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    Chemistry

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    Also known as: 657-24-9, 1,1-dimethylbiguanide, N,n-dimethylimidodicarbonimidic diamide, Fluamine, Metformine, Metiguanide
    Molecular Formula
    C4H11N5
    Molecular Weight
    129.16  g/mol
    InChI Key
    XZWYZXLIPXDOLR-UHFFFAOYSA-N
    FDA UNII
    9100L32L2N
    Metformin
    A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
    Metformin is a Biguanide.
    1 2D Structure

    Metformin

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

    1. Dimethylbiguanidine

    2. Dimethylguanylguanidine

    3. Glucophage

    4. Hcl, Metformin

    5. Hydrochloride, Metformin

    6. Metformin Hcl

    7. Metformin Hydrochloride

    2.3.2 Depositor-Supplied Synonyms

    1. 657-24-9

    2. 1,1-dimethylbiguanide

    3. N,n-dimethylimidodicarbonimidic Diamide

    4. Fluamine

    5. Metformine

    6. Metiguanide

    7. Dimethylbiguanide

    8. Haurymelin

    9. Flumamine

    10. Gliguanid

    11. Melbin

    12. Imidodicarbonimidic Diamide, N,n-dimethyl-

    13. N,n-dimethylbiguanide

    14. N1,n1-dimethylbiguanide

    15. Dmgg

    16. Nndg

    17. N,n-dimethyldiguanide

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

    19. 1,1-dimethyl Biguanide

    20. Biguanide, 1,1-dimethyl-

    21. La-6023

    22. Metformin Extended Release

    23. Chembl1431

    24. Chebi:6801

    25. Glifage

    26. Islotin

    27. Siofor

    28. Dimethyldiguanide

    29. Diaformin

    30. 9100l32l2n

    31. Metformina [dcit]

    32. Metforminum

    33. Metformina

    34. Metformina [spanish]

    35. Metformine [inn-french]

    36. Metforminum [inn-latin]

    37. Metformin [usan:inn:ban]

    38. Mls000028493

    39. [14c]metformin

    40. [14c]-metformin

    41. 657m249

    42. Metformin (usan/inn)

    43. Ncgc00016564-01

    44. Smr000058277

    45. Einecs 211-517-8

    46. Cas-1115-70-4

    47. Dianben

    48. Obimet

    49. Dimethylbiguanid

    50. Ccris 9321

    51. Unii-9100l32l2n

    52. N-dimethylbiguanide

    53. Dmbg

    54. Glucophage (salt/mix)

    55. Metformin [inn]

    56. N',n'-dimethylbiguanide

    57. Metformin [mi]

    58. Metformin [usan]

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

    60. Prestwick0_000004

    61. Prestwick1_000004

    62. Prestwick2_000004

    63. Prestwick3_000004

    64. Metformin [vandf]

    65. Dsstox_cid_3270

    66. N,n-dimethylguanylguanidin

    67. Metformin [who-dd]

    68. Schembl8944

    69. Dsstox_rid_76950

    70. Dsstox_gsid_23270

    71. Bspbio_000007

    72. Bspbio_002314

    73. Kbiogr_002310

    74. Kbioss_002312

    75. Cid_14219

    76. La 6023 (salt/mix)

    77. Bidd:gt0697

    78. Spbio_001928

    79. Bpbio1_000009

    80. Gtpl4503

    81. Gtpl4779

    82. Schembl9913821

    83. Dtxsid2023270

    84. Schembl10276396

    85. Bdbm57047

    86. Kbio2_002310

    87. Kbio2_004878

    88. Kbio2_007446

    89. Kbio3_002790

    90. Cmap_000016

    91. Hms2089d19

    92. Hy-b0627

    93. Tox21_302370

    94. Bbl012337

    95. Bdbm50229665

    96. Hsci1_000295

    97. Mfcd00242652

    98. Nsc813213

    99. S5958

    100. Stk011633

    101. Stl483693

    102. Stl484070

    103. Zinc12859773

    104. Akos000121065

    105. Akos005206848

    106. Akos015966566

    107. Ccg-102605

    108. Db00331

    109. Nsc-813213

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

    111. Ncgc00016564-02

    112. Ncgc00016564-03

    113. Ncgc00016564-05

    114. Ncgc00016564-07

    115. Ncgc00188959-01

    116. Ncgc00255255-01

    117. Ac-32484

    118. As-65365

    119. Cas-657-24-9

    120. Sbi-0206876.p001

    121. 1-carbamimidamido-n,n-dimethylmethanimidamide

    122. Cs-0009563

    123. Ft-0628266

    124. A19551

    125. C07151

    126. D04966

    127. D72476

    128. Q19484

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

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

    131. W-109589

    132. Brd-k79602928-003-04-1

    133. Brd-k79602928-003-08-2

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

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

    136. Mf8

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

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

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

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

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

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

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

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

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

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

    4.2 Therapeutic Uses

    Hypoglycemic Agents

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

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

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

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

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

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

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

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

    4.3 Drug Warning

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

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

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

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

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

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

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

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

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

    4.4 Drug Indication

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

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

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

    5.2 MeSH Pharmacological Classification

    Hypoglycemic Agents

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

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

    A10BA02

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

    A10BA02

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

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BA - Biguanides

    A10BA02 - Metformin

    5.5 Absorption, Distribution and Excretion

    Absorption

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

    Route of Elimination

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

    Volume of Distribution

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

    Clearance

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

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

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

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

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

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

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

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

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

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

    5.6 Metabolism/Metabolites

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

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

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

    5.7 Biological Half-Life

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

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

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

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

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

    5.8 Mechanism of Action

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

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

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

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

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

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

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

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

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

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    Granules India Limited

    India
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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

    Registration Number : 305MF10066

    Registrant's Address : 2nd Floor, 3rd Block My Home Hub, Madhapur, Hyderabad, Telangana 500081 India

    Initial Date of Registration : 2023-05-24

    Latest Date of Registration : 2023-05-24

    Granules India

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    02

    USV Private Limited

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

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    Japanese Pharmacopoeia Metformin Hydrochloride

    Registration Number : 219MF10176

    Registrant's Address : Arvind Vithal Gandhi Chowk,B. S. D. Marg, Govandi, Mumbai-400 088, India

    Initial Date of Registration : 2007-06-01

    Latest Date of Registration : 2014-11-17

    USV Private Limited

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    03

    Farmhispania S. A.

    Spain
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    SupplySide West 2024
    Not Confirmed
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    Virtual BoothFarmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

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    Metformin hydrochloride

    Registration Number : 220MF10154

    Registrant's Address : Balmes 85, Atico, 08008 (Barcelona), Spain

    Initial Date of Registration : 2008-06-30

    Latest Date of Registration : 2008-06-30

    Farmhispania

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    04

    Exemed Pharmaceuticals

    India
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    Exemed Pharmaceuticals

    India
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    Not Confirmed
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    Metformin Hydrochloride (Japanese Pharmacopoeia)

    Registration Number : 302MF10117

    Registrant's Address : Block No. 628 (A&B), ECP Canal Road, Village-Luna, Tal-Padra, Dist. -Vadodara, Gujara...

    Initial Date of Registration : 2020-10-01

    Latest Date of Registration : 2022-09-08

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    05

    Harman Finochem Ltd.

    India
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    Not Confirmed
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    Harman Finochem Ltd.

    India
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    Not Confirmed
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    Japanese Pharmacopoeia Metformin Hydrochloride

    Registration Number : 230MF10085

    Registrant's Address : 107-A, Vinay Bhavya Complex, 159-A, C. S. T Road, Kalina, Santa Cruz (East), Mumbai-4...

    Initial Date of Registration : 2018-07-13

    Latest Date of Registration : 2024-05-08

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    06

    Harman Finochem Ltd.

    India
    SupplySide West 2024
    Not Confirmed
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    Harman Finochem Ltd.

    India
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    Not Confirmed
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    Japanese Pharmacopoeia Metformin Hydrochloride

    Registration Number : 301MF10009

    Registrant's Address : 107-A, Vinay Bhavya Complex, 159-A, C. S. T Road, Kalina, Santa Cruz (East), Mumbai-4...

    Initial Date of Registration : 2019-05-28

    Latest Date of Registration : 2019-05-28

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    07

    Laurus Labs Limited

    India
    SupplySide West 2024
    Not Confirmed
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    Laurus Labs Limited

    India
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    SupplySide West 2024
    Not Confirmed
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    Metformin hydrochloride

    Registration Number : 306MF10025

    Registrant's Address : 2nd Floor, Serene Chambers, Road No:7, Banjara Hills, Hyderabad - 500034, Telangana, ...

    Initial Date of Registration : 2024-02-07

    Latest Date of Registration : 2024-02-07

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    08

    Ningxia Hengkang Technology Co. , L...

    China
    SupplySide West 2024
    Not Confirmed
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    Ningxia Hengkang Technology Co. , L...

    China
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    Not Confirmed
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    Metformin hydrochloride

    Registration Number : 304MF10032

    Registrant's Address : East Road of Hongsheng, Biotech Park of Yinchuan, NINGXIA, CHINA

    Initial Date of Registration : 2022-02-10

    Latest Date of Registration : 2022-02-10

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    09

    Shandong Keyuan Pharmaceutical Co. ...

    China
    SupplySide West 2024
    Not Confirmed
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    Shandong Keyuan Pharmaceutical Co. ...

    China
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    Not Confirmed
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    Metformin Hydrochloride

    Registration Number : 222MF10034

    Registrant's Address : Keyuan Street, Shandong Shanghe Economic Development Zone, Jinan City, Shandong, Chin...

    Initial Date of Registration : 2010-01-28

    Latest Date of Registration : 2022-03-24

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    10

    Uquifa Mexico, S. A. de C. V.

    Spain
    SupplySide West 2024
    Not Confirmed
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    Uquifa Mexico, S. A. de C. V.

    Spain
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    Metformin Hydrochloride

    Registration Number : 306MF10080

    Registrant's Address : Calle 37 Este No. 126, CIVAC, 62578, Jiutepec, Morelos, Mexico

    Initial Date of Registration : 2024-06-18

    Latest Date of Registration : 2024-06-18

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    01

    Granules India Limited

    India
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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

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    02

    Granules India Limited

    India
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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 (Ph. Eur./ USP)

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0028

    Address of the Firm : 15/A/1, Phase III, IDA, Jeedimetla, Hyderabad- 500 057

    Granules India

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    03

    Granules India Limited

    India
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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/EP/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

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    04

    IOL Chemicals and Pharmaceuticals

    India
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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

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    05

    USV Private Limited

    India
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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

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    06

    Alekhya Drugs Pvt. Limited.,

    India
    SupplySide West 2024
    Not Confirmed
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    Alekhya Drugs Pvt. Limited.,

    India
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    Not Confirmed
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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

    Exemed Pharmaceuticals

    India
    SupplySide West 2024
    Not Confirmed
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    Exemed Pharmaceuticals

    India
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    SupplySide West 2024
    Not Confirmed
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    Metformin Hydrochloride (EP/BP/USP/JP)

    Date of Issue : 2021-01-18

    Valid Till : 2023-12-03

    Written Confirmation Number : WC-276

    Address of the Firm : Block No. 628 A &B, ECP Canal Road, Village- Luna, Tal-Padra, Dist-Vadodara-3914...

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    08

    Laurus Labs

    India
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    Not Confirmed
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    Laurus Labs

    India
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    SupplySide West 2024
    Not Confirmed
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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
    SupplySide West 2024
    Not Confirmed
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    Laurus Labs

    India
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    SupplySide West 2024
    Not Confirmed
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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

    Sun Pharmaceutical Industries Limited

    India
    SupplySide West 2024
    Not Confirmed
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    Sun Pharmaceutical Industries Limited

    India
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    Not Confirmed
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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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    API Reference Price

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VADODARA, GUJARAT","supplier":"FOREFRONT ENTERPRISE CO ","supplierCountry":"INDIA","foreign_port":"KAOHSIUNG","customer":"EXEMED PHARMACEUTICALS","customerCountry":"INDIA","quantity":"5856.07","actualQuantity":"5856.072","unit":"KGS","unitRateFc":"4.8","totalValueFC":"30709.6","currency":"USD","unitRateINR":"439.5","date":"24-Sep-2024","totalValueINR":"2573503.55","totalValueInUsd":"30709.6","indian_port":"JNPT","hs_no":"29252990","bill_no":"5781299","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"7F, NO. 156, FU- HSING ROAD, TAIPEI SDNF SDNF Taiwan","customerAddress":"BLOCK NO.628, EPC CANAL ROAD"}]
    01-Sep-2023
    30-Sep-2024
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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    Drugs in Development

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

    Dr. Reddy's Laboratories announces its launch of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S.

    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

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    Dr. Reddy's Laboratories

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

    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

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories announces its launch of Saxagliptin and Metformin Hydrochloride Extended-...

    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

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    Virtual Booth

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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Tiefenbacher Pharmaceuticals Successfully Launches Generic Version of The Diabetes Medicine Vildagliptin and Vildagliptin /metformin in Africa

    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

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    Tiefenbacher Group

    Germany
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    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

    DEALS_DEV arrow-down

    Tiefenbacher Pharmaceuticals Successfully Launches Generic Version of The Diabetes Medicine Vildag...

    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

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    Virtual Booth

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

    USV Launches Jalra Trio for Management of Type 2 Diabetes in India

    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

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    USV Private Limited

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

    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

    DEALS_DEV arrow-down

    USV Launches Jalra Trio for Management of Type 2 Diabetes in India

    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

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    Virtual Booth

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

    Granules India Limited Announces USFDA Approval of Metformin Hydrochloride ER Tablets USP, 500 mg and 1000 mg

    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

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    Granules India Limited

    India
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    Lead Product(s) : Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Limited Announces USFDA Approval of Metformin Hydrochloride ER Tablets USP, 500 mg ...

    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

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    Chiglitazar and Metformin Approved by NMPA for Type 2 Diabetes Treatment

    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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    Shenzhen Chipscreen Biosciences

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    Shenzhen Chipscreen Biosciences

    China
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    Lead Product(s) : Chiglitazar Sodium,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Chiglitazar and Metformin Approved by NMPA for Type 2 Diabetes Treatment

    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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    Lupin receives US FDA tentative marketing approval for generic Trijardy XR tablets

    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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    Lupin Ltd

    India
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    Lupin Ltd

    India
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    Lead Product(s) : Empagliflozin,Linagliptin,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin receives US FDA tentative marketing approval for generic Trijardy XR tablets

    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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    Indoco's ANDA for Canagliflozin, Metformin Gets Tentative Approval

    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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    Indoco Remedies Limited

    India
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    Indoco Remedies Limited

    India
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    Lead Product(s) : Canagliflozin,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Indoco's ANDA for Canagliflozin, Metformin Gets Tentative Approval

    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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    Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Type 2 diabetes

    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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    08

    Glenmark Pharmaceuticals

    India
    arrow
    2024 ACI Convention
    Not Confirmed

    Glenmark Pharmaceuticals

    India
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    2024 ACI Convention
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Glenmark to launch a Triple-drug FDC of Teneligliptin + Dapagliflozin + Metformin in India for Typ...

    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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    Rejuvenate Biomed Announces Positive Results from Phase 1b Clinical Trial with RJx-01 in Sarcopenia

    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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    09

    Rejuvenate Biomed

    Belgium
    arrow
    2024 ACI Convention
    Not Confirmed

    Rejuvenate Biomed

    Belgium
    arrow
    2024 ACI Convention
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Galantamine Hydrobromide,Metformin

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Rejuvenate Biomed Announces Positive Results from Phase 1b Clinical Trial with RJx-01 in Sarcopeni...

    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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    Akums Gets DCGI Nod for Triple Combination Diabetes Medication

    Details:

    Sitagliptin, Pioglitazone & Metformin are combined for the treatment of diabetes. Metformin, coupled with the functional and corrective influence of pioglitazone on beta-cell and metabolic syndrome and the stability of Sitagliptin, make an effective solution for diabetes.


    Lead Product(s): Sitagliptin Phosphate,Pioglitazone,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 July 27, 2023

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    10

    Akums Drugs & Pharmaceuticals Ltd

    India
    arrow
    2024 ACI Convention
    Not Confirmed

    Akums Drugs & Pharmaceuticals Ltd

    India
    arrow
    2024 ACI Convention
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Sitagliptin Phosphate,Pioglitazone,Metformin

    Therapeutic Area : Endocrinology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Akums Gets DCGI Nod for Triple Combination Diabetes Medication

    Details : Sitagliptin, Pioglitazone & Metformin are combined for the treatment of diabetes. Metformin, coupled with the functional and corrective influence of pioglitazone on beta-cell and metabolic syndrome and the stability of Sitagliptin, make an effective solu...

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 27, 2023

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    Europe

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    01

    SANOFI SpA

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

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    Corporate PDF

    02

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

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    03

    Helvepharm AG

    France
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    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    04

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    Corporate PDF

    05

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    Corporate PDF

    06

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    07

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    08

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Helvepharm AG

    France
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Contact Supplier Contact Supplier
    Flag France
    Virtual Booth Virtual Booth
    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

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

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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;ORAL - 2.5MG;1GM

    USFDA APPLICATION NUMBER - 201281

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    USFDA APPLICATION NUMBER - 203414

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    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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    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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    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;1MG

    USFDA APPLICATION NUMBER - 22386

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    Related Excipient Companies

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    Fillers, Diluents & Binders

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    01

    Rochem International Inc

    U.S.A
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    AusBiotech 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders, Taste Masking

    Brand Name : Mannitol

    Application : Fillers, Diluents & Binders, Taste Masking

    Excipient Details : Mannitol is mainly used as a bulking agent in tableting. It is also used as taste masking agent in ODT formulations.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Mannitol

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    Mannitol

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    02

    Rochem International Inc

    U.S.A
    arrow
    AusBiotech 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Brand Name : Xylitol

    Application : Chewable & Orodispersible Aids, Coating Systems & Additives, Fillers, Diluents & Binders

    Excipient Details : Xylitol is used as coating agent & filler, binder agent in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Xylitol Excipient

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    Xylitol

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    03

    Rochem International Inc

    U.S.A
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    AusBiotech 2024
    Not Confirmed
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    • EDQM
    • WHO-GMP

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

    Brand Name : Gum Arabic

    Application : API Stability Enhancers, Emulsifying Agents, Fillers, Diluents & Binders

    Excipient Details : Acacia, also known as gum arabic, is used in the pharmaceutical industry as an emulsifier, stabilizing agent, and tablet binder in various formulations.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Gum Arabic

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    04

    SPI Pharma

    U.S.A
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    CPhI India 2024
    Booth #8.Q31
    • fda
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    Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

    Brand Name : Pharmaburst 500

    Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

    Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Mannitol

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    05

    SPI Pharma

    U.S.A
    arrow
    CPhI India 2024
    Booth #8.Q31
    • fda
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    • WHO-GMP

    Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

    Dosage Form : Tablet

    Grade : Oral

    Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

    Brand Name : Mannogem® XL Opal

    Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

    Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

    Pharmacopoeia Ref : NA

    Technical Specs : 160 µm Powder Mannitol

    Ingredient(s) : Mannitol

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    SPI Pharma Mannogem® XL Opal

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    06

    DKSH

    Switzerland
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    Fi Europe 2024
    Exhibiting
    • fda
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    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Dosage Form : Capsule, Granule / Pellet, Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : CALCITEC PURO PH V/40S HT

    Application : Fillers, Diluents & Binders

    Excipient Details : Calcitec Puro PHV/40S HT is used as filler and binder in oral solid dosage forms including tablets, capsules, granules, and pellets.

    Pharmacopoeia Ref : N/A

    Technical Specs : N/A

    Ingredient(s) : Calcium Carbonate Excipient

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    CALCITEC PURO PH V/40S HT

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    07

    Jai Radhe Sales

    India
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    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Sodium Stearyl Fumarate

    Application : Fillers, Diluents & Binders

    Excipient Details : Sodium stearyl fumarate mostly used as lubricant in solid oral dosage forms such as tablets, capsules due to its lubricant levels and superior hardness characteristics.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Sodium Stearyl Fumarate

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    Sodium Stearyl Fumarate

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    08

    Boai NKY Pharmaceuticals Ltd

    China
    arrow
    CPhI India 2024
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

    Dosage Form : Capsule, Tablet

    Grade : Oral (Pharma Grade)

    Category : Fillers, Diluents & Binders

    Brand Name : KoVidone® K25

    Application : Fillers, Diluents & Binders

    Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

    Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

    Technical Specs : NA

    Ingredient(s) : Polyvinylpyrrolidone

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    KoVidone® K25

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    09

    Chynops Pharma

    India
    arrow
    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothChynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Category : Lubricants & Glidants

    Brand Name : Sodium Stearyl Fumarate

    Application : Lubricants & Glidants

    Excipient Details : Sodium stearyl fumarate is used as a lubricant to reduce friction and adhesion in pharmaceutical solid oral formulations such as tablets and capsules.

    Pharmacopoeia Ref : IH/BP/USP

    Technical Specs : NA

    Ingredient(s) : Sodium Stearyl Fumarate Excipient

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    Sodium Stearyl Fumarate

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    10

    Gangwal Healthcare

    India
    arrow
    CPhI India 2024
    Booth #8.Q10
    • fda
    • EDQM
    • WHO-GMP

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

    Brand Name : STARLOSE®

    Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

    Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

    Pharmacopoeia Ref : IP/EP/USP-NF/IH

    Technical Specs : NA

    Ingredient(s) : Lactose Monohydrate

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    Gangwal Healthcare STARLOSE®

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    Only 10 entries up to this point, click to access all click full view read-more
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    Coating Systems & Additives

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    Evonik

    Germany
    arrow
    Bio-Europe 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEvonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!

    Brand Name : EUDRAGIT® E 100

    Application : Coating Systems & Additives, Controlled & Modified Release, Disintegrants & Superdisintegrants, Film Formers & Plasticizers, Taste Masking

    Excipient Details : EUDRAGIT® E is an immediate-release polymer used as a taste masking & coating agent to improve swallowability of tablets, ODTs, capsules, powder, etc.

    Pharmacopoeia Ref : NA

    Technical Specs : Available as granules; Other grades- EUDRAGIT® E 12,5, EUDRAGITÂ...

    Ingredient(s) : Amino Methacrylate Copolymer

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    EUDRAGIT® E 100

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    02

    Rochem International Inc

    U.S.A
    arrow
    AusBiotech 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Brand Name : Carboxymethyl Cellulose

    Application : Coating Systems & Additives, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Thickeners and Stabilizers

    Excipient Details : Carboxymethylcellulose is used in oral formulations like tablets, capsules due to its viscosity increasing properties as a binding, coating, stabilizing, suspending & disintegrant agent. It is also used in topical forms to stabilize emulsions.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Carboxymethyl cellulose excipient

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    Carboxymethyl Cellulose

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    03

    Rochem International Inc

    U.S.A
    arrow
    AusBiotech 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

    Brand Name : Xylitol

    Application : Chewable & Orodispersible Aids, Coating Systems & Additives, Fillers, Diluents & Binders

    Excipient Details : Xylitol is used as coating agent & filler, binder agent in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Xylitol Excipient

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    Xylitol

    Excipients Web Link

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    04

    SPI Pharma

    U.S.A
    arrow
    CPhI India 2024
    Booth #8.Q31
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

    Dosage Form : Tablet

    Grade : Oral

    Category : Coating Systems & Additives

    Brand Name : ACTILLETS

    Application : Coating Systems & Additives

    Excipient Details : ACTILLETSâ„¢ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.

    Pharmacopoeia Ref : NA

    Technical Specs : Bulk density: 0.80

    Ingredient(s) : Microcrystalline Cellulose

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    ACTILLETS

    Excipients Web Link

    Market Place

    Digital Content

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    05

    DKSH

    Switzerland
    arrow
    Fi Europe 2024
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Brand Name : Titanium dioxide PRETIOX AV01FG

    Application : Coating Systems & Additives, Coloring Agents

    Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.

    Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...

    Technical Specs : Ti 59.95% and O 40.05%

    Ingredient(s) : Titanium Dioxide

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    Titanium dioxide PRETIOX AV01FG

    Excipients Web Link

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    06

    Jai Radhe Sales

    India
    arrow
    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

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

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Category : Fillers, Diluents & Binders

    Brand Name : Sodium Stearyl Fumarate

    Application : Fillers, Diluents & Binders

    Excipient Details : Sodium stearyl fumarate mostly used as lubricant in solid oral dosage forms such as tablets, capsules due to its lubricant levels and superior hardness characteristics.

    Pharmacopoeia Ref : NA

    Technical Specs : NA

    Ingredient(s) : Sodium Stearyl Fumarate

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    Sodium Stearyl Fumarate

    Excipients Web Link

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    Digital Content

    Virtual Booth

    07

    Chynops Pharma

    India
    arrow
    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothChynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.

    Dosage Form : Capsule, Tablet

    Grade : Oral

    Category : Lubricants & Glidants

    Brand Name : Sodium Stearyl Fumarate

    Application : Lubricants & Glidants

    Excipient Details : Sodium stearyl fumarate is used as a lubricant to reduce friction and adhesion in pharmaceutical solid oral formulations such as tablets and capsules.

    Pharmacopoeia Ref : IH/BP/USP

    Technical Specs : NA

    Ingredient(s) : Sodium Stearyl Fumarate Excipient

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    Sodium Stearyl Fumarate

    Excipients Web Link

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    08

    NEWEDGE Overseas

    India
    AusBiotech 2024
    Not Confirmed
    arrow

    09

    DKSH

    Switzerland
    arrow
    Fi Europe 2024
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

    Brand Name : Titanium dioxide PRETIOX AV01PhG

    Application : Coating Systems & Additives, Coloring Agents

    Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.

    Pharmacopoeia Ref : N/A

    Technical Specs : Ti 59.95% and O 40.05%

    Ingredient(s) : Titanium Dioxide

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    Titanium dioxide PRETIOX AV01PhG

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    10

    Kerry

    U.S.A
    AusBiotech 2024
    Not Confirmed
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    Only 10 entries up to this point, click to access all click full view read-more
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    Direct Compression

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