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    Chemistry

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    Also known as: Glucobay, Precose, Prandase, Bay-g-5421, Bay-g 5421, Beta-acarbose
    Molecular Formula
    C25H43NO18
    Molecular Weight
    645.6  g/mol
    InChI Key
    XUFXOAAUWZOOIT-SXARVLRPSA-N
    Acarbose
    An inhibitor of ALPHA-GLUCOSIDASES that retards the digestion and absorption of DIETARY CARBOHYDRATES in the SMALL INTESTINE.
    1 2D Structure

    Acarbose

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3R,4R,5S,6R)-5-[(2R,3R,4R,5S,6R)-5-[(2R,3R,4S,5S,6R)-3,4-dihydroxy-6-methyl-5-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-en-1-yl]amino]oxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-(hydroxymethyl)oxane-2,3,4-triol
    2.1.2 InChI
    InChI=1S/C25H43NO18/c1-6-11(26-8-2-7(3-27)12(30)15(33)13(8)31)14(32)19(37)24(40-6)43-22-10(5-29)42-25(20(38)17(22)35)44-21-9(4-28)41-23(39)18(36)16(21)34/h2,6,8-39H,3-5H2,1H3/t6-,8+,9-,10-,11-,12-,13+,14+,15+,16-,17-,18-,19-,20-,21-,22-,23-,24-,25-/m1/s1
    2.1.3 InChI Key
    XUFXOAAUWZOOIT-SXARVLRPSA-N
    2.1.4 Canonical SMILES
    CC1C(C(C(C(O1)OC2C(OC(C(C2O)O)OC3C(OC(C(C3O)O)O)CO)CO)O)O)NC4C=C(C(C(C4O)O)O)CO
    2.1.5 Isomeric SMILES
    C[C@@H]1[C@H]([C@@H]([C@H]([C@H](O1)O[C@@H]2[C@H](O[C@@H]([C@@H]([C@H]2O)O)O[C@@H]3[C@H](O[C@H]([C@@H]([C@H]3O)O)O)CO)CO)O)O)N[C@H]4C=C([C@H]([C@@H]([C@H]4O)O)O)CO
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Bay G 5421

    2. Glucobay

    3. Glucor

    4. Glumida

    5. Prandase

    6. Precose

    2.2.2 Depositor-Supplied Synonyms

    1. Glucobay

    2. Precose

    3. Prandase

    4. Bay-g-5421

    5. Bay-g 5421

    6. Beta-acarbose

    7. 56180-94-0

    8. Bay G 5421

    9. Chembl1566

    10. Alpha-acarbose

    11. Glucor

    12. Dsstox_cid_26034

    13. Dsstox_rid_81300

    14. Dsstox_gsid_46034

    15. Cas-56180-94-0

    16. Arcabose

    17. Ascarbose

    18. 1agm

    19. 1ukt

    20. Nsc-758915

    21. Ncgc00159353-02

    22. Qps

    23. Acarbose, >=95%

    24. Schembl16848

    25. Gtpl6791

    26. Chebi:94035

    27. Bcpp000442

    28. Hms3269l19

    29. Hms3413p19

    30. Hms3677p19

    31. Hms3713b18

    32. Tox21_111597

    33. Bdbm50333465

    34. S1271

    35. Zinc85537042

    36. Akos024457233

    37. Tox21_111597_1

    38. Bcp9000224

    39. Ccg-220568

    40. Ncgc00160515-02

    41. Ab01274765-01

    42. Ab01274765_02

    43. A830944

    44. Q338005

    45. Brd-k44276885-001-01-7

    46. Brd-k44276885-001-07-4

    47. Acarbose, European Pharmacopoeia (ep) Reference Standard

    48. Acarbose, United States Pharmacopeia (usp) Reference Standard

    49. Acarbose For Identification, European Pharmacopoeia (ep) Reference Standard

    50. Acarbose, Pharmaceutical Secondary Standard; Certified Reference Material

    51. Acarbose For Peak Identification, European Pharmacopoeia (ep) Reference Standard

    52. (2r,3r,4r,5r,6r)-5-((2r,3r,4r,5s,6r)-5-((2r,3r,4s,5s,6r)-3,4-dihydroxy-6-methyl-5-((1s,4r,5s,6s)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-enylamino)-tetrahydro-2h-pyran-2-yloxy)-3,4-dihydroxy-6-(hydroxymethyl)-tetrahydro-2h-pyran-2-yloxy)-6-(hydroxymethyl)-tetrahydro-2h-pyran-2,3,4-triol

    53. (2r,3r,4r,5s,6r)-5-((2r,3r,4r,5s,6r)-5-((2r,3r,4s,5s,6r)-3,4-dihydroxy-6-methyl-5-((1s,4r,5s,6s)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-enylamino)-tetrahydro-2h-pyran-2-yloxy)-3,4-dihydroxy-6-(hydroxymethyl)-tetrahydro-2h-pyran-2-yloxy)-6-(hydroxymethyl)-tetrahydro-2h-pyran-2,3,4-triol

    54. (2r,3r,4r,5s,6r)-5-((2r,3r,4r,5s,6r)-5-((2r,3r,4s,5s,6r)-3,4-dihydroxy-6-methyl-5-((1s,4s,5s,6s)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-enylamino)-tetrahydro-2h-pyran-2-yloxy)-3,4-dihydroxy-6-(hydroxymethyl)-tetrahydro-2h-pyran-2-yloxy)-6-(hydroxymethyl)-tetrahydro-2h-pyran-2,3,4-triol

    55. (2r,3r,4r,5s,6r)-5-[(2r,3r,4r,5s,6r)-5-[(2r,3r,4s,5s,6r)-3,4-dihydroxy-6-methyl-5-[[(1s,4r,5s,6s)-4,5,6-trihydroxy-3-(hydroxymethyl)-1-cyclohex-2-enyl]amino]oxan-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-6-(hydroxymethyl)oxane-2,3,4-triol

    56. (3r,4r,5s,6r)-5-((2r,3r,4r,5s,6r)-5-((2r,3r,4s,5s,6r)-3,4-dihydroxy-6-methyl-5-((1s,4r,5s,6s)-4,5,6-trihydroxy-3-(hydroxymethyl)cyclohex-2-enylamino)-tetrahydro-2h-pyran-2-yloxy)-3,4-dihydroxy-6-(hydroxymethyl)-tetrahydro-2h-pyran-2-yloxy)-6-(hydroxymethyl)-tetrahydro-2h-pyran-2,3,4-triol

    57. 4,6-dideoxy-4-([1s]-[1,4,6/5]-4,5,6-trihydroxy-3-hydroxymethyl-2-yclohexenylamino)maltotriose

    58. 4-[5-[3,4-dihydroxy-6-methyl-5-[[2,3,4-trihydroxy-5-(hydroxymethyl)cyclohexyl]amino]tetrahydropyran-2-yl]oxy-3,4-dihydroxy-6-(hydroxymethyl)tetrahydropyran-2-yl]oxy-2,3,5,6-tetrahydroxy-hexanal;acarbose

    59. 4-o-[4-o-[4-[[(1s,4r,5s,6s)-4,5,6-trihydroxy-3-hydroxymethyl-2-cyclohexene-1-yl]amino]-4,6-dideoxy-alpha-d-glucopyranosyl]-alpha-d-glucopyranosyl]-beta-d-glucopyranose

    60. 5-{5-[3,4-dihydroxy-6-methyl-5-(4,5,6-trihydroxy-3-hydroxymethyl-cyclohex-2-enylamino)-tetrahydro-pyran-2-yloxy]-3,4-dihydroxy-6-hydroxymethyl-tetrahydro-pyran-2-yloxy}-6-hydroxymethyl-tetrahydro-pyran-2,3,4-triol

    61. D-glucose, O-4,6-dideoxy-4-[[(1s,4r,5s,6s)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-.alpha.-d-glucopyranosyl-(1->4)-o-.alpha.-d-glucopyranosyl-(1->4)-

    62. O-4,6-dideoxy-4-[[(1s,4r,5s,6s)-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-?-d-glucopyranosyl-(1-4)-o-?-d-glucopyranosyl-(1-4)-d-glucose

    63. Wurcs=2.0/3,3,2/[a2122h-1b_1-5][a2122h-1a_1-5][a2122m-1a_1-5_4*nc^sc^sc^sc^rcco/7=^zc$3/6o/5o/4o]/1-2-3/a4-b1_b4-c1

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 645.6 g/mol
    Molecular Formula C25H43NO18
    XLogP3-8.5
    Hydrogen Bond Donor Count14
    Hydrogen Bond Acceptor Count19
    Rotatable Bond Count9
    Exact Mass645.24801352 g/mol
    Monoisotopic Mass645.24801352 g/mol
    Topological Polar Surface Area321 Ų
    Heavy Atom Count44
    Formal Charge0
    Complexity962
    Isotope Atom Count0
    Defined Atom Stereocenter Count19
    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 4  
    Drug NameAcarbose
    PubMed HealthAcarbose (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelAcarbose Tablets are an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is chemically...
    Active IngredientAcarbose
    Dosage FormTablet
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyVirtus Pharm; Watson Labs; Strides Pharma; Emcure Pharms; Mylan; Roxane; Impax Labs

    2 of 4  
    Drug NamePrecose
    PubMed HealthAcarbose (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelPRECOSE (acarbose tablets) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is...
    Active IngredientAcarbose
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyBayer Hlthcare

    3 of 4  
    Drug NameAcarbose
    PubMed HealthAcarbose (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelAcarbose Tablets are an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is chemically...
    Active IngredientAcarbose
    Dosage FormTablet
    RouteOral
    Strength100mg; 25mg; 50mg
    Market StatusPrescription
    CompanyVirtus Pharm; Watson Labs; Strides Pharma; Emcure Pharms; Mylan; Roxane; Impax Labs

    4 of 4  
    Drug NamePrecose
    PubMed HealthAcarbose (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelPRECOSE (acarbose tablets) is an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation processes of a microorganism, Actinoplanes utahensis, and is...
    Active IngredientAcarbose
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyBayer Hlthcare

    4.2 Therapeutic Uses

    Enzyme Inhibitors; Hypoglycemic Agents

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)

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

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    THERAPEUTIC CATEGORY: Antidiabetic

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 2006., p. 5

    4.3 Drug Warning

    Acarbose is contraindicated in patients with known hypersensitivity to the drug and in patients with diabetic ketoacidosis or cirrhosis. Acarbose is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction. In addition, acarbose is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    Because of its mechanism of action, acarbose when administered alone should not cause hypoglycemia in the fasted or postprandial state. Sulfonylurea agents or insulin may cause hypoglycemia. Because acarbose given in combination with a sulfonylurea or insulin will cause a further lowering of blood glucose, it may increase the potential for hypoglycemia. Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, and no increased incidence of hypoglycemia was observed in patients when acarbose was added to metformin therapy. Oral glucose (dextrose), whose absorption is not inhibited by acarbose, should be used instead of sucrose (cane sugar) in the treatment of mild to moderate hypoglycemia. Sucrose, whose hydrolysis to glucose and fructose is inhibited by acarbose, is unsuitable for the rapid correction of hypoglycemia. Severe hypoglycemia may require the use of either intravenous glucose infusion or glucagon injection.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    Gastrointestinal symptoms are the most common reactions to acarbose. ... In a one-year safety study, during which patients kept diaries of gastrointestinal symptoms, abdominal pain and diarrhea tended to return to pretreatment levels over time, and the frequency and intensity of flatulence tended to abate with time. The increased gastrointestinal tract symptoms in patients treated with acarbose are a manifestation of the mechanism of action of acarbose and are related to the presence of undigested carbohydrate in the lower GI tract. If the prescribed diet is not observed, the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    In long-term studies (up to 12 months, and including acarbose doses up to 300 mg t.i.d.) conducted in the United States, treatment-emergent elevations of serum transaminases (AST and/or ALT) above the upper limit of normal (ULN), greater than 1.8 times the ULN, and greater than 3 times the ULN occurred in 14%, 6%, and 3%, respectively, of acarbose-treated patients as compared to 7%, 2%, and 1%, respectively, of placebo-treated patients. Although these differences between treatments were statistically significant, these elevations were asymptomatic, reversible, more common in females, and, in general, were not associated with other evidence of liver dysfunction. In addition, these serum transaminase elevations appeared to be dose related. In US studies including acarbose doses up to the maximum approved dose of 100 mg t.i.d., treatment-emergent elevations of AST and/or ALT at any level of severity were similar between acarbose-treated patients and placebo-treated patients (p >/= 0.496).

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    For more Drug Warnings (Complete) data for Acarbose (16 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Glycoside Hydrolase Inhibitors

    Compounds that inhibit or block the activity of GLYCOSIDE HYDROLASES such as ALPHA-AMYLASES and ALPHA-GLUCOSIDASES. (See all compounds classified as Glycoside Hydrolase Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    alpha-Glucosidase Inhibitor [EPC]; alpha Glucosidase Inhibitors [MoA]
    5.3 ATC Code

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BF - Alpha glucosidase inhibitors

    A10BF01 - Acarbose

    5.4 Absorption, Distribution and Excretion

    In a study of 6 healthy men, less than 2% of an oral dose of acarbose was absorbed as active drug, while approximately 35% of total radioactivity from a 14C-labeled oral dose was absorbed. An average of 51% of an oral dose was excreted in the feces as unabsorbed drug-related radioactivity within 96 hours of ingestion. Because acarbose acts locally within the gastrointestinal tract, this low systemic bioavailability of parent compound is therapeutically desired.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    Following oral dosing of healthy volunteers with 14C-labeled acarbose, peak plasma concentrations of radioactivity were attained 14-24 hours after dosing, while peak plasma concentrations of active drug were attained at approximately 1 hour. The delayed absorption of acarbose-related radioactivity reflects the absorption of metabolites that may be formed by either intestinal bacteria or intestinal enzymatic hydrolysis.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    Acarbose is metabolized exclusively within the gastrointestinal tract, principally by intestinal bacteria, but also by digestive enzymes. A fraction of these metabolites (approximately 34% of the dose) was absorbed and subsequently excreted in the urine.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    The fraction of acarbose that is absorbed as intact drug is almost completely excreted by the kidneys. When acarbose was given intravenously, 89% of the dose was recovered in the urine as active drug within 48 hours. In contrast, less than 2% of an oral dose was recovered in the urine as active (i.e., parent compound and active metabolite) drug. This is consistent with the low bioavailability of the parent drug.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    For more Absorption, Distribution and Excretion (Complete) data for Acarbose (6 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Acarbose is metabolized exclusively within the gastrointestinal tract, principally by intestinal bacteria, but also by digestive enzymes. ... At least 13 metabolites have been separated chromatographically from urine specimens. The major metabolites have been identified as 4-methylpyrogallol derivatives (i.e., sulfate, methyl, and glucuronide conjugates). One metabolite (formed by cleavage of a glucose molecule from acarbose) also has alpha-glucosidase inhibitory activity. This metabolite, together with the parent compound, recovered from the urine, accounts for less than 2% of the total administered dose.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    5.6 Biological Half-Life

    The plasma elimination half-life of acarbose activity is approximately 2 hours in healthy volunteers.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    5.7 Mechanism of Action

    In contrast to sulfonylureas, acarbose does not enhance insulin secretion. The antihyperglycemic action of acarbose results from a competitive, reversible inhibition of pancreatic alpha-amylase and membrane-bound intestinal alpha-glucoside hydrolase enzymes. Pancreatic alpha-amylase hydrolyzes complex starches to oligosaccharides in the lumen of the small intestine, while the membrane-bound intestinal alpha-glucosidases hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in a delayed glucose absorption and a lowering of postprandial hyperglycemia. Because its mechanism of action is different, the effect of acarbose to enhance glycemic control is additive to that of sulfonylureas, insulin or metformin when used in combination. In addition, acarbose diminishes the insulinotropic and weight-increasing effects of sulfonylureas. Acarbose has no inhibitory activity against lactase and consequently would not be expected to induce lactose intolerance.

    US Natl Inst Health; DailyMed. Current Medication Information for ACARBOSE tablet (February 2009). Available from, as of October 3, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6c2db888-775c-4baf-a1b4-1cfa63b83357

    Acarbose represents a pharmacological approach to achieving the metabolic benefits of a slower carbohydrate absorption in diabetes, by acting as a potent, competitive inhibitor of intestinal alpha-glucosidases. Acarbose molecules attach to the carbohydrate binding sites of alpha-glucosidases, with an affinity constant that is much higher than that of the normal substrate. Because of the reversible nature of the inhibitor-enzyme interaction, the conversion of oligosaccharides to monosaccharides is only delayed rather than completely blocked. Acarbose has the structural features of a tetrasaccharide and does not cross the enterocytes after ingestion. Thus, its pharmacokinetic properties are well suited to the pharmacological action directed exclusively towards the intestinal glucosidases. ...

    PMID:8906894 Salvatore T, Giugliano D; Clin Pharmacokinet 30 (2): 94-106 (1996)

    The aim of the present study was to reveal the possible involvement of thyroid hormones in the antihyperglycaemic and antiperoxidative effects of acarbose. The effects of acarbose on changes in serum concentration of thyroid hormones, insulin and glucose in dexamethasone-induced type 2 diabetic mice were investigated. Simultaneously, changes in lipid peroxidation (LPO), reduced glutathione (GSH) content and the activity of associated endogenous anti-oxidant enzymes, such as superoxide dismuatase (SOD) and catalase (CAT), were investigated in renal and cardiac tissues, which are commonly affected in diabetes mellitus. Although administration of dexamethasone (1.0 mg/kg, i.m., for 22 days) caused hyperglycaemia with a parallel increase in serum insulin and tissue LPO, it decreased thyroid hormone concentrations and the activity of SOD and CAT. When dexamethasone-induced hyperglycemic mice were treated with acarbose (10 mg/kg per day, p.o., for 15 days), levels of thyroid hormones were increased and most of the abnormalities, including serum insulin and glucose levels, tissue LPO, SOD and CAT activity and GSH content, were reversed. These findings suggest the involvement of thyroid hormones in the mode of action of acarbose in amelioration of type 2 diabetes mellitus.

    PMID:17042922 Rameshwar J, Anand K; Clin Exp Pharmacol Physiol 33 (11): 1104-6 (2006)

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INCHEON INT\\'","customer":"EMCURE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"580","totalValueFC":"87593.7","currency":"USD","unitRateINR":"49068","date":"01-Oct-2024","totalValueINR":"7360200","totalValueInUsd":"87593.7","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"5901097","productDescription":"API","marketType":"","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"8, CHUNGJEONG-RO, SEODAEMUN-GU SEOU L 03742 SOUTH KOREA Seoul, , Korea, Republic of Korea, Republic of","customerAddress":"T-184, MIDC, BHOSARI,"}]
    08-Mar-2021
    01-Oct-2024
    KGS
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    DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20482

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    DOSAGE - TABLET;ORAL - 25MG **Federal Registe...DOSAGE - TABLET;ORAL - 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20482

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    DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20482

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    ABOUT THIS PAGE

    Acarbose Manufacturers

    A Acarbose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acarbose, including repackagers and relabelers. The FDA regulates Acarbose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acarbose API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Acarbose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Acarbose Suppliers

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

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

    Acarbose USDMF

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

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

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

    Acarbose JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Acarbose Drug Master File in Japan (Acarbose JDMF) empowers Acarbose API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Acarbose JDMF during the approval evaluation for pharmaceutical products. At the time of Acarbose JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Acarbose suppliers with JDMF on PharmaCompass.

    Acarbose KDMF

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

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

    After submitting a Acarbose KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Acarbose API can apply through the Korea Drug Master File (KDMF).

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

    Acarbose CEP

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

    A Acarbose CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acarbose CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Acarbose suppliers with CEP (COS) on PharmaCompass.

    Acarbose NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Acarbose as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Acarbose API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Acarbose as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Acarbose and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acarbose NDC to their finished compounded human drug products, they may choose to do so.

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

    Acarbose GMP

    Acarbose Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Acarbose GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Acarbose GMP manufacturer or Acarbose GMP API supplier for your needs.

    Acarbose CoA

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

    Acarbose CoA mostly includes findings from lab analyses of a specific batch. For each Acarbose CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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