Aspen API. More than just an API.
01 1Aspen API
02 1Bayer AG
03 1Fujifilm Diosynth Biotechnologies
04 1Merck & Co
01 4ESTRIOL
01 1Germany
02 1Netherlands
03 1U.S.A
04 1United Kingdom
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12141
Submission : 1996-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12476
Submission : 1997-04-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3837
Submission : 1980-05-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1407
Submission : 1969-08-12
Status : Inactive
Type : II
A Estriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estriol, including repackagers and relabelers. The FDA regulates Estriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estriol 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 Estriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estriol supplier is an individual or a company that provides Estriol active pharmaceutical ingredient (API) or Estriol finished formulations upon request. The Estriol suppliers may include Estriol API manufacturers, exporters, distributors and traders.
click here to find a list of Estriol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Estriol DMF (Drug Master File) is a document detailing the whole manufacturing process of Estriol active pharmaceutical ingredient (API) in detail. Different forms of Estriol DMFs exist exist since differing nations have different regulations, such as Estriol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Estriol DMF submitted to regulatory agencies in the US is known as a USDMF. Estriol USDMF includes data on Estriol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Estriol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Estriol suppliers with USDMF on PharmaCompass.
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