01 1Bayer AG
02 1Qinhuangdao Zizhu Pharmaceutical
01 1GESTODENE
02 1GESTODENE (MICRONIZED)
01 1China
02 1Germany
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6174
Submission : 1985-12-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29345
Submission : 2015-06-08
Status : Active
Type : II
A Gestodene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gestodene, including repackagers and relabelers. The FDA regulates Gestodene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gestodene 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 Gestodene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gestodene supplier is an individual or a company that provides Gestodene active pharmaceutical ingredient (API) or Gestodene finished formulations upon request. The Gestodene suppliers may include Gestodene API manufacturers, exporters, distributors and traders.
click here to find a list of Gestodene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gestodene DMF (Drug Master File) is a document detailing the whole manufacturing process of Gestodene active pharmaceutical ingredient (API) in detail. Different forms of Gestodene DMFs exist exist since differing nations have different regulations, such as Gestodene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gestodene DMF submitted to regulatory agencies in the US is known as a USDMF. Gestodene USDMF includes data on Gestodene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gestodene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gestodene suppliers with USDMF on PharmaCompass.
We have 2 companies offering Gestodene
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?