01 1ACS DOBFAR SPA
01 1CEFOTETAN DISODIUM (STERILE BULK)
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18977
Submission : 2005-11-28
Status : Active
Type : II
A Cefotetan Disodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefotetan Disodium, including repackagers and relabelers. The FDA regulates Cefotetan Disodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefotetan Disodium 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 Disodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefotetan Disodium supplier is an individual or a company that provides Cefotetan Disodium active pharmaceutical ingredient (API) or Cefotetan Disodium finished formulations upon request. The Cefotetan Disodium suppliers may include Cefotetan Disodium API manufacturers, exporters, distributors and traders.
click here to find a list of Cefotetan Disodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefotetan Disodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefotetan Disodium active pharmaceutical ingredient (API) in detail. Different forms of Cefotetan Disodium DMFs exist exist since differing nations have different regulations, such as Cefotetan Disodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefotetan Disodium DMF submitted to regulatory agencies in the US is known as a USDMF. Cefotetan Disodium USDMF includes data on Cefotetan Disodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefotetan Disodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefotetan Disodium suppliers with USDMF on PharmaCompass.
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