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