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ABOUT THIS PAGE
A Sodium taurocholate hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium taurocholate hydrate, including repackagers and relabelers. The FDA regulates Sodium taurocholate hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium taurocholate hydrate 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 taurocholate hydrate supplier is an individual or a company that provides Sodium taurocholate hydrate active pharmaceutical ingredient (API) or Sodium taurocholate hydrate finished formulations upon request. The Sodium taurocholate hydrate suppliers may include Sodium taurocholate hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium taurocholate hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium taurocholate hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium taurocholate hydrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium taurocholate hydrate DMFs exist exist since differing nations have different regulations, such as Sodium taurocholate hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium taurocholate hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium taurocholate hydrate USDMF includes data on Sodium taurocholate hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium taurocholate hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium taurocholate hydrate suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sodium taurocholate hydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium taurocholate hydrate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Sodium taurocholate hydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Sodium taurocholate hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium taurocholate hydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium taurocholate hydrate suppliers with NDC on PharmaCompass.
Sodium taurocholate hydrate 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 taurocholate hydrate 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 taurocholate hydrate GMP manufacturer or Sodium taurocholate hydrate GMP API supplier for your needs.
A Sodium taurocholate hydrate CoA (Certificate of Analysis) is a formal document that attests to Sodium taurocholate hydrate's compliance with Sodium taurocholate hydrate specifications and serves as a tool for batch-level quality control.
Sodium taurocholate hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium taurocholate hydrate 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 taurocholate hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium taurocholate hydrate EP), Sodium taurocholate hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium taurocholate hydrate USP).
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