Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
DRUG PRODUCT COMPOSITIONS0
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
API SUPPLIERS
Space Peptides Pharmaceutical delivers Peptide CRDMO Services at Premium Speed & Quality to transform healthcare worldwide.
Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.
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 : 2026-12-31
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.
Fujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39522
Submission : 2024-03-07
Status : Active
Type : II
NDC Package Code : 84502-108
Start Marketing Date : 2025-10-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2025-07-09
Registration Number : 20250619-210-J-1943(A)
Manufacturer Name : Fujian Genohope Biotech Ltd.
Manufacturer Address : No. 288 Renyang, Binglun Village, Hushi Town Xiuyu District Putian, Fujian 351146, China
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API™
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USDMF
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Space Peptides Pharmaceutical delivers Peptide CRDMO Services at Premium Speed & Quality to transform healthcare worldwide.
About the Company : Space Peptides Pharmaceutical is a Swiss-Chinese company headquartered in Bern, Switzerland. We provides a full range of pharmaceutical peptide CDMO services and a portfolio of gen...
Guizhou Utide Biotechnology Co., Ltd. - Specialized GMP manufacturing for next-generation GLP-1 peptide APIs.
About the Company : Guizhou Utide Biotechnology Co., Ltd., based in Zunyi, Guizhou, is a specialized manufacturer of GLP-1 peptide APIs with 20,000 m² of manufacturing facilities. Backed by a core te...
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 cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approv...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
Fujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.
About the Company : Fujian Genohope Biotech Ltd, established in 2019, specializes in high-potency polypeptide APIs and provides global API and preparation manufacturing services. Co-founded by New Hop...
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
About the Company : Vtides Life Sciences Pvt Ltd specializes in the design and synthesis of complex peptides using advanced chemical approaches, including microwave-assisted solid-phase synthesis. The...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Aspen API. More than just an API™
About the Company : Aspen API is a cooperative entity formed by Aspen Oss in the Netherlands and Fine Chemicals Corporation in South Africa. The company supplies a broad portfolio of over 50 high-qual...
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.6...DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.68MG/ML)
USFDA APPLICATION NUMBER - 209637
DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1...DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1.34MG/ML)
USFDA APPLICATION NUMBER - 209637
DOSAGE - SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.3...DOSAGE - SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.34MG/ML)
USFDA APPLICATION NUMBER - 209637
DOSAGE - SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.6...DOSAGE - SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.68MG/ML)
USFDA APPLICATION NUMBER - 209637
Related Excipient Companies
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
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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.
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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.
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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).
