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1. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
2. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
3. Bms 512148
4. Bms-512148
5. Bms512148
6. Farxiga
7. Forxiga
1. 461432-26-8
2. Bms-512148
3. Forxiga
4. Bms 512148
5. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
6. Dagagflozin
7. (1s)-1,5-anhydro-1-c-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-d-glucitol
8. 1ull0qj8uc
9. Chembl429910
10. Chebi:85078
11. Lyn-045
12. Dapagliflozin [usan:inn]
13. (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol
14. (2s,3r,4r,5s,6r)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol
15. Bms512148
16. Forxiga (tn)
17. Chembl3125458
18. D-glucitol, 1,5-anhydro-1-c-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-, (1s)-
19. (2s,3r,4r,5s,6r)-2-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol
20. Dapagliflozin [usan]
21. Unii-1ull0qj8uc
22. Bms5121458
23. S1548_selleck
24. C-aryl Glucoside, 6
25. Dapagliflozin [mi]
26. Dapagliflozin [inn]
27. Dapagliflozin (usan/inn)
28. 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2h-pyran-3,4,5-triol
29. Dapagliflozin [vandf]
30. Schembl157820
31. Dapagliflozin [who-dd]
32. Gtpl4594
33. Bdbm20880
34. Dtxsid20905104
35. Ex-a005
36. Bcpp000265
37. Dapagliflozin [orange Book]
38. Amy18541
39. Zinc3819138
40. Bdbm50448923
41. Mfcd13182359
42. S1548
43. Qternmet Component Dapaglifozin
44. Akos005145763
45. Dapagliflozin Component Qternmet
46. Bcp9000583
47. Bl-0052
48. Ccg-229917
49. Cs-0781
50. Db06292
51. Ex-7214
52. Ncgc00250402-09
53. Ac-24699
54. Bd164346
55. Hy-10450
56. Qternmet Xr Component Dapagliflozin
57. Dapagliflozin Component Of Qternmet Xr
58. A25150
59. C22193
60. D08897
61. 432d268
62. Q409898
63. J-500392
64. Brd-k58160573-001-01-3
65. Brd-k58160573-001-05-4
66. 1-[3-(beta-d-glucopyranosyl)-6-chlorobenzyl]-4-ethoxybenzene
67. (1s)-1,5-anhydro-1-[4-chloro-3-(4-ethoxybenzyl)phenyl]-d-glucitol
68. (2s, 3r, 4r, 5s, 6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
69. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol
70. (2s,3r,4r,5s,6r)-2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-(hydroxymethyl)-tetrahydro-2h-pyran-3,4,5-triol;bms-512148
71. (2s,3r,4r,5s,6r)-2-[4-chloro-3-(4-ethoxy-benzyl)-phenyl]-6-hydroxymethyl-tetrahydro-pyran-3,4,5-triol
Molecular Weight | 408.9 g/mol |
---|---|
Molecular Formula | C21H25ClO6 |
XLogP3 | 2.3 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 6 |
Exact Mass | 408.1339662 g/mol |
Monoisotopic Mass | 408.1339662 g/mol |
Topological Polar Surface Area | 99.4 Ų |
Heavy Atom Count | 28 |
Formal Charge | 0 |
Complexity | 472 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 5 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Farxiga |
PubMed Health | Dapagliflozin (By mouth) |
Drug Classes | Antidiabetic |
Drug Label | Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig... |
Active Ingredient | Dapagliflozin |
Dosage Form | Tablet |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Astrazeneca Ab |
2 of 2 | |
---|---|
Drug Name | Farxiga |
PubMed Health | Dapagliflozin (By mouth) |
Drug Classes | Antidiabetic |
Drug Label | Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C21H25ClO6C3H8O2H2O and the molecular weig... |
Active Ingredient | Dapagliflozin |
Dosage Form | Tablet |
Route | Oral |
Strength | 5mg; 10mg |
Market Status | Prescription |
Company | Astrazeneca Ab |
Dapagliflozin is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise.
FDA Label
Forxiga is indicated in adults and children aged 10 years and above for the treatment of 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 type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied.
Heart failure
- Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
- Forxiga is indicated in adults for the treatment of chronic kidney disease.
Type 2 diabetes mellitus
Edistride is indicated in adults and children aged 10 years and above for the treatment of 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 type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.
Heart failure
Edistride is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Chronic kidney disease
Edistride is indicated in adults for the treatment of chronic kidney disease.
Treatment of chronic kidney disease
Prevention of cardiovascular events in patients with chronic heart failure
Treatment of type I diabetes mellitus
Treatment of type II diabetes mellitus
Treatment of ischaemic heart disease
Treatment of Coronavirus disease 2019 (COVID-19)
Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
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.)
A10BK01
A10BK01
A10BK01
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
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
A10BK01 - Dapagliflozin
Absorption
Oral dapagliflozin reaches a maximum concentration within 1 hour of administration when patients have been fasting. When patients have consumed a high fat meal, the time to maximum concentration increases to 2 hours and the maximum concentration decreases by half though a dose adjustment is not necessary. Oral dapagliflozin is 78% bioavailable.
Route of Elimination
75.2% of dapagliflozin is recovered in the urine with 1.6% of the dose unchanged by metabolism. 21% of the dose is excreted in the feces with 15% of the dose unchanged by metabolism.
Volume of Distribution
118L.
Clearance
Oral plasma clearance was 4.9 mL/min/kg, and renal clearance was 5.6 mL/min.
Dapagliflozin is primarily glucuronidated to become the inactive 3-O-glucuronide metabolite(60.7%). Dapagliflozin also produces another minor glucuronidated metabolite(5.4%), a de-ethylated metabolite(<5%), and a hydroxylated metabolite(<5%). Metabolism of dapagliflozin is mediated by cytochrome p-450(CYP)1A1, CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP3A4, uridine diphosphate glucuronyltransferase(UGT)1A9, UGT2B4, and UGT2B7. Glucuronidation to the major metabolite is mediated by UGT1A9.
13.8h.
Dapagliflozin inhibits the sodium-glucose contransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-23
Pay. Date : 2016-12-08
DMF Number : 30555
Submission : 2016-05-12
Status : Active
Type : II
Registration Number : 305MF10084
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2023-07-19
Latest Date of Registration :
Registrant Name : Hiple Co., Ltd.
Registration Date : 2019-09-26
Registration Number : Su30-3-ND
Manufacturer Name : Zakłady Farmaceutyczne Polpharma SA
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
Available Reg Filing : ASMF, CA |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-04-17
Pay. Date : 2017-03-20
DMF Number : 30729
Submission : 2016-12-30
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-12-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 55111-987
Start Marketing Date : 2016-12-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2019-04-03
Registration Number : No. 574-13-ND
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.'s 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No.'s 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District 532409, Andhra Pradesh, India
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36608
Submission : 2022-02-10
Status : Active
Type : II
NDC Package Code : 42765-042
Start Marketing Date : 2022-02-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Date of Issue : 2024-09-23
Valid Till : 2027-09-22
Written Confirmation Number : SD240069
Address of the Firm :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38009
Submission : 2023-02-23
Status : Active
Type : II
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-23
Pay. Date : 2016-12-08
DMF Number : 30555
Submission : 2016-05-12
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-17
Pay. Date : 2017-03-20
DMF Number : 30729
Submission : 2016-12-30
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36608
Submission : 2022-02-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38009
Submission : 2023-02-23
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-21
Pay. Date : 2024-01-08
DMF Number : 39120
Submission : 2023-12-30
Status : Active
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-19
Pay. Date : 2017-01-27
DMF Number : 31235
Submission : 2017-03-23
Status : Active
Type : II
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-01
Pay. Date : 2024-02-14
DMF Number : 36994
Submission : 2023-06-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-06
Pay. Date : 2017-02-10
DMF Number : 31284
Submission : 2017-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-07-05
DMF Number : 31841
Submission : 2017-07-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2017-06-14
DMF Number : 31762
Submission : 2017-07-03
Status : Active
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...
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Details:
Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease. Launching API DMF grade dapagliflozin is an innovative futuristic approach to provide the best in class quality to the patients.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Brand Name: Justoza
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 22, 2021
Lead Product(s) : Dapagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mankind Pharma Launches Justoza to Treat Diabetes, Heart Failure & CKD
Details : Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease. Launching API DMF grade dapagliflozin is an innovative futuristic approach to provide the best in class quality to...
Product Name : Justoza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 22, 2021
Details:
Zemidapa is a fixed-dose combination therapy that brings together two active ingredients: Zemiglo, Korea’s first domestically developed DPP-4 inhibitor, and dapagliflozin, an SGLT-2 inhibitor.
Lead Product(s): Dapagliflozin,Gemigliptin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Zemidapa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 13, 2025
Lead Product(s) : Dapagliflozin,Gemigliptin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
LG Chem Sets Sights on Global Market with Launch of Diabetes Combination Therapy Zemidapa
Details : Zemidapa is a fixed-dose combination therapy that brings together two active ingredients: Zemiglo, Korea’s first domestically developed DPP-4 inhibitor, and dapagliflozin, an SGLT-2 inhibitor.
Product Name : Zemidapa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 13, 2025
Details:
Dapnec (dapagliflozin) is a SGLT2 inhibitor small molecule drug candidate, which is indicated for the treatment of Type 2 diabetes.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Brand Name: Dapnec
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 18, 2025
Lead Product(s) : Dapagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Nectar Life Care Launches Affordable Anti-Diabetic Range of Medicines
Details : Dapnec (dapagliflozin) is a SGLT2 inhibitor small molecule drug candidate, which is indicated for the treatment of Type 2 diabetes.
Product Name : Dapnec
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 18, 2025
Details:
Akums launched apagliflozin and pioglitazone combination tablets, which acts as a dual-action therapy. It is indicated for diabetes management.
Lead Product(s): Dapagliflozin,Pioglitazone
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 04, 2025
Lead Product(s) : Dapagliflozin,Pioglitazone
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Akums Combines Two Potent Diabetes Medicines for Enhanced Treatment Efficacy
Details : Akums launched apagliflozin and pioglitazone combination tablets, which acts as a dual-action therapy. It is indicated for diabetes management.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 04, 2025
Details:
Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, for paediatric patients with type-2 diabetes aged 10 years and older.
Lead Product(s): Dapagliflozin
Therapeutic Area: Endocrinology Brand Name: Farxiga
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2024
Lead Product(s) : Dapagliflozin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Farxiga approved in the US for the treatment of paediatric type-2 diabetes
Details : Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, for paediatric patients with type-2 diabetes aged 10 years and older.
Product Name : Farxiga
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 06, 2024
Details:
Dapagliflozin, metformin and glimepiride fixed dose combination is approved for the treatment of patients with type 2 diabetes.
Lead Product(s): Glimepiride,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 11, 2023
Lead Product(s) : Glimepiride,Dapagliflozin,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mascot Sets New Diabetes Care Standard with DCGI-Approved Dapagliflozin FDC
Details : Dapagliflozin, metformin and glimepiride fixed dose combination is approved for the treatment of patients with type 2 diabetes.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 11, 2023
Details:
DSR 2.0 (icodextrin, dextrose, dapagliflozin) is an implant small molecule drug combination, currently being investigated for heart failure management.
Lead Product(s): Icodextrin,Dapagliflozin,Dextrose
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: DSR 2.0
Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 29, 2023
Lead Product(s) : Icodextrin,Dapagliflozin,Dextrose
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : DSR 2.0 (icodextrin, dextrose, dapagliflozin) is an implant small molecule drug combination, currently being investigated for heart failure management.
Product Name : DSR 2.0
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 29, 2023
Details:
Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.
Lead Product(s): Vildagliptin,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Brand Name: Jalra Trio
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 08, 2023
Lead Product(s) : Vildagliptin,Dapagliflozin,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
USV Launches Jalra Trio for Management of Type 2 Diabetes in India
Details : Jalra-Trio (vildagliptin + dapagliflozin + metformin) is a fixed dose combination medicine that helps control blood sugar levels. It is now approved for the treatment of type-2-diabetes mellitus.
Product Name : Jalra Trio
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 08, 2023
Details:
Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.
Lead Product(s): Teneligliptin Hydrobromide,Dapagliflozin,Metformin
Therapeutic Area: Endocrinology Brand Name: Zita D
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2023
Lead Product(s) : Teneligliptin Hydrobromide,Dapagliflozin,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zita DM contains the DPP4 inhibitor, Teneligliptin, the SGLT2 inhibitor, Dapagliflozin, and Metformin SR in a fixed dose. It must be taken once daily, under prescription, to improve glycemic control in patients with Type 2 diabetes.
Product Name : Zita D
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 18, 2023
Details:
Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, which reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Thus, reducing the risk of cardiovascular death and hospitalisation for heart failure.
Lead Product(s): Dapagliflozin
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Farxiga
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 05, 2023
Lead Product(s) : Dapagliflozin
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Farxiga (dapagliflozin), is first-in-class, oral, USFDA approved, once-daily SGLT2 inhibitor, which reduces reabsorption of filtered glucose and thereby promotes urinary glucose excretion. Thus, reducing the risk of cardiovascular death and hospitalisati...
Product Name : Farxiga
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 05, 2023
(5-bromo-2-chlorophenyl)(4- ethoxyphenyl)methanone
CAS Number : 461432-22-4
End Use API : Dapagliflozin
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
5-bromo-2-chloro-4’- ethoxydiphenylmethane
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
[(2R,3R,4R,5S,6S)-3,4,5- triacetyloxy-6-[4-chloro-...
CAS Number : 461432-25-7
End Use API : Dapagliflozin
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
(5-Bromo-2-chlorophenyl)(4-ethoxyphenyl)methanone
CAS Number : 461432-22-4
End Use API : Dapagliflozin
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
5-Bromo-2-chloro-4'-ethoxydiphenylmethane
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
5-Bromo-2-chloro-4-ethoxydiphenylmethane
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of les...
4-(5-bromo-2-chlorobenzyl) phenyl ethyl ether
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
(2S)-2-(8-amino-1-bromoimidazo[1,5-a] pyrazin-3-yl...
CAS Number : 461432-25-7
End Use API : Dapagliflozin
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
4-(5-Bromo-2- chlorobenzyl)phenyl ethyl ether
CAS Number : 461432-23-5
End Use API : Dapagliflozin
About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...
(5-Bromo-2-chlorophenyl)(4- ethoxyphenyl)methanone
CAS Number : 461432-22-4
End Use API : Dapagliflozin
About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...
Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister, endose
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Qtern
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 05MG; 10MG
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Forxiga
Dosage Form : Film-Coated Tablets
Dosage Strength : 5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Metformini hydrochloridum; Dapagliflozinum
Brand Name : Xigduo XR
Dosage Form : Filmtabl
Dosage Strength : 10mg/1000mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Metformini hydrochloridum; Dapagliflozinum
Brand Name : Xigduo XR
Dosage Form : Filmtabl
Dosage Strength : 5mg/1000mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Metformini hydrochloridum; Dapagliflozinum
Brand Name : Xigduo XR
Dosage Form : Filmtabl
Dosage Strength : 5mg/500mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Saxagliptinum; Dapagliflozinum
Brand Name : Qtern
Dosage Form : Filmtabl
Dosage Strength : 5mg/10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Spain
Brand Name : 60 Icandra 50/850Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Forxiga
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Canada
Brand Name : APO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2527197
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : AURO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2531402
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : AURO-DAPAGLIFLOZIN / METFORMIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2533073
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : GLN-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2519860
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : JAMP DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2531364
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : M-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2535297
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : NRA-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2538334
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : PMS-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 2531550
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : PRO-DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2537664
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SANDOZ DAPAGLIFLOZIN
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2518740
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Forxiga
Dosage Form : tablet
Dosage Strength : 10 mg
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Forxiga
Dosage Form : tablet
Dosage Strength : 10 mg
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Forxiga
Dosage Form : tablet
Dosage Strength : 10 mg
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Forxiga
Dosage Form : tablet
Dosage Strength : 10 mg
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Forxiga
Dosage Form : tablet
Dosage Strength : 10 mg
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Forxiga
Dosage Form : tablet
Dosage Strength : 10 mg
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Dapagliflozin 10 mg Ascend
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : GLUDAPZIN 10
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Synglutra 10/1000
Dosage Form : ERT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Sagalatin 5
Dosage Form : FCT
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Sagalatin 10
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Daptica 5 mg
Dosage Form : TAB
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : DEPAGLOZ 5
Dosage Form : FCT
Dosage Strength : mg1
Packaging : 30X11
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Avaxiga 5
Dosage Form : FCT
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : DAPIFLO 5 mg
Dosage Form : TAB
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : DAPIFLO 10 mg
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Dapagliflozin
Dosage Form : Film-Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Film-Coated Tablet
Dosage Strength : 5MG
Brand Name : Dapagliflozin
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Dapagliflozin
Dosage Form : Film-Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Film-Coated Tablet
Dosage Strength : 10MG
Brand Name : Dapagliflozin
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Dapagliflozin ; Atorva...
Dosage Form : Capsule
Dosage Strength : 10MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 10MG
Brand Name : Dapagliflozin ; Atorva...
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Dapagliflozin ; Atorva...
Dosage Form : Capsule
Dosage Strength : 10MG; 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 20MG
Brand Name : Dapagliflozin ; Atorva...
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Dapagliflozin ; Atorva...
Dosage Form : Capsule
Dosage Strength : 10MG; 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 40MG
Brand Name : Dapagliflozin ; Atorva...
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Dapagliflozin; Rosuvastatin Calcium
Brand Name : Dapagliflozin; Rosuvas...
Dosage Form : Capsule
Dosage Strength : 10MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dapagliflozin; Rosuvastatin Calcium
Dosage : Capsule
Dosage Strength : 10MG; 10MG
Brand Name : Dapagliflozin; Rosuvas...
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Dapagliflozin; Rosuvastatin Calcium
Brand Name : Dapagliflozin ; Rosuva...
Dosage Form : Capsule
Dosage Strength : 10MG; 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dapagliflozin; Rosuvastatin Calcium
Dosage : Capsule
Dosage Strength : 10MG; 20MG
Brand Name : Dapagliflozin ; Rosuva...
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Dapagliflozin; Rosuvastatin Calcium
Brand Name : Dapagliflozin; Rosuvas...
Dosage Form : Capsule
Dosage Strength : 10MG; 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dapagliflozin; Rosuvastatin Calcium
Dosage : Capsule
Dosage Strength : 10MG; 5MG
Brand Name : Dapagliflozin; Rosuvas...
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Dapagliflozin; Ramipri...
Dosage Form : Capsule
Dosage Strength : 10MG; 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 5MG
Brand Name : Dapagliflozin; Ramipri...
Approval Date :
Application Number :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Dapagliflozin; Ramipri...
Dosage Form : Capsule
Dosage Strength : 10MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 10MG; 10MG
Brand Name : Dapagliflozin; Ramipri...
Approval Date :
Application Number :
Registration Country : Hungary
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Grade : Oral
Category : Co-Processed Excipients, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Grade : Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : Most popular excipient for the production of tablets and capsules. Offering an efficient and low dosage in capsules.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Specific Surface Area-6-10 m2/g; Particle Size-7-11 µm
Ingredient(s) : Magnesium Stearate
Brand Name : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders
Excipient Details : Microcrystalline Cellulose is most commonly used filler and binder in drug formulations, together with Lactose.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders
Excipient Details : TABCELL serves as an excellent excipient for solid dosage forms, providing numerous advantages for tablet formulations.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : HiCel acts as a strong dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as Comprecel M102, M102CG, M103, M105, M124, M113,...
Ingredient(s) : Microcrystalline Cellulose
Grade : Oral
Category : Fillers, Diluents & Binders, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : Higher specific surface area and a smaller median particle size. This product is preferred for more critical and very fine herbal formulations.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF
Technical Specs : Specific Surface Area-8-12 m2/g; Particle Size-5-9 µm
Ingredient(s) : Magnesium Stearate
Dosage Form : Tablet
Grade : Oral
Category : Coating Systems & Additives, Controlled & Modified Release
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical
Category : Coating Systems & Additives, Rheology Modifiers, Topical
Application : Coating Systems & Additives, Rheology Modifiers, Topical
Excipient Details : Polyglykol 400 is a liquid PEG excipient grade product which is used as solvent, humectant, coating agent and viscosity enhancer.
Pharmacopoeia Ref : USP-NF: Polyethylene glycol 40...
Technical Specs : average molar mass 400 g/mol
Ingredient(s) : Polyethylene Glycol 400
Application : Coating Systems & Additives
Excipient Details : Novomix is used as a ready mix film coating system in the production of pharmaceutical tablets.
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Tablet
Grade : Not Available
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : Immediate Release
Application : Direct Compression
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 440 g/l, Bulk density- 310 g/l; Particl...
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Disintegrants & Superdisintegrants, Granulation
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : HiCel acts as a strong dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Direct Compression
Pharmacopoeia Ref : Conforms to Ph. Eur., Lactose ...
Technical Specs : Density- Tapped density- 906 g/l, Bulk density- 722 g/l; Particle...
Ingredient(s) : Anhydrous Lactose
Dosage Form : Tablet
Grade : Oral
Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Lubricants & Glidants
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : HiCel SMCC has unique combination which result in optimum compaction & superior flow properties.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Direct Compression, Granulation
Excipient Details : HiCellac is used in direct compression & dry granulation suitable for low dose formulations where API content uniformity is critical.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® MCC 101
Application : Direct Compression, Granulation
Excipient Details : Tablets made from these granules are typically easily disintegrated using conventional super disintegrates even when hard tablets are compressed.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Microlex® MCC 102
Application : Direct Compression
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Brand Name : Microlex® LCA 60.m
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCA 120.m, Microlex® LCA 20...
Ingredient(s) : Anhydrous Lactose
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Taste Masking
Excipient Details : HiCel CE15 offers a superior mouthfeel with less chalkiness and gritness in chewable tablets and orally disintegrating tablets (ODTs).
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Guar Gum Excipient
Application : Coating Systems & Additives, Taste Masking
Excipient Details : Ready mix sugar coating system.
Pharmacopoeia Ref : USP, EP, JP & having US DMF
Technical Specs : Sprayable sugar coating system for solid oral dosage form
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : F-Melt Type C is a pharmaceutical excipient used in oral dosage forms like orally disintegrating tablets, sachets, dispersible tablets, chewable tablets and sublingual tablets.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Crospovidone
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical
Category : Coating Systems & Additives, Rheology Modifiers, Topical
Application : Coating Systems & Additives, Rheology Modifiers, Topical
Excipient Details : Polyglykol 400 is a liquid PEG excipient grade product which is used as solvent, humectant, coating agent and viscosity enhancer.
Pharmacopoeia Ref : USP-NF: Polyethylene glycol 40...
Technical Specs : average molar mass 400 g/mol
Ingredient(s) : Polyethylene Glycol 400
Dosage Form : Tablet, Emulsion, Suspension
Grade : Oral
Category : Co-Processed Excipients, Fillers, Diluents & Binders, Rheology Modifiers
Application : Co-Processed Excipients, Fillers, Diluents & Binders, Rheology Modifiers
Excipient Details : HiCel MCG is use in oral suspensions as a stabilizer. It is a good binder for tablets & excellent thickener as well.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Carboxymethyl cellulose sodium
Application : API Stability Enhancers, Thickeners and Stabilizers
Excipient Details : Adsorbent, Moisture Protection, Stabilization of API
Pharmacopoeia Ref : USP-NF, JP, EP
Technical Specs : Also Available as FUJISIL-F
Ingredient(s) : Silicon Dioxide
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Global Sales Information
Company : Astrazeneca
Dapagliflozin/Saxagliptin HCl
Drug Cost (USD) : 1,720,271
Year : 2023
Prescribers : 421
Prescriptions : 1952
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin/Saxagliptin HCl
Drug Cost (USD) : 2,009,101
Year : 2022
Prescribers : 481
Prescriptions : 2304
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin Propanediol
Drug Cost (USD) : 2,584,621,150
Year : 2022
Prescribers : 638800
Prescriptions : 2665029
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin/Metformin HCl
Drug Cost (USD) : 153,804,791
Year : 2022
Prescribers : 35699
Prescriptions : 161366
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin/Saxagliptin HCl
Drug Cost (USD) : 2,228,866
Year : 2021
Prescribers : 583
Prescriptions : 2559
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin Propanediol
Drug Cost (USD) : 1,421,505,274
Year : 2021
Prescribers : 385693
Prescriptions : 1540905
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin/Metformin HCl
Drug Cost (USD) : 114,228,126
Year : 2021
Prescribers : 29188
Prescriptions : 129660
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin/Saxagliptin HCl
Drug Cost (USD) : 1,986,364
Year : 2020
Prescribers : 581
Prescriptions : 2477
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin Propanediol
Drug Cost (USD) : 736,787,564
Year : 2020
Prescribers : 193920
Prescriptions : 858348
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Astrazeneca
Dapagliflozin/Metformin HCl
Drug Cost (USD) : 73,873,720
Year : 2020
Prescribers : 19955
Prescriptions : 93057
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Price Per Pack (Euro) : 26.631
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Price Per Pack (Euro) : 49.082
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Price Per Pack (Euro) : 52.25
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Price Per Pack (Euro) : 147.26
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Price Per Pack (Euro) : 159.93
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Price Per Pack (Euro) : 24.398
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Price Per Pack (Euro) : 44.803
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Price Per Pack (Euro) : 47.663
Published in :
Country : Norway
RX/OTC/DISCN :
2care4
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Price Per Pack (Euro) : 49.082
Published in :
Country : Norway
RX/OTC/DISCN :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
2care4
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Price Per Pack (Euro) : 159.93
Published in :
Country : Norway
RX/OTC/DISCN :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2029-02-19
US Patent Number : 7851502*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 202293
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-02-19
Patent Expiration Date : 2026-04-04
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US Patent Number : 6515117*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 209091
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-04-04
Patent Expiration Date : 2029-12-16
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US Patent Number : 7919598
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 205649
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-16
Patent Expiration Date : 2025-07-13
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
US Patent Number : 8628799
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 210874
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-07-13
Patent Expiration Date : 2027-06-20
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US Patent Number : 8501698
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205649
Patent Use Code : U-493
Delist Requested :
Patent Use Description : TREATMENT OF TYPE 2 DI...
Patent Expiration Date : 2027-06-20
Patent Expiration Date : 2029-12-16
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US Patent Number : 7919598
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 205649
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-12-16
Patent Expiration Date : 2025-10-04
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US Patent Number : 6515117
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 205649
Patent Use Code : U-493
Delist Requested :
Patent Use Description : TREATMENT OF TYPE 2 DI...
Patent Expiration Date : 2025-10-04
Patent Expiration Date : 2028-09-21
US Patent Number : 8361972*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 202293
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-09-21
Patent Expiration Date : 2028-09-21
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
US Patent Number : 8361972*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 209091
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-09-21
Patent Expiration Date : 2030-11-12
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
US Patent Number : 9616028
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 205649
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-11-12
Exclusivity Code : M-298
Exclusivity Expiration Date : 2026-05-08
Application Number : 202293
Product Number : 1
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-12
Application Number : 202293
Product Number : 1
Exclusivity Details :
Exclusivity Code : M-298
Exclusivity Expiration Date : 2026-05-08
Application Number : 202293
Product Number : 2
Exclusivity Details :
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-12
Application Number : 202293
Product Number : 2
Exclusivity Details :
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-12
Application Number : 205649
Product Number : 1
Exclusivity Details :
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-12
Application Number : 205649
Product Number : 2
Exclusivity Details :
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-12
Application Number : 205649
Product Number : 3
Exclusivity Details :
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-12
Application Number : 205649
Product Number : 4
Exclusivity Details :
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Exclusivity Code : NPP
Exclusivity Expiration Date : 2027-06-12
Application Number : 205649
Product Number : 5
Exclusivity Details :
Exclusivity Code : PED
Exclusivity Expiration Date : 2026-11-08
Application Number : 202293
Product Number : 1
Exclusivity Details :
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
64
PharmaCompass offers a list of Dapagliflozin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dapagliflozin manufacturer or Dapagliflozin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dapagliflozin manufacturer or Dapagliflozin supplier.
PharmaCompass also assists you with knowing the Dapagliflozin API Price utilized in the formulation of products. Dapagliflozin API Price is not always fixed or binding as the Dapagliflozin Price is obtained through a variety of data sources. The Dapagliflozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Forxiga (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Forxiga (TN), including repackagers and relabelers. The FDA regulates Forxiga (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Forxiga (TN) 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 Forxiga (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Forxiga (TN) supplier is an individual or a company that provides Forxiga (TN) active pharmaceutical ingredient (API) or Forxiga (TN) finished formulations upon request. The Forxiga (TN) suppliers may include Forxiga (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Forxiga (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Forxiga (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Forxiga (TN) active pharmaceutical ingredient (API) in detail. Different forms of Forxiga (TN) DMFs exist exist since differing nations have different regulations, such as Forxiga (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Forxiga (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Forxiga (TN) USDMF includes data on Forxiga (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Forxiga (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Forxiga (TN) suppliers with USDMF on PharmaCompass.
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 Forxiga (TN) Drug Master File in Japan (Forxiga (TN) JDMF) empowers Forxiga (TN) 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 Forxiga (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Forxiga (TN) 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 Forxiga (TN) suppliers with JDMF 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 Forxiga (TN) Drug Master File in Korea (Forxiga (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Forxiga (TN). The MFDS reviews the Forxiga (TN) KDMF as part of the drug registration process and uses the information provided in the Forxiga (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Forxiga (TN) 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 Forxiga (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Forxiga (TN) suppliers with KDMF on PharmaCompass.
A Forxiga (TN) written confirmation (Forxiga (TN) WC) is an official document issued by a regulatory agency to a Forxiga (TN) manufacturer, verifying that the manufacturing facility of a Forxiga (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Forxiga (TN) APIs or Forxiga (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Forxiga (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Forxiga (TN) suppliers with Written Confirmation (WC) on PharmaCompass.
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 Forxiga (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Forxiga (TN) 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 Forxiga (TN) 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 Forxiga (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Forxiga (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Forxiga (TN) suppliers with NDC on PharmaCompass.
Forxiga (TN) 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 Forxiga (TN) 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 Forxiga (TN) GMP manufacturer or Forxiga (TN) GMP API supplier for your needs.
A Forxiga (TN) CoA (Certificate of Analysis) is a formal document that attests to Forxiga (TN)'s compliance with Forxiga (TN) specifications and serves as a tool for batch-level quality control.
Forxiga (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Forxiga (TN) 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.
Forxiga (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Forxiga (TN) EP), Forxiga (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Forxiga (TN) USP).