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ABOUT THIS PAGE
A Sodium Fluoride 18F manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Fluoride 18F, including repackagers and relabelers. The FDA regulates Sodium Fluoride 18F manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Fluoride 18F 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 Sodium Fluoride 18F supplier is an individual or a company that provides Sodium Fluoride 18F active pharmaceutical ingredient (API) or Sodium Fluoride 18F finished formulations upon request. The Sodium Fluoride 18F suppliers may include Sodium Fluoride 18F API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Fluoride 18F suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Fluoride 18F DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Fluoride 18F active pharmaceutical ingredient (API) in detail. Different forms of Sodium Fluoride 18F DMFs exist exist since differing nations have different regulations, such as Sodium Fluoride 18F USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Fluoride 18F DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Fluoride 18F USDMF includes data on Sodium Fluoride 18F's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Fluoride 18F USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Fluoride 18F suppliers with USDMF on PharmaCompass.
Sodium Fluoride 18F 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 Sodium Fluoride 18F 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 Sodium Fluoride 18F GMP manufacturer or Sodium Fluoride 18F GMP API supplier for your needs.
A Sodium Fluoride 18F CoA (Certificate of Analysis) is a formal document that attests to Sodium Fluoride 18F's compliance with Sodium Fluoride 18F specifications and serves as a tool for batch-level quality control.
Sodium Fluoride 18F CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Fluoride 18F 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.
Sodium Fluoride 18F may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Fluoride 18F EP), Sodium Fluoride 18F JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Fluoride 18F USP).
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