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
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A Mepacrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mepacrine, including repackagers and relabelers. The FDA regulates Mepacrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mepacrine 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 Mepacrine supplier is an individual or a company that provides Mepacrine active pharmaceutical ingredient (API) or Mepacrine finished formulations upon request. The Mepacrine suppliers may include Mepacrine API manufacturers, exporters, distributors and traders.
click here to find a list of Mepacrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mepacrine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mepacrine active pharmaceutical ingredient (API) in detail. Different forms of Mepacrine DMFs exist exist since differing nations have different regulations, such as Mepacrine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mepacrine DMF submitted to regulatory agencies in the US is known as a USDMF. Mepacrine USDMF includes data on Mepacrine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mepacrine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mepacrine suppliers with USDMF on PharmaCompass.
