01 1Ajinomoto Company
02 1Aspire Lifesciences Pvt Ltd
03 1Aurisco Pharmaceutical
04 2Aurobindo Pharma Limited
05 1Cipla
06 1Gilead Sciences
07 1Hetero Drugs
08 1Pellsys Pharma
09 1Signa S.A. de C.V.
10 1Spansules Pharma
11 1Titan Laboratories
12 1Viatris
13 1Yuki Gosei Kogyo
14 1Zhejiang Candorly Pharmaceutical
15 1Zim Laboratories
01 2China
02 9India
03 2Japan
04 1Mexico
05 2U.S.A
01 3Active
02 8Inactive
03 5Blank
01 1Valid
02 1Withdrawn by Holder
03 14Blank
01 16Blank
01 1WC-0023
02 15Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17657
Submission : 2004-08-30
Status : Active
Type : II
Certificate Number : R1-CEP 2007-301 - Rev 02
Issue Date : 2017-02-03
Type : Chemical
Substance Number : 2200
Status : Valid
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0023
Address of the Firm :
NDC Package Code : 65862-322
Start Marketing Date : 2024-01-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20870
Submission : 2007-09-17
Status : Active
Type : II
NDC Package Code : 65862-322
Start Marketing Date : 2024-01-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21215
Submission : 2007-12-21
Status : Active
Type : II
Certificate Number : R0-CEP 2013-356 - Rev 01
Issue Date : 2017-09-18
Type : Chemical
Substance Number : 2200
Status : Withdrawn by Holder
NDC Package Code : 65015-794
Start Marketing Date : 2011-05-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20947
Submission : 2007-10-12
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 : 23635
Submission : 2010-04-16
Status : Inactive
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 : 8017
Submission : 1989-04-08
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 : 17413
Submission : 2004-05-26
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.
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