01 1Anmol Chemicals
01 1BUTYLATED HYDROXYTOLUENE USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41970
Submission : 2025-08-09
Status : Active
Type : IV
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A AOX 4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AOX 4, including repackagers and relabelers. The FDA regulates AOX 4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AOX 4 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 AOX 4 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A AOX 4 supplier is an individual or a company that provides AOX 4 active pharmaceutical ingredient (API) or AOX 4 finished formulations upon request. The AOX 4 suppliers may include AOX 4 API manufacturers, exporters, distributors and traders.
click here to find a list of AOX 4 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A AOX 4 DMF (Drug Master File) is a document detailing the whole manufacturing process of AOX 4 active pharmaceutical ingredient (API) in detail. Different forms of AOX 4 DMFs exist exist since differing nations have different regulations, such as AOX 4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AOX 4 DMF submitted to regulatory agencies in the US is known as a USDMF. AOX 4 USDMF includes data on AOX 4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AOX 4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AOX 4 suppliers with USDMF on PharmaCompass.
