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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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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin HCl EP/ USP

Date of Issue : 2022-06-30

Valid Till : 2025-07-02

Written Confirmation Number : WC-0028

Address of the Firm : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandai, Medchal-Malkajgiri Distr...

Granules India

02

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin Hydrochloride IP/BP/EP/USP

Date of Issue : 2022-06-29

Valid Till : 2025-07-02

Written Confirmation Number : WC-0116

Address of the Firm : H. No. 6-5 & 6-11, Temple Road, Bonthapalli, Jinnaram Mandal, Medak Dist., Hyder...

Granules India

03

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin Hydrochloride IP/IH/BP/USP

Date of Issue : 2022-07-08

Valid Till : 2025-06-28

Written Confirmation Number : WC-0024

Address of the Firm : Plot No-8, Jawaharlal Nehru Pharamacity,Tadi (v), Parawada (M), Vishakapatnam Di...

Granules India

04

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Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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Metformin Hydrochloride IP/BP/EP/USP/JP

Date of Issue : 2022-03-24

Valid Till : 2025-03-17

Written Confirmation Number : WC-0004

Address of the Firm : Village Fatehgarh Chana, Mansa Road, Barnala, Punjab

IOL Chemicals

05

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Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

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Metformin Hydrochloride BP/Ph.Eur.lUSP

Date of Issue : 2022-06-27

Valid Till : 2025-06-02

Written Confirmation Number : WC-0012

Address of the Firm : MIs USV Private Limited ,B-1/8,MIDC, Lote Parshuram, Tal., Dist. Ratnagiri, Khed...

USV Private Limited

06

Pharma, Lab & Chemical Expo
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Pharma, Lab & Chemical Expo
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Metformine Hydrochloride (IP/USP/BP/Ph.Eur.)/DC granules 90% & 95%

Date of Issue : 2013-08-30

Valid Till : 2016-07-02

Written Confirmation Number : WC-0240

Address of the Firm : Plot No.145-150,153,154A,IDA, Kondapally, Ibrahimpatnam Mandal,Krishna District-...

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07

Pharma, Lab & Chemical Expo
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Metformin Hydrochloride BP/EP/USP/JP/CP

Date of Issue : 2024-03-01

Valid Till : 2026-12-03

Written Confirmation Number : WC-0276

Address of the Firm : Plot No. 628 A &B, ECP Canal Road, Village- Luna, Tal-Padra, Dist-Vadodara-39144...

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08

Laurus Labs

India
Pharma, Lab & Chemical Expo
Not Confirmed
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Laurus Labs

India
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Pharma, Lab & Chemical Expo
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Metformin Hydrochloride (IP/USP/Ph.Eur/BP/JP/IH)

Date of Issue : 2023-07-03

Valid Till : 2025-07-02

Written Confirmation Number : WC-0213

Address of the Firm : Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakh...

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09

Laurus Labs

India
Pharma, Lab & Chemical Expo
Not Confirmed
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Laurus Labs

India
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Metformin HCl EP

Date of Issue : 2021-08-27

Valid Till : 2024-08-26

Written Confirmation Number : WC-0507

Address of the Firm : Plot No 19, 20 & 21, Western sector, APSEZ, Atchutapuram Mandal, Vishakhapatnam ...

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10

Pharma, Lab & Chemical Expo
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Metformin Hydrochloride (USP/EP/BP)

Date of Issue : 2022-06-08

Valid Till : 2025-07-25

Written Confirmation Number : WC-0159

Address of the Firm : A-7/A-8, MIDC, Ahmednagar-414 111, Maharashtra State

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KDMF

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01

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2022-05-17

Registration Number : 20050831-37-C-34-05(11)

Manufacturer Name : Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

02

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2020-07-21

Registration Number : 20200721-37-C-387-28

Manufacturer Name : Granules India Limited

Manufacturer Address : H.No. 6-5 & 6-11, Temple Road, Bonthapally Village Gummadidala Mandal Sangareddy Dist...

Granules India

03

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Hiple Co., Ltd.

Registration Date : 2011-06-15

Registration Number : 20050831-37-C-34-05(4)

Manufacturer Name : GRANULES INDIA LIMITED

Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, IDA Jeedimetla, Quthbullapur Mandal, Medchal-Malkajg...

Granules India

04

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Korea United Pharmaceutical Co., Ltd.

Registration Date : 2011-06-15

Registration Number : 20050831-37-C-34-05(5)

Manufacturer Name : Granules India Ltd

Manufacturer Address : 15A/1, Phase-Ⅲ IDA, Jeedimetla, Hyderabad-500055, Telangana, India_x000D_

Granules India

05

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Wonpung Pharmaceutical Co., Ltd.

Registration Date : 2011-10-07

Registration Number : 20050831-37-C-34-05(7)

Manufacturer Name : Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

06

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Agerson Bio Co., Ltd.

Registration Date : 2023-01-13

Registration Number : 20050831-37-C-34-05(13)

Manufacturer Name : M/s Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

07

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2012-10-12

Registration Number : 20050831-37-C-34-05(9)

Manufacturer Name : Granules India Limited

Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri ...

Granules India

08

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Youngpoong Pharmaceutical Co., Ltd.

Registration Date : 2011-08-19

Registration Number : 20050831-37-C-34-05(6)

Manufacturer Name : Granules India Ltd.

Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, IDA Jeedimetla, Quthbullapur Mandal, Medchal-Malkajg...

Granules India

09

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Palm East Co., Ltd.

Registration Date : 2021-10-20

Registration Number : 20050831-37-C-34-05(10)

Manufacturer Name : M/s Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

10

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin hydrochloride

Registrant Name : Base Farm Co., Ltd.

Registration Date : 2011-12-09

Registration Number : 20050831-37-C-34-05(8)

Manufacturer Name : Granules India Limited

Manufacturer Address : 15A/1, Phase-Ⅲ IDA, Jeedimetla, Hyderabad-500055

Granules India
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NDC API

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01

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-417

Start Marketing Date : 2021-03-25

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (750mg/kg)

Marketing Category : EXPORT ONLY

Granules India

02

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-144

Start Marketing Date : 2021-07-23

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (97mg/100mg)

Marketing Category : EXPORT ONLY

Granules India

03

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-012

Start Marketing Date : 2017-10-24

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

Granules India

04

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-416

Start Marketing Date : 2021-03-25

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (500mg/kg)

Marketing Category : EXPORT ONLY

Granules India

05

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-951

Start Marketing Date : 2017-08-11

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Granules India

06

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-711

Start Marketing Date : 2013-10-24

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (95mg/100mg)

Marketing Category : EXPORT ONLY

Granules India

07

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-400

Start Marketing Date : 2017-08-17

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (95mg/100mg)

Marketing Category : EXPORT ONLY

Granules India

08

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-931

Start Marketing Date : 2018-05-15

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

Granules India

09

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Pharma, Lab & Chemical Expo
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 62207-012

Start Marketing Date : 2017-10-24

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

Granules India

10

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Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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METFORMIN HYDROCHLORIDE

NDC Package Code : 49716-336

Start Marketing Date : 2023-10-15

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

IOL Chemicals
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Metformin HCl

About the Company : Granules is a vertically integrated fast-growing Pharmaceutical company headquartered in Hyderabad with best-in-class facilities & a commitment to operational excellence, quality, ...

Granules is a vertically integrated fast-growing Pharmaceutical company headquartered in Hyderabad with best-in-class facilities & a commitment to operational excellence, quality, & customer service. The company is present in the manufacturing of the entire value chain – from APIs, Formulation Intermediates, & Formulations. Their products are being distributed to over 300+ customers with a global presence extending to over 80+ countries with offices across India, US & UK.
Granules India

02

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Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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Metformin

About the Company : With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty ch...

With a history spanning over three decades, IOL Chemicals and Pharmaceuticals Limited is an innovation-driven company that specializes in bulk drugs, intermediates and specialty chemicals. As an API-based company, IOL Chemicals has substantial manufacturing capacities that provide economies of scale and cost advantages. It also has extensive expertise in specialty chemicals. IOL Chemicals’ API portfolio includes various therapeutic categories such as pain management, anti-diabetic, anti-hypertensive and anti-convulsant. IOL Chemicals is a backward-integrated company that produces all intermediates and key starting materials for ibuprofen.
IOL Chemicals

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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Metformin

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

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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Metformin

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
Rochem

05

Temad Co

Iran
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Virtual BoothTemad- We think of world-class quality.

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Metformin

About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...

Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Middle East. Apart from complying with Iranian GMP regulations, Temad has acquired the national & international standards of API manufacturing such as ISO 9001/14001/17025/45001 and OHSAS 18001. It currently manufactures more than 115 pharmaceutical products, including narcotics and non-narcotics, in accordance with GMP and WHO standards and regulations. Temad exports its products to 45 countries worldwide.
Temad

06

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

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Metformin

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

07

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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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Metformin Hydrochloride

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

08

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Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

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Metformin HCl

About the Company : Gangwal Healthcare – a solutions provider for Complex, Innovative & Cutting-edge technological formulations!
The building of a "best-in-class" solution provider starts wit...

Gangwal Healthcare – a solutions provider for Complex, Innovative & Cutting-edge technological formulations! The building of a "best-in-class" solution provider starts with understanding the complexities of a customer's needs and identifying gaps. New technologies and Drug Delivery Systems are studied, and appropriate excipients are identified to resolve the problem. Working closely with our customers for over 35 years, Gangwal has made this possible due to a team of highly technical and marketing professionals with decades of experience in problem-solving.
Gangwal Healthcare CB

09

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

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Metformin

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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Metformin

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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02-Jan-2021
30-Nov-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

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Drugs in Development

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Details:

Saxagliptin and Metformin Hydrochloride extended-release tablets is a dipeptidyl peptidase-4 (DPP4) inhibitor and biguanide combination product indicated for adults with type 2 diabetes mellitus.


Lead Product(s): Saxagliptin,Metformin

Therapeutic Area: Endocrinology Brand Name: Kombiglyze-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 10, 2023

Dr Reddy Company Banner

01

Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : Saxagliptin,Metformin

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Saxagliptin and Metformin Hydrochloride extended-release tablets is a dipeptidyl peptidase-4 (DPP4) inhibitor and biguanide combination product indicated for adults with type 2 diabetes mellitus.

Brand Name : Kombiglyze-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 10, 2023

Dr Reddy Company Banner

Details:

Vildagliptin/Metformin generic version launched in Africa market, the drug ais a diabetes medicine that are used to control the blood glucose (sugar) in adults with type 2 diabetes, by inhibiting DPP-4.


Lead Product(s): Vildagliptin,Metformin

Therapeutic Area: Endocrinology Brand Name: Vildagliptin-Metformin-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 08, 2022

Tiefenbacher Compnay Banner

02

Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : Vildagliptin,Metformin

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Vildagliptin/Metformin generic version launched in Africa market, the drug ais a diabetes medicine that are used to control the blood glucose (sugar) in adults with type 2 diabetes, by inhibiting DPP-4.

Brand Name : Vildagliptin-Metformin-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 08, 2022

Tiefenbacher Compnay Banner

Details:

Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.


Lead Product(s): Vildagliptin,Dapagliflozin,Metformin

Therapeutic Area: Endocrinology Brand Name: Jalra Trio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 11, 2023

USV Private Limited

03

Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : Vildagliptin,Dapagliflozin,Metformin

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.

Brand Name : Jalra Trio

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 11, 2023

USV Private Limited

Details:

Granules India has been granted final FDA approval for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, generic equivalent of Glumetza ER Tablets, 500 mg and 1000 mg, of Bausch Health US LLC (Bausch).


Lead Product(s): Metformin

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2021

Granules India

04

Pharma, Lab & Chemical Expo
Not Confirmed

Lead Product(s) : Metformin

Therapeutic Area : Endocrinology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Granules India has been granted final FDA approval for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, generic equivalent of Glumetza ER Tablets, 500 mg and 1000 mg, of Bausch Hea...

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 13, 2021

Granules India

Details:

Janumet-Generic (sitagliptin & metformin HCl) is a DPP-4 inhibitor & biguanide FDC product indicated as adjunct to diet & exercise to improve glycemic control in adults with type 2 diabetes mellitus.


Lead Product(s): Sitagliptin Phosphate,Metformin

Therapeutic Area: Endocrinology Brand Name: Janumet-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 28, 2024

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05

Lupin Ltd

India
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Lupin Ltd

India
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Janumet-Generic (sitagliptin & metformin HCl) is a DPP-4 inhibitor & biguanide FDC product indicated as adjunct to diet & exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Brand Name : Janumet-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 28, 2024

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Details:

NMPA approved Chiglitazar, a noval PPAR (Peroxidase Proliferator Activated Receptor) full agonist developed by the company independently, combined with Metformin for the treatment of type 2 diabetes.


Lead Product(s): Chiglitazar Sodium,Metformin

Therapeutic Area: Endocrinology Brand Name: Bilessglu

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 19, 2024

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06

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : NMPA approved Chiglitazar, a noval PPAR (Peroxidase Proliferator Activated Receptor) full agonist developed by the company independently, combined with Metformin for the treatment of type 2 diabetes.

Brand Name : Bilessglu

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 19, 2024

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Details:

Trijardy XR-Generic is a combination product of empagliflozin, linagliptin & metformin hydrochloride which is indicated for the treatment of adults with type 2 diabetes mellitus.


Lead Product(s): Empagliflozin,Linagliptin,Metformin

Therapeutic Area: Endocrinology Brand Name: Trijardy XR-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 10, 2024

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07

Lupin Ltd

India
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Lupin Ltd

India
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Trijardy XR-Generic is a combination product of empagliflozin, linagliptin & metformin hydrochloride which is indicated for the treatment of adults with type 2 diabetes mellitus.

Brand Name : Trijardy XR-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 10, 2024

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Details:

Invokamet-Generic (canagliflozin and metformin HCl) T is a SGLT2 inhibitor & biguanide combination product indicated for the treatment of adults with type 2 diabetes mellitus.


Lead Product(s): Canagliflozin,Metformin

Therapeutic Area: Endocrinology Brand Name: Invokamet-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 06, 2024

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08

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Invokamet-Generic (canagliflozin and metformin HCl) T is a SGLT2 inhibitor & biguanide combination product indicated for the treatment of adults with type 2 diabetes mellitus.

Brand Name : Invokamet-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 06, 2024

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Details:

Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.


Lead Product(s): Teneligliptin Hydrobromide,Dapagliflozin,Metformin

Therapeutic Area: Endocrinology Brand Name: Zita DM

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 18, 2023

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09

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.

Brand Name : Zita DM

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 18, 2023

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Details:

RJx-01, a novel combination drug comprising galantamine and metformin, demonstrated positive results in 42 elderly male subjects with disuse-induced muscle atrophy.


Lead Product(s): Galantamine Hydrobromide,Metformin

Therapeutic Area: Musculoskeletal Brand Name: RJx-01

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 04, 2023

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10

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : RJx-01, a novel combination drug comprising galantamine and metformin, demonstrated positive results in 42 elderly male subjects with disuse-induced muscle atrophy.

Brand Name : RJx-01

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 04, 2023

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Europe

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01

SANOFI SpA

France
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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Italy

Metformin; Glyburide

Brand Name : Suguan M

Dosage Form : Metformin+Glibenclamide+2,5400 Mg 40 Combined Oral Use

Dosage Strength : 40 cpr riv 2.5 mg + 400mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Sanofi Company Banner

02

Helvepharm AG

France
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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride

Brand Name : Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

03

Helvepharm AG

France
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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride

Brand Name : Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

04

Helvepharm AG

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride

Brand Name : Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

05

Helvepharm AG

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride

Brand Name : Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

06

Helvepharm AG

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride

Brand Name : Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 850mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

07

Helvepharm AG

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride; Sitagliptin

Brand Name : Sitagliptin Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 50/1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

08

Helvepharm AG

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride; Sitagliptin

Brand Name : Sitagliptin Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 50/1000mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

09

Helvepharm AG

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride; Sitagliptin

Brand Name : Sitagliptin Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 50/500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

10

Helvepharm AG

France
arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Metformin hydrochloride; Sitagliptin

Brand Name : Sitagliptin Metformin Zentiva

Dosage Form : Filmtabl

Dosage Strength : 50/850mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner
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Listed Dossiers

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01

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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : US, ROW

Registration Country : India

Dapagliflozin; Metformin

Brand Name :

Dosage Form : Extended ReleaseTablet...

Dosage Strength : 5MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

Granules India

01

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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : US, ROW

Dapagliflozin; Metformin

Dosage : Extended ReleaseTablet...

Dosage Strength : 5MG; 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

02

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : US, ROW

Registration Country : India

Empagliflozin; Linagliptin; Metformin

Brand Name :

Dosage Form : Extended ReleaseTablet...

Dosage Strength : 10MG; 5MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

Granules India

02

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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : US, ROW

Empagliflozin; Linagliptin; Metformin

Dosage : Extended ReleaseTablet...

Dosage Strength : 10MG; 5MG; 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

03

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : US, ROW

Registration Country : India

Empagliflozin; Linagliptin; Metformin

Brand Name :

Dosage Form : Extended ReleaseTablet...

Dosage Strength : 12.5MG; 2.5MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

Granules India

03

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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : US, ROW

Empagliflozin; Linagliptin; Metformin

Dosage : Extended ReleaseTablet...

Dosage Strength : 12.5MG; 2.5MG; 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

04

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : US, ROW

Registration Country : India

Empagliflozin; Metformin

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 5MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

Granules India

04

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : US, ROW

Empagliflozin; Metformin

Dosage : Immediate Release Tabl...

Dosage Strength : 5MG; 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

05

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : US, ROW

Registration Country : India

Empagliflozin; Metformin

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 12.5MG; 850MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

Granules India

05

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : US, ROW

Empagliflozin; Metformin

Dosage : Immediate Release Tabl...

Dosage Strength : 12.5MG; 850MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

06

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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : US, ROW

Registration Country : India

Empagliflozin; Metformin

Brand Name :

Dosage Form : Extended ReleaseTablet...

Dosage Strength : 25MG; 1GM

Packaging :

Approval Date :

Application Number :

Regulatory Info : US, ROW

Registration Country : India

Granules India

06

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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : US, ROW

Empagliflozin; Metformin

Dosage : Extended ReleaseTablet...

Dosage Strength : 25MG; 1GM

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

07

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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : ROW, US

Registration Country : India

Linagliptin; Metformin

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 2.5MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

07

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : ROW, US

Linagliptin; Metformin

Dosage : Immediate Release Tabl...

Dosage Strength : 2.5MG; 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

08

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : ROW, US

Registration Country : India

Metformin

Brand Name :

Dosage Form : Extended ReleaseTablet...

Dosage Strength : 750MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

08

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : ROW, US

Metformin

Dosage : Extended ReleaseTablet...

Dosage Strength : 750MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

09

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : ROW, US

Registration Country : India

Sitagliptin Phosphate; Metformin

Brand Name :

Dosage Form : Extended Release Table...

Dosage Strength : 50MG; 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

09

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : ROW, US

Sitagliptin Phosphate; Metformin

Dosage : Extended Release Table...

Dosage Strength : 50MG; 500MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India

10

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Regulatory Info : ROW, US

Registration Country : India

Sitagliptin Phosphate; Metformin

Brand Name :

Dosage Form : Immediate Release Tabl...

Dosage Strength : 50MG; 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

10

arrow
Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : ROW, US

Sitagliptin Phosphate; Metformin

Dosage : Immediate Release Tabl...

Dosage Strength : 50MG; 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Granules India
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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

USFDA APPLICATION NUMBER - 200678

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 5MG BASE

USFDA APPLICATION NUMBER - 200678

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG;EQ 5MG BASE

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

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

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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