01 1PCAS
02 1Gedeon Richter
03 1Industriale Chimica
04 1NEWCHEM SPA
01 3ESTETROL MONOHYDRATE
02 1Estetrol Monohydrate
01 1France
02 1Hungary
03 2Italy
01 4Active
01 4Blank
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42550
Submission : 2025-09-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42050
Submission : 2025-06-26
Status : Active
Type : II
35
PharmaCompass offers a list of Estetrol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Estetrol manufacturer or Estetrol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Estetrol manufacturer or Estetrol supplier.
PharmaCompass also assists you with knowing the Estetrol API Price utilized in the formulation of products. Estetrol API Price is not always fixed or binding as the Estetrol Price is obtained through a variety of data sources. The Estetrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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