01 1PCAS
02 1Gedeon Richter
01 1ESTETROL MONOHYDRATE
02 1Estetrol Monohydrate
01 1France
02 1Hungary
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34214
Submission : 2019-11-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37136
Submission : 2022-06-10
Status : Active
Type : II
A Estetrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estetrol, including repackagers and relabelers. The FDA regulates Estetrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estetrol 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 Estetrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estetrol supplier is an individual or a company that provides Estetrol active pharmaceutical ingredient (API) or Estetrol finished formulations upon request. The Estetrol suppliers may include Estetrol API manufacturers, exporters, distributors and traders.
click here to find a list of Estetrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estetrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Estetrol active pharmaceutical ingredient (API) in detail. Different forms of Estetrol DMFs exist exist since differing nations have different regulations, such as Estetrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estetrol DMF submitted to regulatory agencies in the US is known as a USDMF. Estetrol USDMF includes data on Estetrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estetrol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estetrol suppliers with USDMF on PharmaCompass.
We have 2 companies offering Estetrol
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?