01 1F. Hoffmann-La Roche
02 1Gilead Sciences
01 12',3'-DIDEOXYCYTIDINE
02 1HIVID DIDEOXYCYTIDINE SYRUP
01 1Switzerland
02 1U.S.A
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8637
Submission : 1990-07-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6805
Submission : 1987-01-28
Status : Inactive
Type : II
A Zalcitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zalcitabine, including repackagers and relabelers. The FDA regulates Zalcitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zalcitabine 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 Zalcitabine supplier is an individual or a company that provides Zalcitabine active pharmaceutical ingredient (API) or Zalcitabine finished formulations upon request. The Zalcitabine suppliers may include Zalcitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Zalcitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zalcitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Zalcitabine active pharmaceutical ingredient (API) in detail. Different forms of Zalcitabine DMFs exist exist since differing nations have different regulations, such as Zalcitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zalcitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Zalcitabine USDMF includes data on Zalcitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zalcitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zalcitabine suppliers with USDMF on PharmaCompass.
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