01 1ALP Pharm
02 1Apotex Pharmachem
03 1Cipla
04 1Qilu Pharmaceutical
05 1RANBAXY LABORATORIES LIMITED
06 1Sigmapharm Laboratories, LLC
07 1Viatris
01 5ADEFOVIR DIPIVOXIL
02 1ADEFOVIR DIPIVOXIL (NON STERILE, API)
03 1AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION)
01 1Canada
02 2China
03 2India
04 2U.S.A
01 2Active
02 5Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24336
Submission : 2010-10-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-26
Pay. Date : 2012-12-06
DMF Number : 26630
Submission : 2012-12-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20192
Submission : 2007-03-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25641
Submission : 2011-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23993
Submission : 2010-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23844
Submission : 2010-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26117
Submission : 2012-05-30
Status : Inactive
Type : II
A Adefovir Dipivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adefovir Dipivoxil, including repackagers and relabelers. The FDA regulates Adefovir Dipivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adefovir Dipivoxil 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 Adefovir Dipivoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Adefovir Dipivoxil supplier is an individual or a company that provides Adefovir Dipivoxil active pharmaceutical ingredient (API) or Adefovir Dipivoxil finished formulations upon request. The Adefovir Dipivoxil suppliers may include Adefovir Dipivoxil API manufacturers, exporters, distributors and traders.
click here to find a list of Adefovir Dipivoxil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Adefovir Dipivoxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Adefovir Dipivoxil active pharmaceutical ingredient (API) in detail. Different forms of Adefovir Dipivoxil DMFs exist exist since differing nations have different regulations, such as Adefovir Dipivoxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adefovir Dipivoxil DMF submitted to regulatory agencies in the US is known as a USDMF. Adefovir Dipivoxil USDMF includes data on Adefovir Dipivoxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adefovir Dipivoxil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Adefovir Dipivoxil suppliers with USDMF on PharmaCompass.
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