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PharmaCompass offers a list of Exenatide 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 Exenatide manufacturer or Exenatide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Exenatide manufacturer or Exenatide supplier.
PharmaCompass also assists you with knowing the Exenatide API Price utilized in the formulation of products. Exenatide API Price is not always fixed or binding as the Exenatide Price is obtained through a variety of data sources. The Exenatide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Exenatide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exenatide Acetate, including repackagers and relabelers. The FDA regulates Exenatide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exenatide Acetate 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 Exenatide Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Exenatide Acetate supplier is an individual or a company that provides Exenatide Acetate active pharmaceutical ingredient (API) or Exenatide Acetate finished formulations upon request. The Exenatide Acetate suppliers may include Exenatide Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Exenatide Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Exenatide Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Exenatide Acetate active pharmaceutical ingredient (API) in detail. Different forms of Exenatide Acetate DMFs exist exist since differing nations have different regulations, such as Exenatide Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exenatide Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Exenatide Acetate USDMF includes data on Exenatide Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exenatide Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Exenatide Acetate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Exenatide Acetate Drug Master File in Japan (Exenatide Acetate JDMF) empowers Exenatide Acetate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Exenatide Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Exenatide Acetate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Exenatide Acetate suppliers with JDMF 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 Exenatide Acetate Drug Master File in Korea (Exenatide Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Exenatide Acetate. The MFDS reviews the Exenatide Acetate KDMF as part of the drug registration process and uses the information provided in the Exenatide Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Exenatide Acetate 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 Exenatide Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Exenatide Acetate suppliers with KDMF on PharmaCompass.
A Exenatide Acetate written confirmation (Exenatide Acetate WC) is an official document issued by a regulatory agency to a Exenatide Acetate manufacturer, verifying that the manufacturing facility of a Exenatide Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Exenatide Acetate APIs or Exenatide Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Exenatide Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Exenatide Acetate 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 Exenatide Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Exenatide Acetate 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 Exenatide Acetate 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 Exenatide Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Exenatide Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Exenatide Acetate suppliers with NDC on PharmaCompass.
Exenatide Acetate 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 Exenatide Acetate 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 Exenatide Acetate GMP manufacturer or Exenatide Acetate GMP API supplier for your needs.
A Exenatide Acetate CoA (Certificate of Analysis) is a formal document that attests to Exenatide Acetate's compliance with Exenatide Acetate specifications and serves as a tool for batch-level quality control.
Exenatide Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Exenatide Acetate 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.
Exenatide Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Exenatide Acetate EP), Exenatide Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Exenatide Acetate USP).
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