01 2BrightGene Bio-Medical Technology Co.,Ltd
02 1SAFC
01 1MERTANSINE
02 1MERTANSINE (MTB)
03 1MERTANSINE (MTS)
01 2China
02 1U.S.A
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36200
Submission : 2021-08-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35973
Submission : 2021-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31393
Submission : 2017-11-21
Status : Active
Type : II
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PharmaCompass offers a list of Maytansinoid DM1 API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Maytansinoid DM1 manufacturer or Maytansinoid DM1 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Maytansinoid DM1 manufacturer or Maytansinoid DM1 supplier.
PharmaCompass also assists you with knowing the Maytansinoid DM1 API Price utilized in the formulation of products. Maytansinoid DM1 API Price is not always fixed or binding as the Maytansinoid DM1 Price is obtained through a variety of data sources. The Maytansinoid DM1 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mertansine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mertansine, including repackagers and relabelers. The FDA regulates Mertansine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mertansine 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 Mertansine supplier is an individual or a company that provides Mertansine active pharmaceutical ingredient (API) or Mertansine finished formulations upon request. The Mertansine suppliers may include Mertansine API manufacturers, exporters, distributors and traders.
click here to find a list of Mertansine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mertansine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mertansine active pharmaceutical ingredient (API) in detail. Different forms of Mertansine DMFs exist exist since differing nations have different regulations, such as Mertansine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mertansine DMF submitted to regulatory agencies in the US is known as a USDMF. Mertansine USDMF includes data on Mertansine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mertansine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mertansine suppliers with USDMF on PharmaCompass.
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