Synopsis
Synopsis
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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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Regulatory FDF Prices
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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

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Details:
Semaglutide, a peptide targeting GLP-1 receptor, shows promise in weight loss, offering a potential breakthrough in obesity treatment.
Lead Product(s): Semaglutide,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Wegovy-Generic
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 24, 2025
Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr Reddy’s Approved to Produce Generic Semaglutide for Weight Loss
Details : Semaglutide, a peptide targeting GLP-1 receptor, shows promise in weight loss, offering a potential breakthrough in obesity treatment.
Product Name : Wegovy-Generic
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
October 24, 2025
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,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Semaglutide-Generic
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2023
Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Semaglutide-Generic
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
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,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Semaglutide-Generic
Study Phase: Phase IIIProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2023
Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Semaglutide-Generic
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
October 18, 2023
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Details:
The collaboration aims to advance type 2 diabetes treatment through the development of Semaglutide, an unconjugated peptide targeting the GLP-1 receptor.
Lead Product(s): Semaglutide,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Extensior
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Abbott Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 27, 2026

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Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Abbott Laboratories
Deal Size : Undisclosed
Deal Type : Collaboration
Abbott Partners with Novo Nordisk for Semaglutide Deal
Details : The collaboration aims to advance type 2 diabetes treatment through the development of Semaglutide, an unconjugated peptide targeting the GLP-1 receptor.
Product Name : Extensior
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
February 27, 2026

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Details:
Semaglutide, a peptide targeting GLP-1 receptor, shows promise in treating Type 2 diabetes.
Lead Product(s): Semaglutide,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Semaglyn
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2026

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Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Plans Launch of Semaglutide Generic in Reusable Pen Form
Details : Semaglutide, a peptide targeting GLP-1 receptor, shows promise in treating Type 2 diabetes.
Product Name : Semaglyn
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
February 26, 2026

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Details:
The collaboration aims to advance Semaglutide, an unconjugated peptide targeting the GLP-1 receptor, for the treatment of Type 2 diabetes.
Lead Product(s): Semaglutide,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Natco Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 24, 2026

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Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Natco Pharma
Deal Size : Undisclosed
Deal Type : Collaboration
Eris Lifesciences Partners Natco to Commercialise Semaglutide
Details : The collaboration aims to advance Semaglutide, an unconjugated peptide targeting the GLP-1 receptor, for the treatment of Type 2 diabetes.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
February 24, 2026

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Details:
NPM-139 (Semaglutide) is a peptide drug, which is currently being evaluated in Phase I clinical studies for the treatment of obesity.
Lead Product(s): Semaglutide,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: NPM-139
Study Phase: Phase IProduct Type: Peptide, Unconjugated
Sponsor: Avance Clinical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 24, 2026

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Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Avance Clinical
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant
Details : NPM-139 (Semaglutide) is a peptide drug, which is currently being evaluated in Phase I clinical studies for the treatment of obesity.
Product Name : NPM-139
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
February 24, 2026

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Details:
The peptide-based, unconjugated lead product targets GLP-1R for the treatment of type 2 diabetes.
Lead Product(s): Semaglutide,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Semaglutide-Generic
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 15, 2026

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Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Natco Gets CDSCO Approval for Semaglutide in India
Details : The peptide-based, unconjugated lead product targets GLP-1R for the treatment of type 2 diabetes.
Product Name : Semaglutide-Generic
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
February 15, 2026

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Details:
BIO101 (20-Hydroxyecdysone) is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of cachexia.
Lead Product(s): 20-Hydroxyecdysone,Semaglutide
Therapeutic Area: Nutrition and Weight Loss Brand Name: BIO101
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 13, 2026

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Lead Product(s) : 20-Hydroxyecdysone,Semaglutide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : BIO101 (20-Hydroxyecdysone) is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of cachexia.
Product Name : BIO101
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 13, 2026

Details:
Semaglutide is a peptide drug, which is currently being evaluated in Approved FDF clinical studies for the treatment of obesity.
Lead Product(s): Semaglutide,Inapplicable
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 05, 2026

Lead Product(s) : Semaglutide,Inapplicable
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Hims & Hers to Launch $49 Generic Wegovy Pill
Details : Semaglutide is a peptide drug, which is currently being evaluated in Approved FDF clinical studies for the treatment of obesity.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
February 05, 2026

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CAS Number : 2061897-68-3
End Use API : Semaglutide
About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...
CAS Number : 1143516-05-5
End Use API : Semaglutide
About The Company : CongenPharma, founded in 2013 and headquartered in Guangzhou, is a leading manufacturer of pharmaceutical peptide intermediates, cosmetic peptides, and ingredie...

Octadecanedioic acid mono-tert-butyl ester
CAS Number : 843666-40-0
End Use API : Semaglutide
About The Company : CongenPharma, founded in 2013 and headquartered in Guangzhou, is a leading manufacturer of pharmaceutical peptide intermediates, cosmetic peptides, and ingredie...

CAS Number : 2061897-68-3
End Use API : Semaglutide
About The Company : CongenPharma, founded in 2013 and headquartered in Guangzhou, is a leading manufacturer of pharmaceutical peptide intermediates, cosmetic peptides, and ingredie...

Boc-L-His(Trt)-Aib-L-Glu(OtBu)-Gly-OH
CAS Number : 1890228-73-5
End Use API : Semaglutide
About The Company : CongenPharma, founded in 2013 and headquartered in Guangzhou, is a leading manufacturer of pharmaceutical peptide intermediates, cosmetic peptides, and ingredie...

tBuO-Ste-L-Glu(AEEA-AEEA-OH)OtBu
CAS Number : 1118767-16-0
End Use API : Semaglutide
About The Company : CongenPharma, founded in 2013 and headquartered in Guangzhou, is a leading manufacturer of pharmaceutical peptide intermediates, cosmetic peptides, and ingredie...

Fmoc-L-Lys[tBuO-Ste-L-Glu(AEEA-AEEA)-OtBu]-OH
CAS Number : 1662688-20-1
End Use API : Semaglutide
About The Company : CongenPharma, founded in 2013 and headquartered in Guangzhou, is a leading manufacturer of pharmaceutical peptide intermediates, cosmetic peptides, and ingredie...

2-(2-(2-AMINOETHOXY)ETHOXY)ACETIC ACID HYDROCHLORI...
CAS Number : 134979-01-4
End Use API : Semaglutide
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

17-amino-10-oxo-3,6,12,15-tetraoxa-9-azaheptadecan...
CAS Number : 1143516-05-5
End Use API : Semaglutide
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

2,2-Dimethyl-4,13-dioxo-3,8,11,17,20-pentaoxa-5,14...
CAS Number : 1069067-08-8
End Use API : Semaglutide
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
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.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Solution For Injection
Dosage Strength : 4MG/3ML
Packaging : Pre-filled Pen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
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
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
35
PharmaCompass offers a list of Semaglutide 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 Semaglutide manufacturer or Semaglutide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Semaglutide manufacturer or Semaglutide supplier.
PharmaCompass also assists you with knowing the Semaglutide API Price utilized in the formulation of products. Semaglutide API Price is not always fixed or binding as the Semaglutide Price is obtained through a variety of data sources. The Semaglutide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Semaglutide [USAN:INN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Semaglutide [USAN:INN], including repackagers and relabelers. The FDA regulates Semaglutide [USAN:INN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Semaglutide [USAN:INN] 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 [USAN:INN] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Semaglutide [USAN:INN] supplier is an individual or a company that provides Semaglutide [USAN:INN] active pharmaceutical ingredient (API) or Semaglutide [USAN:INN] finished formulations upon request. The Semaglutide [USAN:INN] suppliers may include Semaglutide [USAN:INN] API manufacturers, exporters, distributors and traders.
click here to find a list of Semaglutide [USAN:INN] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Semaglutide [USAN:INN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Semaglutide [USAN:INN] active pharmaceutical ingredient (API) in detail. Different forms of Semaglutide [USAN:INN] DMFs exist exist since differing nations have different regulations, such as Semaglutide [USAN:INN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Semaglutide [USAN:INN] DMF submitted to regulatory agencies in the US is known as a USDMF. Semaglutide [USAN:INN] USDMF includes data on Semaglutide [USAN:INN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Semaglutide [USAN:INN] USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Semaglutide [USAN:INN] 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 [USAN:INN] Drug Master File in Korea (Semaglutide [USAN:INN] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Semaglutide [USAN:INN]. The MFDS reviews the Semaglutide [USAN:INN] KDMF as part of the drug registration process and uses the information provided in the Semaglutide [USAN:INN] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Semaglutide [USAN:INN] 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 [USAN:INN] API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Semaglutide [USAN:INN] suppliers with KDMF on PharmaCompass.
A Semaglutide [USAN:INN] written confirmation (Semaglutide [USAN:INN] WC) is an official document issued by a regulatory agency to a Semaglutide [USAN:INN] manufacturer, verifying that the manufacturing facility of a Semaglutide [USAN:INN] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Semaglutide [USAN:INN] APIs or Semaglutide [USAN:INN] finished pharmaceutical products to another nation, regulatory agencies frequently require a Semaglutide [USAN:INN] WC (written confirmation) as part of the regulatory process.
click here to find a list of Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Semaglutide [USAN:INN] 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 [USAN:INN] 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 [USAN:INN] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Semaglutide [USAN:INN] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Semaglutide [USAN:INN] suppliers with NDC on PharmaCompass.
Semaglutide [USAN:INN] 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 [USAN:INN] 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 [USAN:INN] GMP manufacturer or Semaglutide [USAN:INN] GMP API supplier for your needs.
A Semaglutide [USAN:INN] CoA (Certificate of Analysis) is a formal document that attests to Semaglutide [USAN:INN]'s compliance with Semaglutide [USAN:INN] specifications and serves as a tool for batch-level quality control.
Semaglutide [USAN:INN] CoA mostly includes findings from lab analyses of a specific batch. For each Semaglutide [USAN:INN] 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 [USAN:INN] may be tested according to a variety of international standards, such as European Pharmacopoeia (Semaglutide [USAN:INN] EP), Semaglutide [USAN:INN] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Semaglutide [USAN:INN] USP).