is by promoting the metabolism of glucose by increasing glucagon-like peptide I (GLP-1) as well as increasing gut utilization of glucose. In addition to the above pathway, the mechanism of action of metformin may be explained by other ways, and its exact mechanism of action has been under extensive study in recent years.


Metformin is widely used to treat hyperglycemia. However, metformin treatment may induce intrahepatic cholestasis and liver injury in a few patients with type II diabetes through an unknown mechanism. Here we show that metformin decreases SIRT1 protein levels in primary hepatocytes and liver. Both metformin-treated wild-type C57 mice and hepatic SIRT1-mutant mice had increased hepatic and serum bile acid levels. However, metformin failed to change systemic bile acid levels in hepatic SIRT1-mutant mice. Molecular mechanism study indicates that SIRT1 directly interacts with and deacetylates Foxa2 to inhibit its transcriptional activity on expression of genes involved in bile acids synthesis and transport. Hepatic SIRT1 mutation elevates Foxa2 acetylation levels, which promotes Foxa2 binding to and activating genes involved in bile acids metabolism, impairing hepatic and systemic bile acid homeostasis. Our data clearly suggest that hepatic SIRT1 mediates metformin effects on systemic bile acid metabolism and modulation of SIRT1 activity in liver may be an attractive approach for treatment of bile acid-related diseases such as cholestasis.

PMID:27816442 Chen Q et al; Biochim Biophys Acta 1864 (1):101-112 (2016)


Metformin is antihyperglycemic, not hypoglycemic. It does not cause insulin release from the pancreas and does not cause hypoglycemia, even in large doses. Metformin has no significant effects on the secretion of glucagon, cortisol, growth hormone or somatostatin. Metformin reduces glucose levels primarily by decreasing hepatic glucose production and by increasing insulin action in muscle and fat. ... May decrease plasma glucose by reducing the absorption of glucose from the intestine. /Salt not specified/

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1705


Metformin potentiates the effect of insulin by mechanisms not fully understood. Metformin does not stimulate pancreatic beta cells to increase secretion of insulin; insulin secretion must be present for metformin to work properly. It is postulated that metformin decreases hepatic glucose production and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. /Salt not specified/

MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 22nd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2002. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 2004


People with Type 2 diabetes mellitus (T2DM) have reduced bone mineral density and an increased risk of fractures due to altered mesenchymal stem cell (MSC) differentiation in the bone marrow. This leads to a shift in the balance of differentiation away from bone formation (osteogenesis) in favour of fat cell development (adipogenesis). The commonly used anti-diabetic drug, metformin, activates the osteogenic transcription factor Runt-related transcription factor 2 (Runx2), which may suppress adipogenesis, leading to improved bone health. Here we investigate the involvement of the metabolic enzyme, AMP-activated protein kinase (AMPK), in these protective actions of metformin. The anti-adipogenic actions of metformin were observed in multipotent C3H10T1/2 MSCs, in which metformin exerted reciprocal control over the activities of Runx2 and the adipogenic transcription factor, PPARgamma, leading to suppression of adipogenesis. These effects appeared to be independent of AMPK activation but rather through the suppression of the mTOR/p70S6K signalling pathway. Basal AMPK and mTOR/p70S6K activity did appear to be required for adipogenesis, as demonstrated by the use of the AMPK inhibitor, compound C. This observation was further supported by using AMPK knockout mouse embryo fibroblasts (MEFs) where adipogenesis, as assessed by reduced lipid accumulation and expression of the adipogeneic transcription factor, C/EBPbeta, was found to display an absolute requirement for AMPK. Further activation of AMPK in wild type MEFS, with either metformin or the AMPK-specific activator, A769662, was also associated with suppression of adipogenesis. It appears, therefore, that basal AMPK activity is required for adipogenesis and that metformin can inhibit adipogenesis through AMPK-dependent or -independent mechanisms, depending on the cellular context.

PMID:27856330 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5228588 Chen SC et al; Mol Cell Endocrinol. 2016 Nov 14. pii: S0303-7207(16)30470-1. doi: 10.1016/j.mce.2016.11.011. (Epub ahead of print)


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Singapore","customerAddress":"2ND FLOOR, SERENE CHAMBERS,,ROAD N"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751913000,"product":"METFORMIN HYDROCHLORIDE EP (PHARMACEUTICAL PRODUCTS) METFORMIN HYDROCHLORIDE EP (PHARMACEUTICAL PRODUCTS)","address":"SITE NO.1,BOMMASANDRA INDL.AREA,IV","city":"ANEKAL TALUK,BANGALORE","supplier":"SHOUGUANG FUKANG PHARM CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"APOTEX RESEARCH PRIVATE LTD","customerCountry":"INDIA","quantity":"60.00","actualQuantity":"60","unit":"KGS","unitRateFc":"20","totalValueFC":"1201.9","currency":"USD","unitRateINR":"1724","date":"08-Jul-2025","totalValueINR":"103440","totalValueInUsd":"1201.9","indian_port":"Bangalore Air","hs_no":"29339990","bill_no":"3125166","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NORTH-EAST OF DONGWAIHUAN ROAD DONGCHENG INDUSTRIAL AREA, SHOUGUANG CITY CN","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV"}]
01-Jan-2022
31-Jul-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 200678

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 200678

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 200678

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DOSAGE - TABLET;ORAL - 2.5MG;1GM

USFDA APPLICATION NUMBER - 201281

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DOSAGE - TABLET;ORAL - 2.5MG;500MG

USFDA APPLICATION NUMBER - 201281

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DOSAGE - TABLET;ORAL - 2.5MG;850MG

USFDA APPLICATION NUMBER - 201281

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DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;1GM

USFDA APPLICATION NUMBER - 203414

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DOSAGE - TABLET;ORAL - EQ 12.5MG BASE;500MG

USFDA APPLICATION NUMBER - 203414

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DOSAGE - TABLET;ORAL - 1GM **Federal Register...DOSAGE - TABLET;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20357

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DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20357

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DOSAGE - TABLET;ORAL - 625MG **Federal Regist...DOSAGE - TABLET;ORAL - 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20357

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DOSAGE - TABLET;ORAL - 750MG **Federal Regist...DOSAGE - TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20357

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DOSAGE - TABLET;ORAL - 850MG **Federal Regist...DOSAGE - TABLET;ORAL - 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20357

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150MG;1GM

USFDA APPLICATION NUMBER - 205879

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 150MG;500MG

USFDA APPLICATION NUMBER - 205879

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;1GM

USFDA APPLICATION NUMBER - 205879

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;500MG

USFDA APPLICATION NUMBER - 205879

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DOSAGE - TABLET;ORAL - 1.25MG;250MG **Federal...DOSAGE - TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21178

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DOSAGE - TABLET;ORAL - 2.5MG;500MG **Federal ...DOSAGE - TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21178

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DOSAGE - TABLET;ORAL - 5MG;500MG **Federal Re...DOSAGE - TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21178

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21202

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 750M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21202

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DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORA...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORAL - 500MG/5ML

USFDA APPLICATION NUMBER - 212595

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21574

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21574

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DOSAGE - SOLUTION;ORAL - 500MG/5ML **Federal ...DOSAGE - SOLUTION;ORAL - 500MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21591

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM

USFDA APPLICATION NUMBER - 21748

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG

USFDA APPLICATION NUMBER - 21748

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DOSAGE - TABLET;ORAL - 500MG;EQ 15MG BASE **F...DOSAGE - TABLET;ORAL - 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21842

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DOSAGE - TABLET;ORAL - 850MG;EQ 15MG BASE

USFDA APPLICATION NUMBER - 21842

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 15MG BASE

USFDA APPLICATION NUMBER - 22024

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 30MG BASE

USFDA APPLICATION NUMBER - 22024

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DOSAGE - TABLET;ORAL - 1GM;EQ 50MG BASE

USFDA APPLICATION NUMBER - 22044

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DOSAGE - TABLET;ORAL - 500MG;EQ 50MG BASE

USFDA APPLICATION NUMBER - 22044

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DOSAGE - TABLET;ORAL - 500MG;1MG

USFDA APPLICATION NUMBER - 22386

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DOSAGE - TABLET;ORAL - 500MG;2MG

USFDA APPLICATION NUMBER - 22386

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ABOUT THIS PAGE

Looking for 1115-70-4 / Metformin API manufacturers, exporters & distributors?

Metformin manufacturers, exporters & distributors 1

51

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

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

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

API | Excipient name

Metformin

Synonyms

657-24-9, 1,1-dimethylbiguanide, N,n-dimethylimidodicarbonimidic diamide, Fluamine, Metformine, Metiguanide

Cas Number

1115-70-4

Unique Ingredient Identifier (UNII)

9100L32L2N

About Metformin

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

Riomet Manufacturers

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

Riomet Suppliers

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

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

Riomet USDMF

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

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

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

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

Riomet KDMF

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

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

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

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

Riomet CEP

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

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

Riomet WC

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

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

Riomet 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 Riomet as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Riomet GMP

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

Riomet CoA

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

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

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