01 2Johnson & Johnson Innovative Medicine
02 1Blank
01 1CARFENTANIL CITRATE (CODE NO. 33799)
02 1CARFENTANIL INJECTION 3MG./ML.
03 1[11C]-CARFENTANIL INJECTION
01 2U.S.A
02 1Blank
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5630
Submission : 1984-11-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5615
Submission : 1984-10-24
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32546
Submission : 2018-03-02
Status : Inactive
Type : II
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A Carfentanil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carfentanil, including repackagers and relabelers. The FDA regulates Carfentanil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carfentanil 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 Carfentanil supplier is an individual or a company that provides Carfentanil active pharmaceutical ingredient (API) or Carfentanil finished formulations upon request. The Carfentanil suppliers may include Carfentanil API manufacturers, exporters, distributors and traders.
click here to find a list of Carfentanil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carfentanil DMF (Drug Master File) is a document detailing the whole manufacturing process of Carfentanil active pharmaceutical ingredient (API) in detail. Different forms of Carfentanil DMFs exist exist since differing nations have different regulations, such as Carfentanil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carfentanil DMF submitted to regulatory agencies in the US is known as a USDMF. Carfentanil USDMF includes data on Carfentanil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carfentanil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carfentanil suppliers with USDMF on PharmaCompass.
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