01 1PCAS
02 1Aurisco Pharmaceutical
03 1Gedeon Richter
04 1Industriale Chimica
05 1NEWCHEM SPA
01 1ESTETROL
02 3ESTETROL MONOHYDRATE
03 1Estetrol Monohydrate
01 1China
02 1France
03 1Hungary
04 2Italy
01 5Active
01 1Complete
02 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 : 43729
Submission : 2026-03-30
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 : Complete
Rev. Date : 2026-02-26
Pay. Date : 2025-09-15
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
30
PharmaCompass offers a list of Estetrol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Estetrol Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estetrol Monohydrate, including repackagers and relabelers. The FDA regulates Estetrol Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estetrol Monohydrate 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 Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Estetrol Monohydrate supplier is an individual or a company that provides Estetrol Monohydrate active pharmaceutical ingredient (API) or Estetrol Monohydrate finished formulations upon request. The Estetrol Monohydrate suppliers may include Estetrol Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Estetrol Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Estetrol Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Estetrol Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Estetrol Monohydrate DMFs exist exist since differing nations have different regulations, such as Estetrol Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estetrol Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Estetrol Monohydrate USDMF includes data on Estetrol Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estetrol Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estetrol Monohydrate suppliers with USDMF on PharmaCompass.
We have 5 companies offering Estetrol Monohydrate
Get in contact with the supplier of your choice:
