01 1Apac Pharmaceutical
02 1ChemPacific Corp
03 1Blank
01 1DYCLONINE HCL
02 1DYCLONINE HYDROCHLORIDE DRUG SUBSTANCE
03 1DYCLONINE HYDROCHLORIDE USP
01 2U.S.A
02 1Blank
01 2Active
02 1Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-04-24
Pay. Date : 2015-06-08
DMF Number : 28587
Submission : 2015-02-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19497
Submission : 2006-03-31
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4032
Submission : 1980-12-23
Status : Inactive
Type : II
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A Dyclonine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dyclonine, including repackagers and relabelers. The FDA regulates Dyclonine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dyclonine 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 Dyclonine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dyclonine supplier is an individual or a company that provides Dyclonine active pharmaceutical ingredient (API) or Dyclonine finished formulations upon request. The Dyclonine suppliers may include Dyclonine API manufacturers, exporters, distributors and traders.
click here to find a list of Dyclonine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dyclonine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dyclonine active pharmaceutical ingredient (API) in detail. Different forms of Dyclonine DMFs exist exist since differing nations have different regulations, such as Dyclonine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dyclonine DMF submitted to regulatory agencies in the US is known as a USDMF. Dyclonine USDMF includes data on Dyclonine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dyclonine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dyclonine suppliers with USDMF on PharmaCompass.
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