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