01 1Actylis
02 1Blank
01 15-BROMO-2' -DEOXYURIDINE (BDU)-PRODUCT NO. 6706
02 1BROXURIDINE
01 1U.S.A
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3750
Submission : 1980-02-28
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7980
Submission : 1989-03-16
Status : Inactive
Type : II
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A Broxuridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Broxuridine, including repackagers and relabelers. The FDA regulates Broxuridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Broxuridine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Broxuridine supplier is an individual or a company that provides Broxuridine active pharmaceutical ingredient (API) or Broxuridine finished formulations upon request. The Broxuridine suppliers may include Broxuridine API manufacturers, exporters, distributors and traders.
click here to find a list of Broxuridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Broxuridine DMF (Drug Master File) is a document detailing the whole manufacturing process of Broxuridine active pharmaceutical ingredient (API) in detail. Different forms of Broxuridine DMFs exist exist since differing nations have different regulations, such as Broxuridine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Broxuridine DMF submitted to regulatory agencies in the US is known as a USDMF. Broxuridine USDMF includes data on Broxuridine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Broxuridine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Broxuridine suppliers with USDMF on PharmaCompass.
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