01 2Aventacell Biomedical
01 1HUMAN FIBRINOGEN DEPLETED PLATELET LYSATE
02 1HUMAN FIBRINOGEN DEPLETED PLATELET LYSATE XENO FREE
01 2U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33983
Submission : 2019-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33614
Submission : 2019-05-27
Status : Active
Type : II
A Fibrinogen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fibrinogen, including repackagers and relabelers. The FDA regulates Fibrinogen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fibrinogen 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 Fibrinogen supplier is an individual or a company that provides Fibrinogen active pharmaceutical ingredient (API) or Fibrinogen finished formulations upon request. The Fibrinogen suppliers may include Fibrinogen API manufacturers, exporters, distributors and traders.
click here to find a list of Fibrinogen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fibrinogen DMF (Drug Master File) is a document detailing the whole manufacturing process of Fibrinogen active pharmaceutical ingredient (API) in detail. Different forms of Fibrinogen DMFs exist exist since differing nations have different regulations, such as Fibrinogen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fibrinogen DMF submitted to regulatory agencies in the US is known as a USDMF. Fibrinogen USDMF includes data on Fibrinogen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fibrinogen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fibrinogen suppliers with USDMF on PharmaCompass.
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