01 3NITTO DENKO CORP
02 6Nitto Denko Avecia
03 2Sigma-Aldrich Corporation
01 1DPC 1528 (OLIGONUCLEOTIDE ARM), API
02 1NFKB (OLIGONUCLEOTIDE ATO) ACTIVE PHARMACEUTICAL INGREDIENT (API)
03 1OLIGONUCLEOTIDE 2006 ACTIVE PHARMACEUTICAL INGREDIENT
04 1OLIGONUCLEOTIDE ANV
05 1OLIGONUCLEOTIDE APH
06 1OLIGONUCLEOTIDE APO
07 1OLIGONUCLEOTIDE APQ
08 1OLIGONUCLEOTIDE GTI-2501
09 1OLIGONUCLEOTIDE INX-3001
10 1OLIGONUCLEOTIDE MG98 API
11 1OLIGONUCLEOTIDES
01 3Japan
02 8U.S.A
01 11Inactive
01 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16836
Submission : 2003-09-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16631
Submission : 2003-06-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16073
Submission : 2002-07-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13803
Submission : 1998-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13049
Submission : 1998-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21924
Submission : 2008-08-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16355
Submission : 2003-01-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12152
Submission : 1996-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15388
Submission : 2001-04-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15199
Submission : 2000-12-13
Status : Inactive
Type : II
A Oligonucleotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oligonucleotide, including repackagers and relabelers. The FDA regulates Oligonucleotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oligonucleotide 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 Oligonucleotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oligonucleotide supplier is an individual or a company that provides Oligonucleotide active pharmaceutical ingredient (API) or Oligonucleotide finished formulations upon request. The Oligonucleotide suppliers may include Oligonucleotide API manufacturers, exporters, distributors and traders.
click here to find a list of Oligonucleotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oligonucleotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Oligonucleotide active pharmaceutical ingredient (API) in detail. Different forms of Oligonucleotide DMFs exist exist since differing nations have different regulations, such as Oligonucleotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oligonucleotide DMF submitted to regulatory agencies in the US is known as a USDMF. Oligonucleotide USDMF includes data on Oligonucleotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oligonucleotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oligonucleotide suppliers with USDMF on PharmaCompass.
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