01 1SIGMA TAU
01 1QUINACRINE HCL.
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3905
Submission : 1980-08-08
Status : Inactive
Type : II
A Quinacrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quinacrine, including repackagers and relabelers. The FDA regulates Quinacrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quinacrine 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 Quinacrine supplier is an individual or a company that provides Quinacrine active pharmaceutical ingredient (API) or Quinacrine finished formulations upon request. The Quinacrine suppliers may include Quinacrine API manufacturers, exporters, distributors and traders.
click here to find a list of Quinacrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quinacrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Quinacrine active pharmaceutical ingredient (API) in detail. Different forms of Quinacrine DMFs exist exist since differing nations have different regulations, such as Quinacrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quinacrine DMF submitted to regulatory agencies in the US is known as a USDMF. Quinacrine USDMF includes data on Quinacrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quinacrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quinacrine suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?
