01 1Hubei Gedian Humanwell Pharmaceutical
01 1BUTYLPARABEN
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34432
Submission : 2020-01-07
Status : Active
Type : IV
A Butyl 4-Hydroxybenzoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butyl 4-Hydroxybenzoate, including repackagers and relabelers. The FDA regulates Butyl 4-Hydroxybenzoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butyl 4-Hydroxybenzoate 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 Butyl 4-Hydroxybenzoate supplier is an individual or a company that provides Butyl 4-Hydroxybenzoate active pharmaceutical ingredient (API) or Butyl 4-Hydroxybenzoate finished formulations upon request. The Butyl 4-Hydroxybenzoate suppliers may include Butyl 4-Hydroxybenzoate API manufacturers, exporters, distributors and traders.
click here to find a list of Butyl 4-Hydroxybenzoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butyl 4-Hydroxybenzoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Butyl 4-Hydroxybenzoate active pharmaceutical ingredient (API) in detail. Different forms of Butyl 4-Hydroxybenzoate DMFs exist exist since differing nations have different regulations, such as Butyl 4-Hydroxybenzoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butyl 4-Hydroxybenzoate DMF submitted to regulatory agencies in the US is known as a USDMF. Butyl 4-Hydroxybenzoate USDMF includes data on Butyl 4-Hydroxybenzoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butyl 4-Hydroxybenzoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butyl 4-Hydroxybenzoate suppliers with USDMF on PharmaCompass.
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