01 1Curia
02 1Fujifilm Diosynth Biotechnologies
01 2ALTRENOGEST
01 1U.S.A
02 1United Kingdom
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28843
Submission : 2014-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16346
Submission : 2003-01-03
Status : Inactive
Type : II
A Altrenogest manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Altrenogest, including repackagers and relabelers. The FDA regulates Altrenogest manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Altrenogest 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 Altrenogest manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Altrenogest supplier is an individual or a company that provides Altrenogest active pharmaceutical ingredient (API) or Altrenogest finished formulations upon request. The Altrenogest suppliers may include Altrenogest API manufacturers, exporters, distributors and traders.
click here to find a list of Altrenogest suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Altrenogest DMF (Drug Master File) is a document detailing the whole manufacturing process of Altrenogest active pharmaceutical ingredient (API) in detail. Different forms of Altrenogest DMFs exist exist since differing nations have different regulations, such as Altrenogest USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Altrenogest DMF submitted to regulatory agencies in the US is known as a USDMF. Altrenogest USDMF includes data on Altrenogest's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Altrenogest USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Altrenogest suppliers with USDMF on PharmaCompass.
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