01 1Hebei Wordstar Chemical Co.,Ltd
01 14AA (4-ACETOXYAZETIDIN-2-ONE)
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30911
Submission : 2016-08-23
Status : Active
Type : II
A 4-Acetoxy-2-Azetidinone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 4-Acetoxy-2-Azetidinone, including repackagers and relabelers. The FDA regulates 4-Acetoxy-2-Azetidinone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 4-Acetoxy-2-Azetidinone 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 4-Acetoxy-2-Azetidinone supplier is an individual or a company that provides 4-Acetoxy-2-Azetidinone active pharmaceutical ingredient (API) or 4-Acetoxy-2-Azetidinone finished formulations upon request. The 4-Acetoxy-2-Azetidinone suppliers may include 4-Acetoxy-2-Azetidinone API manufacturers, exporters, distributors and traders.
click here to find a list of 4-Acetoxy-2-Azetidinone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 4-Acetoxy-2-Azetidinone DMF (Drug Master File) is a document detailing the whole manufacturing process of 4-Acetoxy-2-Azetidinone active pharmaceutical ingredient (API) in detail. Different forms of 4-Acetoxy-2-Azetidinone DMFs exist exist since differing nations have different regulations, such as 4-Acetoxy-2-Azetidinone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 4-Acetoxy-2-Azetidinone DMF submitted to regulatory agencies in the US is known as a USDMF. 4-Acetoxy-2-Azetidinone USDMF includes data on 4-Acetoxy-2-Azetidinone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 4-Acetoxy-2-Azetidinone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 4-Acetoxy-2-Azetidinone suppliers with USDMF on PharmaCompass.
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