01 1Haoyuan Chemexpress Co.Ltd
02 1Levena Biopharma
03 1Waterstone Pharmaceuticals Inc.
04 1WuXi AppTec
05 1Zhejiang Huida Biotech
01 1MMAE (HM-297C_22)
02 2MONOMETHYL AURISTATIN E (MMAE)
03 1Monomethyl Auristatin E
04 1“MONOMETHYL AURISTATIN E (MMAE)”
01 5China
01 5Active
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36741
Submission : 2022-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37623
Submission : 2022-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38589
Submission : 2024-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36104
Submission : 2021-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38481
Submission : 2023-07-17
Status : Active
Type : II
A Monomethyl Auristatin E manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monomethyl Auristatin E, including repackagers and relabelers. The FDA regulates Monomethyl Auristatin E manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monomethyl Auristatin E 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 Monomethyl Auristatin E manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Monomethyl Auristatin E supplier is an individual or a company that provides Monomethyl Auristatin E active pharmaceutical ingredient (API) or Monomethyl Auristatin E finished formulations upon request. The Monomethyl Auristatin E suppliers may include Monomethyl Auristatin E API manufacturers, exporters, distributors and traders.
click here to find a list of Monomethyl Auristatin E suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Monomethyl Auristatin E DMF (Drug Master File) is a document detailing the whole manufacturing process of Monomethyl Auristatin E active pharmaceutical ingredient (API) in detail. Different forms of Monomethyl Auristatin E DMFs exist exist since differing nations have different regulations, such as Monomethyl Auristatin E USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monomethyl Auristatin E DMF submitted to regulatory agencies in the US is known as a USDMF. Monomethyl Auristatin E USDMF includes data on Monomethyl Auristatin E's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monomethyl Auristatin E USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monomethyl Auristatin E suppliers with USDMF on PharmaCompass.
We have 5 companies offering Monomethyl Auristatin E
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
