01 1AVT (Shanghai)
01 1CETALKONIUM CHLORIDE (FOR INJECTION)
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37285
Submission : 2022-07-01
Status : Active
Type : IV
A Cetalkonium Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetalkonium Chloride, including repackagers and relabelers. The FDA regulates Cetalkonium Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetalkonium Chloride 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 Cetalkonium Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetalkonium Chloride supplier is an individual or a company that provides Cetalkonium Chloride active pharmaceutical ingredient (API) or Cetalkonium Chloride finished formulations upon request. The Cetalkonium Chloride suppliers may include Cetalkonium Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cetalkonium Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetalkonium Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetalkonium Chloride active pharmaceutical ingredient (API) in detail. Different forms of Cetalkonium Chloride DMFs exist exist since differing nations have different regulations, such as Cetalkonium Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetalkonium Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cetalkonium Chloride USDMF includes data on Cetalkonium Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetalkonium Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetalkonium Chloride suppliers with USDMF on PharmaCompass.
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