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
15
PharmaCompass offers a list of Mertansine 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 Mertansine manufacturer or Mertansine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mertansine manufacturer or Mertansine supplier.
PharmaCompass also assists you with knowing the Mertansine API Price utilized in the formulation of products. Mertansine API Price is not always fixed or binding as the Mertansine Price is obtained through a variety of data sources. The Mertansine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Maytansinoid DM1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maytansinoid DM1, including repackagers and relabelers. The FDA regulates Maytansinoid DM1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maytansinoid DM1 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 Maytansinoid DM1 supplier is an individual or a company that provides Maytansinoid DM1 active pharmaceutical ingredient (API) or Maytansinoid DM1 finished formulations upon request. The Maytansinoid DM1 suppliers may include Maytansinoid DM1 API manufacturers, exporters, distributors and traders.
click here to find a list of Maytansinoid DM1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maytansinoid DM1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Maytansinoid DM1 active pharmaceutical ingredient (API) in detail. Different forms of Maytansinoid DM1 DMFs exist exist since differing nations have different regulations, such as Maytansinoid DM1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maytansinoid DM1 DMF submitted to regulatory agencies in the US is known as a USDMF. Maytansinoid DM1 USDMF includes data on Maytansinoid DM1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maytansinoid DM1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maytansinoid DM1 suppliers with USDMF on PharmaCompass.
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