Synopsis
Synopsis
0
CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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1. 1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene
2. Bi 10773
3. Bi-10773
4. Bi10773
5. Jardiance
1. 864070-44-0
2. Jardiance
3. Bi 10773
4. Bi-10773
5. Bi10773
6. Empagliflozin (bi 10773)
7. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-(((s)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
8. Hdc1r2m35u
9. 1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene
10. Chebi:82720
11. (1s)-1,5-anhydro-1-(4-chloro-3-{4-[(3s)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-d-glucitol
12. (2s,3r,4r,5s,6r)-2-[4-chloro-3-({4-[(3s)-oxolan-3-yloxy]phenyl}methyl)phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
13. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[[4-[(3s)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
14. (1s)-1,5-anhydro-1-c-{4-chloro-3-((4-{((3s)-oxolan-3-yl)oxy}phenyl)methyl)phenyl}-d-glucitol
15. (2s,3r,4r,5s,6r)-2-[4-chloranyl-3-[[4-[(3s)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
16. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-(((3s)-tetrahydro-3-furanyl)oxy)phenyl)methyl)phenyl)-, (1s)-
17. Empagliflozin [inn]
18. Unii-hdc1r2m35u
19. Empagliflozin [usan:inn]
20. Mfcd22566222
21. Jardiance (tn)
22. (s)-empagliflozin D4
23. Empagliflozin [mi]
24. Bi-10773;empagliflozin
25. Empagliflozin [jan]
26. Empagliflozin [usan]
27. Empagliflozin (bi10773)
28. Empagliflozin [vandf]
29. Schembl899986
30. Empagliflozin [who-dd]
31. Gtpl4754
32. Chembl2107830
33. Empagliflozin (jan/usan/inn)
34. Amy1858
35. Ex-a414
36. Bdbm150162
37. Dtxsid601026093
38. Empagliflozin [orange Book]
39. Bbl104150
40. S8022
41. Stl557964
42. Us8980829, Empagliflozin
43. Zinc36520252
44. Akos024464680
45. Glyxambi Component Empagliflozin
46. Ccg-269242
47. Cs-0940
48. Db09038
49. Ds-9824
50. Pb23119
51. (1s)-1,5-anhydro-1-c-[4-chloro-3-[[4-[[(3s)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-d-glucitol
52. Ac-27643
53. Empagliflozin Component Of Glyxambi
54. Empagliflozin Component Of Synjardy
55. Hy-15409
56. Trijardy Xr Component Empagliflozin
57. Empagliflozin Component Of Trijardy Xr
58. Sw219120-1
59. C22194
60. D10459
61. A852380
62. Au-004/43508285
63. Q5373824
64. Empagliflozin (bi-10773;bi 10773;bi10773)
65. 1,5-anhydro-1-{4-chloro-3-[4-(tetrahydro-3-furanyloxy)benzyl]phenyl}hexitol
66. (1s)-1,5-anhydro-1-c-(4-chloro-3-((4-(((3s)-oxan-3-yl)oxy)phenyl)methyl)phenyl)-d-glucitol
67. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-((s)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol
68. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-((s)-tetrahydrofuran-3-yloxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
69. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[[4-[(3s)-tetrahydrofuran-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)tetrahydropyran-3,4,5-triol
70. 7r3
| Molecular Weight | 450.9 g/mol |
|---|---|
| Molecular Formula | C23H27ClO7 |
| XLogP3 | 2 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 6 |
| Exact Mass | 450.1445309 g/mol |
| Monoisotopic Mass | 450.1445309 g/mol |
| Topological Polar Surface Area | 109 Ų |
| Heavy Atom Count | 31 |
| Formal Charge | 0 |
| Complexity | 558 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Empagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes. It is also indicated to reduce the risk of cardiovascular death in adult patients with both type 2 diabetes mellitus and established cardiovascular disease. Empagliflozin is also available as a combination product with either metformin and linagliptin as an adjunct to diet and exercise in the management of type 2 diabetes mellitus in adults. An extended-release combination product containing empagliflozin, metformin, and linagliptin 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. Empagliflozin is also approved to reduce the risk of cardiovascular mortality and hospitalization in adults with heart failure with reduced ejection fraction regardless of whether or not the patient has concomitant diabetes. Empagliflozin is not approved for use in patients with type 1 diabetes.
Type 2 diabetes mellitus
Jardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance - in addition to other medicinal products for the treatment of diabetes For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.
Heart failure
Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure.
Treatment of type I diabetes mellitus
Treatment of chronic kidney disease
Prevention of cardiovascular events in patients with chronic heart failure
Treatment of type II diabetes mellitus
Empagliflozin lowers blood glucose levels by preventing glucose reabsorption in the kidneys, thereby increasing the amount of glucose excreted in the urine. It has a relatively long duration of action requiring only once-daily dosing. Patients should be monitored closely for signs and symptoms of ketoacidosis regardless of blood glucose level as empagliflozin may precipitate diabetic ketoacidosis in the absence of hyperglycemia. As its mechanism of action is contingent on the renal excretion of glucose, empagliflozin may be held in cases of acute kidney injury and/or discontinued in patients who develop chronic renal disease. The overexcretion of glucose creates a sugar-rich urogenital environment which increases the risk of urogenital infections - including urosepsis, pyelonephritis, mycotic infections, and even Fournier's gangrene - in both male and female patients - monitor closely for signs and symptoms of developing infection.
Sodium-Glucose Transporter 2 Inhibitors
Compounds that inhibit SODIUM-GLUCOSE TRANSPORTER 2. They lower blood sugar by preventing the reabsorption of glucose by the kidney and are used in the treatment of TYPE 2 DIABETES MELLITUS. (See all compounds classified as Sodium-Glucose Transporter 2 Inhibitors.)
A10BK03
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10B - Blood glucose lowering drugs, excl. insulins
A10BK - Sodium-glucose co-transporter 2 (sglt2) inhibitors
A10BK03 - Empagliflozin
Absorption
Following oral administration, peak plasma concentrations are reached in approximately 1.5 hours (Tmax). At steady-state, plasma AUC and Cmax were 1870 nmolh/L and 259 nmol/L, respectively, following therapy with empagliflozin 10mg daily and 4740 nmolh/L and 687 nmol/L, respectively, following therapy with empagliflozin 25mg daily. Administration with food does not significantly affect the absorption of empagliflozin.
Route of Elimination
After oral administration of radiolabeled empagliflozin approximately 41.2% of the administered dose was found eliminated in feces and 54.4% eliminated in urine. The majority of radioactivity in the feces was due to unchanged parent drug while approximately half of the radioactivity in urine was due to unchanged parent drug.
Volume of Distribution
The estimated apparent steady-state volume of distribution is 73.8 L.
Clearance
Apparent oral clearance was found to be 10.6 L/h based on a population pharmacokinetic analysis.
Empagliflozin undergoes minimal metabolism. It is primarily metabolized via glucuronidation by 5'-diphospho-glucuronosyltransferases 2B7, 1A3, 1A8, and 1A9 to yield three glucuronide metabolites: 2-O-, 3-O-, and 6-O-glucuronide. No metabolite represented more than 10% of total drug-related material.
The apparent terminal elimination half-life was found to be 12.4 h based on population pharmacokinetic analysis.
The vast majority of glucose filtered through the glomerulus is reabsorbed within the proximal tubule, primarily via SGLT2 (sodium-glucose linked co-transporter-2) which is responsible for ~90% of the total glucose reabsorption within the kidneys. Na+/K+-ATPase on the basolateral membrane of proximal tubular cells utilize ATP to actively pump Na+ ions into the interstitium surrounding the tubule, establishing a Na+ gradient within the tubular cell. SGLT2 on the apical membrane of these cells then utilize this gradient to facilitate secondary active co-transport of both Na+ and glucose out of the filtrate, thereby reabsorbing glucose back into the blood inhibiting this co-transport, then, allows for a marked increase in glucosuria and decrease in blood glucose levels. Empagliflozin is a potent inhibitor of renal SGLT2 transporters located in the proximal tubules of the kidneys and works to lower blood glucose levels via an increase in glucosuria. Empagliflozin also appears to exert cardiovascular benefits - specifically in the prevention of heart failure - independent of its blood glucose-lowering effects, though the exact mechanism of this benefit is not precisely understood. Several theories have been posited, including the potential inhibition of Na+/H+ exchanger (NHE) 1 in the myocardium and NHE3 in the proximal tubule, reduction of pre-load via diuretic/natriuretic effects and reduction of blood pressure, prevention of cardiac fibrosis via suppression of pro-fibrotic markers, and reduction of pro-inflammatory adipokines.
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 204629
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 204629
DOSAGE - TABLET;ORAL - 10MG;5MG
USFDA APPLICATION NUMBER - 206073
DOSAGE - TABLET;ORAL - 25MG;5MG
USFDA APPLICATION NUMBER - 206073
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ABOUT THIS PAGE
A JARDIANCE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of JARDIANCE, including repackagers and relabelers. The FDA regulates JARDIANCE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. JARDIANCE 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 JARDIANCE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A JARDIANCE supplier is an individual or a company that provides JARDIANCE active pharmaceutical ingredient (API) or JARDIANCE finished formulations upon request. The JARDIANCE suppliers may include JARDIANCE API manufacturers, exporters, distributors and traders.
click here to find a list of JARDIANCE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A JARDIANCE DMF (Drug Master File) is a document detailing the whole manufacturing process of JARDIANCE active pharmaceutical ingredient (API) in detail. Different forms of JARDIANCE DMFs exist exist since differing nations have different regulations, such as JARDIANCE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A JARDIANCE DMF submitted to regulatory agencies in the US is known as a USDMF. JARDIANCE USDMF includes data on JARDIANCE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The JARDIANCE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of JARDIANCE suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a JARDIANCE Drug Master File in Korea (JARDIANCE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of JARDIANCE. The MFDS reviews the JARDIANCE KDMF as part of the drug registration process and uses the information provided in the JARDIANCE KDMF to evaluate the safety and efficacy of the drug.
After submitting a JARDIANCE 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 JARDIANCE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of JARDIANCE suppliers with KDMF on PharmaCompass.
A JARDIANCE written confirmation (JARDIANCE WC) is an official document issued by a regulatory agency to a JARDIANCE manufacturer, verifying that the manufacturing facility of a JARDIANCE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting JARDIANCE APIs or JARDIANCE finished pharmaceutical products to another nation, regulatory agencies frequently require a JARDIANCE WC (written confirmation) as part of the regulatory process.
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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 JARDIANCE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for JARDIANCE API and other APIs are published in this directory by the FDA.
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 JARDIANCE 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.
The NDC directory also contains data on finished compounded human drug products that contain JARDIANCE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a JARDIANCE NDC to their finished compounded human drug products, they may choose to do so.
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JARDIANCE 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 JARDIANCE 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 JARDIANCE GMP manufacturer or JARDIANCE GMP API supplier for your needs.
A JARDIANCE CoA (Certificate of Analysis) is a formal document that attests to JARDIANCE's compliance with JARDIANCE specifications and serves as a tool for batch-level quality control.
JARDIANCE CoA mostly includes findings from lab analyses of a specific batch. For each JARDIANCE 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.
JARDIANCE may be tested according to a variety of international standards, such as European Pharmacopoeia (JARDIANCE EP), JARDIANCE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (JARDIANCE USP).
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