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