01 1Luohe Chief Pharmaceutical
02 1Lupin Ltd
03 1Olon S.p.A
01 1RIFABUTIN
02 1RIFABUTIN (USP)
03 1RIFABUTIN USP
01 1China
02 1India
03 1Italy
01 3Active
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35705
Submission : 2024-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19902
Submission : 2006-10-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-20
Pay. Date : 2018-05-08
DMF Number : 29047
Submission : 2015-01-22
Status : Active
Type : II
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A AC-19109 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AC-19109, including repackagers and relabelers. The FDA regulates AC-19109 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AC-19109 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 AC-19109 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A AC-19109 supplier is an individual or a company that provides AC-19109 active pharmaceutical ingredient (API) or AC-19109 finished formulations upon request. The AC-19109 suppliers may include AC-19109 API manufacturers, exporters, distributors and traders.
click here to find a list of AC-19109 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A AC-19109 DMF (Drug Master File) is a document detailing the whole manufacturing process of AC-19109 active pharmaceutical ingredient (API) in detail. Different forms of AC-19109 DMFs exist exist since differing nations have different regulations, such as AC-19109 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AC-19109 DMF submitted to regulatory agencies in the US is known as a USDMF. AC-19109 USDMF includes data on AC-19109's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AC-19109 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AC-19109 suppliers with USDMF on PharmaCompass.
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