01 1Amphastar Pharmaceuticals
01 1SODIUM TAUROCHOLATE HYDRATE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33258
Submission : 2018-11-21
Status : Active
Type : IV
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A Sodium Taurocholate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Taurocholate, including repackagers and relabelers. The FDA regulates Sodium Taurocholate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Taurocholate 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 supplier is an individual or a company that provides Sodium Taurocholate active pharmaceutical ingredient (API) or Sodium Taurocholate finished formulations upon request. The Sodium Taurocholate suppliers may include Sodium Taurocholate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Taurocholate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sodium Taurocholate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Taurocholate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Taurocholate DMFs exist exist since differing nations have different regulations, such as Sodium Taurocholate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Taurocholate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Taurocholate USDMF includes data on Sodium Taurocholate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Taurocholate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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