01 1Fareva
01 1ESTRADIOL BENZOATE
01 1Luxembourg
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23836
Submission : 2010-05-18
Status : Active
Type : II
A Estradiol Benzoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estradiol Benzoate, including repackagers and relabelers. The FDA regulates Estradiol Benzoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estradiol Benzoate 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 Estradiol Benzoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estradiol Benzoate supplier is an individual or a company that provides Estradiol Benzoate active pharmaceutical ingredient (API) or Estradiol Benzoate finished formulations upon request. The Estradiol Benzoate suppliers may include Estradiol Benzoate API manufacturers, exporters, distributors and traders.
click here to find a list of Estradiol Benzoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estradiol Benzoate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estradiol Benzoate active pharmaceutical ingredient (API) in detail. Different forms of Estradiol Benzoate DMFs exist exist since differing nations have different regulations, such as Estradiol Benzoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estradiol Benzoate DMF submitted to regulatory agencies in the US is known as a USDMF. Estradiol Benzoate USDMF includes data on Estradiol Benzoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estradiol Benzoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estradiol Benzoate suppliers with USDMF on PharmaCompass.
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