01 1Yili Chuanning Biotechnology Co., Ltd
01 1DEACETYL-7-AMINOCEPHALOSPORANIC ACID (D-7-ACA)
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32326
Submission : 2017-11-25
Status : Inactive
Type : II
25
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A Desacetyl glutaryl 7-aminocephalosporanic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Desacetyl glutaryl 7-aminocephalosporanic acid, including repackagers and relabelers. The FDA regulates Desacetyl glutaryl 7-aminocephalosporanic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Desacetyl glutaryl 7-aminocephalosporanic acid 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 Desacetyl glutaryl 7-aminocephalosporanic acid supplier is an individual or a company that provides Desacetyl glutaryl 7-aminocephalosporanic acid active pharmaceutical ingredient (API) or Desacetyl glutaryl 7-aminocephalosporanic acid finished formulations upon request. The Desacetyl glutaryl 7-aminocephalosporanic acid suppliers may include Desacetyl glutaryl 7-aminocephalosporanic acid API manufacturers, exporters, distributors and traders.
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A Desacetyl glutaryl 7-aminocephalosporanic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Desacetyl glutaryl 7-aminocephalosporanic acid active pharmaceutical ingredient (API) in detail. Different forms of Desacetyl glutaryl 7-aminocephalosporanic acid DMFs exist exist since differing nations have different regulations, such as Desacetyl glutaryl 7-aminocephalosporanic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Desacetyl glutaryl 7-aminocephalosporanic acid DMF submitted to regulatory agencies in the US is known as a USDMF. Desacetyl glutaryl 7-aminocephalosporanic acid USDMF includes data on Desacetyl glutaryl 7-aminocephalosporanic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Desacetyl glutaryl 7-aminocephalosporanic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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