Synopsis
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CEP/COS
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JDMF
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EU WC
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VMF
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EDQM
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USP
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JP
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Others
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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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...
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...
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 solutions, offering global API and preparation production services. Co-founded by...
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, employing advanced chemical strategies such as microwave-assisted solid-phase synthesis. T...
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 ...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
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...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Semaglutide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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
Upfront Cash : Inapplicable
October 19, 2023
Lead Product(s) : Semaglutide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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
Upfront Cash : Inapplicable
October 18, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 2061897-68-3
End Use API : Semaglutide
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
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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
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ABOUT THIS PAGE
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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 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).
