01 1Zhejiang Huida Biotech
01 1MAYTANSINE DMI
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37293
Submission : 2022-07-11
Status : Active
Type : II
A DM4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DM4, including repackagers and relabelers. The FDA regulates DM4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DM4 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 DM4 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DM4 supplier is an individual or a company that provides DM4 active pharmaceutical ingredient (API) or DM4 finished formulations upon request. The DM4 suppliers may include DM4 API manufacturers, exporters, distributors and traders.
click here to find a list of DM4 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DM4 DMF (Drug Master File) is a document detailing the whole manufacturing process of DM4 active pharmaceutical ingredient (API) in detail. Different forms of DM4 DMFs exist exist since differing nations have different regulations, such as DM4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DM4 DMF submitted to regulatory agencies in the US is known as a USDMF. DM4 USDMF includes data on DM4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DM4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DM4 suppliers with USDMF on PharmaCompass.
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