01 23M Company
02 23M Drug Delivery Systems
01 1R-848 DRUG SUBSTANCE AND DRUG PRODUCT (ORAL)
02 1R-848 ORAL DRUG PRODUCT
03 1RESIQUIMOD DRUG SUBSTANCE
04 1RESIQUIMOD TOPICAL GEL
01 4U.S.A
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14687
Submission : 2000-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13956
Submission : 1999-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24080
Submission : 2010-08-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24093
Submission : 2010-08-17
Status : Inactive
Type : II
A Resiquimod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Resiquimod, including repackagers and relabelers. The FDA regulates Resiquimod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Resiquimod 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 Resiquimod supplier is an individual or a company that provides Resiquimod active pharmaceutical ingredient (API) or Resiquimod finished formulations upon request. The Resiquimod suppliers may include Resiquimod API manufacturers, exporters, distributors and traders.
click here to find a list of Resiquimod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Resiquimod DMF (Drug Master File) is a document detailing the whole manufacturing process of Resiquimod active pharmaceutical ingredient (API) in detail. Different forms of Resiquimod DMFs exist exist since differing nations have different regulations, such as Resiquimod USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Resiquimod DMF submitted to regulatory agencies in the US is known as a USDMF. Resiquimod USDMF includes data on Resiquimod's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Resiquimod USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Resiquimod suppliers with USDMF on PharmaCompass.
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