01 1BrightGene Bio-Medical Technology Co.,Ltd
02 1Haoyuan Chemexpress Co.Ltd
03 1Levena Biopharma
04 1WuXi AppTec
05 1Zhejiang Huida Biotech
06 1Blank
01 1EXATECAN MESYLATE
02 2EXATECAN MESYLATE
03 1EXATECAN MESYLATE (HM-582_10)
04 1LND1030 (EXATECAN MESYLATE)
05 1PAYLOAD-LINKER EXATECAN MESYLATE
01 5China
02 1Blank
01 6Active
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37214
Submission : 2022-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36708
Submission : 2022-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37905
Submission : 2022-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37610
Submission : 2023-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36614
Submission : 2022-01-03
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37906
Submission : 2023-07-31
Status : Active
Type : II
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A Exatecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exatecan, including repackagers and relabelers. The FDA regulates Exatecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exatecan 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 Exatecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Exatecan supplier is an individual or a company that provides Exatecan active pharmaceutical ingredient (API) or Exatecan finished formulations upon request. The Exatecan suppliers may include Exatecan API manufacturers, exporters, distributors and traders.
click here to find a list of Exatecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Exatecan DMF (Drug Master File) is a document detailing the whole manufacturing process of Exatecan active pharmaceutical ingredient (API) in detail. Different forms of Exatecan DMFs exist exist since differing nations have different regulations, such as Exatecan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exatecan DMF submitted to regulatory agencies in the US is known as a USDMF. Exatecan USDMF includes data on Exatecan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exatecan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Exatecan suppliers with USDMF on PharmaCompass.
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