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ABOUT THIS PAGE
A Fructose 1,6-Bisphosphate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fructose 1,6-Bisphosphate Sodium, including repackagers and relabelers. The FDA regulates Fructose 1,6-Bisphosphate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fructose 1,6-Bisphosphate Sodium 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 Fructose 1,6-Bisphosphate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fructose 1,6-Bisphosphate Sodium supplier is an individual or a company that provides Fructose 1,6-Bisphosphate Sodium active pharmaceutical ingredient (API) or Fructose 1,6-Bisphosphate Sodium finished formulations upon request. The Fructose 1,6-Bisphosphate Sodium suppliers may include Fructose 1,6-Bisphosphate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Fructose 1,6-Bisphosphate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fructose 1,6-Bisphosphate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fructose 1,6-Bisphosphate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Fructose 1,6-Bisphosphate Sodium DMFs exist exist since differing nations have different regulations, such as Fructose 1,6-Bisphosphate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fructose 1,6-Bisphosphate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Fructose 1,6-Bisphosphate Sodium USDMF includes data on Fructose 1,6-Bisphosphate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fructose 1,6-Bisphosphate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fructose 1,6-Bisphosphate Sodium 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 Fructose 1,6-Bisphosphate Sodium Drug Master File in Japan (Fructose 1,6-Bisphosphate Sodium JDMF) empowers Fructose 1,6-Bisphosphate Sodium 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 Fructose 1,6-Bisphosphate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Fructose 1,6-Bisphosphate Sodium 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 Fructose 1,6-Bisphosphate Sodium suppliers with JDMF on PharmaCompass.
Fructose 1,6-Bisphosphate Sodium 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 Fructose 1,6-Bisphosphate Sodium 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 Fructose 1,6-Bisphosphate Sodium GMP manufacturer or Fructose 1,6-Bisphosphate Sodium GMP API supplier for your needs.
A Fructose 1,6-Bisphosphate Sodium CoA (Certificate of Analysis) is a formal document that attests to Fructose 1,6-Bisphosphate Sodium's compliance with Fructose 1,6-Bisphosphate Sodium specifications and serves as a tool for batch-level quality control.
Fructose 1,6-Bisphosphate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Fructose 1,6-Bisphosphate Sodium 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.
Fructose 1,6-Bisphosphate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Fructose 1,6-Bisphosphate Sodium EP), Fructose 1,6-Bisphosphate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fructose 1,6-Bisphosphate Sodium USP).
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