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    Chemistry

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    Also known as: 72432-03-2, Glyset, (2r,3r,4r,5s)-1-(2-hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol, Bay-m-1099, Bay m 1099, Miglitol (glyset)
    Molecular Formula
    C8H17NO5
    Molecular Weight
    207.22  g/mol
    InChI Key
    IBAQFPQHRJAVAV-ULAWRXDQSA-N
    FDA UNII
    0V5436JAQW
    Miglitol
    Miglitol is a desoxynojirimycin derivative and inhibitor of alpha-glucosidase with antihyperglycemic activity. Miglitol binds to and inhibits alpha-glucosidase, an enteric enzyme found in the brush border of the small intestines that hydrolyzes oligosaccharides and disaccharides into glucose and other monosaccharides. This prevents the breakdown of larger carbohydrates into glucose and decreases the rise in postprandial blood glucose levels. Compared to acarbose, miglitol is systemically absorbed.
    Miglitol is an alpha-Glucosidase Inhibitor. The mechanism of action of miglitol is as an alpha Glucosidase Inhibitor.
    1 2D Structure

    Miglitol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol
    2.1.2 InChI
    InChI=1S/C8H17NO5/c10-2-1-9-3-6(12)8(14)7(13)5(9)4-11/h5-8,10-14H,1-4H2/t5-,6+,7-,8-/m1/s1
    2.1.3 InChI Key
    IBAQFPQHRJAVAV-ULAWRXDQSA-N
    2.1.4 Canonical SMILES
    C1C(C(C(C(N1CCO)CO)O)O)O
    2.1.5 Isomeric SMILES
    C1[C@@H]([C@H]([C@@H]([C@H](N1CCO)CO)O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    0V5436JAQW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Bay M 1099

    2. Bay-m 1099

    3. Bay-m-1099

    4. Diastabol

    5. Glyset

    6. Miglitol, 4-methylbenzenesulfonate Salt, ((d)-isomer)

    7. N-hydroxyethyl-1-desoxy-nojirimycin

    8. N-hydroxyethyl-1-desoxynojirimycin

    9. Plumarol

    2.3.2 Depositor-Supplied Synonyms

    1. 72432-03-2

    2. Glyset

    3. (2r,3r,4r,5s)-1-(2-hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol

    4. Bay-m-1099

    5. Bay M 1099

    6. Miglitol (glyset)

    7. Seibule

    8. Chembl1561

    9. (2r,3r,4r,5s)-1-(2-hydroxyethyl)-2-(hydroxymethyl)-3,4,5-piperidinetriol

    10. 0v5436jaqw

    11. Chebi:6935

    12. Diastabol

    13. Plumarol

    14. Nsc-758702

    15. Dsstox_cid_3323

    16. Dsstox_rid_76977

    17. Dsstox_gsid_23323

    18. Miglitolum

    19. N-(2-hydroxyethyl)-1-deoxynojirimycin

    20. Smr000466381

    21. Miglitolum [latin]

    22. Cas-72432-03-2

    23. Glyset (tn)

    24. Unii-0v5436jaqw

    25. Miglitol [usan:inn:ban]

    26. Bay 1099

    27. Hsdb 8022

    28. Ncgc00095127-01

    29. Einecs 276-661-6

    30. Mfcd00867240

    31. Sk-983

    32. Baym1099

    33. Miglitol [usan]

    34. Miglitol [inn]

    35. Miglitol [jan]

    36. Miglitol [mi]

    37. Miglitol [vandf]

    38. Miglitol [mart.]

    39. Bay M1009

    40. Miglitol [who-dd]

    41. Schembl22593

    42. Mls000759514

    43. Mls001424128

    44. Mls006011963

    45. Bidd:gt0732

    46. Bay-m1099

    47. Miglitol [orange Book]

    48. Cid_441314

    49. Gtpl4842

    50. Miglitol (jp17/usan/inn)

    51. Dtxsid0023323

    52. Bay1099

    53. Hms2051d05

    54. Hms3713j07

    55. N-hydroxylethyl-1-deoxynojirimycin

    56. Hy-b0481

    57. Zinc4097426

    58. Tox21_111436

    59. Bdbm50242271

    60. Akos015969689

    61. Tox21_111436_1

    62. Ccg-100920

    63. Db00491

    64. Ks-1242

    65. Nc00170

    66. Nsc 758702

    67. Ncgc00270540-02

    68. M2302

    69. S2589

    70. C07708

    71. C76308

    72. D00625

    73. Ab00639982-06

    74. Ab00639982_08

    75. 432m032

    76. A837526

    77. Q772735

    78. Sr-01000759413

    79. Sr-01000759413-4

    80. W-104490

    81. 1,5-dideoxy-1,5-((2-hydroxyethyl)imino)-d-glucitol

    82. Brd-k44779798-001-06-5

    83. Z1541638520

    84. (2r,3r,4r,5s)-1-ethoxy-2-(hydroxymethyl)piperidine-3,4,5-triol

    85. (4r,5r)-1-(2-hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol

    86. (2r,3r,4r,5s)-1-(2-hydroxyethyl)-2-(2-hydroxymethyl)-3,4,5-piperidinetriol

    87. 1204250-58-7

    88. 3,4,5-piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2r-(2.alpha.,3.beta.,4.alpha.,5.beta.))-

    89. 3,4,5-piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2r-(2alpha,3beta,4alpha,5beta))-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 207.22 g/mol
    Molecular Formula C8H17NO5
    XLogP3-2.6
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count3
    Exact Mass207.11067264 g/mol
    Monoisotopic Mass207.11067264 g/mol
    Topological Polar Surface Area104 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity179
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    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 2  
    Drug NameGlyset
    PubMed HealthMiglitol (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelGLYSET Tablets contain miglitol, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, 1-(2-hydr...
    Active IngredientMiglitol
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    2 of 2  
    Drug NameGlyset
    PubMed HealthMiglitol (By mouth)
    Drug ClassesAntidiabetic
    Drug LabelGLYSET Tablets contain miglitol, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, 1-(2-hydr...
    Active IngredientMiglitol
    Dosage FormTablet
    RouteOral
    Strength25mg; 100mg; 50mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    4.2 Therapeutic Uses

    1-Deoxynojirimycin/*analogs & derivatives; alpha-Glucosidases/antagonists & inhibitors; Enzyme Inhibitors

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

    Reduction in postprandial blood glucose concentrations persists for 3-4 hours following a single dose in healthy individuals.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    Miglitol is 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 GLYSET (miglitol) tablet, film coated (October 2010). Available from, as of February 21, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75711d16-2d27-476e-a312-d5af448a0e25

    4.3 Drug Warning

    Miglitol is contraindicated in patients with known hypersensitivity to the drug or diabetic ketoacidosis. The drug is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or predisposition to this condition, chronic intestinal diseases associated with marked disorders of digestion or absorption, and coexisting conditions that may deteriorate as a result of increased intestinal gas formation.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    Miglitol should not cause hypoglycemia when administered alone in the fasting or postprandial state. There is an increased risk of hypoglycemia when miglitol is used concomitantly with insulinor a sulfonylurea antidiabetic agent. If hypoglycemia occurs, dosage of these agents should be adjusted appropriately.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    Oral glucose (dextrose) should be used for the treatment of mild to moderate hypoglycemia instead of sucrose (table sugar, a disaccharide); absorption of oral glucose (a monosaccharide) is not delayed by miglitol. Severe hypoglycemia may require the use of either iv glucose infusion or parenteral glucagon.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    There is a risk of possible loss of glycemic control in patients receiving miglitol during periods of stress (e.g., fever, trauma, infection, surgery); temporary administration of insulin may be required.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    For more Drug Warnings (Complete) data for Miglitol (11 total), please visit the HSDB record page.

    4.4 Drug Indication

    For use as an adjunct to diet to improve glycemic control in patients with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be managed with diet alone.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Miglitol, an oral alpha-glucosidase inhibitor, is a desoxynojirimycin derivative that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, miglitol reduce levels of glycosylated hemoglobin in patients with Type II (non-insulin-dependent) diabetes mellitus. Systemic nonenzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time. Because its mechanism of action is different, the effect of miglitol to enhance glycemic control is additive to that of sulfonylureas when used in combination. In addition, miglitol diminishes the insulinotropic and weight-increasing effects of sulfonylureas. Miglitol has minor inhibitory activity against lactase and consequently, at the recommended doses, would not be expected to induce lactose intolerance.

    5.2 MeSH Pharmacological Classification

    Enzyme Inhibitors

    Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

    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.)

    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
    MIGLITOL
    5.3.2 FDA UNII
    0V5436JAQW
    5.3.3 Pharmacological Classes
    alpha-Glucosidase Inhibitor [EPC]; alpha Glucosidase Inhibitors [MoA]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BF - Alpha glucosidase inhibitors

    A10BF02 - Miglitol

    5.5 Absorption, Distribution and Excretion

    Absorption

    Absorption of miglitol is saturable at high doses with 25 mg being completely absorbed while a 100-mg dose is only 50-70% absorbed. No evidence exists to show that systemic absorption of miglitol adds to its therapeutic effect.

    Route of Elimination

    Miglitol is not metabolized in man or in any animal species studied. It is eliminated by renal excretion as an unchanged drug.

    Volume of Distribution

    0.18 L/kg

    Absorption of miglitol is saturable at high doses: a dose of 25 mg is completely absorbed, whereas a dose of 100 mg is only 50% - 70% absorbed. For all doses, peak concentrations are reached in 2-3 hours.

    US Natl Inst Health; DailyMed. Current Medication Information for GLYSET (miglitol) tablet, film coated (October 2010). Available from, as of February 21, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75711d16-2d27-476e-a312-d5af448a0e25

    Therapeutic effects principally result from local actions on the small intestine; there is no evidence that systemic absorption contributes to therapeutic response.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    The protein binding of miglitol is negligible (<4.0%). Miglitol has a volume of distribution of 0.18 L/kg, consistent with distribution primarily into the extracellular fluid.

    US Natl Inst Health; DailyMed. Current Medication Information for GLYSET (miglitol) tablet, film coated (October 2010). Available from, as of February 21, 2011: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75711d16-2d27-476e-a312-d5af448a0e25

    Miglitol is distributed principally into extracellular fluid and concentrated in enterocytes of the small intestine.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    For more Absorption, Distribution and Excretion (Complete) data for Miglitol (9 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Miglitol is not metabolized in man or in any animal species studied.

    Miglitol is not metabolized in man or in any animal species studied. No metabolites have been detected in plasma, urine, or feces, indicating a lack of either systemic or pre-systemic metabolism.

    US Natl Inst Health; DailyMed. Current Medication Information for GLYSET (miglitol) tablet, film coated (October 2010). Available from, as of February 21, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75711d16-2d27-476e-a312-d5af448a0e25

    5.7 Biological Half-Life

    The elimination half-life of miglitol from plasma is approximately 2 hours.

    ... Miglitol is rapidly eliminated from plasma with apparent elimination half-lives of 0.4-1.8 hr. ... At very low concentration levels a terminal elimination phase of radioactivity characterized by half-lives of 50-110 hr...

    PMID:9239452 Ahr HJ et al; Arzneimittelforschung 47 (6): 734-45 (1997)

    The elimination half-life of miglitol from plasma is approximately 2 hours.

    US Natl Inst Health; DailyMed. Current Medication Information for GLYSET (miglitol) tablet, film coated (October 2010). Available from, as of February 21, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75711d16-2d27-476e-a312-d5af448a0e25

    5.8 Mechanism of Action

    In contrast to sulfonylureas, miglitol does not enhance insulin secretion. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane-bound intestinal a-glucoside hydrolase enzymes. Membrane-bound intestinal a-glucosidases hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycemia.

    Miglitol is a desoxynojirimycin derivative that delays the digestion of ingested carbohydrates, thereby resulting in a smaller rise in blood glucose concentration following meals. As a consequence of plasma glucose reduction, miglitol tablets reduce levels of glycosylated hemoglobin in patients with Type II (non-insulin-dependent) diabetes mellitus. Systemic nonenzymatic protein glycosylation, as reflected by levels of glycosylated hemoglobin, is a function of average blood glucose concentration over time.

    US Natl Inst Health; DailyMed. Current Medication Information for GLYSET (miglitol) tablet, film coated (October 2010). Available from, as of February 21, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75711d16-2d27-476e-a312-d5af448a0e25

    Miglitol inhibits alpha-glucosidase enzymes (e.g., sucrase, glucoamylase, maltase, isomaltase) that hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the small intestinal brush border. The drug has little or no inhibitory effect on trehalase, lactase, or pancreatic alpha-amylase; it is not expected to produce lactose intolerance. Miglitol delays carbohydrate breakdown and glucose absorption and reduces postprandial hyperglycemia in diabetic patients; fasting blood glucose concentrations are mildly decreased.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    In contrast to sulfonylurea antidiabetic agents, miglitol does not enhance insulin secretion. The drug does not produce hypoglycemia when given as monotherapy in the fasted or postprandial state. When used in combination with sulfonylurea antidiabetic agents, miglitol reduces the insulinotropic and weight-increasing effects of sulfonylureas. Miglitol does not produce clinically important weight loss.

    American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

    Oral administration of miglitol has been reported to produce glucagon-like peptide 1 (GLP-1). /The authors/ hypothesized that p.o. administration of miglitol, an absorbable antidiabetic drug, reduces myocardial infarct size by stimulating GLP-1 receptors and inhibiting glycogenolysis in the myocardium. The effects of p.o. and i.v. administration of miglitol on myocardial infarct size were compared in a rabbit model of ischemia induced by 30 min of coronary occlusion and 48 hr of reperfusion. The levels of phospho(p)-PI3kinase and p-Akt were measured in cardiac tissue by use of Western blot analysis. Both p.o. and i.v. administration of miglitol reduced the infarct size, and this effect was greater after p.o. than after i.v. administration under similar plasma miglitol concentrations. The reduction in infarct size induced by p.o. miglitol but not that induced by i.v. miglitol was partially inhibited by treatment with exendin(9-39), a GLP-1 receptor blocker. Both p.o. and i.v. miglitol improved ejection fraction and +/-dP/dt after myocardial infarction. Miglitol administered p.o. but not i.v. up-regulated the myocardial expression of phospho(p)-PI3kinase and p-Akt following myocardial infarction; an effect that was inhibited by exendin(9-39). Administration of miglitol p.o. reduces myocardial infarct size through stimulation of GLP-1 receptors and activation of PI3kinase-Akt pathway in addition to the inhibition of glycogenolysis. These findings may have clinical implications for the p.o. administration of miglitol for the treatment of patients with diabetes mellitus combined with coronary artery disease.

    PMID:21426318 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3171865 Iwasa M et al; Br J Pharmacol 164 (1): 119-31 (2011)

    Imino sugars are used to treat type 2 diabetes mellitus (miglitol (Glyset)) and lysosomal storage disorders (miglustat (Zavesca)) based on the inhibition of alpha-glucosidases and glucosyltransferases. In this substrate specificity study, /investigators/ examined the interactions of imino sugars with a novel human glucose sensor, sodium/glucose cotransporter type 3 (hSGLT3), using expression in Xenopus laevis oocytes and electrophysiology. The results for hSGLT3 are compared with those for alpha-glucosidases and human SGLT type 1 (hSGLT1), a well characterized sodium/glucose cotransporter of the SGLT family. In general, substrates have lower apparent affinities (K0.5) for hSGLT3 than hSGLT1 (D-glucose, alpha-methyl-D-glucose, 1-deoxy-D-glucose, and 4-deoxy-4-fluoro-D-glucose exhibit K0.5 values of 19, 21, 43, and 17 mM, respectively, for hSGLT3, and 0.5, 0.7, 10, and 0.07 mM, respectively, for hSGLT1). However, specificity of hSGLT3 binding is greater (D-galactose and 4-deoxy-4-fluoro-D-galactose are not hSGLT3 substrates, but have hSGLT1 K0.5 values of 0.6 and 1.3 mM). An important deviation from this trend is potent hSGLT3 activation by the imino sugars 1-deoxynojirimycin (DNJ), N-hydroxylethyl-1-deoxynojirimycin (miglitol), N-butyl-1-deoxynojirimycin (miglustat), N-ethyl-1-deoxynojirimycin, and 1-deoxynojirimycin-1-sulfonic acid, with K0.5 values of 0.5 to 9 microM. The diastereomer 1-deoxygalactonojirimycin activates hSGT3 with a K0.5 value of 11 mM, a 3000-fold less potent interaction than is observed for DNJ (4 microM). These imino sugar binding characteristics are similar to those for alpha-glucosidases, but there are no interactions with hSGLT1. This work provides insights into hSGLT3 and -1 substrate binding interactions, establishes a pharmacological profile to study endogenous hSGLT3, and may have important ramifications for the clinical application of imino sugars.

    PMID:17110502 Voss AA et al; Mol Pharmacol 71 (2): 628-34 (2007)

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 100MG

    USFDA APPLICATION NUMBER - 20682

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    DOSAGE - TABLET;ORAL - 25MG

    USFDA APPLICATION NUMBER - 20682

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    DOSAGE - TABLET;ORAL - 50MG

    USFDA APPLICATION NUMBER - 20682

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    ABOUT THIS PAGE

    Miglitol Manufacturers

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

    Miglitol Suppliers

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

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

    Miglitol USDMF

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

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

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

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

    Miglitol 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 Miglitol as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Miglitol GMP

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

    Miglitol CoA

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

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

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