Synopsis
Synopsis
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Weekly News Recap #Phispers
1. Ozempic
2. Rybelsus
1. Nn9535
2. Ozempic
3. Rybelsus
4. 910463-68-2
5. Nn 9535
6. Nnc 0113-0217
7. Nn-9535
8. Unii-53axn4nnhx
9. Semaglutide [usan:inn]
10. Wegovy
11. 53axn4nnhx
12. Rybelsus (oral Semaglutide)
13. Gtpl9724
14. Ozempic (injectable Semaglutide)
15. Chebi:167574
16. Ex-a2424
17. Ac-32580
18. Nnc-0113-0217
19. Rybelsus;ozempic;nn9535;og217sc;nnc 0113-0217
Molecular Weight | 4114 g/mol |
---|---|
Molecular Formula | C187H291N45O59 |
XLogP3 | -5.8 |
Hydrogen Bond Donor Count | 57 |
Hydrogen Bond Acceptor Count | 63 |
Rotatable Bond Count | 151 |
Exact Mass | 4112.1187318 g/mol |
Monoisotopic Mass | 4111.1153770 g/mol |
Topological Polar Surface Area | 1650 Ų |
Heavy Atom Count | 291 |
Formal Charge | 0 |
Complexity | 9590 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 30 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
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 or contraindications;
- 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.
Treatment of obesity
Treatment of type II diabetes mellitus
Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in combination with 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.
Treatment of type II diabetes mellitus
Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
- 30 kg/m (obesity), or
- 27 kg/m to < 30 kg/m (overweight) in the presence of at least one weight-related comorbidity e. g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
A10BJ06
A10BJ06
A10BJ06
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10B - Blood glucose lowering drugs, excl. insulins
A10BJ - Glucagon-like peptide-1 (glp-1) analogues
A10BJ06 - Semaglutide
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-30
Pay. Date : 2023-03-02
DMF Number : 37594
Submission : 2023-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35875
Submission : 2021-04-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-21
Pay. Date : 2021-06-10
DMF Number : 36015
Submission : 2021-08-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-31
Pay. Date : 2023-03-27
DMF Number : 38177
Submission : 2023-08-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-14
Pay. Date : 2021-07-19
DMF Number : 36101
Submission : 2021-07-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-20
Pay. Date : 2023-08-24
DMF Number : 36009
Submission : 2022-05-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-20
Pay. Date : 2021-09-29
DMF Number : 36273
Submission : 2021-11-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-09
Pay. Date : 2021-10-12
DMF Number : 36345
Submission : 2021-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35511
Submission : 2021-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35712
Submission : 2021-03-18
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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API Imports and Exports
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Average Price (USD/KGS) |
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Subcutaneous Pen
Dosage Strength : 0.25MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Subcutaneous Pen
Dosage Strength : 0.25MG/0.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Subcutaneous Pen
Dosage Strength : 0.5MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Subcutaneous Pen
Dosage Strength : 0.5MG/0.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Subcutaneous Pen
Dosage Strength : 1MG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Subcutaneous Pen
Dosage Strength : 1MG/0.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Subcutaneous Pen
Dosage Strength : 1.7MG/0.75ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Subcutaneous Pen
Dosage Strength : 1.7MG/0.75ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Subcutaneous Pen
Dosage Strength : 2.4MG/0.75ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Subcutaneous Pen
Dosage Strength : 2.4MG/0.75ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 14MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 14MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 3MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : USA
Dosage : Tablet
Dosage Strength : 3MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 7MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : USA
Dosage : Tablet
Dosage Strength : 7MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Subcutan...
Dosage Strength : 2MG/1.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : USA
Dosage : Injection For Subcutan...
Dosage Strength : 2MG/1.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Solution For Injection
Dosage Strength : 2MG/1.5ML
Packaging : Pre-filled Pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging : Pre-filled Pen
Regulatory Info :
Dosage : Solution For Injection
Dosage Strength : 2MG/1.5ML
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
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