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PharmaCompass offers a list of Gabexato 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 Gabexato manufacturer or Gabexato supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gabexato manufacturer or Gabexato supplier.
PharmaCompass also assists you with knowing the Gabexato API Price utilized in the formulation of products. Gabexato API Price is not always fixed or binding as the Gabexato Price is obtained through a variety of data sources. The Gabexato Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gabexato manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabexato, including repackagers and relabelers. The FDA regulates Gabexato manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabexato API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Gabexato supplier is an individual or a company that provides Gabexato active pharmaceutical ingredient (API) or Gabexato finished formulations upon request. The Gabexato suppliers may include Gabexato API manufacturers, exporters, distributors and traders.
click here to find a list of Gabexato suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Gabexato Drug Master File in Japan (Gabexato JDMF) empowers Gabexato 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 Gabexato JDMF during the approval evaluation for pharmaceutical products. At the time of Gabexato 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 Gabexato suppliers with JDMF on PharmaCompass.
Gabexato 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 Gabexato 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 Gabexato GMP manufacturer or Gabexato GMP API supplier for your needs.
A Gabexato CoA (Certificate of Analysis) is a formal document that attests to Gabexato's compliance with Gabexato specifications and serves as a tool for batch-level quality control.
Gabexato CoA mostly includes findings from lab analyses of a specific batch. For each Gabexato 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.
Gabexato may be tested according to a variety of international standards, such as European Pharmacopoeia (Gabexato EP), Gabexato JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gabexato USP).