01 1Apicore LLC
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1MSN Laboratories
04 1Natco Pharma
05 1PharmaMar
06 1Wisdom Pharmaceutical
07 1Xiling Lab
01 7LURBINECTEDIN
01 3China
02 3India
03 1Spain
01 7Active
01 3Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-28
Pay. Date : 2024-01-16
DMF Number : 39171
Submission : 2024-01-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39228
Submission : 2023-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-05-08
Pay. Date : 2024-04-18
DMF Number : 39672
Submission : 2024-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-03-21
DMF Number : 37785
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33969
Submission : 2019-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37624
Submission : 2023-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39620
Submission : 2024-09-06
Status : Active
Type : II
A Lurbinectedin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurbinectedin, including repackagers and relabelers. The FDA regulates Lurbinectedin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurbinectedin 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 Lurbinectedin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurbinectedin supplier is an individual or a company that provides Lurbinectedin active pharmaceutical ingredient (API) or Lurbinectedin finished formulations upon request. The Lurbinectedin suppliers may include Lurbinectedin API manufacturers, exporters, distributors and traders.
click here to find a list of Lurbinectedin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lurbinectedin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurbinectedin active pharmaceutical ingredient (API) in detail. Different forms of Lurbinectedin DMFs exist exist since differing nations have different regulations, such as Lurbinectedin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lurbinectedin DMF submitted to regulatory agencies in the US is known as a USDMF. Lurbinectedin USDMF includes data on Lurbinectedin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurbinectedin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lurbinectedin suppliers with USDMF on PharmaCompass.
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