01 1Jiangsu Jiaerke Pharmaceuticals Group
02 1Productos Quimicos Naturales
01 1D.H.A. PURE PRASTERONE
02 1PRASTERONE
01 1China
02 1Mexico
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32361
Submission : 2017-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7829
Submission : 1988-12-12
Status : Inactive
Type : II
A Prasterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prasterone, including repackagers and relabelers. The FDA regulates Prasterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prasterone 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 Prasterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prasterone supplier is an individual or a company that provides Prasterone active pharmaceutical ingredient (API) or Prasterone finished formulations upon request. The Prasterone suppliers may include Prasterone API manufacturers, exporters, distributors and traders.
click here to find a list of Prasterone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prasterone DMF (Drug Master File) is a document detailing the whole manufacturing process of Prasterone active pharmaceutical ingredient (API) in detail. Different forms of Prasterone DMFs exist exist since differing nations have different regulations, such as Prasterone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prasterone DMF submitted to regulatory agencies in the US is known as a USDMF. Prasterone USDMF includes data on Prasterone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prasterone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prasterone suppliers with USDMF on PharmaCompass.
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