01 1MSN Laboratories
01 1INDOXIMOD
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34623
Submission : 2020-02-26
Status : Active
Type : II
A Indoximod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indoximod, including repackagers and relabelers. The FDA regulates Indoximod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indoximod 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 Indoximod supplier is an individual or a company that provides Indoximod active pharmaceutical ingredient (API) or Indoximod finished formulations upon request. The Indoximod suppliers may include Indoximod API manufacturers, exporters, distributors and traders.
click here to find a list of Indoximod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indoximod DMF (Drug Master File) is a document detailing the whole manufacturing process of Indoximod active pharmaceutical ingredient (API) in detail. Different forms of Indoximod DMFs exist exist since differing nations have different regulations, such as Indoximod USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indoximod DMF submitted to regulatory agencies in the US is known as a USDMF. Indoximod USDMF includes data on Indoximod's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indoximod USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indoximod suppliers with USDMF on PharmaCompass.
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