01 1Desano Pharmaceutical
02 1Huangshi Fuertai
03 2Jingmen Shuaibang Technology
04 1Shanghai Desano Bio-Pharmaceutical
05 1Shijiazhuang Lonzeal Pharmac.Co. ltd
06 1Blank
01 1PMPA
02 5TENOFOVIR
03 1TENOFOVIR DISOPROXIL FUMARATE (DRUG SUBSTANCE)
01 6China
02 1Blank
01 6Active
02 1Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31146
Submission : 2016-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33406
Submission : 2018-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28815
Submission : 2014-11-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33549
Submission : 2019-03-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26767
Submission : 2012-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35544
Submission : 2021-08-02
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35444
Submission : 2021-05-17
Status : Active
Type : II
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A Tenofovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenofovir, including repackagers and relabelers. The FDA regulates Tenofovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenofovir 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 Tenofovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tenofovir supplier is an individual or a company that provides Tenofovir active pharmaceutical ingredient (API) or Tenofovir finished formulations upon request. The Tenofovir suppliers may include Tenofovir API manufacturers, exporters, distributors and traders.
click here to find a list of Tenofovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tenofovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Tenofovir active pharmaceutical ingredient (API) in detail. Different forms of Tenofovir DMFs exist exist since differing nations have different regulations, such as Tenofovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tenofovir DMF submitted to regulatory agencies in the US is known as a USDMF. Tenofovir USDMF includes data on Tenofovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tenofovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tenofovir suppliers with USDMF on PharmaCompass.
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