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
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PharmaCompass offers a list of Anidulafungin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Anidulafungin manufacturer or Anidulafungin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Anidulafungin manufacturer or Anidulafungin supplier.
PharmaCompass also assists you with knowing the Anidulafungin API Price utilized in the formulation of products. Anidulafungin API Price is not always fixed or binding as the Anidulafungin Price is obtained through a variety of data sources. The Anidulafungin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eraxis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eraxis, including repackagers and relabelers. The FDA regulates Eraxis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eraxis 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 Eraxis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eraxis supplier is an individual or a company that provides Eraxis active pharmaceutical ingredient (API) or Eraxis finished formulations upon request. The Eraxis suppliers may include Eraxis API manufacturers, exporters, distributors and traders.
click here to find a list of Eraxis suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eraxis DMF (Drug Master File) is a document detailing the whole manufacturing process of Eraxis active pharmaceutical ingredient (API) in detail. Different forms of Eraxis DMFs exist exist since differing nations have different regulations, such as Eraxis USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eraxis DMF submitted to regulatory agencies in the US is known as a USDMF. Eraxis USDMF includes data on Eraxis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eraxis USDMF is kept confidential to protect the manufacturer’s intellectual property.
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