01 2Aventacell Biomedical
02 1KM Biologics
01 1Japan
02 2U.S.A
01 2Active
02 1Blank
01 3Blank
01 1227MF10083
02 2Blank
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33614
Submission : 2019-05-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33983
Submission : 2019-07-22
Status : Active
Type : II
Registration Number : 227MF10083
Registrant's Address : 1-6-1 Okubo, Kita-ku, Kumamoto City, Kumamoto Prefecture
Initial Date of Registration : 2015-03-12
Latest Date of Registration : --
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.
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