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