01 1ACS DOBFAR SPA
02 1Astellas Pharma
01 1ACID CEFOTETAN
02 1CEFOTETAN
01 1Italy
02 1Japan
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19167
Submission : 2006-02-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5074
Submission : 1983-09-06
Status : Inactive
Type : II
A Cefotetan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefotetan, including repackagers and relabelers. The FDA regulates Cefotetan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefotetan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Cefotetan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefotetan supplier is an individual or a company that provides Cefotetan active pharmaceutical ingredient (API) or Cefotetan finished formulations upon request. The Cefotetan suppliers may include Cefotetan API manufacturers, exporters, distributors and traders.
click here to find a list of Cefotetan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefotetan DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefotetan active pharmaceutical ingredient (API) in detail. Different forms of Cefotetan DMFs exist exist since differing nations have different regulations, such as Cefotetan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefotetan DMF submitted to regulatory agencies in the US is known as a USDMF. Cefotetan USDMF includes data on Cefotetan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefotetan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefotetan suppliers with USDMF on PharmaCompass.
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