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ABOUT THIS PAGE
A Sodium Acetate Trihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Acetate Trihydrate, including repackagers and relabelers. The FDA regulates Sodium Acetate Trihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Acetate Trihydrate 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 Sodium Acetate Trihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Acetate Trihydrate supplier is an individual or a company that provides Sodium Acetate Trihydrate active pharmaceutical ingredient (API) or Sodium Acetate Trihydrate finished formulations upon request. The Sodium Acetate Trihydrate suppliers may include Sodium Acetate Trihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Acetate Trihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Acetate Trihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Acetate Trihydrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Acetate Trihydrate DMFs exist exist since differing nations have different regulations, such as Sodium Acetate Trihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Acetate Trihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Acetate Trihydrate USDMF includes data on Sodium Acetate Trihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Acetate Trihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Acetate Trihydrate suppliers with USDMF on PharmaCompass.
A Sodium Acetate Trihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Acetate Trihydrate Certificate of Suitability (COS). The purpose of a Sodium Acetate Trihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Acetate Trihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Acetate Trihydrate to their clients by showing that a Sodium Acetate Trihydrate CEP has been issued for it. The manufacturer submits a Sodium Acetate Trihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Acetate Trihydrate CEP holder for the record. Additionally, the data presented in the Sodium Acetate Trihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Acetate Trihydrate DMF.
A Sodium Acetate Trihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Acetate Trihydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Sodium Acetate Trihydrate suppliers with CEP (COS) on PharmaCompass.
Sodium Acetate Trihydrate 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 Acetate Trihydrate 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 Acetate Trihydrate GMP manufacturer or Sodium Acetate Trihydrate GMP API supplier for your needs.
A Sodium Acetate Trihydrate CoA (Certificate of Analysis) is a formal document that attests to Sodium Acetate Trihydrate's compliance with Sodium Acetate Trihydrate specifications and serves as a tool for batch-level quality control.
Sodium Acetate Trihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Acetate Trihydrate 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 Acetate Trihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Acetate Trihydrate EP), Sodium Acetate Trihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Acetate Trihydrate USP).
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