01 1Sichuan Xieli Pharmaceutical
02 1Blank
01 1PTI G-2535 (UNCONJAGATED ISOFLAVONES-70)
02 1SOY ISOFLAVONES
01 1China
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26488
Submission : 2012-09-21
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12545
Submission : 1997-05-23
Status : Inactive
Type : II
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A Soybean Extract manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Soybean Extract, including repackagers and relabelers. The FDA regulates Soybean Extract manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Soybean Extract 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 Soybean Extract manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Soybean Extract supplier is an individual or a company that provides Soybean Extract active pharmaceutical ingredient (API) or Soybean Extract finished formulations upon request. The Soybean Extract suppliers may include Soybean Extract API manufacturers, exporters, distributors and traders.
click here to find a list of Soybean Extract suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Soybean Extract DMF (Drug Master File) is a document detailing the whole manufacturing process of Soybean Extract active pharmaceutical ingredient (API) in detail. Different forms of Soybean Extract DMFs exist exist since differing nations have different regulations, such as Soybean Extract USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Soybean Extract DMF submitted to regulatory agencies in the US is known as a USDMF. Soybean Extract USDMF includes data on Soybean Extract's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Soybean Extract USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Soybean Extract suppliers with USDMF on PharmaCompass.
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