01 2Shanghai Wonder Pharmaceutical
01 1UNITHIOL
02 1UNITHIOLUM
01 2China
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38151
Submission : 2023-03-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35613
Submission : 2021-03-02
Status : Active
Type : II
A Unithiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Unithiol, including repackagers and relabelers. The FDA regulates Unithiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Unithiol 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 Unithiol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Unithiol supplier is an individual or a company that provides Unithiol active pharmaceutical ingredient (API) or Unithiol finished formulations upon request. The Unithiol suppliers may include Unithiol API manufacturers, exporters, distributors and traders.
click here to find a list of Unithiol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Unithiol DMF (Drug Master File) is a document detailing the whole manufacturing process of Unithiol active pharmaceutical ingredient (API) in detail. Different forms of Unithiol DMFs exist exist since differing nations have different regulations, such as Unithiol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Unithiol DMF submitted to regulatory agencies in the US is known as a USDMF. Unithiol USDMF includes data on Unithiol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Unithiol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Unithiol suppliers with USDMF on PharmaCompass.
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