01 1Derivados Quimicos SAU
01 1DIOXANONE
01 1Spain
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25481
Submission : 2011-11-07
Status : Inactive
Type : II
A 1,2-Dioxan-3-One manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2-Dioxan-3-One, including repackagers and relabelers. The FDA regulates 1,2-Dioxan-3-One manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2-Dioxan-3-One 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 1,2-Dioxan-3-One supplier is an individual or a company that provides 1,2-Dioxan-3-One active pharmaceutical ingredient (API) or 1,2-Dioxan-3-One finished formulations upon request. The 1,2-Dioxan-3-One suppliers may include 1,2-Dioxan-3-One API manufacturers, exporters, distributors and traders.
click here to find a list of 1,2-Dioxan-3-One suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1,2-Dioxan-3-One DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,2-Dioxan-3-One active pharmaceutical ingredient (API) in detail. Different forms of 1,2-Dioxan-3-One DMFs exist exist since differing nations have different regulations, such as 1,2-Dioxan-3-One USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,2-Dioxan-3-One DMF submitted to regulatory agencies in the US is known as a USDMF. 1,2-Dioxan-3-One USDMF includes data on 1,2-Dioxan-3-One's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,2-Dioxan-3-One USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1,2-Dioxan-3-One suppliers with USDMF on PharmaCompass.
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