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 : 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 : 61281-8700
Start Marketing Date : 2024-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
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
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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.
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 : 61281-8700
Start Marketing Date : 2024-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC Package Code : 71796-039
Start Marketing Date : 2021-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42973-397
Start Marketing Date : 2024-06-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 32861-0011
Start Marketing Date : 2023-01-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14403-0018
Start Marketing Date : 2024-06-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 0420-9008
Start Marketing Date : 2017-12-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84223-001
Start Marketing Date : 2024-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 84649-000
Start Marketing Date : 2024-08-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
About the Company : With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology comp...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
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, ...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
About the Company : Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosyn...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Semaglutide is a GLP-1 receptor agonist, which is being investigated in Phase 3 for the treatment of weight loss type 2 diabetes and chronic kidney disease.
Lead Product(s): Semaglutide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Semaglutide-Generic
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2023
Lead Product(s) : Semaglutide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dr Reddy’s Labs Gets Nod to Study Popular Weight Loss Medication
Details : Semaglutide is a GLP-1 receptor agonist, which is being investigated in Phase 3 for the treatment of weight loss type 2 diabetes and chronic kidney disease.
Brand Name : Semaglutide-Generic
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 19, 2023
Details:
subcutaneous semaglutide is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults.
Lead Product(s): Semaglutide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Semaglutide-Generic
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2023
Lead Product(s) : Semaglutide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dr Reddy's Gears up for Weight Loss Drug Study
Details : subcutaneous semaglutide is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults.
Brand Name : Semaglutide-Generic
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 18, 2023
Details:
Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to reduce the risk of non-fatal myocardial infarction in adults.
Lead Product(s): Semaglutide
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Wegovy
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 27, 2024
Lead Product(s) : Semaglutide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Canada Approves Novo Nordisk's Obesity Drug to Reduce Risk of Non-Fatal Heart Attack
Details : Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to reduce the risk of non-fatal myocardial infarction in adults.
Brand Name : Wegovy
Molecule Type : Peptide
Upfront Cash : Not Applicable
November 27, 2024
Details:
Wegovy (semaglutide) is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management & treatment of obesity.
Lead Product(s): Semaglutide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Wegovy
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2024
Lead Product(s) : Semaglutide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novo Nordisk Launches Obesity Drug Wegovy in China
Details : Wegovy (semaglutide) is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management & treatment of obesity.
Brand Name : Wegovy
Molecule Type : Peptide
Upfront Cash : Not Applicable
November 18, 2024
Details:
Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with obesity or overweight with established cardiovascular disease (CVD) and without diabetes.
Lead Product(s): Semaglutide
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Wegovy
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2024
Lead Product(s) : Semaglutide
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
SELECT Trial Shows Semaglutide Reduces Hospital Admissions in Heart Disease Patients
Details : Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with obesity or overweight with established cardiovascular disease (CVD) and without diabetes.
Brand Name : Wegovy
Molecule Type : Peptide
Upfront Cash : Not Applicable
November 03, 2024
Details:
Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.
Lead Product(s): Semaglutide
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Wegovy
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2024
Lead Product(s) : Semaglutide
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Novo Nordisk’s Semaglutide Excels in Liver Fibrosis and MASH Resolution in ESSENCE Trial
Details : Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.
Brand Name : Wegovy
Molecule Type : Peptide
Upfront Cash : Not Applicable
November 01, 2024
Details:
Anti-CD3 antibody TZLS-401 (foralumab) in combination with semaglutide, a GLP-1 agonist is being investigated for obesity.
Lead Product(s): Foralumab,Semaglutide
Therapeutic Area: Nutrition and Weight Loss Brand Name: TZLS-401
Study Phase: PreclinicalProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2024
Lead Product(s) : Foralumab,Semaglutide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Tiziana Announces Success in Ozempic and Nasal Anti-CD3 Combination Study
Details : Anti-CD3 antibody TZLS-401 (foralumab) in combination with semaglutide, a GLP-1 agonist is being investigated for obesity.
Brand Name : TZLS-401
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 30, 2024
Details:
Oral DehydraTECH-technology processed semaglutide and liraglutide (GLP-1 agonist) is being investigated for obesity.
Lead Product(s): Liraglutide,Semaglutide
Therapeutic Area: Endocrinology Brand Name: DehydraTECH-liraglutide
Study Phase: PreclinicalProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2024
Lead Product(s) : Liraglutide,Semaglutide
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Positive Partial 12-Week Blood Sugar Results from Lexaria’s GLP-1 Diabetes Animal Study
Details : Oral DehydraTECH-technology processed semaglutide and liraglutide (GLP-1 agonist) is being investigated for obesity.
Brand Name : DehydraTECH-liraglutide
Molecule Type : Peptide
Upfront Cash : Not Applicable
October 24, 2024
Details:
NG101 is an oral, peripherally restricted dopamine D2 receptor antagonist, being investigated for nausea and vomiting side effects caused by GLP-1 agonist medication.
Lead Product(s): Metopimazine Mesylate,Semaglutide
Therapeutic Area: Neurology Brand Name: NG101
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2024
Lead Product(s) : Metopimazine Mesylate,Semaglutide
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Neurogastrx Shows Positive Data for NG101 in GLP-1 Related Nausea
Details : NG101 is an oral, peripherally restricted dopamine D2 receptor antagonist, being investigated for nausea and vomiting side effects caused by GLP-1 agonist medication.
Brand Name : NG101
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 16, 2024
Details:
Semaglutide is a peptide GLP-1 agonist, peptide drug candidate, which is being evaluated for the treatment of type 2 diabetes & obesity.
Lead Product(s): Semaglutide
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 21, 2024
Lead Product(s) : Semaglutide
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
ProLynx Unveils Monthly Dosing Preclinical Results for Long-Acting Semaglutide
Details : Semaglutide is a peptide GLP-1 agonist, peptide drug candidate, which is being evaluated for the treatment of type 2 diabetes & obesity.
Brand Name : Undisclosed
Molecule Type : Peptide
Upfront Cash : Not Applicable
August 21, 2024
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 : Tabl
Dosage Strength : 3mg
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 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 :
Registration Country : Canada
Brand Name : RYBELSUS
Dosage Form : TABLET
Dosage Strength : 3MG
Packaging : 30
Approval Date :
Application Number : 2497581
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : RYBELSUS
Dosage Form : TABLET
Dosage Strength : 7MG
Packaging : 30
Approval Date :
Application Number : 2497603
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : RYBELSUS
Dosage Form : TABLET
Dosage Strength : 14MG
Packaging : 30
Approval Date :
Application Number : 2497611
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : OZEMPIC
Dosage Form : SOLUTION
Dosage Strength : 1.34MG/ML
Packaging : 2 X2MG/PEN
Approval Date :
Application Number : 2471469
Regulatory Info :
Registration Country : Canada
Regulatory Info :
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 :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : OZEMPIC
Dosage Form : SOLUTION
Dosage Strength : 0.68MG/ML
Packaging :
Approval Date :
Application Number : 2540258
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 2MG/1.5ML
Packaging :
Approval Date :
Application Number : 2528517
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 4MG/3ML
Packaging :
Approval Date :
Application Number : 2528525
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 6.8MG/3ML
Packaging :
Approval Date :
Application Number : 2528533
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : WEGOVY
Dosage Form : SOLUTION
Dosage Strength : 9.6MG/3ML
Packaging :
Approval Date :
Application Number : 2528541
Regulatory Info :
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
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Ozempic
Dosage Form : PED
Dosage Strength : 1.34mg/ml
Packaging : 1.5X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Ozempic
Dosage Form : PED
Dosage Strength : 1.34mg/ml
Packaging : 3X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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 : 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.
Packaging :
Regulatory Info : USA
Dosage : Tablet
Dosage Strength : 14MG
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
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
A Semaglutide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Semaglutide, including repackagers and relabelers. The FDA regulates Semaglutide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Semaglutide 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 Semaglutide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Semaglutide supplier is an individual or a company that provides Semaglutide active pharmaceutical ingredient (API) or Semaglutide finished formulations upon request. The Semaglutide suppliers may include Semaglutide API manufacturers, exporters, distributors and traders.
click here to find a list of Semaglutide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Semaglutide DMF (Drug Master File) is a document detailing the whole manufacturing process of Semaglutide active pharmaceutical ingredient (API) in detail. Different forms of Semaglutide DMFs exist exist since differing nations have different regulations, such as Semaglutide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Semaglutide DMF submitted to regulatory agencies in the US is known as a USDMF. Semaglutide USDMF includes data on Semaglutide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Semaglutide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Semaglutide suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Semaglutide Drug Master File in Korea (Semaglutide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Semaglutide. The MFDS reviews the Semaglutide KDMF as part of the drug registration process and uses the information provided in the Semaglutide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Semaglutide 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 Semaglutide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Semaglutide suppliers with KDMF 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 Semaglutide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Semaglutide 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 Semaglutide 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 Semaglutide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Semaglutide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Semaglutide suppliers with NDC on PharmaCompass.
Semaglutide 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 Semaglutide 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 Semaglutide GMP manufacturer or Semaglutide GMP API supplier for your needs.
A Semaglutide CoA (Certificate of Analysis) is a formal document that attests to Semaglutide's compliance with Semaglutide specifications and serves as a tool for batch-level quality control.
Semaglutide CoA mostly includes findings from lab analyses of a specific batch. For each Semaglutide 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.
Semaglutide may be tested according to a variety of international standards, such as European Pharmacopoeia (Semaglutide EP), Semaglutide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Semaglutide USP).
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