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