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
A Dydrogesterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dydrogesterone, including repackagers and relabelers. The FDA regulates Dydrogesterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dydrogesterone 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 Dydrogesterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dydrogesterone supplier is an individual or a company that provides Dydrogesterone active pharmaceutical ingredient (API) or Dydrogesterone finished formulations upon request. The Dydrogesterone suppliers may include Dydrogesterone API manufacturers, exporters, distributors and traders.
click here to find a list of Dydrogesterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dydrogesterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Dydrogesterone active pharmaceutical ingredient (API) in detail. Different forms of Dydrogesterone DMFs exist exist since differing nations have different regulations, such as Dydrogesterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dydrogesterone DMF submitted to regulatory agencies in the US is known as a USDMF. Dydrogesterone USDMF includes data on Dydrogesterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dydrogesterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dydrogesterone suppliers with USDMF on PharmaCompass.
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