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