01 1Bayer AG
01 1ELTANOLONE
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10703
Submission : 1994-01-31
Status : Inactive
Type : II
A Allopregnanolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Allopregnanolone, including repackagers and relabelers. The FDA regulates Allopregnanolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Allopregnanolone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Allopregnanolone supplier is an individual or a company that provides Allopregnanolone active pharmaceutical ingredient (API) or Allopregnanolone finished formulations upon request. The Allopregnanolone suppliers may include Allopregnanolone API manufacturers, exporters, distributors and traders.
click here to find a list of Allopregnanolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Allopregnanolone DMF (Drug Master File) is a document detailing the whole manufacturing process of Allopregnanolone active pharmaceutical ingredient (API) in detail. Different forms of Allopregnanolone DMFs exist exist since differing nations have different regulations, such as Allopregnanolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Allopregnanolone DMF submitted to regulatory agencies in the US is known as a USDMF. Allopregnanolone USDMF includes data on Allopregnanolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Allopregnanolone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Allopregnanolone suppliers with USDMF on PharmaCompass.
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