01 1Ajinomoto Company
02 1Aurisco Pharmaceutical
03 2Aurobindo Pharma Limited
04 1Cipla
05 1Gilead Sciences
06 1Hetero Drugs
07 1Signa S.A. de C.V.
08 1Viatris
09 1Yuki Gosei Kogyo
10 1Zhejiang Candorly Pharmaceutical
01 12',3'-DIDEOXYINOSINE
02 12'3'-DIDEOXYINOSINE
03 12,3,-DIDEOXYINOSINE
04 2DIDANOSINE
05 1DIDANOSINE EUR.PH NON-STERILE DRUG SUBSTANCE
06 3DIDANOSINE USP
07 1DIDANOSINE USP, NON-STERILE DRUG SUBSTANCE
08 1DIDEOXYINOSINE
01 2China
02 4India
03 2Japan
04 1Mexico
05 2U.S.A
01 3Active
02 8Inactive
01 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7694
Submission : 1988-09-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20870
Submission : 2007-09-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17657
Submission : 2004-08-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19784
Submission : 2008-11-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7680
Submission : 1988-09-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18733
Submission : 2005-09-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17413
Submission : 2004-05-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21215
Submission : 2007-12-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8017
Submission : 1989-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20947
Submission : 2007-10-12
Status : Inactive
Type : II
A Didanosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Didanosine, including repackagers and relabelers. The FDA regulates Didanosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Didanosine 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 Didanosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Didanosine supplier is an individual or a company that provides Didanosine active pharmaceutical ingredient (API) or Didanosine finished formulations upon request. The Didanosine suppliers may include Didanosine API manufacturers, exporters, distributors and traders.
click here to find a list of Didanosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Didanosine DMF (Drug Master File) is a document detailing the whole manufacturing process of Didanosine active pharmaceutical ingredient (API) in detail. Different forms of Didanosine DMFs exist exist since differing nations have different regulations, such as Didanosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Didanosine DMF submitted to regulatory agencies in the US is known as a USDMF. Didanosine USDMF includes data on Didanosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Didanosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Didanosine suppliers with USDMF on PharmaCompass.
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