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ABOUT THIS PAGE
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PharmaCompass offers a list of Aprindine Hydrochloride 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 Aprindine Hydrochloride manufacturer or Aprindine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aprindine Hydrochloride manufacturer or Aprindine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Aprindine Hydrochloride API Price utilized in the formulation of products. Aprindine Hydrochloride API Price is not always fixed or binding as the Aprindine Hydrochloride Price is obtained through a variety of data sources. The Aprindine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fiboran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fiboran, including repackagers and relabelers. The FDA regulates Fiboran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fiboran 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 Fiboran supplier is an individual or a company that provides Fiboran active pharmaceutical ingredient (API) or Fiboran finished formulations upon request. The Fiboran suppliers may include Fiboran API manufacturers, exporters, distributors and traders.
click here to find a list of Fiboran 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 Fiboran Drug Master File in Japan (Fiboran JDMF) empowers Fiboran 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 Fiboran JDMF during the approval evaluation for pharmaceutical products. At the time of Fiboran 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 Fiboran suppliers with JDMF on PharmaCompass.
A Fiboran written confirmation (Fiboran WC) is an official document issued by a regulatory agency to a Fiboran manufacturer, verifying that the manufacturing facility of a Fiboran active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fiboran APIs or Fiboran finished pharmaceutical products to another nation, regulatory agencies frequently require a Fiboran WC (written confirmation) as part of the regulatory process.
click here to find a list of Fiboran suppliers with Written Confirmation (WC) on PharmaCompass.
Fiboran 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 Fiboran 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 Fiboran GMP manufacturer or Fiboran GMP API supplier for your needs.
A Fiboran CoA (Certificate of Analysis) is a formal document that attests to Fiboran's compliance with Fiboran specifications and serves as a tool for batch-level quality control.
Fiboran CoA mostly includes findings from lab analyses of a specific batch. For each Fiboran 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.
Fiboran may be tested according to a variety of international standards, such as European Pharmacopoeia (Fiboran EP), Fiboran JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fiboran USP).
