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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 : Reviewed
Rev. Date : 2024-04-30
Pay. Date : 2023-03-02
DMF Number : 37594
Submission : 2023-03-16
Status : Active
Type : II
NDC Package Code : 55463-0040
Start Marketing Date : 2024-04-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
NDC Package Code : 61281-8600
Start Marketing Date : 2024-09-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6282
Start Marketing Date : 2024-08-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2024-02-05
Registration Number : 20240205-210-J-1604
Manufacturer Name : Sinopep-Allsino Biopharmaceu...
Manufacturer Address : No. 28, Linpu Road, Economic & Technological Development Zone, Lianyungang, Jiangsu P...
Registrant Name : Sampoong Finechem Co., Ltd.
Registration Date : 2024-07-03
Registration Number : 20240205-210-J-1604(1)
Manufacturer Name : Sinopep-Allsino Biopharmaceu...
Manufacturer Address : No. 28, Linpu Road, Economic & Technological Development Zone, Lianyungang, Jiangsu P...
Registrant Name : Iksoo Pharmaceutical Co., Ltd.
Registration Date : 2024-09-13
Registration Number : 69-18-ND
Manufacturer Name : Zhejiang Peptites Biotech Co...
Manufacturer Address : No.8, Hengyizhi Road, Sanjie Town, Shengzhou City, Shaoxing City, Zhejiang Province, ...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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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.
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.
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.
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.
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.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 14MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
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.
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.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 14MG
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.
Regulatory Info : USA
Registration Country : Greece
Brand Name :
Dosage Form : Injection For Subcutaneous Use
Dosage Strength : 2MG/1.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : USA
Registration Country : Greece
RLD : Yes
TE Code :
Brand Name : OZEMPIC
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2MG/1.5ML (1.34MG/ML)
Approval Date : 2017-12-05
Application Number : 209637
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OZEMPIC
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 4MG/3ML (1.34MG/ML)
Approval Date : 2019-04-09
Application Number : 209637
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OZEMPIC
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 8MG/3ML (2.68MG/ML)
Approval Date : 2022-03-28
Application Number : 209637
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OZEMPIC
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2MG/3ML (0.68MG/ML)
Approval Date : 2022-10-06
Application Number : 209637
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RYBELSUS
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG
Approval Date : 2019-09-20
Application Number : 213051
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RYBELSUS
Dosage Form : TABLET;ORAL
Dosage Strength : 7MG
Approval Date : 2019-09-20
Application Number : 213051
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : RYBELSUS
Dosage Form : TABLET;ORAL
Dosage Strength : 14MG
Approval Date : 2019-09-20
Application Number : 213051
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : RYBELSUS
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG
Approval Date :
Application Number : 213182
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : WEGOVY
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 1MG/0.5ML (1MG/0.5ML)
Approval Date : 2021-06-04
Application Number : 215256
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : WEGOVY
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 1.7MG/0.75ML (1.7MG/0.75ML)
Approval Date : 2021-06-04
Application Number : 215256
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ozempic DualDose
Dosage Form : Inj L?s
Dosage Strength : 2mg/1.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ozempic FixDose
Dosage Form : Inj L?s
Dosage Strength : 4mg/3ml(1mg/dose)
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rybelsus
Dosage Form : Tabl
Dosage Strength : 14mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rybelsus
Dosage Form : Tabl
Dosage Strength : 14mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rybelsus
Dosage Form : Tablet
Dosage Strength : 7mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Rybelsus
Dosage Form : Tablet
Dosage Strength : 7mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Wegovy
Dosage Form : Multi Fixdose Inj L?s
Dosage Strength : 0.25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Wegovy
Dosage Form : Multi Fixdose Inj Solution
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Wegovy
Dosage Form : Multi Fixdose Inj Solution
Dosage Strength : 1.7mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Wegovy
Dosage Form : Multi Fixdose Inj Solution
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : RYBELSUS
Dosage Form : TABLET
Dosage Strength : 3MG
Packaging : 30
Approval Date :
Application Number : 2497581
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : RYBELSUS
Dosage Form : TABLET
Dosage Strength : 7MG
Packaging : 30
Approval Date :
Application Number : 2497603
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : RYBELSUS
Dosage Form : TABLET
Dosage Strength : 14MG
Packaging : 30
Approval Date :
Application Number : 2497611
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : OZEMPIC
Dosage Form : SOLUTION
Dosage Strength : 1MG/ACT
Packaging : 2 X2MG/PEN
Approval Date :
Application Number : 2471469
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : OZEMPIC
Dosage Form : SOLUTION
Dosage Strength : 1.34MG/ML
Packaging : 1X 2MG/PEN
Approval Date :
Application Number : 2471477
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 1MG/1.5ML
Packaging :
Approval Date :
Application Number : 2528509
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 2MG/1.5ML
Packaging :
Approval Date :
Application Number : 2528517
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 4MG/3ML
Packaging :
Approval Date :
Application Number : 2528525
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 6.8MG/3ML
Packaging :
Approval Date :
Application Number : 2528533
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 9.6MG/3ML
Packaging :
Approval Date :
Application Number : 2528541
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Ozempic
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ozempic
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ozempic
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ozempic
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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