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01 1GLYCEROL MONOSTEARATE
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3095
Submission : 1977-12-14
Status : Inactive
Type : II
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A Glyceryl Stearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glyceryl Stearate, including repackagers and relabelers. The FDA regulates Glyceryl Stearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glyceryl Stearate 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 Glyceryl Stearate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glyceryl Stearate supplier is an individual or a company that provides Glyceryl Stearate active pharmaceutical ingredient (API) or Glyceryl Stearate finished formulations upon request. The Glyceryl Stearate suppliers may include Glyceryl Stearate API manufacturers, exporters, distributors and traders.
click here to find a list of Glyceryl Stearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glyceryl Stearate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glyceryl Stearate active pharmaceutical ingredient (API) in detail. Different forms of Glyceryl Stearate DMFs exist exist since differing nations have different regulations, such as Glyceryl Stearate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glyceryl Stearate DMF submitted to regulatory agencies in the US is known as a USDMF. Glyceryl Stearate USDMF includes data on Glyceryl Stearate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glyceryl Stearate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glyceryl Stearate suppliers with USDMF on PharmaCompass.
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