01 1CSPC CENWAY TIANJIN PHARMACEUTICALS CO LTD
02 1Otsuka Chemical Co Ltd
03 1TIANJIN GENCOM PHARMACEUTICAL CO LTD
01 1GCLE
02 1GCLE (NON-STERILE, BULK FORM)
03 1P-METHOXYBENZYL(6R,7R)-3-CHLOROMETHYL-8-OXO-7-PHENYLACETAMIDO-5-THIA-1-AZABICYCLO [4.2.0]OCT-2-ENE-2-CARBOXYLATE, GCLE
01 2China
02 1Japan
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20146
Submission : 2007-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20451
Submission : 2007-04-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21168
Submission : 2007-12-14
Status : Active
Type : II
A Gcle:Intermediate For Cephalosporin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gcle:Intermediate For Cephalosporin, including repackagers and relabelers. The FDA regulates Gcle:Intermediate For Cephalosporin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gcle:Intermediate For Cephalosporin 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 Gcle:Intermediate For Cephalosporin supplier is an individual or a company that provides Gcle:Intermediate For Cephalosporin active pharmaceutical ingredient (API) or Gcle:Intermediate For Cephalosporin finished formulations upon request. The Gcle:Intermediate For Cephalosporin suppliers may include Gcle:Intermediate For Cephalosporin API manufacturers, exporters, distributors and traders.
click here to find a list of Gcle:Intermediate For Cephalosporin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gcle:Intermediate For Cephalosporin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gcle:Intermediate For Cephalosporin active pharmaceutical ingredient (API) in detail. Different forms of Gcle:Intermediate For Cephalosporin DMFs exist exist since differing nations have different regulations, such as Gcle:Intermediate For Cephalosporin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gcle:Intermediate For Cephalosporin DMF submitted to regulatory agencies in the US is known as a USDMF. Gcle:Intermediate For Cephalosporin USDMF includes data on Gcle:Intermediate For Cephalosporin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gcle:Intermediate For Cephalosporin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gcle:Intermediate For Cephalosporin suppliers with USDMF on PharmaCompass.
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