01 1Bayer AG
02 1Gedeon Richter
03 1Hubei Gedian Humanwell Pharmaceutical
04 1Industriale Chimica
05 1LABORCHEMIE APOLDA GMBH
06 1Lupin Ltd
07 1Olon S.p.A
08 1Qinhuangdao Zizhu Pharmaceutical
09 1Sterling Spa
01 8DIENOGEST
02 1DIENOGEST (MICRONIZED)
01 2China
02 2Germany
03 1Hungary
04 1India
05 3Italy
01 6Active
02 3Inactive
01 1Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14014
Submission : 1999-02-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24479
Submission : 2010-12-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37957
Submission : 2023-01-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-27
Pay. Date : 2024-10-17
DMF Number : 23428
Submission : 2010-01-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25251
Submission : 2011-08-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24513
Submission : 2011-03-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25193
Submission : 2011-06-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28680
Submission : 2014-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37039
Submission : 2022-04-06
Status : Active
Type : II
A Dienogest manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dienogest, including repackagers and relabelers. The FDA regulates Dienogest manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dienogest 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 Dienogest manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dienogest supplier is an individual or a company that provides Dienogest active pharmaceutical ingredient (API) or Dienogest finished formulations upon request. The Dienogest suppliers may include Dienogest API manufacturers, exporters, distributors and traders.
click here to find a list of Dienogest suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dienogest DMF (Drug Master File) is a document detailing the whole manufacturing process of Dienogest active pharmaceutical ingredient (API) in detail. Different forms of Dienogest DMFs exist exist since differing nations have different regulations, such as Dienogest USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dienogest DMF submitted to regulatory agencies in the US is known as a USDMF. Dienogest USDMF includes data on Dienogest's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dienogest USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dienogest suppliers with USDMF on PharmaCompass.
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