01 1SAFC
01 1ETHYLENE OXIDE STERILISATION
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17262
Submission : 2004-03-26
Status : Inactive
Type : II
A Homotaurine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Homotaurine, including repackagers and relabelers. The FDA regulates Homotaurine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Homotaurine 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 Homotaurine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Homotaurine supplier is an individual or a company that provides Homotaurine active pharmaceutical ingredient (API) or Homotaurine finished formulations upon request. The Homotaurine suppliers may include Homotaurine API manufacturers, exporters, distributors and traders.
click here to find a list of Homotaurine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Homotaurine DMF (Drug Master File) is a document detailing the whole manufacturing process of Homotaurine active pharmaceutical ingredient (API) in detail. Different forms of Homotaurine DMFs exist exist since differing nations have different regulations, such as Homotaurine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Homotaurine DMF submitted to regulatory agencies in the US is known as a USDMF. Homotaurine USDMF includes data on Homotaurine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Homotaurine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Homotaurine suppliers with USDMF on PharmaCompass.
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