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Also known as: 668270-12-0, Tradjenta, Bi 1356, Bi-1356, Ondero, Linagliptin (bi-1356)
Molecular Formula
C25H28N8O2
Molecular Weight
472.5  g/mol
InChI Key
LTXREWYXXSTFRX-QGZVFWFLSA-N
FDA UNII
3X29ZEJ4R2

Linagliptin
A purine and quinazoline derivative that functions as an INCRETIN and DIPEPTIDYL-PEPTIDASE IV INHIBTOR. It is used as a HYPOGLYCEMIC AGENT in the treatment of TYPE II DIABETES MELLITUS.
Linagliptin is a Dipeptidyl Peptidase 4 Inhibitor. The mechanism of action of linagliptin is as a Dipeptidyl Peptidase 4 Inhibitor.
1 2D Structure

Linagliptin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
8-[(3R)-3-aminopiperidin-1-yl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione
2.1.2 InChI
InChI=1S/C25H28N8O2/c1-4-5-13-32-21-22(29-24(32)31-12-8-9-17(26)14-31)30(3)25(35)33(23(21)34)15-20-27-16(2)18-10-6-7-11-19(18)28-20/h6-7,10-11,17H,8-9,12-15,26H2,1-3H3/t17-/m1/s1
2.1.3 InChI Key
LTXREWYXXSTFRX-QGZVFWFLSA-N
2.1.4 Canonical SMILES
CC#CCN1C2=C(N=C1N3CCCC(C3)N)N(C(=O)N(C2=O)CC4=NC5=CC=CC=C5C(=N4)C)C
2.1.5 Isomeric SMILES
CC#CCN1C2=C(N=C1N3CCC[C@H](C3)N)N(C(=O)N(C2=O)CC4=NC5=CC=CC=C5C(=N4)C)C
2.2 Other Identifiers
2.2.1 UNII
3X29ZEJ4R2
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (r)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

2. 1356, Bi

3. 1h-purine-2,6-dione, 8-((3r)-3-amino-1-piperidinyl)-7-(2-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2-quinazolinyl)methyl)-

4. Bi 1356

5. Bi-1356

6. Bi1356

7. Tradjenta

8. Trajenta

2.3.2 Depositor-Supplied Synonyms

1. 668270-12-0

2. Tradjenta

3. Bi 1356

4. Bi-1356

5. Ondero

6. Linagliptin (bi-1356)

7. Trajenta

8. Trazenta

9. Bi-1356-bs

10. Bs 1356 Bs

11. Ione

12. 3x29zej4r2

13. Chembl237500

14. (r)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

15. Bi-1356bs

16. Chebi:68610

17. Bi 1356 Bs

18. Bs-1356-bs

19. (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1h-purine-2,6(3h,7h)-dione

20. (r)-8-(3-aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methylquinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione

21. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-yn-1-yl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-dione

22. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione

23. 8-[(3r)-3-aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3- Methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-dione

24. 8-[(3r)-3-aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-dione

25. C25h28n8o2

26. Unii-3x29zej4r2

27. Linaglitpin

28. Linagliptin [usan:inn:jan]

29. Hsdb 8204

30. Tradjenta (tn)

31. 8-((3r)-3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1h-purine-2,6-dione

32. 8-[(3r)-3-amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1h-purine-2,6-dione

33. Linagliptin [mi]

34. Linagliptin [inn]

35. Linagliptin [jan]

36. Linagliptin [usan]

37. Linagliptin [vandf]

38. Linagliptin [mart.]

39. Linagliptin [who-dd]

40. Mls006010217

41. Schembl160188

42. Linagliptin (jan/usan/inn)

43. Gtpl6318

44. Amy8953

45. Ex-a076

46. Linagliptin [orange Book]

47. Bcpp000185

48. Dtxsid201021653

49. Bcp02462

50. Zinc3820029

51. Bdbm50228403

52. Glyxambi Component Linagliptin

53. Mfcd14635356

54. S3031

55. Akos015951179

56. Akos015995251

57. Ac-8761

58. Bcp9000854

59. Ccg-269463

60. Cs-0637

61. Db08882

62. Linagliptin Component Of Glyxambi

63. Trijardy Xr Component Linagliptin

64. Ncgc00346655-01

65. Ncgc00346655-02

66. 1h-purine-2,6-dione, 8-((3r)-3-amino-1-piperidinyl)-7-(2-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2-quinazolinyl)methyl)-

67. As-35080

68. Bl164627

69. Hy-10284

70. Jentadueto Component Of Linagliptin

71. Linagliptin Component Of Jentadueto

72. Smr004701306

73. Linagliptin Component Of Trijardy Xr

74. Sw219813-1

75. D09566

76. Ab01563307_01

77. Ab01563307_03

78. 270l120

79. Q909745

80. J-519354

81. (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1h-purine-2,6(3h,7h)-dione

82. (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1h-purine-2,6-dione

83. 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(r)-aminopiperidin-1-yl)xanthine

84. 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(r)aminopiperidin-1-yl)xanthine

85. 1-[(4-methyl-quinazolin-2yl) Methyl]-3-methyl-7-(2-butyn-1-yl)-8-[3-(r) Amino-piperidin-1-yl]-xanthine

86. 1-[(4-methylquinazolin-2-yl)-methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(r)-aminopiperidin-1-yl)-xanthine

87. 1-[(4-methylquinazolin-2-yl)methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(r)-aminopiperidin-1-yl)-xanthine

88. 1233245-11-8

89. 1h-purine-2,6-dione, 8-((3r)-3-amino-1-piperidinyl)-7-(2-butynyl)-3,7-dihydro-3-methyl-1-((4-methyl-2- Quinazolinyl)methyl)-

90. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-yn-1-yl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-d

91. 8-[(3r)-3-aminopiperidin-1-yl]-7-but-2-yn-1-yl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1h-purine-2,6-d Ione

92. Linagliptin; (r)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1h-purine-2,6(3h,7h)-dione

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 472.5 g/mol
Molecular Formula C25H28N8O2
XLogP31.9
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count4
Exact Mass472.23352217 g/mol
Monoisotopic Mass472.23352217 g/mol
Topological Polar Surface Area114 Ų
Heavy Atom Count35
Formal Charge0
Complexity885
Isotope Atom Count0
Defined Atom Stereocenter Count1
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 NameTradjenta
PubMed HealthLinagliptin (By mouth)
Drug ClassesHypoglycemic
Drug LabelTRADJENTA (linagliptin) tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,...
Active IngredientLinagliptin
Dosage FormTablet
RouteOral
Strength5mg
Market StatusPrescription
CompanyBoehringer Ingelheim

2 of 2  
Drug NameTradjenta
PubMed HealthLinagliptin (By mouth)
Drug ClassesHypoglycemic
Drug LabelTRADJENTA (linagliptin) tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,...
Active IngredientLinagliptin
Dosage FormTablet
RouteOral
Strength5mg
Market StatusPrescription
CompanyBoehringer Ingelheim

4.2 Therapeutic Uses

Hypoglycemic Agents

National Library of Medicine's Medical Subject Headings. Linagliptin. Online file (MeSH, 2014). Available from, as of July 18, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html


Tradjenta 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/

NIH; DailyMed. Current Medication Information for Tradjenta (Linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


4.3 Drug Warning

/BOXED WARNING/ WARNING: RISK OF LACTIC ACIDOSIS. Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, Jentadueto should be discontinued and the patient hospitalized immediately. /Linagliptin and metformin hydrochloride combination product/

NIH; DailyMed. Current Medication Information for Jentadueto (Linagliptin and Metformin Hydrochloride) Tablets (Revised: May 2014). Available from, as of July 18, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f6dd9b86-0d18-95d4-2bc7-05591bfdd597


FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics. Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information. ... FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report. The Warnings and Precautions section of drug labels and patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics. FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer. At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels. ...

US FDA; Safety Alerts for Human Medicial Products: Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas (Posted March 14, 1013). Available from, as of August 1, 2014: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343805.htm


There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking Tradjenta. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue Tradjenta and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Tradjenta.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Tradjenta. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with Tradjenta, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue Tradjenta, assess for other potential causes for the event, and institute alternative treatment for diabetes. Angioedema has also been reported with other dipeptidyl peptidase-4 (DPP-4) inhibitors. Use caution in a patient with a history of angioedema to another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with Tradjenta.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


For more Drug Warnings (Complete) data for Linagliptin (20 total), please visit the HSDB record page.


4.4 Drug Indication

Linagliptin is indicated for the treatment of type II diabetes in addition to diet and exercise. It should not be used to treat type I diabetes or in diabetic ketoacidosis. 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


Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:

as

* monotherapy:

- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

as

* combination therapy:

- in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.

- in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

- in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.


5 Pharmacology and Biochemistry
5.1 Pharmacology

A 5mg oral dose of linagliptin results in >80% inhibition of dipeptidyl peptidase 4 (DPP-4) for 24 hours. Inhibition of DPP-4 increases the concentration of glucagon-like peptide 1 (GLP-1), leading to decreased glycosylated hemoglobin and fasting plasma glucose.


5.2 MeSH Pharmacological Classification

Dipeptidyl-Peptidase IV Inhibitors

Compounds that suppress the degradation of INCRETINS by blocking the action of DIPEPTIDYL-PEPTIDASE IV. This helps to correct the defective INSULIN and GLUCAGON secretion characteristic of TYPE 2 DIABETES MELLITUS by stimulating insulin secretion and suppressing glucagon release. (See all compounds classified as Dipeptidyl-Peptidase IV Inhibitors.)


Hypoglycemic Agents

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


Incretins

Peptides which stimulate INSULIN release from the PANCREATIC BETA CELLS following oral nutrient ingestion, or postprandially. (See all compounds classified as Incretins.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
LINAGLIPTIN
5.3.2 FDA UNII
3X29ZEJ4R2
5.3.3 Pharmacological Classes
Dipeptidyl Peptidase 4 Inhibitors [MoA]; Dipeptidyl Peptidase 4 Inhibitor [EPC]
5.4 ATC Code

A10BH05


A - Alimentary tract and metabolism

A10 - Drugs used in diabetes

A10B - Blood glucose lowering drugs, excl. insulins

A10BH - Dipeptidyl peptidase 4 (dpp-4) inhibitors

A10BH05 - Linagliptin


5.5 Absorption, Distribution and Excretion

Absorption

Oral bioavailability of linagliptin is 30%.


Route of Elimination

84.7% of linagliptin is eliminated in the feces and 5.4% is eliminated in the urine.


Volume of Distribution

A single intravenous dose of 5mg results in a volume of distribution of 1110L. However an intravenous infusion of 0.5-10mg results in a volume of distribution of 380-1540L.


Clearance

Total clearance of linagliptin is 374mL/min.


Available animal data have shown excretion of linagliptin in milk at a milk-to-plasma ratio of 4:1.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


After oral administration of a single 5-mg dose to healthy subjects, peak plasma concentrations of linagliptin occurred at approximately 1.5 hours post dose (Tmax); the mean plasma area under the curve (AUC) was 139 nmol*h/L and maximum concentration (Cmax) was 8.9 nmol/L.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


The absolute bioavailability of linagliptin is approximately 30%. High-fat meal reduced Cmax by 15% and increased AUC by 4%; this effect is not clinically relevant. Tradjenta may be administered with or without food.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


Following administration of an oral (14C)-linagliptin dose to healthy subjects, approximately 85% of the administered radioactivity was eliminated via the enterohepatic system (80%) or urine (5%) within 4 days of dosing. Renal clearance at steady state was approximately 70 mL/min.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


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


5.6 Metabolism/Metabolites

An oral dose of linagliptin is excreted primarily in the feces. 90% of an oral dose is excreted unchanged in the urine and feces. The predominant metabolite in the plasma is CD1790 and the predominant metabolite recovered after excretion was M489(1). Other metabolites are produced through oxidation, oxidative degradation, N-acetylation, glucuronidation, and cysteine adduct formation. Other metabolites have been identified through mass spectrometry though no structures were determined. Metabolism of linagliptin is mediated by cytochrome P450 3A4, aldo-keto reductases, and carbonyl reductases.


Following oral administration, the majority (about 90%) of linagliptin is excreted unchanged, indicating that metabolism represents a minor elimination pathway. A small fraction of absorbed linagliptin is metabolized to a pharmacologically inactive metabolite, which shows a steady-state exposure of 13.3% relative to linagliptin.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


5.7 Biological Half-Life

The terminal half life of linagliptin is 155 hours.


The effective half-life for accumulation of linagliptin, as determined from oral administration of multiple doses of linagliptin 5 mg, is approximately 12 hours.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


Plasma concentrations of linagliptin decline in at least a biphasic manner with a long terminal half-life (>100 hours), related to the saturable binding of linagliptin to DPP-4.

NIH; DailyMed. Current Medication Information for Tradjenta (linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of August 1, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


5.8 Mechanism of Action

Linagliptin is a competitive, reversible DPP-4 inhibitor. Inhibition of this enzyme slows the breakdown of GLP-1 and glucose-dependant insulinotropic polypeptide (GIP). GLP-1 and GIP stimulate the release of insulin from beta cells in the pancreas while inhibiting release of glucagon from pancreatic beta cells. These effects together reduce the breakdown of glycogen in the liver and increase insulin release in response to glucose.


Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta-cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha-cells, resulting in a reduction in hepatic glucose output.

NIH; DailyMed. Current Medication Information for Tradjenta (Linagliptin) Tablet, Film-coated (Revised: June 2014). Available from, as of July 31, 2014: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f


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DMF Number : 27907

Submission : 2014-03-24

Status : Active

Type : II

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06

BioProcess International
Not Confirmed

06

BioProcess International
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-07

Pay. Date : 2014-11-25

DMF Number : 28785

Submission : 2014-12-22

Status : Active

Type : II

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07

Honour Lab Ltd

India

USDMF

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BioProcess International
Not Confirmed

07

BioProcess International
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-13

Pay. Date : 2014-12-23

DMF Number : 28877

Submission : 2015-01-07

Status : Active

Type : II

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08

BioProcess International
Not Confirmed

08

BioProcess International
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-02

Pay. Date : 2014-10-08

DMF Number : 28098

Submission : 2014-03-28

Status : Active

Type : II

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09

BioProcess International
Not Confirmed

09

BioProcess International
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-04-20

Pay. Date : 2014-10-28

DMF Number : 28769

Submission : 2014-11-11

Status : Active

Type : II

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10

BioProcess International
Not Confirmed

10

BioProcess International
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-22

Pay. Date : 2014-10-30

DMF Number : 28748

Submission : 2014-10-31

Status : Active

Type : II

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INCHEON INT\\'","customer":"TO ORDER","customerCountry":"REPUBLIC OF KOREA","quantity":"9.40","actualQuantity":"9.4","unit":"KGS","unitRateFc":"7250","totalValueFC":"67797.3","currency":"USD","unitRateINR":598943.89574468089,"date":"06-Aug-2024","totalValueINR":"5630072.62","totalValueInUsd":"67797.3","indian_port":"Bombay Air","hs_no":"29333929","bill_no":"2999587","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723401000,"product":"LINAGLIPTIN IHB NO-LGI24502MFG.JUN-2024 RETEST DT.MAY-2027","address":"MOREPEN VILLAGE, NALAGARH ROAD,","city":"N\/A","supplier":"MOREPEN LABORATORIES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"1313","totalValueFC":"56277.8","currency":"EUR","unitRateINR":116836.45,"date":"12-Aug-2024","totalValueINR":"4673458","totalValueInUsd":"56277.8","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"3128916","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"MOREPEN VILLAGE, NALAGARH ROAD,, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723746600,"product":"LINAGLIPTIN (IN-HOUSE), (EXPORT INVOICENO:6124010255 DT:03.08.2024)","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"AL-ESRAA PHARMACEUTICAL OPTIMA.","customerCountry":"EGYPT","quantity":"1.10","actualQuantity":"1.099","unit":"KGS","unitRateFc":"1300","totalValueFC":"1358","currency":"USD","unitRateINR":102615.07734303913,"date":"16-Aug-2024","totalValueINR":"112773.97","totalValueInUsd":"1358","indian_port":"Hyderabad Air","hs_no":"29333200","bill_no":"3230262","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SYNO.257 258\/1, DNO.11-6\/56,, VILLAGE BALANGAR POST HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723746600,"product":"LINAGLIPTIN IH (PHARMACEUTICAL ALLOPATHIC RAW MATERIAL)","address":"RAGHAVA PRIDE,8-2-603\/1\/27,28,,RD","city":"BANJARA HILLS HYDERABAD,TELANGANA","supplier":"RAGHAVA LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"BANK ALFALAH LIMITED","customerCountry":"PAKISTAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1000","totalValueFC":"933.3","currency":"USD","unitRateINR":77500,"date":"16-Aug-2024","totalValueINR":"77500","totalValueInUsd":"933.3","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"3254405","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"RAGHAVA PRIDE,8-2-603\/1\/27,28,,RD, BANJARA HILLS HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724783400,"product":"LINAGLIPTIN (EXPORT INVOICE NO. 6124010267, DATE: 17.08.2024)","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"AVVA RUS JSC","customerCountry":"RUSSIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3950","totalValueFC":"3830.5","currency":"USD","unitRateINR":318098,"date":"28-Aug-2024","totalValueINR":"318098","totalValueInUsd":"3830.5","indian_port":"Hyderabad Air","hs_no":"29333200","bill_no":"3537587","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SYNO.257 258\/1, DNO.11-6\/56,, VILLAGE BALANGAR POST HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724783400,"product":"LINAGLIPTIN IN-HOUSE","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"M\/S P&C PELLETS & CR PRODUCT","customerCountry":"EGYPT","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"800","totalValueFC":"15909.3","currency":"USD","unitRateINR":66057.399999999994,"date":"28-Aug-2024","totalValueINR":"1321148","totalValueInUsd":"15909.3","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"3561621","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669746600,"product":"LINAGLIPTIN 5 MG AND METFORMIN HYDROCHLORIDE 1000 MG (EXTENDED RELEASE) TABLETS(90 TABLETS)(LOT #3208414)","address":"UNIT NO .3 ,CORPORATE PARK, SION TROMBAY ROAD, CHEMBUR","city":"MUMBAI","supplier":"GOOD HEALTH PHARMA ","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ABBOTT LABORATORIES","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"3040","totalValueFC":"2313.4","currency":"USD","unitRateINR":"377600.4","date":"30-Nov-2022","totalValueINR":"188800.2","totalValueInUsd":"2313.4","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"3529515","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"UNIT NO .3 ,CORPORATE PARK, SION TROMBAY ROAD, CHEMBUR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685989800,"product":"LINAGLIPTIN. B\/N: D5425-23-001 (2.5 KG) & MFG. DT. 20\/04\/23B\/N: D5425-23-002M1 (2.5 KG) MFG. DT. 21\/04\/23 RETEST DT. 03","address":"UNISON HOUSE, NR. PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR","city":"AHMEDABAD","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"UNISON PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"2500","totalValueFC":"12683.1","currency":"USD","unitRateINR":"208499.9","date":"06-Jun-2023","totalValueINR":"1042500.333","totalValueInUsd":"12683.1","indian_port":"AHMEDABAD AIR","hs_no":"29334900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"UNISON HOUSE, NR. PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721413800,"product":"LINAGLIPTIN. B\/N: D5425-23-004M1 MFG. DT. 04\/06\/2023 RETESTDT. 05\/2028.","address":"PLOT NO.5222, PHASE- IV,","city":"AHMEDABAD -","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"UNISON PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.80","actualQuantity":"0.8","unit":"KGS","unitRateFc":"2500","totalValueFC":"2036.3","currency":"USD","unitRateINR":"211375","date":"20-Jul-2024","totalValueINR":"169100","totalValueInUsd":"2036.3","indian_port":"Ahmedabad Air","hs_no":"29334900","bill_no":"4613450","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"XUNQIAO,LINHAI ,ZHEJIANG 317024 CHISDNF CHINA","customerAddress":"PLOT NO.5222, PHASE- IV,"}]
04-Jan-2021
28-Aug-2024
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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 201280

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DOSAGE - TABLET;ORAL - 2.5MG;1GM

USFDA APPLICATION NUMBER - 201281

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USFDA APPLICATION NUMBER - 201281

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USFDA APPLICATION NUMBER - 206073

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USFDA APPLICATION NUMBER - 206073

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ABOUT THIS PAGE

Linagliptin Manufacturers | Traders | Suppliers

Linagliptin Manufacturers, Traders, Suppliers 1
98

We have 81 companies offering Linagliptin

Get in contact with the supplier of your choice:

  1. Polpharma
  2. LGM Pharma
  3. Metrochem API Private Limited
  4. Rochem International Inc
  5. Suanfarma
  6. Dr. Reddy's Laboratories
  7. Jai Radhe Sales
  8. Faran Shimi Pharmaceutical
  9. Virupaksha Organics
  10. Aptra Synthesis
  11. Century Pharmaceuticals
  12. HRV Global Life Sciences
  13. Nortec Quimica
  14. Shandong Loncom Pharmaceutical
  15. Shanghai Minbiotech
  16. Tofigh Daru
  17. Granules India Limited
  18. Alembic Pharmaceuticals Limited
  19. Amino Chemicals
  20. Anhui HaiKang Pharmaceutical
  21. Aspen Biopharma Labs
  22. Aurobindo Pharma Limited
  23. Bajaj Healthcare
  24. Bakul Group
  25. Beijing Huikang Boyuan Chemical Tech CO.
  26. Beijing Mesochem Technology
  27. Biocon
  28. Bulat Pharmaceutical
  29. Calyx Chemicals & Pharmaceuticals Limited
  30. Centaur Pharmaceuticals
  31. CHEMO
  32. Chengda Pharmaceuticals
  33. Cipla
  34. CTX Lifesciences
  35. DEAFARMA
  36. Diligent Life Care
  37. Fuxin Long Rui Pharmaceutical
  38. Glenmark Life Sciences
  39. Glenmark Pharmaceuticals
  40. Guangzhou Tosun Pharmaceutical
  41. Hanmi Pharmaceutical
  42. Haoyuan Chemexpress Co.Ltd
  43. Harman Finochem
  44. HEC Pharm
  45. Hetero Drugs
  46. HONOUR LAB LTD
  47. Jin Dun Medical
  48. Kimia Biosciences
  49. Kukjeon Pharmaceutical
  50. Lee Pharma
  51. Lewens Labs
  52. Macleods Pharmaceuticals Limited
  53. Mehta API
  54. Micro Labs Limited
  55. MilverPharma Pvt Ltd
  56. Morepen Laboratories
  57. MSN Laboratories
  58. Oneiro Lifecare
  59. Optimus Pharma
  60. Phalanx Labs
  61. Piramal Pharma Solutions
  62. Remedy Labs
  63. SGMR Pharmaceuticals
  64. Shanghai Wonder Pharmaceutical
  65. Shouyuan Chemical
  66. SMS Pharmaceuticals
  67. Srini Pharmaceuticals
  68. SS Pharma
  69. Sun Pharmaceutical Industries Limited
  70. Symed Labs
  71. Teva API
  72. Teva Pharmaceutical Industries
  73. Valence Labs
  74. Venkata Narayana Active Ingredients
  75. Viatris
  76. Viwit Pharmaceuticals Limited
  77. Wisdom Pharmaceutical
  78. Wockhardt
  79. Yangtze River Pharmaceutical Group
  80. Zhejiang Huahai Pharmaceutical
  81. Zydus Lifesciences
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