01 1Aurisco Pharmaceutical
02 1Xi'an Guokang Ruijin Pharmaceutical
01 2DYDROGESTERONE
01 2China
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36569
Submission : 2022-01-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36271
Submission : 2022-04-01
Status : Active
Type : II
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PharmaCompass offers a list of Dydrogesterone 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 Dydrogesterone manufacturer or Dydrogesterone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dydrogesterone manufacturer or Dydrogesterone supplier.
A Gynorest manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gynorest, including repackagers and relabelers. The FDA regulates Gynorest manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gynorest 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 Gynorest manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Gynorest supplier is an individual or a company that provides Gynorest active pharmaceutical ingredient (API) or Gynorest finished formulations upon request. The Gynorest suppliers may include Gynorest API manufacturers, exporters, distributors and traders.
click here to find a list of Gynorest suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Gynorest DMF (Drug Master File) is a document detailing the whole manufacturing process of Gynorest active pharmaceutical ingredient (API) in detail. Different forms of Gynorest DMFs exist exist since differing nations have different regulations, such as Gynorest USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gynorest DMF submitted to regulatory agencies in the US is known as a USDMF. Gynorest USDMF includes data on Gynorest's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gynorest USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gynorest suppliers with USDMF on PharmaCompass.
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