01 1Banner Chemical
02 1Zhejiang Jiuzhou Pharmaceutical
01 11-[2-AMINO-1-(4-METHOXYPHENYL) ETHYL] CYCLOHEXANOL HYDROCHLORIDE (VERSION NO.:1)
02 11-[2-AMINO-1-(4-METHOXYPHENYL)ETHYL]-CYCLOHEXANOL HYDROCHLORIDE (VERSION NO.:1)
01 2China
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26980
Submission : 2013-03-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27280
Submission : 2013-07-01
Status : Inactive
Type : II
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A 603-EP2308471A1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 603-EP2308471A1, including repackagers and relabelers. The FDA regulates 603-EP2308471A1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 603-EP2308471A1 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 603-EP2308471A1 supplier is an individual or a company that provides 603-EP2308471A1 active pharmaceutical ingredient (API) or 603-EP2308471A1 finished formulations upon request. The 603-EP2308471A1 suppliers may include 603-EP2308471A1 API manufacturers, exporters, distributors and traders.
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A 603-EP2308471A1 DMF (Drug Master File) is a document detailing the whole manufacturing process of 603-EP2308471A1 active pharmaceutical ingredient (API) in detail. Different forms of 603-EP2308471A1 DMFs exist exist since differing nations have different regulations, such as 603-EP2308471A1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 603-EP2308471A1 DMF submitted to regulatory agencies in the US is known as a USDMF. 603-EP2308471A1 USDMF includes data on 603-EP2308471A1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 603-EP2308471A1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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