01 1Xellia Pharmaceuticals ApS
02 2Blank
01 3COLISTIN SULFATE
01 1Denmark
02 2Blank
01 1Active
02 2Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2012-11-15
DMF Number : 13362
Submission : 1998-09-01
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13301
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13289
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A colistin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of colistin, including repackagers and relabelers. The FDA regulates colistin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. colistin 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 colistin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A colistin supplier is an individual or a company that provides colistin active pharmaceutical ingredient (API) or colistin finished formulations upon request. The colistin suppliers may include colistin API manufacturers, exporters, distributors and traders.
click here to find a list of colistin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A colistin DMF (Drug Master File) is a document detailing the whole manufacturing process of colistin active pharmaceutical ingredient (API) in detail. Different forms of colistin DMFs exist exist since differing nations have different regulations, such as colistin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A colistin DMF submitted to regulatory agencies in the US is known as a USDMF. colistin USDMF includes data on colistin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The colistin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of colistin suppliers with USDMF on PharmaCompass.
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