01 2BrightGene Bio-Medical Technology Co.,Ltd
02 1North China Pharmaceutical Huasheng Co Ltd
01 2FIDAXOMICIN
02 1FIDAXOMICIN CRYSTALLINE
01 3China
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-04
Pay. Date : 2023-09-20
DMF Number : 38815
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-25
Pay. Date : 2014-11-24
DMF Number : 28803
Submission : 2014-11-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-04
Pay. Date : 2015-09-22
DMF Number : 29374
Submission : 2015-09-29
Status : Active
Type : II
A Fidaxomicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fidaxomicin, including repackagers and relabelers. The FDA regulates Fidaxomicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fidaxomicin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Fidaxomicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fidaxomicin supplier is an individual or a company that provides Fidaxomicin active pharmaceutical ingredient (API) or Fidaxomicin finished formulations upon request. The Fidaxomicin suppliers may include Fidaxomicin API manufacturers, exporters, distributors and traders.
click here to find a list of Fidaxomicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fidaxomicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Fidaxomicin active pharmaceutical ingredient (API) in detail. Different forms of Fidaxomicin DMFs exist exist since differing nations have different regulations, such as Fidaxomicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fidaxomicin DMF submitted to regulatory agencies in the US is known as a USDMF. Fidaxomicin USDMF includes data on Fidaxomicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fidaxomicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fidaxomicin suppliers with USDMF on PharmaCompass.
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