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