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