01 3NANOTHERAPEUTICS INC
02 3Nanopharmaceutics
01 1TRIAPINE CAPSULE
02 1TRIAPINE DRUG SUBSTANCE
03 1TRIAPINE INJECTION
04 1TRIAPINE® CAPSULES
05 1TRIAPINE® DRUG SUBSTANCE
06 1TRIAPINE® INJECTION
01 3India
02 3U.S.A
01 6Active
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33189
Submission : 2018-10-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33755
Submission : 2019-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33272
Submission : 2018-10-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25943
Submission : 2012-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25942
Submission : 2012-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17639
Submission : 2004-10-06
Status : Active
Type : II
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A Triapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triapine, including repackagers and relabelers. The FDA regulates Triapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triapine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Triapine supplier is an individual or a company that provides Triapine active pharmaceutical ingredient (API) or Triapine finished formulations upon request. The Triapine suppliers may include Triapine API manufacturers, exporters, distributors and traders.
click here to find a list of Triapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Triapine DMF (Drug Master File) is a document detailing the whole manufacturing process of Triapine active pharmaceutical ingredient (API) in detail. Different forms of Triapine DMFs exist exist since differing nations have different regulations, such as Triapine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triapine DMF submitted to regulatory agencies in the US is known as a USDMF. Triapine USDMF includes data on Triapine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triapine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Triapine suppliers with USDMF on PharmaCompass.
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