01 1SAFC
01 1SODIUM OCTANOATE-1-13C
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20302
Submission : 2007-02-23
Status : Inactive
Type : II
A Sodium Octanoate-1-13C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Octanoate-1-13C, including repackagers and relabelers. The FDA regulates Sodium Octanoate-1-13C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Octanoate-1-13C 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 Octanoate-1-13C supplier is an individual or a company that provides Sodium Octanoate-1-13C active pharmaceutical ingredient (API) or Sodium Octanoate-1-13C finished formulations upon request. The Sodium Octanoate-1-13C suppliers may include Sodium Octanoate-1-13C API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Octanoate-1-13C suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Octanoate-1-13C DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Octanoate-1-13C active pharmaceutical ingredient (API) in detail. Different forms of Sodium Octanoate-1-13C DMFs exist exist since differing nations have different regulations, such as Sodium Octanoate-1-13C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Octanoate-1-13C DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Octanoate-1-13C USDMF includes data on Sodium Octanoate-1-13C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Octanoate-1-13C USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Octanoate-1-13C suppliers with USDMF on PharmaCompass.
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