01 1Biocon
02 1BrightGene Bio-Medical Technology Co.,Ltd
01 1ANIDULAFUNGIN (DRUG SUBSTANCE INTERMEDIATE)
02 1ANIDULAFUNGIN (NON-STERILE API)
01 1China
02 1India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32877
Submission : 2018-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32010
Submission : 2017-08-28
Status : Active
Type : II
A Anidulafungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anidulafungin, including repackagers and relabelers. The FDA regulates Anidulafungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anidulafungin 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 Anidulafungin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Anidulafungin supplier is an individual or a company that provides Anidulafungin active pharmaceutical ingredient (API) or Anidulafungin finished formulations upon request. The Anidulafungin suppliers may include Anidulafungin API manufacturers, exporters, distributors and traders.
click here to find a list of Anidulafungin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Anidulafungin DMF (Drug Master File) is a document detailing the whole manufacturing process of Anidulafungin active pharmaceutical ingredient (API) in detail. Different forms of Anidulafungin DMFs exist exist since differing nations have different regulations, such as Anidulafungin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anidulafungin DMF submitted to regulatory agencies in the US is known as a USDMF. Anidulafungin USDMF includes data on Anidulafungin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anidulafungin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anidulafungin suppliers with USDMF on PharmaCompass.
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