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01 1Arch Pharmalabs
02 2Aurobindo Pharma Limited
03 1Cipla
04 1Esteve Quimica
05 1HEC Pharm
06 2Hetero Drugs
07 1MATRIX LABORATORIES XIAMEN LTD.
08 1Matrix Pharmaceutical Inc
09 1RANBAXY LABORATORIES LIMITED
10 1SIBRA PHARMACEUTICALS LTD
11 1ST Pharma
12 1Shanghai Desano Bio-Pharmaceutical
13 1Shanghai Shyndec Pharmaceutical
14 1Signa S.A. de C.V.
15 1Solara Active Pharma Sciences
16 3Viatris
17 1ZHEJIANG LANGHUA PHARMACEUTICAL
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01 2AZT (ZIDOVUDINE)
02 2ZIDOVUDINE
03 1ZIDOVUDINE (NON-STERILE, BULK FORM)
04 1ZIDOVUDINE (PROCESS I)
05 1ZIDOVUDINE (PROCESS II)
06 1ZIDOVUDINE DRUG SUBSTANCE
07 7ZIDOVUDINE USP
08 1ZIDOVUDINE USP (PROCESS II)
09 1ZIDOVUDINE USP (PROCESS III)
10 1ZIDOVUDINE USP (PROCESS-I)
11 1ZIDOVUDINE USP DRUG SUBSTANCE
12 1ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM
13 1ZIDOVUDINE, USP
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01 5China
02 9India
03 1Mexico
04 1South Korea
05 1Spain
06 4U.S.A
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01 10Active
02 11Inactive
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01 5Complete
02 16Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-13
DMF Number : 18714
Submission : 2005-08-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17638
Submission : 2004-08-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16677
Submission : 2003-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23762
Submission : 2010-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2013-01-18
DMF Number : 18291
Submission : 2005-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-02
Pay. Date : 2013-01-04
DMF Number : 24608
Submission : 2011-02-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-14
DMF Number : 21277
Submission : 2008-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-08
Pay. Date : 2014-07-09
DMF Number : 27207
Submission : 2013-06-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25009
Submission : 2011-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17751
Submission : 2004-10-08
Status : Active
Type : II
A AZT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AZT, including repackagers and relabelers. The FDA regulates AZT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AZT 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 AZT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AZT supplier is an individual or a company that provides AZT active pharmaceutical ingredient (API) or AZT finished formulations upon request. The AZT suppliers may include AZT API manufacturers, exporters, distributors and traders.
click here to find a list of AZT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AZT DMF (Drug Master File) is a document detailing the whole manufacturing process of AZT active pharmaceutical ingredient (API) in detail. Different forms of AZT DMFs exist exist since differing nations have different regulations, such as AZT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AZT DMF submitted to regulatory agencies in the US is known as a USDMF. AZT USDMF includes data on AZT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AZT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AZT suppliers with USDMF on PharmaCompass.
We have 17 companies offering AZT
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