01 1Apicore LLC
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1Extrovis AG
04 1Haoyuan Chemexpress Co.Ltd
05 1Jiangsu Hengrui Medicine
06 1Johnson & Johnson Innovative Medicine
07 1MSN Laboratories
08 1PharmaMar
01 5TRABECTEDIN
02 1TRABECTEDIN (HM-326A_42)
03 1TRABECTEDIN (R279741)
04 1TRABECTEDIN, NON-STERILE, BULK DRUG SUBSTANCE
01 3China
02 2India
03 1Spain
04 1Switzerland
05 1U.S.A
01 6Active
02 2Inactive
01 3Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-06-07
DMF Number : 35828
Submission : 2021-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39165
Submission : 2023-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39511
Submission : 2024-02-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-03
Pay. Date : 2023-01-19
DMF Number : 36724
Submission : 2022-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33677
Submission : 2019-05-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22020
Submission : 2008-11-12
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-08
Pay. Date : 2020-08-31
DMF Number : 34311
Submission : 2019-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21755
Submission : 2008-06-23
Status : Active
Type : II
A Trabectedin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trabectedin, including repackagers and relabelers. The FDA regulates Trabectedin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trabectedin 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 Trabectedin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trabectedin supplier is an individual or a company that provides Trabectedin active pharmaceutical ingredient (API) or Trabectedin finished formulations upon request. The Trabectedin suppliers may include Trabectedin API manufacturers, exporters, distributors and traders.
click here to find a list of Trabectedin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trabectedin DMF (Drug Master File) is a document detailing the whole manufacturing process of Trabectedin active pharmaceutical ingredient (API) in detail. Different forms of Trabectedin DMFs exist exist since differing nations have different regulations, such as Trabectedin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trabectedin DMF submitted to regulatory agencies in the US is known as a USDMF. Trabectedin USDMF includes data on Trabectedin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trabectedin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trabectedin suppliers with USDMF on PharmaCompass.
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